Description

Cefazolin Impurity 7 (Cefazolin Trimethylsilyl Ester) is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antibiotic Cefazolin. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories and quality control departments in the pharmaceutical industry, supporting compliance with stringent regulatory requirements for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefazolin-related impurities in drug substance and finished product analysis.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring Cefazolin API meets pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Cefazolin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate comprehensive impurity understanding and control strategies.
• Research on Degradation Pathways: Serves as a key intermediate or marker in studies investigating the synthesis, metabolism, and degradation pathways of Cefazolin.

Basic Information

Product Name	Cefazolin Impurity 7 (Cefazolin Trimethylsilyl Ester)
CAS No.	1072000-00-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Trimethylsilyl Ester; Cefazolin Related Compound 7; (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 Trimethylsilyl Ester; Cefazolin Silyl Ester; Cefazolin Impurity F (Trimethylsilyl); Cefazolin EP Impurity G (Trimethylsilyl); Cefazolin USP Related Compound G
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches 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 guidelines
Water Content (KF)	≤ 5.0% w/w

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