Description

Cefprozil Impurity C CAS NO 147103-93-3 is a specified impurity of the antibiotic Cefprozil, a second-generation cephalosporin. 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 Cefprozil drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cefprozil Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the drug manufacturing process.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data required for drug approval.
• Quality Control Testing: Employed in routine batch release testing to ensure Cefprozil APIs and formulations meet stringent pharmacopeial (USP, EP) impurity limits.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Cefprozil, leading to improved formulation strategies.

Basic Information

Product Name	Cefprozil Impurity C
CAS No.	147103-93-3
Molecular Formula	C18H19N3O5S
Molecular Weight	389.43 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-[(E)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefprozil Related Compound C; Cefprozil EP Impurity C; Cefprozil USP Impurity C; (6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-8-oxo-3-[(E)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefprozil Impurity 3
EINECS	Contact for details

Quality Control

Our Cefprozil Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for identity, purity, and related substances. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

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.