Description

Repaglinide Impurity 15 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the anti-diabetic drug Repaglinide by serving as a key marker for impurity profiling and analytical method validation. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method development, stability studies, and regulatory compliance for generic drug manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Repaglinide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control and Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Repaglinide API, supporting compliance with pharmacopoeial standards (USP, EP).
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Essential for preparing impurity profiles and analytical data packages required for regulatory filings (e.g., ANDA, DMF) with agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Repaglinide Impurity 15
CAS No.	147769-96-8
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; (S)-Repaglinide Carboxylic Acid Metabolite; AG-EE 623 ZW; Repaglinide Related Compound 15; Repaglinide Acid Metabolite; Repaglinide Impurity F; Repaglinide EP Impurity F; Repaglinide Carboxylate
EINECS	Contact for details

Quality Control

Every batch of Repaglinide Impurity 15 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, test methods, and traceability.

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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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