Description

Mitiglinide Calcium Dihydrate is a high-purity active pharmaceutical ingredient (API) primarily used in the treatment of type 2 diabetes. This compound matters as a potent and fast-acting insulin secretagogue, offering precise glycemic control for patients. Pharmaceutical manufacturers and research institutions globally require this API for the formulation of anti-diabetic medications and for advanced metabolic research.

Application

• Primary Pharmaceutical Ingredient: Core active component in the formulation of oral anti-diabetic tablets and capsules.
• Clinical Research Material: Used in preclinical and clinical studies investigating new diabetes therapies and combination treatments.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical labs.
• Metabolic Disorder Research: Key reagent in biochemical research focused on insulin secretion mechanisms and pancreatic β-cell function.
• Generic Drug Manufacturing: Essential for companies producing generic versions of mitiglinide-based medications.
• Drug Delivery System Development: Used in R&D for novel drug delivery systems aiming to optimize the pharmacokinetic profile of mitiglinide.

Basic Information

Product Name	Mitiglinide Calcium Dihydrate
CAS No.	207844-01-7
Molecular Formula	C19H26CaN2O7 • 2H2O
Molecular Weight	494.55 g/mol
Synonyms	Mitiglinide Calcium Salt Dihydrate; Calcium (2S)-2-benzyl-4-((3aR,7aS)-octahydro-2H-isoindol-2-yl)-4-oxobutanoate dihydrate; KAD-1229; S 21403; Glufast (brand name basis); Fast-acting insulin secretagogue; Nateglinide analogue
EINECS	Contact for details

Quality Control

Our Mitiglinide Calcium Dihydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) confirming compliance with in-house specifications are provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	6.0% - 8.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with Ph. Eur. 2.6.12/2.6.13

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