Description

Imipenem Ep Impurity B is a specified impurity 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 utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Imipenem API (Active Pharmaceutical Ingredient).
• Essential component in analytical method development and validation for HPLC, UPLC, and related chromatographic techniques.
• Critical for stability studies and degradation pathway profiling of Imipenem formulations.
• Used in pharmacopoeial testing to comply with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and other international quality standards.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug submissions.
• Valuable for academic and institutional research focused on antibiotic chemistry and impurity synthesis.

Basic Information

Product Name	Imipenem Ep Impurity B
CAS No.	1197869-90-1
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 B; Imipenem Related Compound B; Imipenem EP Impurity B; (5R,6S)-6-[(1R)-1-Hydroxyethyl]-3-[[(2S)-2-amino-1-carboxyethyl]thio]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Imipenem Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications aligned with pharmacopoeial guidelines.

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
Specific Optical Rotation	Contact for details

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