Description

Cefepime Impurity A CAS NO 97164-57-3 is a critical pharmaceutical reference standard used for the identification and quantification of related substances in the active pharmaceutical ingredient (API) Cefepime. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of Cefepime-based injectable antibiotics.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the precise identification and quantification of Cefepime Impurity A in bulk drug substances and finished pharmaceutical products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity qualification and establishing specification limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Research and Development (R&D): Used in synthetic chemistry research to study the degradation pathways of Cefepime and to develop improved manufacturing processes with lower impurity levels.
• Pharmacopoeial Standards: Acts as a reference compound for testing against monographs in pharmacopoeias such as USP, EP, or BP where Cefepime and its impurities are specified.

Basic Information

Product Name	Cefepime Impurity A
CAS No.	97164-57-3
Molecular Formula	C19H25N6O5S2
Molecular Weight	481.57 g/mol
Synonyms	(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; 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; Cefepime Related Compound A; Cefepime EP Impurity A; Cefepime USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Cefepime Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of residual solvents and moisture content. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with pharmacopoeial standards. Our quality commitment ensures the material's suitability for its intended use in regulatory and analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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