Description

Cefpirome Impurity 3 is a specified impurity and degradation product of the fourth-generation cephalosporin antibiotic, Cefpirome. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily used by analytical chemists and quality assurance professionals in pharmaceutical manufacturing and regulatory testing laboratories for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Cefpirome drug substance and finished products.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity during stability testing and forced degradation studies of Cefpirome.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity assays.
• Quality Control (QC) & Quality Assurance (QA): Provides a benchmark for in-process control and release testing of Cefpirome API to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity identification and qualification reports.
• Research & Development: Utilized in R&D to study the degradation pathways and chemical stability of Cefpirome formulations.

Basic Information

Product Name	Cefpirome Impurity 3
CAS No.	130431-30-0
Molecular Formula	C22H22N6O5S2
Molecular Weight	514.58 g/mol
Synonyms	(6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(1-methylpyrrolidin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Cefpirome Related Compound C; Cefpirome EP Impurity C; Cefpirome USP Impurity C; Cefpirome Degradant; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium
EINECS	Contact for details

Quality Control

Every batch of Cefpirome Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for tests including identification, assay, and related substances by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.