Description

Gemcitabine Impurity 21 is a designated impurity of the vital anticancer drug Gemcitabine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Gemcitabine-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Gemcitabine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Gemcitabine.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathways of impurities during the synthesis and purification of Gemcitabine, enabling process optimization.

Basic Information

Product Name	Gemcitabine Impurity 21
CAS No.	866473-33-8
Molecular Formula	C9H11F2N3O4
Molecular Weight	263.20 g/mol
Synonyms	2'-Deoxy-2',2'-difluorocytidine 3',5'-Diacetate; Gemcitabine 3',5'-Di-O-acetyl Impurity; 1-(3,5-Di-O-acetyl-2-deoxy-2,2-difluoro-D-erythro-pentofuranosyl)-4-aminopyrimidin-2(1H)-one; 4-Amino-1-((2R,4R,5R)-3,5-diacetoxy-4-fluoro-5-(fluoromethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one; Gemcitabine Diacetate Impurity; Difluorodeoxycytidine Diacetate
EINECS	Contact for details

Quality Control

Our Gemcitabine Impurity 21 is manufactured under strict quality-controlled conditions. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.