Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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"
            }
          }
        ]
      }
    }
  ]
}