Janagliflozin API | SGLT2 Inhibitor API Manufacturer in India

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Janagliflozin API

Janagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor under development for the treatment of metabolic disorders, particularly type 2 diabetes mellitus. It is designed to reduce renal glucose reabsorption, thereby increasing urinary glucose excretion and lowering blood glucose levels.

Janagliflozin API Manufacturer in India

Janagliflozin is a specialized antidiabetic pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, residue on ignition, polymorphic form and stability.

Chemical Information

CAS Number: 2377614-95-2
Molecular Formula: C24H27ClO7
Molecular Weight: 462.92 g/mol
Drug Class: Antidiabetic Agent
Pharmacological Class: SGLT2 Inhibitor
Therapeutic Class: Sodium-Glucose Cotransporter-2 Inhibitor
Therapeutic Area: Endocrinology / Metabolic Disorders

Mechanism of Action

Janagliflozin selectively inhibits SGLT2, a transporter responsible for most renal glucose reabsorption in the proximal renal tubules.

SGLT2 inhibition:

  • Reduces renal glucose reabsorption
  • Increases urinary glucose excretion
  • Lowers blood glucose
  • Produces a mild osmotic diuretic effect
  • Can contribute to reduced body weight and blood pressure

Pharmaceutical Applications

Janagliflozin is being investigated primarily for:

  • Type 2 diabetes mellitus
  • Glycemic control
  • SGLT2 inhibitor combination therapy
  • Metabolic disease research

As an investigational/development-stage compound in some markets, its approved indications and regulatory status should be confirmed for the applicable jurisdiction.

SGLT2 Inhibitor Characteristics

Janagliflozin belongs to the gliflozin class of glucose-lowering agents. Its mechanism is independent of insulin secretion and instead acts through the kidney by increasing glucose elimination in urine.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of substituted aromatic intermediates
  2. Controlled chemical synthesis
  3. Formation of the glucoside-related structure
  4. Purification
  5. Crystallization
  6. Filtration
  7. Drying
  8. Milling where required
  9. Final analytical testing
  10. Controlled packaging

Quality and Analytical Testing

Janagliflozin API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Organic impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Polymorphic-form characterization
  • Particle-size distribution where required
  • Stability testing

Storage

Janagliflozin should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.

Pharmaceutical Research and Development

Janagliflozin is relevant to research involving:

  • SGLT2 inhibition
  • Type 2 diabetes
  • Renal glucose transport
  • Glycemic control
  • Gliflozin development
  • Metabolic disorders
  • Antidiabetic drug development
  • Combination therapy
  • Cardiometabolic research

Janagliflozin API Summary

Janagliflozin is an SGLT2 inhibitor with CAS Number 2377614-95-2, molecular formula C24H27ClO7, and molecular weight 462.92 g/mol. It acts by inhibiting renal glucose reabsorption and increasing urinary glucose excretion, making it relevant to type 2 diabetes and metabolic-disease research.

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 1.0%
Water Content NMT 1.0%
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