Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
// Substance General Properties
{
"resourceType" : "Bundle",
"id" : "bundle-drug-substance-general-properties-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-general-properties-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:57a9af63-315d-1585-a261-0e337b289390",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "substancedefinition-substance-drug-pq-ex1",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substancedefinition-substance-drug-pq-ex1\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"substancedefinition-substance-drug-pq-ex1\"> </a><a name=\"hcsubstancedefinition-substance-drug-pq-ex1\"> </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 "substancedefinition-substance-drug-pq-ex1" </p></div><blockquote><p><b>property</b></p><p><b>type</b>: Appearance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#appearance)</span></p><p><b>value</b>: white to slightly yellow powder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility purified water (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-water-pheur)</span></p><p><b>value</b>: freely soluble <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-value-pq-example.html\">Substance Property Value - example</a>#sol-free "Freely soluble")</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 23-27 mg/mL</p><p><b>type</b>: Solubility purified water (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-water-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility Acetone (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-acetone-pheur)</span></p><p><b>value</b>: slightly soluble <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-value-pq-example.html\">Substance Property Value - example</a>#sol-slight "Slightly soluble")</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 2-3 mg/mL</p><p><b>type</b>: Solubility acetone (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-acetone-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility Ethanol (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-ethanol-pheur)</span></p><p><b>value</b>: soluble <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-value-pq-example.html\">Substance Property Value - example</a>#sol-soluble "Soluble")</span></p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 15-17 mg/mL</p><p><b>type</b>: Solubility ethanol (PhEur) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-ethanol-pheur)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Solubility at saturation in Purifed Water after 2 hours (approx) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-aq-water-2h-approx)</span></p><p><b>value</b>: 21 mg/mL</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Glucose solution (5%) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-aq-glucose-2h-approx "Solubility at saturation in Glucose (5%) after 2 hours (approx)")</span></p><p><b>value</b>: 2.5 mg/mL</p></blockquote><blockquote><p><b>property</b></p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: pH (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code pH = 'pH', stated as 'pH')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1.2</p></blockquote><p><b>type</b>: Solubility as a function of pH in USP buffers <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-usp-ph)</span></p><p><b>value</b>: 22 mg/mL</p></blockquote><blockquote><p><b>property</b></p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: pH (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code pH = 'pH', stated as 'pH')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 4.5</p></blockquote><p><b>type</b>: Solubility as a function of pH in USP buffers <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#solubility-usp-ph)</span></p><p><b>value</b>: 29 mg/mL</p></blockquote><blockquote><p><b>property</b></p><p><b>Extension - Substance Property Range PQ</b>: 6.7-6.8</p><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Concentration (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code concentration = 'Concentration', stated as 'Concentration')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 10 mg/ml</p></blockquote><blockquote><p><b>Extension - Substance Property Parameter PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Temperature (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example code temperature = 'Temperature', stated as 'Temperature')</p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 25 °C</p></blockquote><p><b>type</b>: pH in aqueous solution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#ph-aq)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Hygroscopy <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#hygroscopy)</span></p><p><b>value</b>: Hygroscopic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-substance-property-pq-example.html\">Substance Property - example</a>#hygroscopy-hygroscopic)</span></p></blockquote><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Stereochemistry</b></td></tr><tr><td style=\"display: none\">*</td><td>One asymmetric center and one axis of chirality; (S,M) - enantiomer <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table><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>"
},
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "appearance",
"display" : "Appearance"
}
]
},
"valueCodeableConcept" : {
"text" : "white to slightly yellow powder"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-water-pheur",
"display" : "Solubility purified water (PhEur)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example",
"code" : "sol-free",
"display" : "Freely soluble"
}
],
"text" : "freely soluble"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq",
"valueRange" : {
"low" : {
"value" : 23,
"unit" : "mg/mL"
},
"high" : {
"value" : 27,
"unit" : "mg/mL"
}
}
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-water-pheur",
"display" : "Solubility purified water (PhEur)"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-acetone-pheur",
"display" : "Solubility Acetone (PhEur)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example",
"code" : "sol-slight",
"display" : "Slightly soluble"
}
],
"text" : "slightly soluble"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq",
"valueRange" : {
"low" : {
"value" : 2,
"unit" : "mg/mL"
},
"high" : {
"value" : 3,
"unit" : "mg/mL"
}
}
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-acetone-pheur",
"display" : "Solubility acetone (PhEur)"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-ethanol-pheur",
"display" : "Solubility Ethanol (PhEur)"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-value-pq-example",
"code" : "sol-soluble",
"display" : "Soluble"
}
],
"text" : "soluble"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq",
"valueRange" : {
"low" : {
"value" : 15,
"unit" : "mg/mL"
},
"high" : {
"value" : 17,
"unit" : "mg/mL"
}
}
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-ethanol-pheur",
"display" : "Solubility ethanol (PhEur)"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-aq-water-2h-approx",
"display" : "Solubility at saturation in Purifed Water after 2 hours (approx)"
}
]
},
"valueQuantity" : {
"value" : 21,
"unit" : "mg/mL"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-aq-glucose-2h-approx",
"display" : "Solubility at saturation in Glucose (5%) after 2 hours (approx)"
}
],
"text" : "Glucose solution (5%)"
},
"valueQuantity" : {
"value" : 2.5,
"unit" : "mg/mL"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq",
"extension" : [
{
"url" : "parameter",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "pH",
"display" : "pH"
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 1.2
}
}
]
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-usp-ph",
"display" : "Solubility as a function of pH in USP buffers"
}
]
},
"valueQuantity" : {
"value" : 22,
"unit" : "mg/mL"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq",
"extension" : [
{
"url" : "parameter",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "pH",
"display" : "pH"
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 4.5
}
}
]
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "solubility-usp-ph",
"display" : "Solubility as a function of pH in USP buffers"
}
]
},
"valueQuantity" : {
"value" : 29,
"unit" : "mg/mL"
}
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq",
"valueRange" : {
"low" : {
"value" : 6.7
},
"high" : {
"value" : 6.8
}
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq",
"extension" : [
{
"url" : "parameter",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "concentration",
"display" : "Concentration"
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 10,
"unit" : "mg/ml"
}
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq",
"extension" : [
{
"url" : "parameter",
"valueCoding" : {
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "temperature",
"display" : "Temperature"
}
},
{
"url" : "value",
"valueQuantity" : {
"value" : 25,
"unit" : "°C"
}
}
]
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "ph-aq",
"display" : "pH in aqueous solution"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "hygroscopy",
"display" : "Hygroscopy"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-pq-example",
"code" : "hygroscopy-hygroscopic",
"display" : "Hygroscopic"
}
],
"text" : "Hygroscopic"
}
}
],
"structure" : // solubility acetone
// solubility ethanol
// purified water
// pH
{
"stereochemistry" : {
"text" : "One asymmetric center and one axis of chirality; (S,M) - enantiomer"
}
},
"name" : [
{
"name" : "Stelbatolol"
}
]
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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