Description

2-Desisopropyl-2-Phenyl Repaglinide is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of the antidiabetic drug Repaglinide. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on metabolic disorder therapeutics and advanced process chemistry.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the antidiabetic API Repaglinide.
• Reference Standard: Used as an impurity standard in HPLC and other chromatographic methods for quality control of Repaglinide batches.
• Process Development & Research: Employed in route scouting, process optimization, and scale-up studies for Repaglinide manufacturing.
• Analytical Method Development: Serves as a critical component for developing and validating stability-indicating assay methods.
• Regulatory Compliance: Essential for preparing documentation and impurity profiles required for regulatory submissions (e.g., FDA, EMA).
• Metabolite Studies: Used in research investigating the pharmacokinetics and metabolic pathways of Repaglinide.

Basic Information

Product Name	2-Desisopropyl-2-Phenyl Repaglinide
CAS No.	107362-12-9
Molecular Formula	C24H28N2O3
Molecular Weight	392.49 g/mol
Synonyms	2-Desisopropyl-2-phenyl Repaglinide; Desisopropyl Phenyl Repaglinide; Repaglinide Desisopropyl Phenyl Impurity; Repaglinide Impurity D; AG-EE 623 ZS; (S)-2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid
EINECS	Contact for details

Quality Control

Our 2-Desisopropyl-2-Phenyl Repaglinide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical impurity standards and intermediates. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with customer specifications and relevant ICH guidelines.

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 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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