Description

Repaglinide Impurity 16 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the anti-diabetic drug Repaglinide, ensuring the safety and efficacy of the final pharmaceutical product. It is primarily utilized by analytical laboratories, quality assurance departments, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Repaglinide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global regulatory requirements.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research & Development: Used in metabolic studies and to understand the degradation pathways of Repaglinide.

Basic Information

Product Name	Repaglinide Impurity 16
CAS No.	219921-93-4
Molecular Formula	C27H33N3O4
Molecular Weight	463.57 g/mol
Synonyms	(2S)-2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic acid; Repaglinide Related Compound 16; Repaglinide EP Impurity G; Repaglinide USP Impurity; Prandin Impurity; S-(-)-Enantiomer of Repaglinide Carboxylic Acid Metabolite
EINECS	Contact for details

Quality Control

Every batch of Repaglinide Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced analytical techniques. Certificates of Analysis (COA) detailing batch-specific results are available upon request, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent absorption of atmospheric moisture, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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%
Residue on Ignition	≤ 0.1%

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