Description

Cephalexin Sodium Impurity Vi is a specified impurity and reference standard used in the quality control of the antibiotic Cephalexin Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cephalexin Sodium bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Cephalexin Sodium under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research on Degradation Pathways: Used in studies to understand the chemical stability and degradation mechanisms of cephalosporin antibiotics.

Basic Information

Product Name	Cephalexin Sodium Impurity Vi
CAS No.	65870-52-2
Molecular Formula	C16H17N3O4S
Molecular Weight	347.39 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cephalexin Related Compound F; Cephalexin Impurity F; Cephalexin EP Impurity F; Cephalexin Sodium Related Substance F; 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid; δ2-Cephalexin
EINECS	Contact for details

Quality Control

Our Cephalexin Sodium Impurity Vi is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) with detailed results, ensuring traceability and compliance with ICH guidelines and relevant pharmacopeial standards for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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