Description

Cilastatin Sodium is a potent and specific renal dehydropeptidase-I inhibitor used in combination with β-lactam antibiotics to prevent their renal metabolism and degradation. This compound is critical for enhancing the efficacy and pharmacokinetic profile of co-administered antibiotics, such as imipenem, by protecting them from inactivation in the kidney. It is an essential pharmaceutical intermediate and active pharmaceutical ingredient (API) for manufacturers in the global pharmaceutical industry, particularly for producing combination injectable antibiotics.

Application

• Primary use as a pharmaceutical intermediate in the synthesis of combination antibiotic drugs.
• Critical component in the formulation of imipenem/cilastatin sodium for injection, a broad-spectrum carbapenem antibiotic.
• Used in research and development of novel β-lactamase inhibitor combinations.
• Employed in pharmacokinetic studies to understand renal drug metabolism.
• Essential raw material for API manufacturers supplying the hospital and clinical sectors.
• Potential applications in veterinary medicine for treating serious bacterial infections.

Basic Information

Product Name	Cilastatin Sodium
CAS No.	81129-83-1
Molecular Formula	C16H25N2NaO5S
Molecular Weight	380.44 g/mol
Synonyms	(Z)-7-[(2-Amino-2-carboxyethyl)thio]-2-[[(1S)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid sodium salt; MK-0791 sodium; Sodium cilastatin; Cilastatin Na; (Z)-Sodium 7-((2-amino-2-carboxyethyl)thio)-2-(((S)-2,2-dimethylcyclopropane-1-carbonyl)amino)hept-2-enoate; Imipenem/Cilastatin component; Dehydropeptidase inhibitor I sodium salt
EINECS	Contact for details

Quality Control

Our Cilastatin Sodium is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing parameters such as assay, related substances, residual solvents, and microbiological quality. We can supply material compliant with pharmaceutical grade specifications, and support documentation for regulatory submissions.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
pH (5% solution)	6.0 - 8.0
Specific Rotation	-85° to -95° (c=1 in H2O)
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.17 EU/mg (if applicable)
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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