Description

Imipenem-Cilastatin Sodium Hydrate is a sterile, lyophilized combination of a potent broad-spectrum carbapenem antibiotic and a renal dehydropeptidase inhibitor. This synergistic formulation is critical for combating severe and multi-drug resistant bacterial infections by ensuring therapeutic antibiotic levels are maintained. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the production of injectable antibacterial formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of sterile injectable antibiotic formulations.
• Treatment of Severe Infections: Used in drugs targeting complicated intra-abdominal infections, urinary tract infections, lower respiratory tract infections, and septicemia.
• Hospital-Acquired (Nosocomial) Infections: Critical for managing infections caused by multi-drug resistant organisms like Pseudomonas aeruginosa and Acinetobacter species.
• Empirical Therapy: Serves in broad-spectrum antibiotic combinations for life-threatening infections before specific pathogens are identified.
• Research & Development: Used in microbiological studies, antibiotic resistance research, and development of new combination therapies.
• Veterinary Medicine: Potential application in treating serious bacterial infections in animals under strict veterinary supervision.

Basic Information

Product Name	Imipenem-Cilastatin Sodium Hydrate
CAS No.	92309-29-0
Molecular Formula	C12H17N3O4S•C16H25N2O5S•Na•xH2O
Molecular Weight	Imipenem (anhydrous): 299.35 g/mol; Cilastatin Sodium (anhydrous): 380.42 g/mol
Synonyms	Imipenem and Cilastatin Sodium; Imipenem-Cilastatin Sodium; Imipenem Monohydrate and Cilastatin Sodium; (5R,6S)-3-[[2-(Formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid compound with (Z)-7-[(R)-2-amino-2-carboxyethyl]thio]-2-[[(S)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid sodium salt; Primaxin (Brand Name); Tienam; Zienam
EINECS	Contact for details

Quality Control

Our Imipenem-Cilastatin Sodium Hydrate is manufactured under strict cGMP conditions, ensuring compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes rigorous analytical testing including HPLC for assay and impurity profiling, sterility testing, bacterial endotoxin testing, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) documenting all specifications is provided with every shipment to guarantee traceability and quality assurance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a freezer at or below -20°C to ensure long-term stability. Under these conditions, the product is typically stable for 24-36 months from the date of manufacture. The container must be kept dry due to the hygroscopic nature of the material. Allow the sealed container to equilibrate to room temperature before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder or crystalline mass
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	90.0% - 102.0% (on anhydrous basis)
Imipenem Content	47.5% - 52.5%
Cilastatin Sodium Content	47.5% - 52.5%
Water Content (KF)	≤ 2.0%
pH (in solution)	6.5 - 8.5
Specific Optical Rotation	+85° to +95°
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 1.0%
Bacterial Endotoxins	< 0.17 EU/mg
Sterility	Sterile

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