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
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:2.16.840.1.113883.4.82/3003040516active: 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
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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