Description

Biapenem Impurity 1 CAS NO 162559-31-1 is a specified impurity of the carbapenem antibiotic Biapenem, used as a critical reference standard in pharmaceutical analysis. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of Biapenem.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Biapenem Impurity 1 in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in compliance with ICH Q3A and Q3B guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Biapenem API and finished formulations meet stringent purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry studies to minimize impurity formation during API synthesis.

Basic Information

Product Name	Biapenem Impurity 1
CAS No.	162559-31-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1R,5S,6S)-2-[(3S,5S)-5-[(S)-3-Hydroxybutyrylamido]pyrrolidin-3-ylthio]-6-[(R)-1-hydroxyethyl]-1-methylcarbapen-2-em-3-carboxylic Acid; Biapenem Related Compound A; LJC 11,036 Impurity; L-627 Impurity; Biapenem EP Impurity A; Biapenem USP Impurity; (4R,5S,6S)-3-[[(3S,5S)-5-[[(2S)-3-Hydroxy-1-oxobutyl]amino]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Biapenem Impurity 1 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC and mass spectrometry. We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with relevant pharmacopeial expectations (USP, EP).

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 handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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