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Pharmacopeial Impurities (EP / USP / BP)

Gemcitabine EP Impurity B

Reference StandardAvailable on request

Gemcitabine EP Impurity B (CAS 95058-85-8) supplier Zemixal: C9H11F2N3O4, COA and SDS with every lot, worldwide shipping.

Pack sizes
Gemcitabine EP Impurity B chemical structure
CAS number95058-85-8
FormulaC9H11F2N3O4
Molar mass263.2 g/mol
Physical formSolid
HS code38229090
InChIKeySDUQYLNIPVEERB-QXRNQMCJSA-N
IUPAC name4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one

About Gemcitabine EP Impurity B

Zemixal lists Gemcitabine EP Impurity B for laboratories that identify, quantify or control Gemcitabine and its related substances. Identity at a glance (Reference Standard): CAS 95058-85-8, formula C9H11F2N3O4 and molar mass 263.2 g/mol. It is handled as a solid.

Use cases we see most often

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

Order it in 10 mg, 25 mg, 50 mg and 100 mg packs or ask for a bulk quotation. Every shipment includes a certificate of analysis with characterisation data. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Gemcitabine

See every impurity, metabolite and related compound we list for this API.

Gemcitabine standards

Typical uses

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

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Gemcitabine EP Impurity B
Product nameGemcitabine EP Impurity B
Catalogue numberZX-029722
CAS number95058-85-8
IUPAC name4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
Molecular formulaC9H11F2N3O4
Molar mass263.2 g/mol
Exact mass263.0718
GradeReference Standard
Physical formSolid
XLogP3-1.5
H-bond donors / acceptors3 / 6
Topological polar surface area108 Ų
HS code38229090
InChIKeySDUQYLNIPVEERB-QXRNQMCJSA-N
SMILESC1=CN(C(=O)N=C1N)[C@@H]2C([C@@H]([C@H](O2)CO)O)(F)F
PubChem CID9943183
SynonymsGemcitabine 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

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

No GHS classification is on file for this item. Handle it as an unknown laboratory chemical and request the SDS with your quotation.

Pack sizes

Pack sizes of Gemcitabine EP Impurity B
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Gemcitabine EP Impurity B

Which CAS number identifies Gemcitabine EP Impurity B?
Gemcitabine EP Impurity B is registered under CAS 95058-85-8. You may also see it listed as Gemcitabine Hydrochloride - Impurity B, Gemcitabine α-Anomer, Gemcitabine alpha-anomer. Our catalogue number for this item is ZX-029722.
What are the formula and molar mass of Gemcitabine EP Impurity B?
For Gemcitabine EP Impurity B, its formula is C9H11F2N3O4 and its molar mass is 263.2 g/mol. The systematic (IUPAC) name is 4-amino-1-[(2S,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one. InChIKey SDUQYLNIPVEERB-QXRNQMCJSA-N lets you match it in any structure database.
How is Gemcitabine EP Impurity B used in pharmaceutical QC?
Gemcitabine EP Impurity B is a characterised reference material linked to Gemcitabine. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Gemcitabine EP Impurity B?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Gemcitabine EP Impurity B?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Gemcitabine EP Impurity B to my country?
Yes. Gemcitabine EP Impurity B ships worldwide by express courier, air cargo or sea freight, quoted on the Incoterm you prefer, with full export documents.

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