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 a last-line therapeutic agent for severe and life-threatening infections in hospital settings. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing sterile injectable formulations, particularly for use in intensive care units and for immunocompromised patients.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable antibiotic formulations.
• Hospital-Acquired Infections: Treatment of severe infections including pneumonia, septicemia, and complicated urinary tract infections.
• Empirical Therapy: Used for infections where the causative organism is unknown but broad-spectrum coverage is urgently required.
• Combination Therapy: Often formulated with cilastatin sodium to inhibit renal metabolism, enhancing its efficacy and stability in the body.
• Research & Development: Serves as a reference standard and key intermediate in antimicrobial research and the development of new antibiotic compounds.

Basic Information

Product Name	Imipenem
CAS No.	74431-23-5
Molecular Formula	C12H17N3O4S•H2O
Molecular Weight	317.36 g/mol (anhydrous basis)
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 cGMP conditions, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting purity, potency, and conformance to specifications is provided with each shipment to ensure full traceability and quality assurance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or as specified on the label (typically 2-8°C for long-term stability). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.0% - 6.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Specific Optical Rotation	+84° to +92°
Bacterial Endotoxins	< 0.17 EU/mg
Sterility (for sterile grade)	Sterile

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