Description

Cilastatin-15N-D3 is a stable isotope-labeled analog of the renal dehydropeptidase inhibitor Cilastatin, specifically enriched with nitrogen-15 and deuterium. This compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories developing and validating LC-MS/MS assays for Cilastatin and Imipenem/Cilastatin combination therapies.

Application

• Quantitative Bioanalysis: Serves as a high-purity internal standard for the precise quantification of Cilastatin in biological matrices (plasma, serum, urine) via LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and non-clinical research.
• Method Development & Validation: Critical for establishing robust, sensitive, and selective analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Metabolite Identification & Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based studies.
• DMPK (Drug Metabolism and Pharmacokinetics) Research: Used in discovery and development stages to understand the in-vivo behavior of β-lactamase inhibitor combinations.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and assay validation for Cilastatin active pharmaceutical ingredient (API).

Basic Information

Item	Details
Product Name	Cilastatin-15N-D3
CAS No.	2738376-83-3
Molecular Formula	C16H23D315N2O5S
Molecular Weight	~ 380.48 g/mol (Contact for exact value)
Synonyms	(Z)-7-[[(2-Amino-2-carboxyethyl)thio]-15N]-2-[[(2,2-dimethylcyclopropyl)carbonyl]amino]-2-heptenoic-3,3,4,4-d4 Acid; Cilastatin (15N, d3); Cilastatin-15N,d3; Deuterated and 15N-Labeled Cilastatin; MK-0791-15N,d3; Isotopically Labeled Cilastatin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Cilastatin-15N-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive testing including HPLC for chemical purity, NMR and MS for isotopic enrichment and positional verification, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. The product is hygroscopic (moisture-sensitive); allow the vial to equilibrate to room temperature in a dry environment before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (15N)	≥ 98 atom % 15N
Isotopic Purity (D)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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