Description

(R,R)-Cilastatin CAS NO 107872-23-1 is a high-purity, stereochemically defined pharmaceutical intermediate and active ingredient. This compound is critically important as a renal dehydropeptidase-I inhibitor, used to prevent the degradation of certain β-lactam antibiotics in the kidneys. It is essential for manufacturers in the pharmaceutical industry developing combination antibiotic therapies, particularly for injectable formulations. Its specific stereochemistry is vital for ensuring optimal biological activity and therapeutic efficacy.

Application

• Pharmaceutical Active Ingredient (API): Primary use as a component in combination antibiotic drugs, most notably paired with imipenem.
• Renal Protection Agent: Inhibits the enzymatic breakdown of co-administered carbapenem antibiotics in the renal tubules, increasing their urinary concentration and efficacy.
• Sterile Injectable Formulations: Used in the production of lyophilized powders or solutions for intravenous administration.
• Research & Development: Serves as a critical reference standard and building block in antimicrobial research and new drug development programs.
• GMP Manufacturing: Supplied as a raw material for the production of finished dosage forms under Good Manufacturing Practice (GMP) guidelines.
• Veterinary Pharmaceuticals: Applied in advanced veterinary medicines for treating serious bacterial infections in animals.

Basic Information

Product Name	(R,R)-Cilastatin
CAS No.	107872-23-1
Molecular Formula	C16H26N2O5S
Molecular Weight	358.46 g/mol
Synonyms	(R,R)-Cilastatin; (R,R)-Cilastatin Sodium; (Z)-7-[[(2R,3R)-2-[(Hydroxymethyl)-1-oxo-3-[(2-thienylacetyl)amino]-4-azabutylidene]amino]oxy]heptanoic Acid; MK-0791; Cilastatin (R,R)-isomer; Sodium (R,R)-Cilastatin; Dehydropeptidase Inhibitor I; Primaxin component
EINECS	Contact for details

Quality Control

Our (R,R)-Cilastatin is manufactured and tested to meet stringent pharmaceutical-grade standards. Each batch is subjected to comprehensive analytical testing, including chiral purity verification, to ensure identity, potency, and purity. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) documenting compliance with in-house specifications are available for every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (HPLC)	≥ 99.0% (R,R)-isomer
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61> requirements

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