Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## : Example: Bundle – Substance Specification - JSON Representation

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    //  Substance Specification
    {
      "resourceType" : "Bundle",
      "id" : "bundle-drug-substance-specification-pq-ex1",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq"
        ]
      },
      "type" : "collection",
      "entry" : [
        {
          "fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
          "resource" : {
            "resourceType" : "PlanDefinition",
            "id" : "specificationProtocol",
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_specificationProtocol\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"specificationProtocol\"> </a><a name=\"hcspecificationProtocol\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition &quot;specificationProtocol&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION FOR DRUG SUBSTANCE</p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb</p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification for Drug Substance</p><p><b>code</b>: Overall set of actions <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9\">http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3\">http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a\">http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121\">http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17\">http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d\">http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce\">http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d\">http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f\">http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</a></td></tr></table></blockquote></div>"
            },
            "url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
            "title" : "SPECIFICATION FOR DRUG SUBSTANCE",
            "status" : "active",
            "subjectReference" : // http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
            {
              "reference" : "SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb"
            },
            "description" : "Narrative description of specifications",
            "action" : [
              // SubstanceDefinition/substance1
              {
                "title" : "Specification for Drug Substance",
                "code" : //  this is then entire thing
                {
                  "text" : "Overall set of actions"
                },
                "action" : [
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"
                  },
                  // ObservationDefinition/Description
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"
                  },
                  // ObservationDefinition/Identification
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"
                  },
                  // ObservationDefinition/Assay
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"
                  },
                  // ObservationDefinition/Impurities
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"
                  },
                  // ObservationDefinition/Mutagenic
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"
                  },
                  // ObservationDefinition/Enantiomeric
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"
                  },
                  // ObservationDefinition/Solvents
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"
                  },
                  // ObservationDefinition/Water
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"
                  }
                ]
              }
            ]
          }
        },
        // ObservationDefinition/Particles
        {
          "fullUrl" : "urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "52176085-1f30-0c67-9ad7-523c486c82c9",
            "text" : // Description
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_52176085-1f30-0c67-9ad7-523c486c82c9\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"52176085-1f30-0c67-9ad7-523c486c82c9\"> </a><a name=\"hc52176085-1f30-0c67-9ad7-523c486c82c9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;52176085-1f30-0c67-9ad7-523c486c82c9&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DESC)</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9",
            "title" : "Description",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "DESC",
                  "display" : "Description"
                }
              ],
              "text" : "Description"
            },
            "method" : {
              "text" : "Visual inspection"
            },
            "qualifiedValue" : [
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                    "valueString" : "A white to brown powder"
                  }
                ]
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:b50d892c-8980-0774-39d4-d449732873a3",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "b50d892c-8980-0774-39d4-d449732873a3",
            "text" : // Identification
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_b50d892c-8980-0774-39d4-d449732873a3\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"b50d892c-8980-0774-39d4-d449732873a3\"> </a><a name=\"hcb50d892c-8980-0774-39d4-d449732873a3\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;b50d892c-8980-0774-39d4-d449732873a3&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: Identification by IR spectroscopy Identification by HPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3",
            "title" : "Identification",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "IDT",
                  "display" : "Identification"
                }
              ],
              "text" : "Identification"
            },
            "method" : {
              "text" : "Identification by IR spectroscopy Identification by HPLC"
            },
            "qualifiedValue" : [
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                    "valueString" : "Conforms with reference"
                  }
                ]
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "d460b561-110c-7eb6-5d69-788abcca391a",
            "text" : // Assay
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_d460b561-110c-7eb6-5d69-788abcca391a\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d460b561-110c-7eb6-5d69-788abcca391a\"> </a><a name=\"hcd460b561-110c-7eb6-5d69-788abcca391a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;d460b561-110c-7eb6-5d69-788abcca391a&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>98-102 % w/w</td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a",
            "title" : "Assay",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "ASSAY",
                  "display" : "Assay"
                }
              ],
              "text" : "Assay"
            },
            "method" : {
              "text" : "Assay by LC"
            },
            "qualifiedValue" : [
              {
                "range" : {
                  "low" : {
                    "value" : 98,
                    "unit" : "% w/w",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "%"
                  },
                  "high" : {
                    "value" : 102,
