Description

Cefprozilimpurity M CAS NO 1605314-84-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Cefprozil by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and product development.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefprozilimpurity M 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 analysis in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor and control impurity levels during the manufacturing and stability studies of Cefprozil.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory documentation for agencies like the US FDA, EMA, and PMDA by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Research on Degradation Pathways: Facilitates research into the chemical stability and degradation mechanisms of cephalosporin antibiotics.

Basic Information

Product Name	Cefprozilimpurity M
CAS No.	1605314-84-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefprozil Impurity M; Cefprozil Related Compound M; (6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3-(propan-2-yl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefprozil EP Impurity M; Cefprozil USP Impurity M; Cefprozil Degradation Product M
EINECS	Contact for details

Quality Control

Our Cefprozilimpurity M is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production and documentation are aligned with cGMP principles to support regulatory needs.

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 under dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator or under an inert atmosphere for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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