Description

Faropenem Related Compound 4 is a high-purity chemical reference standard, identified by CAS NO 106559-80-2. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Faropenem during its development and manufacturing processes. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and analytical service providers for use in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Faropenem API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for setting impurity acceptance criteria in pharmaceutical QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Faropenem.

Basic Information

Item	Detail
Product Name	Faropenem Related Compound 4
CAS No.	106559-80-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Faropenem Impurity 4; Faropenem Related Substance 4; 5,6-cis-Faropenem; (5R,6S)-6-[(R)-1-Hydroxyethyl]-7-oxo-3-[(R)-tetrahydrofuran-2-yl]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Faropenem Epimer; Faropenem Diastereomer; Penem Derivative Impurity
EINECS	Contact for details

Quality Control

Our Faropenem Related Compound 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data 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). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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