Description

Repaglinide Impurity Iv is a designated impurity standard used in the pharmaceutical development and quality control of the anti-diabetic drug Repaglinide. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation (HPLC, LC-MS).
• Critical component in impurity profiling and stability-indicating assays for Repaglinide drug substance and finished dosage forms.
• Essential for quality control (QC) and batch release testing in pharmaceutical manufacturing to meet ICH guidelines.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development (R&D) for studying degradation pathways and process optimization.
• Serves as a calibrant in quantitative analysis to ensure accurate impurity measurement.

Basic Information

Product Name	Repaglinide Impurity Iv
CAS No.	646054-50-4
Molecular Formula	C27H32N2O4
Molecular Weight	448.56 g/mol
Synonyms	(S)-2-Ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid; (S)-Repaglinide Impurity IV; Repaglinide Related Compound IV; Repaglinide EP Impurity D; Repaglinide USP Impurity D; 2-Ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid (S-enantiomer); (S)-Enantiomer of Repaglinide Carboxylic Acid Metabolite
EINECS	Contact for details

Quality Control

Every batch of Repaglinide Impurity Iv is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability meet the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
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.