Description

Cefpirome Impurity 2 CAS NO 124667-22-7 is a specified impurity of the fourth-generation cephalosporin antibiotic, Cefpirome. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Cefpirome drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefpirome API and formulations.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefpirome.

Basic Information

Product Name	Cefpirome Impurity 2
CAS No.	124667-22-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefpirome Related Compound; Cefpirome Impurity B; Cefpirome EP Impurity B; Cefpirome USP Impurity; (6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Impurity; Cefpirome Degradation Product; Cefpirome Process Impurity
EINECS	Contact for details

Quality Control

Our Cefpirome Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and spectroscopic identification (NMR, MS, IR), to ensure it meets the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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.

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)	Complies
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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