Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot 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-ballot 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 above (Organization/062bf235-44e2-55c4-9213-bbe5e12d5620)

Names

-Name
*Stelbatolol

relationship

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

substanceDefinition: See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad1)

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

amount: ND

relationship

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

substanceDefinition: See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad2)

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

amount: Range: ND-0.2%

relationship

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

substanceDefinition: See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad9)

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

amount: Range: ND–0.3%

relationship

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

substanceDefinition: See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad3)

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

amount: Observed only during stress studies

relationship

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

substanceDefinition: See above (SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad4)

type: Impurity Of (Substance Relationship Type#Impurity; CodeSystem - Impurity Type#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 (CodeSystem - Mutagenicity Classification Type#1233444)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: Statistical (Q)Sar (CodeSystem - Mutagenicity Classification Type#123555)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: ICH M7 Classification (CodeSystem - Mutagenicity Classification Type#123556)

value: Class 5 (CodeSystem - ICH M7 Classification#class-5)

property

type: Mutagenicity Comment (CodeSystem - Mutagenicity Classification Type#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 above (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

-ContentTypeData
*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 (CodeSystem - Mutagenicity Classification Type#1233444)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: Statistical (Q)Sar (CodeSystem - Mutagenicity Classification Type#123555)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: ICH M7 Classification (CodeSystem - Mutagenicity Classification Type#123556)

value: Class 5 (CodeSystem - ICH M7 Classification#class-5)

property

type: Mutagenicity Comment (CodeSystem - Mutagenicity Classification Type#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 above (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

-ContentTypeData
*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 (CodeSystem - Mutagenicity Classification Type#1233444)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: Statistical (Q)Sar (CodeSystem - Mutagenicity Classification Type#123555)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: ICH M7 Classification (CodeSystem - Mutagenicity Classification Type#123556)

value: Class 5 (CodeSystem - ICH M7 Classification#class-5)

property

type: Mutagenicity Comment (CodeSystem - Mutagenicity Classification Type#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 above (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

-ContentTypeData
*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 (CodeSystem - Mutagenicity Classification Type#1233444)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: Statistical (Q)Sar (CodeSystem - Mutagenicity Classification Type#123555)

value: Negative (CodeSystem - Mutagenicity#negative)

property

type: ICH M7 Classification (CodeSystem - Mutagenicity Classification Type#123556)

value: Class 5 (CodeSystem - ICH M7 Classification#class-5)

property

type: Mutagenicity Comment (CodeSystem - Mutagenicity Classification Type#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 above (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

-ContentTypeData
*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 (CodeSystem - Mutagenicity Classification Type#1233444)

value: Positive (CodeSystem - Mutagenicity#positive)

property

type: Statistical (Q)Sar (CodeSystem - Mutagenicity Classification Type#123555)

value: Positive (CodeSystem - Mutagenicity#positive)

property

type: ICH M7 Classification (CodeSystem - Mutagenicity Classification Type#123556)

value: Class 2 (CodeSystem - ICH M7 Classification#class-2)

property

type: Mutagenicity Comment (CodeSystem - Mutagenicity Classification Type#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 above (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

-ContentTypeData
*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

name: AAA Molybdenum Products, Inc.

Contacts

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