Gemcitabine EP Impurity B

Name: Gemcitabine EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-030971

About Gemcitabine EP Impurity B

Vaqora Chemicals supplies Gemcitabine EP Impurity B, a pharmacopeial impurity of Gemcitabine registered under CAS number 95058-85-8. Its molecular formula is C9H11F2N3O4 and its molecular weight is 263.2 g/mol. Systematically, it is named 4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one. Common synonyms include Gemcitabine Hydrochloride - Impurity B and Gemcitabine α-Anomer.

The product is provided 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.

This Gemcitabine impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Gemcitabine 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 Gemcitabine

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

Gemcitabine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Gemcitabine EP Impurity B
Catalogue No.	VQ-030971
CAS Number	95058-85-8
IUPAC name	4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
Molecular formula	C₉H₁₁F₂N₃O₄
Molecular weight	263.2 g/mol
Exact mass	263.0718
Grade	Reference Standard
HSN code	38229090
InChIKey	SDUQYLNIPVEERB-QXRNQMCJSA-N
SMILES	C1=CN(C(=O)N=C1N)[C@@H]2C([C@@H]([C@H](O2)CO)O)(F)F
PubChem CID	9943183

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.5
H-bond donors / acceptors	3 / 6
TPSA	108 Å²
Synonyms	Gemcitabine Hydrochloride - Impurity B, Gemcitabine α-Anomer, Gemcitabine alpha-anomer, 2(1H)-Pyrimidinone, 4-amino-1-(2-deoxy-2,2-difluoro-alpha-D-erythro-pentofuranosyl)-, 4-Amino-1-(2-deoxy-2,2-difluoro-alpha-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone, 1'-Epi Gemcitabine, 4-Amino-1-(2-deoxy-2,2-difluoro-, A-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone

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 Gemcitabine EP Impurity B?

The CAS Registry Number of Gemcitabine EP Impurity B is 95058-85-8. It is also known as Gemcitabine Hydrochloride - Impurity B, Gemcitabine α-Anomer, Gemcitabine alpha-anomer.

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

Gemcitabine EP Impurity B has the molecular formula C9H11F2N3O4 and a molecular weight of 263.2 g/mol. Its IUPAC name is 4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one.

What is Gemcitabine EP Impurity B used for?

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

We supply Gemcitabine 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 Gemcitabine EP Impurity B?

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

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