                    "unit" : "% w/w",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "%"
                  }
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "006a9f7b-91ca-5601-38ef-a3dd26ad7121",
            "text" : // Impurities
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_006a9f7b-91ca-5601-38ef-a3dd26ad7121\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"006a9f7b-91ca-5601-38ef-a3dd26ad7121\"> </a><a name=\"hc006a9f7b-91ca-5601-38ef-a3dd26ad7121\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;006a9f7b-91ca-5601-38ef-a3dd26ad7121&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</code></p><p><b>title</b>: Drug Substance Related Organic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Drug Substance Related Organic impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DGP-s)</span></p><p><b>method</b>: Organic impurities by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121",
            "title" : "Drug Substance Related Organic impurities",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "DGP-s",
                  "display" : "Drug Substance Related Organic impurities"
                }
              ]
            },
            "method" : {
              "text" : "Organic impurities by LC"
            },
            "qualifiedValue" : [
              {
                "appliesTo" : [
                  {
                    "text" : "Impurity 1"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 0.5,
                    "unit" : "% w/w"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "Impurity 2"
                  }
                ],
                "range" : {
                  "high" : {
                    "value" : 0.5,
                    "unit" : "% w/w"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "Any individual unspecified impurity"
                  }
                ],
                "range" : {
                  "high" : {
                    "value" : 0.10,
                    "unit" : "% w/w"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "Total impurities"
                  }
                ],
                "range" : {
                  "high" : {
                    "value" : 2.0,
                    "unit" : "% w/w"
                  }
                }
              }
            ],
            "component" : [
              {
                "code" : //  are expected to have a component that says what impurity this one is
                {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                      "code" : "IMP",
                      "display" : "Impurity"
                    }
                  ]
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "c59deb1b-835c-1be5-4e08-95dea3ae1a17",
            "text" : // Mutagenic
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_c59deb1b-835c-1be5-4e08-95dea3ae1a17\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"c59deb1b-835c-1be5-4e08-95dea3ae1a17\"> </a><a name=\"hcc59deb1b-835c-1be5-4e08-95dea3ae1a17\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;c59deb1b-835c-1be5-4e08-95dea3ae1a17&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</code></p><p><b>title</b>: Mutagenic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Mutagenic impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#MUT)</span></p><p><b>method</b>: Impurity 5 content by LC-MS <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>AppliesTo</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity - Mutagenic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>?-50</td></tr></table><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17",
            "title" : "Mutagenic impurities",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "MUT",
                  "display" : "Mutagenic impurities"
                }
              ]
            },
            "method" : {
              "text" : "Impurity 5 content by LC-MS"
            },
            "qualifiedValue" : [
              {
                "appliesTo" : [
                  {
                    "text" : "Impurity - Mutagenic"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 50,
                    "unit" : "ppm",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "[ppm]"
                  }
                }
              }
            ],
            "component" : [
              {
                "code" : //  are expected to have a component that says what impurity this one is
                {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                      "code" : "IMP",
                      "display" : "Impurity"
                    }
                  ]
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "18e20bae-1a24-202d-11d7-5f354c785e4d",
            "text" : // Enantiomeric
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_18e20bae-1a24-202d-11d7-5f354c785e4d\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"18e20bae-1a24-202d-11d7-5f354c785e4d\"> </a><a name=\"hc18e20bae-1a24-202d-11d7-5f354c785e4d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;18e20bae-1a24-202d-11d7-5f354c785e4d&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</code></p><p><b>title</b>: Enantiomeric purity</p><p><b>status</b>: active</p><p><b>code</b>: Enantiomeric purity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#enantiomeric-purity)</span></p><p><b>method</b>: Enantiomeric purity by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>99.6-? %</td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d",
            "title" : "Enantiomeric purity",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "enantiomeric-purity",
                  "display" : "Enantiomeric purity"
                }
              ],
              "text" : "Enantiomeric purity"
            },
            "method" : {
              "text" : "Enantiomeric purity by LC"
            },
            "qualifiedValue" : [
              {
                "range" : {
                  "low" : {
                    "value" : 99.6,
                    "unit" : "%",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "%"
                  }
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
            "text" : // Solvents
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce\"> </a><a name=\"hc22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</code></p><p><b>title</b>: Residual solvents</p><p><b>status</b>: active</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#SOL)</span></p><p><b>method</b>: Residual solvents by headspace GC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.1</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#SOLV)</span></td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
            "title" : "Residual solvents",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "SOL",
                  "display" : "Residual solvents"
                }
              ]
            },
            "method" : {
              "text" : "Residual solvents by headspace GC"
            },
            "qualifiedValue" : [
              {
                "appliesTo" : [
                  {
                    "text" : "Solvent 1"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 0.1,
                    "unit" : "% w/w"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "Solvent 2"
                  }
