Losartan Potassium API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Losartan Potassium API

Losartan Potassium is an orally active angiotensin II receptor blocker (ARB) used primarily in the treatment of hypertension. It selectively blocks the binding of angiotensin II to the AT1 receptor, reducing vasoconstriction and aldosterone-mediated effects.

Losartan Potassium is also used in the management of hypertension in certain patients with type 2 diabetes and diabetic nephropathy, and for reducing the risk of stroke in selected patients with hypertension and left ventricular hypertrophy.

Losartan Potassium API Manufacturer in India

Losartan Potassium is an established cardiovascular pharmaceutical API used in the manufacture of tablets and other oral dosage forms.

Important quality attributes include identity, assay, related substances, water content, residue on ignition, specific optical rotation where applicable, residual solvents and elemental impurities.

Chemical Information

CAS Number: 124750-99-8
Molecular Formula: C22H23ClN6O·K
Molecular Weight: 461.00 g/mol
Synonym: Losartan Potassium
Drug Class: Angiotensin II Receptor Blocker
Therapeutic Class: Antihypertensive Agent
Therapeutic Area: Cardiovascular / Renal
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Losartan selectively antagonizes the angiotensin II type 1 (AT1) receptor.

AT1 receptor blockade results in:

  • Reduced vasoconstriction
  • Reduced aldosterone secretion
  • Reduced sodium and water retention
  • Reduced peripheral vascular resistance
  • Lower blood pressure
  • Reduced angiotensin II-mediated cardiovascular and renal effects

Unlike ACE inhibitors, Losartan does not directly inhibit ACE and therefore does not inhibit the breakdown of bradykinin.

Pharmaceutical Applications

Losartan Potassium API is used in formulations for:

  • Hypertension
  • Diabetic nephropathy associated with type 2 diabetes
  • Reduction of stroke risk in selected hypertensive patients with left ventricular hypertrophy
  • Cardiovascular drug development
  • Renin-angiotensin system research
  • Antihypertensive formulations

Cardiovascular Applications

Losartan Potassium is particularly important in the development of oral antihypertensive formulations. Its selective AT1 receptor antagonism makes it a widely used member of the ARB drug class.

Physical Characteristics

Losartan Potassium is generally described as a white to off-white crystalline powder. It is soluble in water and exhibits physicochemical characteristics suitable for pharmaceutical formulation.

Manufacturing Process

A controlled Losartan Potassium API manufacturing process may involve:

  1. Preparation of qualified starting materials
  2. Synthesis of substituted imidazole intermediates
  3. Formation of the tetrazole-containing intermediate
  4. Controlled coupling reactions
  5. Purification
  6. Conversion to the potassium salt
  7. Crystallization
  8. Filtration
  9. Drying
  10. Milling where required
  11. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical Losartan Potassium API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residue on ignition
  • Residual solvents
  • Elemental impurities
  • Particle-size testing where applicable
  • Stability testing

Storage

Store Losartan Potassium API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should follow validated stability data and the manufacturer's approved specification.

Pharmaceutical Research

Losartan Potassium is relevant to research involving:

  • Angiotensin II receptors
  • AT1 receptor antagonism
  • Renin-angiotensin-aldosterone system
  • Hypertension
  • Cardiovascular pharmacology
  • Diabetic nephropathy
  • Renal protection
  • Antihypertensive drug development
  • ARB formulations

Losartan Potassium API Summary

Losartan Potassium is an angiotensin II receptor blocker (ARB) API with CAS Number 124750-99-8, molecular formula C22H23ClN6O·K, and molecular weight approximately 461.00 g/mol. It selectively blocks AT1 receptors and is widely used in antihypertensive and cardiovascular pharmaceutical formulations.

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 7.0 – 9.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
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