Description

Repaglinide Ep Impurity E is a high-purity reference standard critical for analytical method development and validation in pharmaceutical manufacturing. This compound serves as a specified impurity for the antidiabetic drug Repaglinide, enabling precise quality control and ensuring final product safety and efficacy. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Repaglinide EP Impurity E in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug substance synthesis and purification processes.
• Quality Control & Assurance: Used in routine QC testing to ensure Repaglinide batches comply with stringent pharmacopeial specifications (e.g., EP, USP) for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and method validation reports.
• Research & Development: Facilitates studies on the degradation pathways, stability, and formation mechanisms of impurities in Repaglinide.
• Calibration and System Suitability: Serves as a system suitability test component to ensure the performance and precision of chromatographic systems used in impurity analysis.

Basic Information

Product Name	Repaglinide Ep Impurity E
CAS No.	147852-26-4
Molecular Formula	C27H36N2O4
Molecular Weight	452.59 g/mol
Synonyms	(S)-2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid; Repaglinide Impurity E; Repaglinide Related Compound E; AG-EE 623 ZW; S-2-Ethoxy-4-(2-((3-methyl-1-(2-(piperidin-1-yl)phenyl)butyl)amino)-2-oxoethyl)benzoic Acid; European Pharmacopoeia Impurity E; (S)-Repaglinide Carboxylic Acid Metabolite
EINECS	Contact for details

Quality Control

Every batch of Repaglinide Ep Impurity E is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the exacting requirements of pharmaceutical reference standard users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per in-house specifications aligned with pharmacopeial guidelines.

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 material is hygroscopic (moisture-sensitive) and should be handled 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 spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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