Description

Faropenem Impurity 7 is a specified impurity and degradation product of the antibiotic Faropenem. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Faropenem drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Faropenem API and formulations.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) documents by providing impurity characterization data.
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Faropenem Impurity 7
CAS No.	120705-68-2
Molecular Formula	C12H15NO5S
Molecular Weight	285.32 g/mol
Synonyms	(5R,6S)-2-[(R)-1-Hydroxyethyl]-6-[(R)-1-sulfomethyl-2-oxo-3-pyrrolidinyl]carbamoylpenem-3-carboxylic Acid; Faropenem Related Compound B; Faropenem Open β-Lactam Ring Impurity; Faropenem Degradant; (5R,6S)-6-[(1R)-1-Hydroxyethyl]-7-oxo-3-[(2R)-2-sulfomethyl-5-oxo-1-pyrrolidinyl]carbamoyl-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Faropenem Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, NMR, and mass spectrometry confirmation. We adhere to relevant ICH guidelines and can support compliance with cGMP standards for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or desiccated conditions after opening to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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