Description

Biapenem Impurity 33 is a specified impurity of the carbapenem antibiotic Biapenem, identified by the CAS registry number 141499-33-4. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for quality assurance laboratories, analytical method development, and regulatory compliance activities within the pharmaceutical industry, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Biapenem API and related drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and stability studies.
• Quality Control and Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against established specifications.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to define impurity limits and justify the control strategy.
• Stability Studies: Employed to track the formation and growth of this specific degradant under various stress conditions (e.g., heat, humidity, light).
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and improve manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Biapenem Impurity 33
CAS No.	141499-33-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5R,6S)-6-[(1R)-1-Hydroxyethyl]-3-[[(3S,5S)-5-[(sulfamoylamino)methyl]-3-pyrrolidinyl]thio]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Biapenem Related Compound 33; LJC 11,036 Impurity 33; Biapenem EP Impurity C; Biapenem USP Impurity C
EINECS	Contact for details

Quality Control

Our Biapenem Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.