Description

Cefazolin Impurity B is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Cefazolin Sodium through rigorous quality control testing. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and compliance monitoring.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cefazolin Impurity B in Cefazolin Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product impurities.
• Research & Development: Serves as a key material in studies investigating the degradation pathways, synthesis impurities, and metabolic profiles of Cefazolin.

Basic Information

Product Name	Cefazolin Impurity B
CAS No.	1798004-55-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Related Compound B; Cefazolin EP Impurity B; Cefazolin USP Impurity B; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefazolin Degradant B; Cefazolin Process Impurity B
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and confirmation of structure. Certificates of Analysis (COA) are provided, detailing batch-specific results against established specifications. We support compliance with cGMP guidelines and relevant pharmacopoeial standards (USP, EP) for pharmaceutical impurities.

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. 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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