Description

Faropenem Related Compound 2 is a high-purity chemical reference standard, identified by CAS No. 429691-43-0, which is critical for ensuring the quality and safety of the antibiotic faropenem. This compound serves as a key impurity marker in pharmaceutical development and manufacturing, enabling precise analytical control. It is essential for quality assurance laboratories, regulatory compliance teams, and research institutions focused on antibiotic production and validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Faropenem API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files.
• Stability Studies: Employed as a benchmark to monitor degradation pathways and establish shelf-life specifications for faropenem formulations.
• Research & Development: Facilitates studies on the synthesis pathways, metabolism, and degradation chemistry of β-lactam antibiotics.
• Quality Control Testing: Integral for routine batch release testing to ensure pharmaceutical products meet stringent purity specifications.

Basic Information

Product Name	Faropenem Related Compound 2
CAS No.	429691-43-0
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 2; Faropenem Related Substance 2; (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 B; Faropenem Intermediate; β-lactam Impurity Standard.
EINECS	Contact for details

Quality Control

Our Faropenem Related Compound 2 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation via spectroscopic methods. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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