                ],
                "range" : {
                  "high" : {
                    "value" : 2.0,
                    "unit" : "% w/w"
                  }
                }
              }
            ],
            "component" : [
              {
                "code" : //  are expected to have a component that says what solvent this one is
                {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                      "code" : "SOLV",
                      "display" : "Solvent"
                    }
                  ]
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "b4f736ff-1bbf-6923-4d5c-85d262285d7d",
            "text" : // Water
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_b4f736ff-1bbf-6923-4d5c-85d262285d7d\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"b4f736ff-1bbf-6923-4d5c-85d262285d7d\"> </a><a name=\"hcb4f736ff-1bbf-6923-4d5c-85d262285d7d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;b4f736ff-1bbf-6923-4d5c-85d262285d7d&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP Karl Fischer titration <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.0</td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d",
            "title" : "Water Content",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "WaterContent",
                  "display" : "Water Content"
                }
              ],
              "text" : "Water Content"
            },
            "method" : {
              "text" : "USP Karl Fischer titration"
            },
            "qualifiedValue" : [
              {
                "range" : {
                  "high" : {
                    "value" : 1.0,
                    "unit" : "% w/w"
                  }
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:233865df-2a71-528d-756c-85f36bd6685f",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "233865df-2a71-528d-756c-85f36bd6685f",
            "text" : // Particles
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_233865df-2a71-528d-756c-85f36bd6685f\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"233865df-2a71-528d-756c-85f36bd6685f\"> </a><a name=\"hc233865df-2a71-528d-756c-85f36bd6685f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;233865df-2a71-528d-756c-85f36bd6685f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</code></p><p><b>title</b>: Particle size distribution</p><p><b>status</b>: active</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#particle-size-distribution)</span></p><p><b>method</b>: Laser diffraction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.9) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-319</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.5) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-145</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.1) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-20</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#particle-size)</span></td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f",
            "title" : "Particle size distribution",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "particle-size-distribution",
                  "display" : "Particle size distribution"
                }
              ]
            },
            "method" : {
              "text" : "Laser diffraction"
            },
            "qualifiedValue" : [
              {
                "appliesTo" : [
                  {
                    "text" : "D(v,0.9)"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 319,
                    "unit" : "µm",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "um"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "D(v,0.5)"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 145,
                    "unit" : "µm",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "um"
                  }
                }
              },
              {
                "appliesTo" : [
                  {
                    "text" : "D(v,0.1)"
                  }
                ],
                "range" : //  could be a code
                {
                  "high" : {
                    "value" : 20,
                    "unit" : "µm",
                    "system" : "http://unitsofmeasure.org",
                    "code" : "um"
                  }
                }
              }
            ],
            "component" : [
              {
                "code" : //  are expected to have a component that says what solvent this one is
                {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                      "code" : "particle-size",
                      "display" : "Particle size"
                    }
                  ]
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "03d68d1c-162c-8b6e-70f9-647b0ea97adb",
            "text" : // substance1
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_03d68d1c-162c-8b6e-70f9-647b0ea97adb\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"03d68d1c-162c-8b6e-70f9-647b0ea97adb\"> </a><a name=\"hc03d68d1c-162c-8b6e-70f9-647b0ea97adb\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition &quot;03d68d1c-162c-8b6e-70f9-647b0ea97adb&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620</p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
            },
            "manufacturer" : [
              {
                "reference" : "Organization/062bf235-44e2-55c4-9213-bbe5e12d5620"
              }
            ],
            "name" : [
              // Organization/substance-manufacturer
              {
                "name" : "Stelbatolol"
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620",
          "resource" : {
            "resourceType" : "Organization",
            "id" : "062bf235-44e2-55c4-9213-bbe5e12d5620",
            "text" : // substance-manufacturer
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_062bf235-44e2-55c4-9213-bbe5e12d5620\"> </a><p><b>Generated Narrative: Organization</b><a name=\"062bf235-44e2-55c4-9213-bbe5e12d5620\"> </a><a name=\"hc062bf235-44e2-55c4-9213-bbe5e12d5620\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization &quot;062bf235-44e2-55c4-9213-bbe5e12d5620&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
            },
            "identifier" : [
              {
                "system" : "urn:oid:2.16.840.1.113883.4.82",
                "value" : "3003040516"
              }
            ],
            "active" : true,
            "type" : [
              //  FDA establishment identifier
              {
                "coding" : [
                  {
                    "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
                    "code" : "drug-substance-manufacture",
                    "display" : "Drug Substance Manufacture"
                  }
                ]
              }
            ],
            "name" : "AAA Molybdenum Products, Inc.",
            "contact" : [
              {
                "address" : {
                  "line" : [
                    "7233 W 116th Pl",
                    "Ste C"
                  ],
                  "city" : "Broomfield",
                  "state" : "Colorado",
                  "postalCode" : "80020",
                  "country" : "USA"
                }
              }
            ]
          }
        }
      ]
    }