Description

Cefmetazole Sodium Impurity 26 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Cefmetazole Sodium. 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 marker for identifying and quantifying related substances during method development and routine batch analysis. Professionals in pharmaceutical R&D, quality assurance, and regulatory compliance rely on this high-purity standard to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Cefmetazole Sodium active pharmaceutical ingredient (API) and finished formulations.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to separate and quantify impurities.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive identification and characterization data for specified impurities.
• Pharmacopeial Testing: Aids in compliance testing against monographs from USP, EP, JP, or other pharmacopeias that list or limit this impurity.
• In-House Quality Control: Used in routine batch release testing to ensure impurity levels are within specified safety thresholds.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Cefmetazole Sodium.

Basic Information

Product Name	Cefmetazole Sodium Impurity 26
CAS No.	57617-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(7R)-7-[[(Cyanomethyl)thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefmetazole Impurity 26; Cefmetazole Related Compound 26; Cefmetazole Sodium EP Impurity C; Cefmetazole Sodium USP Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid derivative
EINECS	Contact for details

Quality Control

Every batch of Cefmetazole Sodium Impurity 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. We support compliance with cGMP, ICH Q3B(R2) guidelines, and relevant pharmacopeial standards (USP, EP).

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. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%

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