Naltrexone EP Impurity I

Name: Naltrexone EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-021281

About Naltrexone EP Impurity I

Vaqora Chemicals supplies Naltrexone EP Impurity I, a pharmacopeial impurity of Naltrexone registered under CAS number 96445-14-6. Formula C20H21NO5, molecular weight 355.4 g/mol. Common synonyms include 10-Ketonaltrexone and Naltrexone Hydrochloride - Impurity I.

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. It carries the GHS signal word “Warning” with 2 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Naltrexone to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

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

Industries

Related to Naltrexone

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

Naltrexone impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Naltrexone EP Impurity I
Catalogue No.	VQ-021281
CAS Number	96445-14-6
IUPAC name	(4S,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-1,2,4,5,6,7a-hexahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7,13-dione
Molecular formula	C₂₀H₂₁NO₅
Molecular weight	355.4 g/mol
Exact mass	355.142
Grade	Reference Standard
HSN code	38229090
InChIKey	MLHMRULRADVYER-FUMNGEBKSA-N
SMILES	C1CC1CN2CC[C@]34[C@@H]5C(=O)CC[C@]3([C@H]2C(=O)C6=C4C(=C(C=C6)O)O5)O
PubChem CID	5486980

Physical properties
Physical form	Solid
LogP (XLogP3)	1
H-bond donors / acceptors	2 / 6
TPSA	87.1 Å²
Synonyms	10-Ketonaltrexone, Naltrexone Hydrochloride - Impurity I, 10-Oxo Naltrexone, Naltrexone impurity I, 17-(Cyclopropylmethyl)-3,14-dihydroxy-4,5-epoxymorphinan-6,10-dione, 17-(Cyclopropylmethyl)-3,14-dihydroxy-5alpha-4,5-epoxymorphinan-6,10-dione, Morphinan-6,10-dione, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dih ydroxy-, (5alpha)-

Safety & hazard information (GHS)

Harmful / irritant

Environmental hazard

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H400Very toxic to aquatic life

Precautionary statements: P264, P270, P273, P301 + P317, P330, P391, 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 Naltrexone EP Impurity I?

The CAS Registry Number of Naltrexone EP Impurity I is 96445-14-6. It is also known as 10-Ketonaltrexone, Naltrexone Hydrochloride - Impurity I, 10-Oxo Naltrexone.

What is the molecular formula and molecular weight of Naltrexone EP Impurity I?

Naltrexone EP Impurity I has the molecular formula C20H21NO5 and a molecular weight of 355.4 g/mol. Its IUPAC name is (4S,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-1,2,4,5,6,7a-hexahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7,13-dione.

What is Naltrexone EP Impurity I used for?

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

We supply Naltrexone EP Impurity I 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 Naltrexone EP Impurity I?

Yes. Every lot of Naltrexone EP Impurity I 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 Naltrexone EP Impurity I be shipped internationally?

Yes. Naltrexone EP Impurity I 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.