Description

Mitiglinide Calcium CAS NO 145525-41-3 is a calcium salt form of the rapid-acting insulin secretagogue, mitiglinide. This high-purity pharmaceutical intermediate is critical for ensuring the efficacy and safety of the final drug product. It is primarily required by manufacturers in the pharmaceutical industry for the synthesis of anti-diabetic medications.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Key building block in the commercial synthesis of mitiglinide-based drugs.
• Type 2 Diabetes Treatment: Used in the formulation of rapid-acting oral hypoglycemic agents to control postprandial blood glucose levels.
• Pharmaceutical Research & Development: Serves as a reference standard and starting material in metabolic disorder research and new drug development.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of branded mitiglinide medications.
• Pre-clinical and Clinical Trial Material: Supplied under controlled conditions for use in studies requiring defined chemical purity.

Basic Information

Item	Detail
Product Name	Mitiglinide Calcium
CAS No.	145525-41-3
Molecular Formula	C19H24N2O3·1/2Ca
Molecular Weight	353.44 (as free acid, C19H24N2O3)
Synonyms	Mitiglinide Calcium Hydrate; Calcium (2S)-2-Benzyl-4-((3aR,7aS)-1H-isoindol-2(3H,3aH,4H,5H,6H,7H,7aH)-yl)-4-oxobutanoate; KAD-1229 Calcium Salt; S 21403 Calcium Salt; Glufast Calcium; (2S)-2-Benzyl-4-((3aR,7aS)-octahydro-2H-isoindol-2-yl)-4-oxobutanoic Acid Calcium Salt
EINECS	Contact for details

Quality Control

Our Mitiglinide Calcium is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use, with comprehensive analytical methods including HPLC for assay and impurity profiling. A Certificate of Analysis (COA) detailing identity, purity, and related substances is provided with every shipment.

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 nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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