LOSARTAN POTASSIUM

Losartan Potassium is a widely used angiotensin II receptor blocker (ARB) for the treatment of hypertension, heart failure, and diabetic nephropathy. By selectively blocking AT1 receptors, it prevents vasoconstriction and reduces blood pressure, while also providing cardiovascular and renal protection.

At Bluepill Express, we manufacture and export high-purity Losartan Potassium API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API ensures excellent chemical stability, high assay purity (≥99%), and low impurity levels, making it ideal for oral tablets, combination therapies, and fixed-dose formulations.

This API is trusted in regulated and semi-regulated global markets for its consistent performance and compliance with international pharmacopoeial standards.

Therapeutic Applications:

• Hypertension management (primary and secondary)
• Heart failure treatment as part of combination therapy
• Diabetic nephropathy to reduce proteinuria
• Prevention of cardiovascular complications associated with high blood pressure

Mechanism of Action:

Losartan selectively blocks the binding of angiotensin II to AT1 receptors, leading to vasodilation, decreased peripheral resistance, and reduced aldosterone secretion. This lowers blood pressure, reduces cardiac workload, and provides renal protection in patients with diabetes.

Technical Specifications:

• Chemical Name: Potassium 2-butyl-4-chloro-1-[(2′-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]-1H-imidazole-5-methanol
• Molecular Formula: C₂₂H₂₂ClKN₆O
• Molecular Weight: 461.0 g/mol
• CAS Number: 124750-99-8
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Solubility: Freely soluble in water, methanol, and ethanol
• Storage Conditions: Store below 25°C, protected from moisture and light

Pharmacological Classification:

• Therapeutic Class: Angiotensin II Receptor Blocker (ARB) / Antihypertensive
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral tablets (25 mg, 50 mg, 100 mg)
  • Combination tablets with hydrochlorothiazide or amlodipine

Manufacturing & Quality Standards – Bluepill Express:

• Manufactured under WHO-GMP and cGMP certified facilities
• High assay purity (≥99%) with low impurity profile
• Validated analytical methods: HPLC, NMR, and FTIR
• DMF-ready documentation for global regulatory filings
• Batch-to-batch consistency with controlled particle size and stability
• Compliant with ICH Q3A/B guidelines and international pharmacopoeial standards

Advantages of Bluepill Express Losartan Potassium API:

• High purity and chemical stability for reliable formulations
• Pharmacopeial grade compliance (IP/BP/USP/EP)
• Optimized particle size for oral tablet production
• Regulatory-ready documentation including COA, MSDS, DMF
• Consistent global supply for pharmaceutical manufacturers

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liners
• Shelf Life: 3 years under recommended storage conditions
• Labeling: Compliant with international pharmacopeial and export regulations
• Export Markets: Europe, Middle East, Africa, Latin America, and Asia-Pacific
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF)
  • Stability and Validation Reports