Levonorgestrel EP Impurity H

Name: Levonorgestrel EP Impurity H
Brand: Vaqora Chemicals
SKU: VQ-022983

About Levonorgestrel EP Impurity H

Levonorgestrel EP Impurity H is a pharmacopeial impurity of Levonorgestrel carrying the CAS registry number 55555-97-0. With the molecular formula C21H28O3, it has a molar mass of 328.4 g/mol. Common synonyms include Levonorgestrel - Impurity H and 6beta-Hydroxylevonorgestrel.

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 “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

As a characterised impurity of Levonorgestrel, 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.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Levonorgestrel EP Impurity H is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

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

Industries

Related to Levonorgestrel

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

Levonorgestrel impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Levonorgestrel EP Impurity H
Catalogue No.	VQ-022983
CAS Number	55555-97-0
IUPAC name	(6R,8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-6,17-dihydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
Molecular formula	C₂₁H₂₈O₃
Molecular weight	328.4 g/mol
Exact mass	328.2038
Grade	Reference Standard
HSN code	38229090
InChIKey	LUDPEOWAWHAHEP-JUYLZWBTSA-N
SMILES	CC[C@]12CC[C@@H]3[C@H]4CCC(=O)C=C4[C@@H](C[C@H]3[C@@H]1CC[C@]2(C#C)O)O
PubChem CID	129318271

Physical properties
Physical form	Solid
LogP (XLogP3)	2
H-bond donors / acceptors	2 / 3
TPSA	57.5 Å²
Synonyms	Levonorgestrel - Impurity H, 6beta-Hydroxylevonorgestrel, (6beta,17alpha)-13-Ethyl-6,17-dihydroxy-18,19-dinorpregn-4-en-20-yn-3-one, 13-Ethyl-6beta,17-dihydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one, 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-6,17-dihydroxy-, (6beta,17alpha)-, Levonorgestrel impurity H, 6b-Hydroxylevonorgestrel, rac 6b-Hydroxy Norgestrel, rac 6beta-Hydroxy Norgestrel, 6, A-Hydroxy Norgestrel, 6beta-Hydroxy Norgestrel

Safety & hazard information (GHS)

Health hazard

Signal word: Danger

Hazard statements

H360May damage 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 Levonorgestrel EP Impurity H?

The CAS Registry Number of Levonorgestrel EP Impurity H is 55555-97-0. It is also known as Levonorgestrel - Impurity H, 6beta-Hydroxylevonorgestrel, (6beta,17alpha)-13-Ethyl-6,17-dihydroxy-18,19-dinorpregn-4-en-20-yn-3-one.

What is the molecular formula and molecular weight of Levonorgestrel EP Impurity H?

Levonorgestrel EP Impurity H has the molecular formula C21H28O3 and a molecular weight of 328.4 g/mol. Its IUPAC name is (6R,8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-6,17-dihydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one.

What is Levonorgestrel EP Impurity H used for?

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

We supply Levonorgestrel EP Impurity H 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 Levonorgestrel EP Impurity H?

Yes. Every lot of Levonorgestrel EP Impurity H 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 Levonorgestrel EP Impurity H be shipped internationally?

Yes. Levonorgestrel EP Impurity H 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.