Description

Imipenem is a broad-spectrum, β-lactam antibiotic belonging to the carbapenem class, renowned for its potent activity against a wide range of Gram-positive and Gram-negative bacteria, including many multi-drug resistant strains. Its primary value lies in its critical role as an active pharmaceutical ingredient (API) in life-saving combination therapies for severe hospital-acquired infections. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) involved in producing sterile injectable formulations. Consistent quality and reliable supply are paramount for this key therapeutic agent.

Application

• Pharmaceutical API: Primary use as the active ingredient in combination with cilastatin (as Imipenem/Cilastatin) for intravenous and intramuscular injectable formulations.
• Hospital Infection Treatment: Critical for treating severe infections such as pneumonia, sepsis, intra-abdominal infections, and complicated urinary tract infections caused by susceptible organisms.
• Antibacterial Research: Serves as a reference standard and key intermediate in microbiological research and the development of new antibacterial agents.
• Generic Drug Manufacturing: Used by manufacturers producing generic versions of branded carbapenem antibiotic products.
• Veterinary Medicine: Applied in advanced veterinary settings for treating serious bacterial infections in animals.

Basic Information

Product Name	Imipenem
CAS No.	64221-86-9
Molecular Formula	C12H17N3O4S•H2O
Molecular Weight	317.36 g/mol (Anhydrous: 299.35)
Synonyms	Imipenem Monohydrate; (5R,6S)-3-[[2-(Formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate; N-Formimidoylthienamycin monohydrate; MK-0787; Primaxin (brand name, with cilastatin); IMI; IMP
EINECS	Contact for details

Quality Control

Our Imipenem is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. We provide Certificates of Analysis (COA) detailing key parameters such as assay, related substances, water content, and residual solvents. Specifications can be aligned with relevant pharmacopeial standards (e.g., USP, EP) upon request to support your regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	4.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH limits
Specific Rotation	+84° to +92°
Bacterial Endotoxins	< 0.17 EU/mg
Sterility	Sterile (for sterile grade)

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