Description

Biapenem Impurity 7 is a specified impurity of the carbapenem antibiotic Biapenem, identified by the CAS registry number 1080648-58-3. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity during drug substance manufacturing. It is an essential material for quality assurance laboratories, analytical method development, and regulatory compliance submissions within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Biapenem drug substance and finished products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability and identification standard in routine QC testing of active pharmaceutical ingredients (APIs).
• Stability Studies: Employed to monitor the formation and level of this specific impurity under various stress and shelf-life conditions.
• Regulatory Compliance and Filing: Essential for preparing impurity profiles and supporting documentation for regulatory submissions (e.g., to FDA, EMA).
• Research on Degradation Pathways: Used in forced degradation studies to understand the chemical behavior and stability of Biapenem.

Basic Information

Product Name	Biapenem Impurity 7
CAS No.	1080648-58-3
Molecular Formula	C15H21N5O4S2
Molecular Weight	423.49 g/mol
Synonyms	(1R,5S,6S)-6-[(1R)-1-Hydroxyethyl]-2-[(3S,5S)-5-[(sulfamoylamino)methyl]pyrrolidin-3-yl]thio-1-methyl-1-carbapen-2-em-3-carboxylic acid; Biapenem Related Compound 7; LJC 11,036 Impurity 7; (4R,5S,6S)-3-[[(3S,5S)-5-[(Aminosulfonylamino)methyl]-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

Every batch of Biapenem Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC, Area %)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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