Description

Faropenem Related Compound 1 is a high-purity chemical reference standard, specifically identified as a related substance of the antibiotic Faropenem. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily utilized by quality assurance laboratories, research institutions, and regulatory bodies involved in the production and analysis of β-lactam antibiotics to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Faropenem drug substance and finished pharmaceutical products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor related substances.
• Quality Control (QC) Testing: Employed in routine QC laboratories to confirm the specificity and accuracy of assays for Faropenem, ensuring batch-to-batch consistency.
• Regulatory Compliance & Submission: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used to track the formation of degradation products in Faropenem formulations under various stress conditions.
• Research & Development: Supports metabolic and pharmacokinetic studies by helping to identify and characterize related compounds in biological matrices.

Basic Information

Product Name	Faropenem Related Compound 1
CAS No.	106560-32-1
Molecular Formula	C12H15NO5S
Molecular Weight	285.32 g/mol
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 Impurity; Faropenem Related Substance 1; (5R,6S)-6-[(1R)-1-Hydroxyethyl]-7-oxo-3-[(2R)-tetrahydro-2-furanyl]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Faropenem EP Impurity C; Faropenem Intermediate
EINECS	Contact for details

Quality Control

Every batch of Faropenem Related Compound 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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