Description

Mitiglinide Impurity 4 is a designated impurity standard of the anti-diabetic drug Mitiglinide, essential for pharmaceutical research and development. This compound is critical for ensuring drug safety and efficacy by serving as a reference marker in analytical method development and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for impurity profiling, stability studies, and compliance testing.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Mitiglinide-related impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for drug substance and product testing.
• Essential for conducting stability studies and degradation pathway elucidation of Mitiglinide formulations.
• Used in pharmaceutical quality control (QC) and quality assurance (QA) laboratories to monitor batch-to-batch consistency.
• Serves as a key impurity marker for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Valuable for research and development in synthetic chemistry to understand and control impurity formation.

Basic Information

Product Name	Mitiglinide Impurity 4
CAS No.	204187-39-3
Molecular Formula	C19H25NO4
Molecular Weight	331.41 g/mol
Synonyms	Mitiglinide Related Compound 4; (2S)-2-Benzyl-4-((3aR,7aS)-1,3a,5,7a-tetrahydro-4H-isoindol-4-yl)-4-oxobutanoic Acid; (S)-2-Benzyl-4-((3aR,7aS)-octahydro-1H-isoindol-4-yl)-4-oxobutanoic Acid; Mitiglinide EP Impurity D; Mitiglinide USP Impurity D; KAD-1229 Impurity 4; S 21403 Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Mitiglinide Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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