Dutasteride EP Impurity A

Name: Dutasteride EP Impurity A
Brand: Vaqora Chemicals
SKU: VQ-025450

About Dutasteride EP Impurity A

Dutasteride EP Impurity A (CAS 104239-97-6) is a pharmacopeial impurity of Dutasteride offered by Vaqora Chemicals. Formula C19H27NO3, molecular weight 317.4 g/mol. Alternative names: Dutasteride - Impurity A and Dutasteride acid.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

This Dutasteride impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Dutasteride EP Impurity A 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 Dutasteride

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

Dutasteride impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Dutasteride EP Impurity A
Catalogue No.	VQ-025450
CAS Number	104239-97-6
IUPAC name	(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-carboxylic acid
Molecular formula	C₁₉H₂₇NO₃
Molecular weight	317.4 g/mol
Exact mass	317.1991
Grade	Reference Standard
HSN code	38229090
InChIKey	FDESQZBVTKLIQN-MLGOENBGSA-N
SMILES	C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)O)CC[C@@H]4[C@@]3(C=CC(=O)N4)C
PubChem CID	9839970

Physical properties
Physical form	Solid
LogP (XLogP3)	2.3
H-bond donors / acceptors	2 / 3
TPSA	66.4 Å²
Synonyms	Dutasteride - Impurity A, Dutasteride acid, 3-Oxo-4-aza-5alpha-androst-1-ene-17beta-carboxylic acid, 4-Aza-5a-androstan-1-ene-3-one-17b-carboxylic acid, Finasteride Acid, (5alpha,17beta)-3-Oxo-4-azaandrost-1-ene-17-carboxylic acid, 3-Oxo-4-aza-5a-androst-1-ene-17b-carboxylic Acid, 3-Oxo-4-aza-5, A-androst-1-ene-17, A-carboxylic acid, (5a,17b)-3-Oxo-4-aza-androst-1-ene-17-carboxylic acid, Dutasteride Impurity A

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P264, P270, P280, P301 + P317, P318, P330, 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 Dutasteride EP Impurity A?

The CAS Registry Number of Dutasteride EP Impurity A is 104239-97-6. It is also known as Dutasteride - Impurity A, Dutasteride acid, 3-Oxo-4-aza-5alpha-androst-1-ene-17beta-carboxylic acid.

What is the molecular formula and molecular weight of Dutasteride EP Impurity A?

Dutasteride EP Impurity A has the molecular formula C19H27NO3 and a molecular weight of 317.4 g/mol. Its IUPAC name is (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-carboxylic acid.

What is Dutasteride EP Impurity A used for?

Dutasteride EP Impurity A is supplied as a characterised reference material related to Dutasteride. 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 Dutasteride EP Impurity A can I order?

We supply Dutasteride EP Impurity A 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 Dutasteride EP Impurity A?

Yes. Every lot of Dutasteride EP Impurity A 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 Dutasteride EP Impurity A be shipped internationally?

Yes. Dutasteride EP Impurity A 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.