Description

Cilastatin Sodium Impurity E(Ep) is a specified impurity and reference standard used in the quality control of the antibiotic combination drug, Imipenem/Cilastatin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cilastatin Sodium Impurity E(Ep) in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Cilastatin Sodium to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.

Basic Information

Product Name	Cilastatin Sodium Impurity E(Ep)
CAS No.	1174657-07-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cilastatin Impurity E (Epimer); Cilastatin EP Impurity E; (Z)-7-(((2-Amino-2-carboxyethyl)thio)-2-(((1S)-2,2-dimethylcyclopropyl)carbonyl)amino)hept-2-enoic Acid Epimer; Sodium (Z)-7-(((2-Amino-2-carboxyethyl)thio)-2-(((1S)-2,2-dimethylcyclopropyl)carbonyl)amino)hept-2-enoate Epimer; Cilastatin Related Compound E
EINECS	Contact for details

Quality Control

Our Cilastatin Sodium Impurity E(Ep) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 5.0%

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