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

-	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 (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

-	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 (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

-	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 (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

-	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 (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

-	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: id: 3003040516

name: AAA Molybdenum Products, Inc.

Contacts

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