Description

Cefprozil Impurity 5 CAS NO 1000980-59-5 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 quality control laboratories, research institutions, and manufacturers engaged in the development and production of Cefprozil API and finished dosage forms.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Cefprozil Active Pharmaceutical Ingredient (API) and drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Cefprozil analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Cefprozil.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Facilitates chemical and pharmacological research related to Cefprozil's degradation pathways and metabolite studies.

Basic Information

Product Name	Cefprozil Impurity 5
CAS No.	1000980-59-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefprozil Related Compound 5; Cefprozil EP Impurity 5; Cefprozil USP Impurity 5; (6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-[(1E)-prop-1-en-1-yl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefprozil Degradation Product; Cefprozil Process Impurity
EINECS	Contact for details

Quality Control

Our Cefprozil Impurity 5 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	≥ 97.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	< 20 ppm

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