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: Example: Bundle - Impurities, substance

Bundle bundle-product-impurities-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "substance1"

> manufacturer: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620

> ### Names

> - | Name
> * | Stelbatolol

> > relationship

> > Extension - Impurity Origin PQ: Enantiomer of API SM (Impurity Origin Codes#enantiomer "Enantiomer")

> > substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad1

> > type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#CH-IMP "Chiral Impurity")

> > amount: ND

> > relationship

> > Extension - Impurity Origin PQ: Step 1a Process Impurity (Impurity Origin Codes#process "Process Impurity")

> > substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad2

> > type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#PR-IMP "Process impurity")

> > amount: Range: ND-0.2%

> > relationship

> > Extension - Impurity Origin PQ: Step 1a Process Impurity (Impurity Origin Codes#process "Process Impurity")

> > substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad9

> > type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#PR-IMP "Process impurity")

> > amount: Range: ND–0.3%

> > relationship

> > Extension - Impurity Origin PQ: API Starting Material (Impurity Origin Codes#starting-material "Starting Material")

> > substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad3

> > type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#ST-IMP "Starting material, forced degradation product")

> > amount: Observed only during stress studies

> > relationship

> > Extension - Impurity Origin PQ: API Process Intermediate (Impurity Origin Codes#intermediate-material "Intermediate Material")

> > substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad4

> > type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#INT-IMP "Process intermediate, forced degradation product")

> > amount: Observed only during stress studies

Entry 2 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad1

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad1"

> > characterization

> > technique: Enantiomeric purity by LC ()

> > characterization

> > technique: Mass spectrometry ()

> > property

> > type: Rule-based (Q)Sar (Substance Property - example#1233444)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: Statistical (Q)Sar (Substance Property - example#123555)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: ICH M7 Classification (Substance Property - example#123556)

> > value: Class 5 (Substance Property Value - example#class-5)

> > property

> > type: Mutagenicity Comment (Substance Property - example#123557)

> > value: Treated as non-mutagenic due to lack of alerting structure ()

> ### MolecularWeights

> - | Amount
> * | 295.80 g/mole (Details: UCUM code g/mol = 'g/mol')

> > structure

> > ### Representations

> > - | Document
> > * | See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad1

> ### Names

> - | Name
> * | R-enantiomer of stelbatalol

Entry 3 - fullUrl = urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad1

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad1"

> status: CURRENT

> > content

> > ### Attachments

> > - | ContentType | Data
> > * | image/x-png | (base64 data - 4429 bytes)

Entry 4 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad2

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad2"

> ### Characterizations

> - | Technique
> * | Organic impurities by HPLC ()

> > property

> > type: Rule-based (Q)Sar (Substance Property - example#1233444)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: Statistical (Q)Sar (Substance Property - example#123555)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: ICH M7 Classification (Substance Property - example#123556)

> > value: Class 5 (Substance Property Value - example#class-5)

> > property

> > type: Mutagenicity Comment (Substance Property - example#123557)

> > value: Treated as non-mutagenic due to lack of alerting structure ()

> ### MolecularWeights

> - | Amount
> * | 344.4 g/mole (Details: UCUM code g/mol = 'g/mol')

> > structure

> > ### Representations

> > - | Document
> > * | See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad2

> ### Names

> - | Name
> * | Impurity 1

Entry 5 - fullUrl = urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad2

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad2"

> status: CURRENT

> > content

> > ### Attachments

> > - | ContentType | Data
> > * | image/x-png | (base64 data - 7004 bytes)

Entry 6 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad9

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad9"

> ### Characterizations

> - | Technique
> * | Organic impurities by LC ()

> > property

> > type: Rule-based (Q)Sar (Substance Property - example#1233444)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: Statistical (Q)Sar (Substance Property - example#123555)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: ICH M7 Classification (Substance Property - example#123556)

> > value: Class 5 (Substance Property Value - example#class-5)

> > property

> > type: Mutagenicity Comment (Substance Property - example#123557)

> > value: Treated as non-mutagenic due to lack of alerting structure ()

> ### MolecularWeights

> - | Amount
> * | 459.58 g/mole (Details: UCUM code g/mol = 'g/mol')

> > structure

> > ### Representations

> > - | Document
> > * | See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad9

> ### Names

> - | Name
> * | Impurity 2

Entry 7 - fullUrl = urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad9

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad9"

> status: CURRENT

> > content

> > ### Attachments

> > - | ContentType | Data
> > * | image/x-png | (base64 data - 7149 bytes)

Entry 8 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad3

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad3"

> > characterization

> > technique: Organic impurities by HPLC ()

> > characterization

> > technique: Chromatographic retention ()

> > property

> > type: Rule-based (Q)Sar (Substance Property - example#1233444)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: Statistical (Q)Sar (Substance Property - example#123555)

> > value: Negative (Substance Property Value - example#negative)

> > property

> > type: ICH M7 Classification (Substance Property - example#123556)

> > value: Class 5 (Substance Property Value - example#class-5)

> > property

> > type: Mutagenicity Comment (Substance Property - example#123557)

> > value: Treated as non-mutagenic due to lack of alerting structure ()

> ### MolecularWeights

> - | Amount
> * | 144.173 g/mole (Details: UCUM code g/mol = 'g/mol')

> > structure

> > > representation

> > > document: See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad3

> > > representation

> > > type: SMILES (Substance Representation Format#SMILES)

> > > representation: OC1=CC2=C(C=C1)C=CC=C2

> > > representation

> > > type: InChI (Substance Representation Format#InChI)

> > > representation: 1S/C10H8O/c11-10-6-5-8-3-1-2-4-9(8)7-10/h1-7,11H

> ### Codes

> - | Code
> * | 2-Naphthol (Chemical abstract codes#135-19-3)

> ### Names

> - | Name
> * | β-naphthol

Entry 9 - fullUrl = urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad3

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad3"

> status: CURRENT

> > content

> > ### Attachments

> > - | ContentType | Data
> > * | image/x-png | (base64 data - 4093 bytes)

Entry 10 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-80f9-647b0ea97ad4

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad4"

> > characterization

> > technique: Impurity content by LC-MS ()

> > characterization

> > technique: UV spectroscopy ()

> > characterization

> > technique: NMR spectroscopy ()

> > property

> > type: Rule-based (Q)Sar (Substance Property - example#1233444)

> > value: Positive (Substance Property Value - example#positive)

> > property

> > type: Statistical (Q)Sar (Substance Property - example#123555)

> > value: Positive (Substance Property Value - example#positive)

> > property

> > type: ICH M7 Classification (Substance Property - example#123556)

> > value: Class 2 (Substance Property Value - example#class-2)

> > property

> > type: Mutagenicity Comment (Substance Property - example#123557)

> > value: Control at or below qualification threshold ()

> ### MolecularWeights

> - | Amount
> * | 245.32 g/mole (Details: UCUM code g/mol = 'g/mol')

> > structure

> > ### Representations

> > - | Document
> > * | See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad4

> ### Names

> - | Name
> * | 1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol

Entry 11 - fullUrl = urn:uuid:13d68d1c-162c-8b6e-80f9-647b0ea97ad4

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad4"

> status: CURRENT

> > content

> > ### Attachments

> > - | ContentType | Data
> > * | image/x-png | (base64 data - 5119 bytes)

Entry 12 - fullUrl = urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "062bf235-44e2-55c4-9213-bbe5e12d5620"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

> - | Address
> * | 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA