Description

Cilastatin Ammonium Salt is a high-purity pharmaceutical intermediate and a potent, specific inhibitor of renal dehydropeptidase-I (DHP-I). This compound is critical for enhancing the efficacy and safety of certain β-lactam antibiotics by preventing their renal metabolism. It is primarily utilized by manufacturers in the pharmaceutical industry for the synthesis of combination antibiotic drugs, particularly in sterile injectable formulations.

Application

• Pharmaceutical Synthesis: Key intermediate in the production of combination antibiotic therapies, most notably with imipenem.
• Renal Dehydropeptidase Inhibition: Used in research and development to study and inhibit the renal metabolism of carbapenem and other β-lactam antibiotics.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a critical component in the formulation of finished dosage forms for intravenous administration.
• Biochemical Research: Employed as a tool compound in pharmacological and enzymatic studies targeting DHP-I activity.
• Reference Standard: Used in quality control laboratories as a high-purity standard for analytical method development and validation.

Basic Information

Product Name	Cilastatin Ammonium Salt
CAS No.	877674-82-3
Molecular Formula	C16H26N2O5S • xNH3
Molecular Weight	380.46 (for free acid, C16H26N2O5S)
Synonyms	(Z)-7-[[(2-Amino-2-carboxyethyl)thio]-2-[[(1S)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid ammonium salt; Cilastatin ammonium; MK-0791 ammonium salt; Dehydropeptidase Inhibitor; Cilastatin (ammonium); Cilastatin monoammonium salt
EINECS	Contact for details

Quality Control

Our Cilastatin Ammonium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and tests for residual solvents and heavy metals, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) compliant with cGMP standards are available upon request.

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 under inert conditions or in a desiccator after opening to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Bacterial Endotoxins	< 0.05 EU/mg (for injectable grade)

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