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Irbesartan is a selective angiotensin II receptor antagonist (ARB) used primarily for the management of hypertension and diabetic nephropathy. By blocking angiotensin II at the AT1 receptor, Irbesartan reduces vasoconstriction and aldosterone secretion, leading to lower blood pressure and renal protection. It is highly effective as monotherapy or in combination with other antihypertensives.
Bluepill Express manufactures high-purity Irbesartan API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with global pharmacopoeial standards (IP, BP, USP, EP). This API is suitable for tablet and capsule formulations for global pharmaceutical markets.
Therapeutic Uses
- Hypertension: Effective blood pressure control
- Diabetic nephropathy: Protects renal function in type 2 diabetes patients
- Heart failure management: Adjunct therapy in selected patients
- Cardiovascular risk reduction: Lowers risk of stroke and myocardial infarction in high-risk patients
- Combination therapy: Used alongside diuretics and other antihypertensives
Mechanism of Action
Irbesartan selectively binds to angiotensin II type 1 (AT1) receptors, blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II. This results in:
- Vasodilation – reduces systemic vascular resistance
- Decreased aldosterone-mediated sodium and water retention
- Renal protection – slows progression of diabetic nephropathy
- No direct effect on bradykinin – lower risk of cough compared to ACE inhibitors
Pharmacological Information
- Chemical Name: 2-butyl-3-[[2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
- Molecular Formula: C25H28N6O
- Molecular Weight: 428.54 g/mol
- CAS Number: 138402-11-6
- Therapeutic Class: Angiotensin II Receptor Blocker (ARB)
- Pharmacological Class: Antihypertensive / Renoprotective
- ATC Code: C09CA04
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Practically insoluble in water; soluble in methanol and ethanol |
| Melting Point | 181°C – 184°C |
| pH (1% aqueous suspension) | 5.5 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moistur |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Irbesartan API is used in:
- Tablet and capsule formulations for hypertension
- Combination therapy with hydrochlorothiazide or other antihypertensives
- Renal protective formulations for type 2 diabetes patients
- Bulk pharmaceutical preparations for export markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
