Norethindrone Acetate EP Impurity B

Name: Norethindrone Acetate EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-023284

About Norethindrone Acetate EP Impurity B

Vaqora Chemicals supplies Norethindrone Acetate EP Impurity B, a pharmacopeial impurity of Norethindrone registered under CAS number 19637-28-6. With the molecular formula C22H28O3, it has a molar mass of 340.5 g/mol. It is also known as Norethiesterone Acetate EP Impurity B or Norethisterone Acetate - Impurity B.

The product is provided 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 “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

As a characterised impurity of Norethindrone, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

We offer Norethindrone Acetate EP Impurity B in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide.

Typical applications

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

Industries

Related to Norethindrone

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

Norethindrone impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Norethindrone Acetate EP Impurity B
Catalogue No.	VQ-023284
CAS Number	19637-28-6
IUPAC name	[(8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-3-oxo-1,2,4,6,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate
Molecular formula	C₂₂H₂₈O₃
Molecular weight	340.5 g/mol
Exact mass	340.2038
Grade	Reference Standard
HSN code	38229090
InChIKey	PKMFOAKNKZEDBU-AANPDWTMSA-N
SMILES	CC(=O)O[C@]1(CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=C3CCC(=O)C4)C)C#C
PubChem CID	54193985

Physical properties
Physical form	Solid
LogP (XLogP3)	2.7
H-bond donors / acceptors	0 / 3
TPSA	43.4 Å²
Synonyms	Norethiesterone Acetate EP Impurity B, ∆-5(10)-Norethindrone Acetate, Norethisterone Acetate EP Impurity B, Norethisterone Acetate - Impurity B, Delta-5(10)-Norethindrone Acetate, (17alpha)-17-(Acetyloxy)-19-norpregn-5(10)-en-20-yn-3-one, 19-Norpregn-5(10)-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)-, (17alpha)-3-Oxo-19-norpregn-5(10)-en-20-yn-17-yl acetate, 3-Oxo-17alpha-19-norpregn-5(10)-en-20-yn-17-yl acetate

Safety & hazard information (GHS)

Toxic

Health hazard

Signal word: Danger

Hazard statements

H301Toxic if swallowed
H360May damage fertility or the unborn child

Precautionary statements: P203, P264, P270, P280, P301 + P316, P318, P321, 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 Norethindrone Acetate EP Impurity B?

The CAS Registry Number of Norethindrone Acetate EP Impurity B is 19637-28-6. It is also known as Norethiesterone Acetate EP Impurity B, ∆-5(10)-Norethindrone Acetate, Norethisterone Acetate EP Impurity B, Norethisterone Acetate - Impurity B.

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

Norethindrone Acetate EP Impurity B has the molecular formula C22H28O3 and a molecular weight of 340.5 g/mol. Its IUPAC name is [(8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-3-oxo-1,2,4,6,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate.

What is Norethindrone Acetate EP Impurity B used for?

Norethindrone Acetate EP Impurity B is supplied as a characterised reference material related to Norethindrone. 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 Norethindrone Acetate EP Impurity B can I order?

We supply Norethindrone Acetate 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 Norethindrone Acetate EP Impurity B?

Yes. Every lot of Norethindrone Acetate 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 Norethindrone Acetate EP Impurity B be shipped internationally?

Yes. Norethindrone Acetate 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.