Description

Cefazolin Impurity 8 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Cefazolin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and routine testing in compliance with stringent regulatory guidelines. Professionals in pharmaceutical R&D and quality assurance rely on this high-purity standard to monitor and control impurity levels throughout the production process.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 8 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Cefazolin analysis.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to establish impurity profiles and ensure each batch of Cefazolin meets pharmacopeial (USP, EP, JP) or internal specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of impurities as per ICH Q3A/B guidelines.
• Research & Development: Supports impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Cefazolin Impurity 8
CAS No.	1675245-47-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Related Compound 8; Cefazolin EP Impurity 8; Cefazolin USP Impurity 8; (6R,7R)-3-[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-yl)acetyl]amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[[(1H-tetrazol-1-yl)acetyl]amino]-, (6R,7R)-; Cefazolin Degradant
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity 8 is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and establish purity. We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, including purity assay and related substance profiles. Our quality commitment ensures the material is suitable for its intended use as a high-grade reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. For long-term storage, keep the container in a cool, dry, and well-ventilated area. Handle the product with care to avoid contamination.

Specification

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

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