Description

Imipenem Impurity 3 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 analytical characterization and quality control of Imipenem drug substances and finished products. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Imipenem API and formulations.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for stability-indicating assays.
• Essential for conducting stability studies and forced degradation studies to understand Imipenem's degradation pathways.
• Used in quality control (QC) laboratories to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (USP, EP, ICH).
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity profiling data.
• Valuable for academic and industrial research into the chemistry, metabolism, and degradation of carbapenem antibiotics.

Basic Information

Product Name	Imipenem Impurity 3
CAS No.	130792-44-8
Molecular Formula	C12H17N3O4S
Molecular Weight	299.35 g/mol
Synonyms	(5R,6S)-3-[(2-{[(3S,5S)-5-[(Dimethylamino)carbonyl]-3-pyrrolidinyl]thio}ethyl)thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Imipenem Open-ring Impurity; Imipenem Degradation Product; Imipenem Related Compound C; Imipenem δ-2 Isomer (in part); N-Formimidoyl Thienamycin Impurity
EINECS	Contact for details

Quality Control

Every batch of Imipenem Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 material 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%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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