Finasteride EP Impurity B

Name: Finasteride EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-022467

About Finasteride EP Impurity B

Finasteride EP Impurity B is a pharmacopeial impurity of Finasteride carrying the CAS registry number 103335-41-7. With the molecular formula C20H29NO3, it has a molar mass of 331.4 g/mol. It is also known as Finasteride - Impurity B or Dutasteride Methyl Ester Impurity.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. It carries the GHS signal word “Warning” with 1 hazard statement. Review the Safety Data Sheet before use.

As a characterised impurity of Finasteride, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. It is used across pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Finasteride EP Impurity B in 10 mg, 25 mg, 50 mg and 100 mg packs, each shipped with a Certificate of Analysis (COA), and exports worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Finasteride

View every impurity, metabolite and intermediate we list for Finasteride.

Finasteride impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Finasteride EP Impurity B
Catalogue No.	VQ-022467
CAS Number	103335-41-7
IUPAC name	methyl (1S,3aS,3bS,5aR,9aR,9bS,11aS)-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxylate
Molecular formula	C₂₀H₂₉NO₃
Molecular weight	331.4 g/mol
Exact mass	331.2147
Grade	Reference Standard
HSN code	38229090
InChIKey	WMSQGMYJYBSBKA-ALHYADCGSA-N
SMILES	C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)OC)CC[C@@H]4[C@@]3(C=CC(=O)N4)C
PubChem CID	11002070

Physical properties
Physical form	Solid
LogP (XLogP3)	2.6
H-bond donors / acceptors	1 / 3
TPSA	55.4 Å²
Synonyms	Finasteride - Impurity B, Dutasteride Methyl Ester Impurity, Dutasteride methyl ester, 17beta-(Methoxycarbonyl)-4-aza-5alpha-androst-1-en-3-one, Methyl (5alpha,17beta)-3-oxo-4-azaandrost-1-ene-17-carboxylate, 4-Azaandrost-1-ene-17-carboxylic acid, 3-oxo-, methyl ester, (5alpha,17beta)-, Methyl 3-Oxo-4-aza-5alpha-androst-1-ene-17beta-carboxylate, Methyl 4-aza-5alpha-Androsta-1-en-3-one-17beta-Carboxylate, 3-Oxo-4-aza-5alpha-alphandrost-1-ene-17beta-carboxylic Acid Methyl Ester, 3-Oxo-4-aza-5a-androst-1-ene-17b-carboxylic Acid Methyl Ester, Methyl 3-Oxo-4-aza-5alpha-androst-1-ene-17beta-carboxylate (Delta-1-Aza Ester), Dutasteride Impurity 1

Safety & hazard information (GHS)

Health hazard

Signal word: Warning

Hazard statements

H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P280, P318, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Finasteride EP Impurity B?

The CAS Registry Number of Finasteride EP Impurity B is 103335-41-7. It is also known as Finasteride - Impurity B, Dutasteride Methyl Ester Impurity, Dutasteride methyl ester.

What is the molecular formula and molecular weight of Finasteride EP Impurity B?

Finasteride EP Impurity B has the molecular formula C20H29NO3 and a molecular weight of 331.4 g/mol. Its IUPAC name is methyl (1S,3aS,3bS,5aR,9aR,9bS,11aS)-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxylate.

What is Finasteride EP Impurity B used for?

Finasteride EP Impurity B is supplied as a characterised reference material related to Finasteride. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Finasteride EP Impurity B can I order?

We supply Finasteride EP Impurity B in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Finasteride EP Impurity B?

Yes. Every lot of Finasteride EP Impurity B is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Finasteride EP Impurity B be shipped internationally?

Yes. Finasteride EP Impurity B is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.