Description

2-Desisopropyl-2-Phenyl Repaglinide-D5 is a high-purity, deuterated impurity standard used in the analytical development and quality control of the antidiabetic drug Repaglinide. This compound is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of related substances. It is an essential reference material for analytical chemists and quality assurance professionals in pharmaceutical research, development, and manufacturing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of process-related impurities and degradation products in Repaglinide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Repaglinide.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Repaglinide under various stress conditions.
• Metabolite Studies & DMPK: The deuterated (D5) label makes it valuable as an internal standard in mass spectrometry for pharmacokinetic, bioavailability, and metabolite identification studies, improving analytical accuracy.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization of the drug substance.

Basic Information

Product Name	2-Desisopropyl-2-Phenyl Repaglinide-D5 (Repaglinide Impurity)
CAS No.	1346598-75-1
Molecular Formula	C23H23D5N2O3
Molecular Weight	~ 382.53 g/mol
Synonyms	Repaglinide Desisopropyl Phenyl Impurity D5; Repaglinide Related Compound D5; 2-[(2-Piperidin-1-yl)phenyl]acetyl]-3-(deuteriomethyl)butanoic Acid-d5; 2-Desisopropyl-2-phenyl Repaglinide Deuterated; Repaglinide Impurity D (D5); Repaglinide EP Impurity D (D5); Repaglinide USP Related Compound D5
EINECS	Contact for details

Quality Control

Every batch of 2-Desisopropyl-2-Phenyl Repaglinide-D5 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 applications. A comprehensive Certificate of Analysis (COA), detailing results from HPLC, NMR, and MS analyses, is provided with each shipment to support your regulatory and quality needs.

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. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Deuteration Degree (D5)	≥ 95 atom % D
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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