Description

Imipenem Impurity 4 is a specified impurity and degradation product of the broad-spectrum carbapenem antibiotic, Imipenem. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the quality control and analytical validation of Imipenem drug substances and finished products. It is primarily required by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology sectors for method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Imipenem API and formulations.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Quality Control & Batch Release: A critical component in the QC testing of Imipenem to ensure it meets pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers with agencies like the FDA and EMA.
• Research on Degradation Pathways: Used in studies to elucidate the chemical degradation mechanisms of Imipenem.

Basic Information

Product Name	Imipenem Impurity 4
CAS No.	85604-01-9
Molecular Formula	C12H17N3O4S
Molecular Weight	299.35 g/mol
Synonyms	(5R,6S)-3-[(2S)-2-Amino-2-carboxyethyl]sulfanyl-6-[(1R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Imipenem Impurity D; Imipenem Related Compound D; (5R,6S)-6-[(1R)-1-Hydroxyethyl]-3-[(2S)-2-amino-2-carboxyethyl]thio-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Imipenem Open Ring Impurity; Imipenem Degradant
EINECS	Contact for details

Quality Control

Our Imipenem Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by advanced techniques like HPLC and LC-MS. We support compliance with pharmacopeial standards (USP, EP) and ICH guidelines for impurities in new drug substances.

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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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