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Ramipril is a prodrug angiotensin-converting enzyme (ACE) inhibitor widely used in the management of hypertension, congestive heart failure, and cardiovascular risk reduction. After oral administration, Ramipril is converted to its active metabolite, Ramiprilat, which selectively inhibits ACE, reducing the conversion of angiotensin I to angiotensin II. This leads to vasodilation, decreased blood pressure, and reduced cardiac workload.
Bluepill Express offers high-purity Ramipril API, manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and global pharmacopoeial compliance (IP, BP, USP, EP). It is suitable for oral solid formulations such as tablets and capsules.
Therapeutic Uses
- Hypertension: Effective blood pressure control and cardiovascular protection
- Heart Failure: Adjunct therapy to improve survival and symptoms
- Post-Myocardial Infarction: Reduces risk of heart failure and recurrent infarction
- Renal Protection: Slows progression of diabetic nephropathy and chronic kidney disease
- Cardiovascular Risk Reduction: Reduces morbidity in high-risk patients
Mechanism of Action
Ramipril inhibits angiotensin-converting enzyme (ACE), blocking the formation of angiotensin II, a potent vasoconstrictor. This results in:
- Vasodilation – lowers systemic vascular resistance
- Reduced aldosterone secretion – decreases sodium and water retention
- Improved cardiac output – lowers cardiac workload and reduces left ventricular hypertrophy
Its active metabolite, Ramiprilat, provides prolonged ACE inhibition, ensuring sustained antihypertensive effect.
Pharmacological Information
- Chemical Name: (2S,3aS,6aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid
- Molecular Formula: C23H32N2O5
- Molecular Weight: 416.52 g/mol
- CAS Number: 87333-19-5
- Therapeutic Class: ACE Inhibitor
- Pharmacological Class: Antihypertensive / Cardioprotective
- ATC Code: C09AA05
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in ethanol, methanol |
| Melting Point | 110°C – 115°C |
| pH (1% aqueous solution) | 4.0 – 6.0 |
| 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 | ≤ 0.3% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Ramipril API is used in:
- Immediate-release and sustained-release tablets
- Capsule formulations
- Combination therapy with diuretics
- Cardiovascular and renal protective therapies
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
