Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:6248d2ea-c9e0-4280-9beb-08b7041071c2

Resource MedicinalProductDefinition:

Profile: Drug Product Impurities

identifier: AmphetamineSalt_1

description:

An uncoated tablet containing amphetamine sulfate

combinedPharmaceuticalDoseForm: TABLET

route: ORAL

Impurities

-	Reference
*	Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000
*	Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000
*	Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000

name

productName: AMPHETAMINE SULFATE 10mg, DEXTROAMPHETAMINE SULFATE 10mg

type: Nonproprietary Name

part

part: AMPHETAMINE SULFATE

type: scientific name

part

part: 10mg

type: AMPHETAMINE SULFATE

part

part: DEXTROAMPHETAMINE SULFATE

type: scientific name

part

part: 10mg

type: DEXTROAMPHETAMINE SULFATE

Entry 3 - fullUrl = urn:uuid:f22ab70c-20c0-4ee4-848b-622b67ec8592

Resource Organization:

Profile: Basic Organization

identifier: DUNS/143265222

name: WunderChem GmbH

Contacts

-	Address
*	123 Deutsche Strasse, Munich, Bavaria, 81541, Germany

Entry 4 - fullUrl = urn:uuid:ac7ac2da-df69-4ed9-b399-4dc40a71b332

Resource SubstanceDefinition:

Profile: Drug Substance Impurity

identifier: PhenylAcetone

classification: Process Related/Process

characterization

technique: IR Spectroscopy

Files

-	ContentType	Data	Title
*	application/x-jcamp-dx	(base64 data - 5,896 base64 chars)	PhenylAcetone-IR.jdx

characterization

technique: Proton NMR and Carbon NMR

description:

A phenylacetone sample was analyzed using HNMR and CNMR spectroscopy. The assignments of the protons and carbons are detailed in the tables below.

Table 1: HNMR Assignments for Phenylacetone

Hydrogen No.	Delta (ppm)	Multiplicity	No. of Protons	Coupling (Hz)
H1	7.251	tt	1	7.71, 1.53
H2,H3	7.305	tdd	2	7.74 1.82 0.55
H4,H5	7.11	dddd	2	7.77 1.53 1.20 0.55
H6,H7	3.589	s	2	--
H8,H9,H10	2.145	s	3	--

Table 2 : CNMR Assignments for Phenylacetone

Carbon No.	Delta (ppm)
C1	128.10
C2,C6	128.60
C3,C5	128.40
C4	133.70
C7	50.24
C8	205.55
C9	29.9

Files

-	ContentType	Data	Title
*	application/x-jcamp-dx	(base64 data - 16,200 base64 chars)	PhenylAecetone-HNMR.jdx
*	image/svg+xml	(base64 data - 199,128 base64 chars)	PhenylAcetone-HNMR.svg
*	application/x-jcamp-dx	(base64 data - 1,760 base64 chars)	PhenylAcetone-CNMR.jdx
*	image/png	(base64 data - 69,124 base64 chars)	PhenylAcetone-CNMR.png

structure

technique: HNMR, IR Spectroscopy

representation

type: String

representation: InChI=1S/C9H10O/c1-8(10)7-9-5-3-2-4-6-9/h2-6H,7H2,1H3

format: InChI File (small molecule)

representation

type: String

representation: CC(=O)CC1=CC=CC=C1

format: SMILES

representation

type: CHEMICAL STRUCTURE

format: SDF

document: Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000

Codes

-	Code
*	O7IZH10V9Y

Names

-	Name	Type	Preferred
*	PHENYL ACETONE	GSRS Preferred Term	true

Entry 5 - fullUrl = urn:uuid:de75e338-626c-4503-a25d-4fcdd8e39bee

Resource DocumentReference:

Profiles: Structure Data Reference, Document Reference Attachment

status: Current

content

Attachments

-	ContentType	Data	Title
*	application/x-mdl-sdfile	(base64 data - 2,556 base64 chars)	phenylAcetone.sdf

Entry 6 - fullUrl = urn:uuid:7f7c63b0-8ad8-4529-b000-bf4b6c384558

Resource SubstanceDefinition:

Profile: Drug Substance Impurity

identifier: MethylAmine

classification: Process Related/Process

characterization

technique: IR Spectroscopy

description:

Table 1: IR spectrum assignments

Wavenumber (cm^-1)	Intensity	Assignment
2930	s	C-H
1615	w	N-H
1060	w	C-N

Files

-	ContentType	Data	Title
*	application/x-jcamp-dx	(base64 data - 6,488 base64 chars)	methylamine-IR.jdx

characterization

technique: NMR Spectroscopy

description:

Methylamine was analyzed using proton NMR and Carbon NMR. Assignment data is included in subsequent tables

Table 1: HNMR assignments for Methylamine

Hydrogen No.	Delta (ppm)	Multiplicity	No. of Protons	Coupling (Hz)
H1,H2,H3	2.231	s	3	--

Table 2: CNMR assignments for Methylamine

Carbon No.	Delta (ppm)
C1	28.3

Files

-	ContentType	Data	Title
*	application/x-jcamp-dx	(base64 data - 1,336 base64 chars)	methylamine-HNMR.jdx
*	application/x-jcamp-dx	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	methylamine-CNMR.jdx
*	image/png	(base64 data - 44,416 base64 chars)	methylamine-CNMR.png
*	image/png	(base64 data - 47,692 base64 chars)	methylamine-HNMR.png

structure

technique: Carbon NMR

representation

type: String

representation: InChI=1S/CH5N/c1-2/h2H2,1H3

format: InChI File (small molecule)

representation

type: String

representation: CN

format: SMILES

Codes

-	Code
*	BSF23SJ79E

Names

-	Name	Type	Preferred
*	METHYLAMINE	GSRS Preferred Term	true

Entry 7 - fullUrl = urn:uuid:8202d18a-df68-4cbd-912d-59c7cff5cfa6

Resource SubstanceDefinition:

Profile: Drug Substance Impurity

identifier: ironImpurity

classification: Elemental Impurities

structure

technique: UV Spectroscopy

Representations

-	Type	Representation	Format
*	String	[Fe]	SMILES

Codes

-	Code
*	E1UOL152H7

Names

-	Name	Type	Preferred
*	IRON	GSRS Preferred Term	true