Description

Cefmetazole Impurity 3 is a specified impurity of the second-generation cephamycin antibiotic, Cefmetazole, and is a critical reference standard for analytical and quality control purposes. This compound is essential for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Cefmetazole drug substances and finished products. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefmetazole Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Cefmetazole.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, as required by ICH Q3A(R2) and Q3B(R2).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefmetazole.

Basic Information

Product Name	Cefmetazole Impurity 3
CAS No.	64278-70-2
Molecular Formula	C15H17N7O5S3
Molecular Weight	479.53 g/mol
Synonyms	(6R,7S)-7-[[(Cyanomethyl)thio]acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 7β-[(Cyanomethylthio)acetamido]-3-(1-methyl-1H-tetrazol-5-ylthiomethyl)-3-cephem-4-carboxylic acid; Cefmetazole Related Compound C; Cefmetazole EP Impurity C; Cefmetazole USP Related Compound C
EINECS	Contact for details

Quality Control

Our Cefmetazole Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and impurities. Our quality standards align with the requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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% w/w
Residue on Ignition	≤ 0.5%

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