Nateglinide Hydrochloride, commonly referred to as Nateglinide HCl, is a pharmaceutical active ingredient belonging to the meglitinide class of insulin secretagogues. It is a short-acting oral antidiabetic compound used in pharmaceutical formulations for the management of type 2 diabetes mellitus.
Nateglinide stimulates insulin secretion from pancreatic β-cells in response to elevated blood glucose concentrations. Its relatively rapid onset and short duration of action make it particularly associated with control of postprandial blood glucose levels.
Nateglinide HCl is a synthetic small-molecule pharmaceutical ingredient relevant to diabetes-focused formulation development, analytical testing and pharmaceutical research.
Nateglinide HCl is a well-characterized antidiabetic pharmaceutical API used in the development and manufacture of oral solid dosage formulations.
Important API quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable pharmaceutical quality parameters.
CAS Number: 105816-04-4
Molecular Formula: C19H27NO3·HCl
Molecular Weight: 357.88 g/mol
Chemical Name: Nateglinide hydrochloride
Drug Class: Meglitinide / Insulin Secretagogue
Therapeutic Class: Antidiabetic
Therapeutic Area: Diabetology / Endocrinology
Molecule Type: Synthetic Small Molecule
Nateglinide acts primarily on pancreatic β-cells to stimulate insulin secretion.
Its pharmacological activity includes:
Nateglinide has a rapid insulin-secretory effect and is particularly associated with controlling post-meal glucose excursions.
Nateglinide HCl API is relevant to:
Nateglinide is an oral insulin secretagogue used in pharmaceutical formulations for the management of type 2 diabetes mellitus.
It promotes insulin secretion from pancreatic β-cells and is particularly useful for addressing increases in blood glucose following meals. Its short-acting pharmacological profile differentiates it from longer-acting insulin secretagogues.
The precise therapeutic use, formulation and regulatory status should be determined according to the applicable regulatory requirements and approved product information in each market.
Nateglinide belongs to the meglitinide class of insulin secretagogues.
Meglitinides act relatively rapidly on pancreatic β-cells and stimulate insulin secretion. Nateglinide's pharmacological profile is therefore associated particularly with meal-related glucose control.
Nateglinide Hydrochloride is generally described as a white to off-white crystalline powder. Its physicochemical properties, particle characteristics and solid-state form should be controlled according to the applicable pharmaceutical/API specification.
The hydrochloride form should be distinguished from Nateglinide, which has a different chemical composition and molecular weight.
A controlled Nateglinide HCl API manufacturing process may involve:
Typical Nateglinide HCl API testing may include:
Store Nateglinide HCl API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Final storage conditions should be established according to validated stability data and the applicable API specification.
Nateglinide HCl is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |