Henagliflozin API | Henagliflozin Pharmaceutical API Manufacturer in India

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Henagliflozin API

Henagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor developed as an oral antihyperglycemic agent. SGLT2 is responsible for the majority of glucose reabsorption in the proximal renal tubules. By inhibiting this transporter, henagliflozin increases urinary glucose excretion and reduces blood glucose levels.

Henagliflozin has been investigated for the management of type 2 diabetes mellitus and related metabolic conditions.

Henagliflozin API Manufacturer in India

Henagliflozin is a specialized small-molecule pharmaceutical API requiring controlled chemical synthesis, purification and comprehensive analytical characterization. API quality control focuses on identity, assay, related substances, residual solvents, water content and other physicochemical parameters.

Chemical Information

CAS Number: 1326035-59-5
Molecular Formula: C24H23ClO6
Molecular Weight: 442.89 g/mol
Drug Class: SGLT2 Inhibitor
Therapeutic Class: Antidiabetic Agent
Therapeutic Area: Endocrinology / Metabolic Disorders

Mechanism of Action

Henagliflozin selectively inhibits SGLT2, a transporter expressed mainly in the proximal renal tubules. Inhibition decreases renal glucose reabsorption and increases urinary glucose excretion.

This insulin-independent mechanism contributes to lowering plasma glucose concentrations.

Pharmaceutical Applications

Henagliflozin has been developed primarily for the treatment of:

  • Type 2 diabetes mellitus
  • Hyperglycemia associated with type 2 diabetes

Its clinical use and approved indications depend on the regulatory status and applicable product labeling in individual markets.

Henagliflozin in Type 2 Diabetes

SGLT2 inhibition provides an insulin-independent pathway for glucose reduction. By promoting urinary glucose elimination, henagliflozin can improve glycemic control while its pharmacological class may also influence body weight and blood pressure through osmotic diuresis and natriuresis.

Physical and Chemical Properties

Henagliflozin is a synthetic, relatively lipophilic small molecule containing a chlorinated aromatic structure and multiple hydroxyl groups. It is generally handled as a crystalline pharmaceutical solid and has limited aqueous solubility.

Quality and Analytical Testing

Henagliflozin API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Enantiomeric purity
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Particle-size analysis
  • Melting range

Storage

Henagliflozin should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage requirements should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Henagliflozin is relevant to pharmaceutical research involving SGLT2 inhibition, glucose reabsorption, renal glucose handling and type 2 diabetes management.

Henagliflozin API Summary

Henagliflozin is an oral SGLT2 inhibitor with CAS Number 1326035-59-5, molecular formula C24H23ClO6, and molecular weight 442.89 g/mol. Its mechanism is based on inhibition of renal glucose reabsorption, thereby increasing urinary glucose excretion and reducing blood glucose.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
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 2.0%
Water Content NMT 1.0%
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