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Pharmacopeial Impurities (EP / USP / BP)

Gemcitabine EP Impurity C

Reference StandardAvailable on request

Gemcitabine EP Impurity C (CAS 114248-23-6) supplier Zemixal: C9H10F2N2O5, COA and SDS with every lot, worldwide shipping.

Pack sizes
Gemcitabine EP Impurity C chemical structure
CAS number114248-23-6
FormulaC9H10F2N2O5
Molar mass264.18 g/mol
Physical formSolid
HS code38229090
InChIKeyFIRDBEQIJQERSE-QPPQHZFASA-N
IUPAC name1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione

About Gemcitabine EP Impurity C

Gemcitabine EP Impurity C is supplied by Zemixal as a characterised reference material for Gemcitabine analysis. For your records (Reference Standard), the material is defined by CAS 114248-23-6, formula C9H10F2N2O5 and molar mass 264.18 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

Handling and storage

Classified under GHS with signal word Danger and hazard statements H302, H312, H315 and H319. Read the SDS before first use.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. You receive a certificate of analysis with characterisation data with each order. 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 C
Product nameGemcitabine EP Impurity C
Catalogue numberZX-024921
CAS number114248-23-6
IUPAC name1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione
Molecular formulaC9H10F2N2O5
Molar mass264.18 g/mol
Exact mass264.0558
GradeReference Standard
Physical formSolid
XLogP3-1.3
H-bond donors / acceptors3 / 7
Topological polar surface area99.1 Ų
HS code38229090
InChIKeyFIRDBEQIJQERSE-QPPQHZFASA-N
SMILESC1=CN(C(=O)NC1=O)[C@H]2C([C@@H]([C@H](O2)CO)O)(F)F
PubChem CID9871558
SynonymsGemcitabine Hydrochloride - Impurity C, 2'-Deoxy-2',2'-difluorouridine, 2',2'-Difluorodeoxyuridine, Uridine, 2'-deoxy-2',2'-difluoro-, 2'-deoxy-2',2'-difluoro-d-uridine, Gemcitabine metabolite, Uridine,2'-deoxy-2',2'-difluoro-, 2Deoxy-22difluorouridine, 2'2'-Difluoro-2'-deoxyuridine, 2'-deoxy-2',2'-fluorouracil nucleoside, 1-(2-Deoxy-2,2-difluoro-beta-D-erythro-pentofuranosyl)pyrimidin-2,4(1H,3H)-dione

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

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard
GHS09 Hazardous to the environment
Hazardous to the environment

Signal word Danger

  • H302Harmful if swallowed
  • H312Harmful in contact with skin
  • H315Causes skin irritation
  • H319Causes serious eye irritation
  • H340May cause genetic defects
  • H351Suspected of causing cancer
  • H360May damage fertility or the unborn child
  • H361Suspected of damaging fertility or the unborn child
  • H372Causes damage to organs through prolonged or repeated exposure
  • H411Toxic to aquatic life with long lasting effects

Precautionary statements P203, P260, P264, P264 + P265, P270, P273, P280, P301 + P317, P302 + P352, P305 + P351 + P338, P317, P318, P319, P321, P330, P332 + P317, P337 + P317, P362 + P364, P391, P405, P501

Classification summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Gemcitabine EP Impurity C
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 C

Which CAS number identifies Gemcitabine EP Impurity C?
Gemcitabine EP Impurity C is registered under CAS 114248-23-6. You may also see it listed as Gemcitabine Hydrochloride - Impurity C, 2'-Deoxy-2',2'-difluorouridine, 2',2'-Difluorodeoxyuridine. Our catalogue number for this item is ZX-024921.
What are the formula and molar mass of Gemcitabine EP Impurity C?
For Gemcitabine EP Impurity C, its formula is C9H10F2N2O5 and its molar mass is 264.18 g/mol. The systematic (IUPAC) name is 1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione. InChIKey FIRDBEQIJQERSE-QPPQHZFASA-N lets you match it in any structure database.
How is Gemcitabine EP Impurity C used in pharmaceutical QC?
Gemcitabine EP Impurity C 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 C?
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 C?
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 C to my country?
Yes. Because Gemcitabine EP Impurity C is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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