Hydrocortisone EP Impurity D

About Hydrocortisone EP Impurity D

Hydrocortisone EP Impurity D is a pharmacopeial impurity of Hydrocortisone carrying the CAS registry number 53-35-0. Its molecular formula is C21H30O6 and its molecular weight is 378.5 g/mol. Alternative names: 6-β-Hydroxy Hydrocortisone and Hydrocortisone - Impurity D.

The product is provided as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. It carries the GHS signal word “Danger” with 2 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Hydrocortisone to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Hydrocortisone EP Impurity D 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 Hydrocortisone

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

Hydrocortisone impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Hydrocortisone EP Impurity D
Catalogue No.	VQ-022800
CAS Number	53-35-0
IUPAC name	(6R,8S,9S,10R,11S,13S,14S,17R)-6,11,17-trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
Molecular formula	C₂₁H₃₀O₆
Molecular weight	378.5 g/mol
Exact mass	378.2042
Grade	Reference Standard
HSN code	38229090
InChIKey	GNFTWPCIRXSCQF-UJXAPRPESA-N
SMILES	C[C@]12CCC(=O)C=C1[C@@H](C[C@@H]3[C@@H]2[C@H](C[C@]4([C@H]3CC[C@@]4(C(=O)CO)O)C)O)O
PubChem CID	6852390

Physical properties
Physical form	Solid
LogP (XLogP3)	0.3
H-bond donors / acceptors	4 / 6
TPSA	115 Å²
Synonyms	6-β-Hydroxy Hydrocortisone, Hydrocortisone - Impurity D, 6beta-Hydroxycortisol, 6beta,11beta,17alpha,21-Tetrahydroxypregn-4-en-3,20-dione, 6beta,11beta,17,21-tetrahydroxypregn-4-ene-3,20-dione, 6,11 beta,17,21-tetrahydroxypregn-4-ene-3,20-dione, 6b-Hydroxy Cortisol, 6beta-Hydroxy cortisol, 6-beta-hydroxycortisol, 6, A-Hydroxycortisol, 6beta,17-Dihydroxycorticosterone

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H341Suspected of causing genetic defects

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 Hydrocortisone EP Impurity D?

The CAS Registry Number of Hydrocortisone EP Impurity D is 53-35-0. It is also known as 6-β-Hydroxy Hydrocortisone, Hydrocortisone - Impurity D, 6beta-Hydroxycortisol.

What is the molecular formula and molecular weight of Hydrocortisone EP Impurity D?

Hydrocortisone EP Impurity D has the molecular formula C21H30O6 and a molecular weight of 378.5 g/mol. Its IUPAC name is (6R,8S,9S,10R,11S,13S,14S,17R)-6,11,17-trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one.

What is Hydrocortisone EP Impurity D used for?

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

We supply Hydrocortisone EP Impurity D 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 Hydrocortisone EP Impurity D?

Yes. Every lot of Hydrocortisone EP Impurity D 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 Hydrocortisone EP Impurity D be shipped internationally?

Yes. Hydrocortisone EP Impurity D 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.