Description

Faropenem Impurity CAS NO 195716-77-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Faropenem. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Faropenem drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and calibrating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine batch testing to ensure Faropenem meets pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of Faropenem formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Faropenem.

Basic Information

Item	Details
Product Name	Faropenem Impurity
CAS No.	195716-77-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Faropenem Related Compound; Faropenem Impurity Standard; (5R,6S)-6-[(1R)-1-Hydroxyethyl]-7-oxo-3-[(2R)-tetrahydrofuran-2-yl]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid impurity; Faropenem EP Impurity; Faropenem USP Impurity; β-Lactam antibiotic impurity
EINECS	Contact for details

Quality Control

Our Faropenem Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

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%
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.