Description

Faropenem Impurity CAS NO 613670-77-2 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 during its development and manufacturing. It serves as a key marker for impurity profiling and method validation in pharmaceutical quality control laboratories. Researchers and QC professionals in the pharmaceutical and fine chemical industries rely on this standard to maintain stringent product specifications.

Application

This impurity standard is essential in various pharmaceutical development and quality assurance processes:

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify related substances in Faropenem drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control.
• Quality Control (QC) Testing: Used in routine batch release testing to ensure Faropenem APIs and formulations meet established purity specifications.
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by identifying and tracking synthetic by-products.

Basic Information

Product Name	Faropenem Impurity
CAS No.	613670-77-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(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; Faropenem Related Compound; Faropenem Degradant; Faropenem Process Impurity; Faropenem Intermediate; Antibiotic Impurity Standard; β-Lactam Impurity.
EINECS	Contact for details

Quality Control

Every batch of Faropenem Impurity CAS 613670-77-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and precise impurity quantification. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and analytical results is provided with each shipment to support your regulatory and research 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider using desiccants.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.