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Gemcitabine Hydrochloride Impurity – B

4-amino-1-(2-deoxy-2,2-difluoro-α-D-erythropentofuranosyl)pyrimidin-2(1H)-one (gemcitabine α-anomer)

Chemical Name 4-amino-1-(2-deoxy-2,2-difluoro-α-D-erythropentofuranosyl)pyrimidin-2(1H)-one (gemcitabine α-anomer)
CAS No. 95058-85-8
Molecular Formula C9H11F2N3O4
Molecular Weight 263.2
Chemical Structure 4-amino-1-(2-deoxy-2,2-difluoro-α-D-erythropentofuranosyl)pyrimidin-2(1H)-one (gemcitabine α-anomer) Structure
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Gemcitabine Hydrochloride Impurity – B

Gemcitabine Hydrochloride Impurity – B is identified as a process-related impurity of Gemcitabine Hydrochloride as per EP pharmacopoeial requirements. Chemically, it is described as 4-amino-1-(2-deoxy-2,2-difluoro-α-D-erythropentofuranosyl)pyrimidin-2(1H)-one (gemcitabine α-anomer). It has the molecular formula C9H11F2N3O4 and a molecular weight of 263.2 g/mol. It is used as a reference standard for impurity profiling, analytical method development, and quality control testing in pharmaceutical laboratories. Offered as a high-purity analytical reference standard for use in HPLC, LC-MS/MS, and other chromatographic techniques.

Gemcitabine Hydrochloride impurities reference standards are useful in pharmaceutical research. They are useful in product development, ANDA and DMF filing, Quality control (QC), method validation, and stability studies. It is also useful in the identification of unknown impurities and the assessment of genotoxic potential.

We are the BHAVANISH LIFE SCIENCES specializes in manufacturing and supplying of Gemcitabine Hydrochloride impurities that meet specific pharmacopeial standards (USP/EP/BP/IP) as well as process-related impurities.

This related products or Impurities are thoroughly characterized. Supplied with detailed COA & analytical data Like NMR / MASS / HPLC / GC / IR / TGA / Potency / Structure elucidation data (SER Report) meeting regulatory compliance.

BHAVANISH LIFE SCIENCES provides this compound for research and development and Analytical testing use only, and is not meant for human consumption. With product information including CAS number, molecular formula, molecular weight details.

BHAVANISH LIFE SCIENCES in providing high-quality impurity standards to support pharmaceutical companies in maintaining drug safety and efficacy.

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