Entecavir EP Impurity B

About Entecavir EP Impurity B

Entecavir EP Impurity B is a pharmacopeial impurity of Entecavir carrying the CAS registry number 1367369-77-4. Its molecular formula is C12H15N5O3 and its molecular weight is 277.28 g/mol. Systematically, it is named 2-amino-9-[(1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1H-purin-6-one. It is also known as Entecavir USP Impurity B or Entecavir impurity B.

It is supplied as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. Good laboratory practice and suitable PPE are recommended during handling.

As a characterised impurity of Entecavir, 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 Entecavir 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 Entecavir

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

Entecavir impurities

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Specifications & identifiers

Chemical identifiers
Product name	Entecavir EP Impurity B
Catalogue No.	VQ-022541
CAS Number	1367369-77-4
IUPAC name	2-amino-9-[(1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1H-purin-6-one
Molecular formula	C₁₂H₁₅N₅O₃
Molecular weight	277.28 g/mol
Exact mass	277.1175
Grade	Reference Standard
HSN code	38229090
InChIKey	QDGZDCVAUDNJFG-CSMHCCOUSA-N
SMILES	C=C1[C@H](C[C@@H]([C@@H]1CO)O)N2C=NC3=C2N=C(NC3=O)N
PubChem CID	136217872

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.3
H-bond donors / acceptors	4 / 5
TPSA	126 Å²
Synonyms	Entecavir USP Impurity B, Entecavir impurity B, Entecavir Monohydrate - Impurity B, 3'-epi-Entecavir, Entecavir 3-epimer, 3-Epi-Entecavir, 9-((1S,3S,4S)-4-Hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)guanine, 3AE-epi-Entecavir, Entecavir 3-epimer impurity, Entecavir (1S,3S,4S) Diastereomer

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 Entecavir EP Impurity B?

The CAS Registry Number of Entecavir EP Impurity B is 1367369-77-4. It is also known as Entecavir USP Impurity B, Entecavir impurity B, Entecavir Monohydrate - Impurity B.

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

Entecavir EP Impurity B has the molecular formula C12H15N5O3 and a molecular weight of 277.28 g/mol. Its IUPAC name is 2-amino-9-[(1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1H-purin-6-one.

What is Entecavir EP Impurity B used for?

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

We supply Entecavir 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 Entecavir EP Impurity B?

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

Yes. We export Entecavir EP Impurity B worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.