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Captopril is a potent angiotensin-converting enzyme (ACE) inhibitor widely used in the management of hypertension, congestive heart failure, and diabetic nephropathy. By inhibiting the ACE enzyme, captopril reduces the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, leading to vasodilation, reduced blood pressure, and decreased cardiac workload.
Bluepill Express manufactures high-purity Captopril 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 oral formulations, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Hypertension: Effective management of high blood pressure
- Congestive Heart Failure: Reduces cardiac workload and symptoms
- Diabetic Nephropathy: Protects kidney function in diabetic patients
- Post-Myocardial Infarction Therapy: Improves survival and cardiac remodeling
- Combination Therapy: Can be used with diuretics or other cardiovascular drugs
Mechanism of Action
Captopril acts by inhibiting angiotensin-converting enzyme (ACE):
- Prevents formation of angiotensin II, reducing vasoconstriction
- Decreases aldosterone secretion, promoting sodium and water excretion
- Reduces blood pressure and afterload on the heart
- Improves renal perfusion and slows progression of kidney disease
Pharmacological Information
- Chemical Name: (2S)-1-[(2S)-2-methyl-3-sulfanylpropanoyl]pyrrolidine-2-carboxylic acid
- Molecular Formula: C9H15NO3S
- Molecular Weight: 217.29 g/mol
- CAS Number: 62571-86-2
- Therapeutic Class: ACE Inhibitor
- Pharmacological Class: Antihypertensive / Cardiovascular Drug
- ATC Code: C09AA01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in water and dilute hydrochloric acid; slightly soluble in ethanol |
| Melting Point | 105°C – 109°C |
| pH (1% aqueous solution) | 4.0 – 5.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
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 | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Captopril API is used in:
- Tablet and capsule formulations for hypertension and heart failure
- Combination cardiovascular therapy formulations
- Bulk API for domestic and international pharmaceutical 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
