ENALAPRIL MALEATE

Enalapril Maleate is an angiotensin-converting enzyme (ACE) inhibitor used primarily in the management of hypertension, congestive heart failure, and asymptomatic left ventricular dysfunction. By blocking the conversion of angiotensin I to angiotensin II, Enalapril Maleate reduces vasoconstriction and aldosterone secretion, leading to decreased blood pressure and improved cardiovascular function.

At Bluepill Express, we manufacture and export pharmaceutical-grade Enalapril Maleate API in compliance with IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, consistent particle size, and excellent stability, suitable for tablets, capsules, and combination formulations.

Each batch undergoes rigorous quality control, including HPLC, IR spectroscopy, and microbial testing, guaranteeing reliable performance for global pharmaceutical manufacturers.

Pharmacological Information:

• Therapeutic Class: Antihypertensive / ACE Inhibitor
• Pharmacological Category: Renin-Angiotensin-Aldosterone System (RAAS) Modulator
• CAS Number: 75847-73-3
• Molecular Formula: C20H28N2O5·C4H4O4
• Molecular Weight: 492.52 g/mol (as maleate)
• Appearance: White to off-white crystalline powder
• Solubility: Soluble in water, slightly soluble in ethanol
• Melting Point: 150°C – 154°C
• Storage: Store in a cool, dry place below 25°C, protected from light and moisture

Mode of Action:

Enalapril Maleate inhibits ACE, preventing the conversion of angiotensin I to angiotensin II. This results in vasodilation, decreased blood pressure, reduced cardiac workload, and lower aldosterone secretion, making it highly effective in treating hypertension and heart failure.

Applications and Uses:

• Hypertension: Lowers systemic blood pressure and reduces cardiovascular risk
• Congestive Heart Failure: Improves symptoms and reduces mortality risk
• Left Ventricular Dysfunction: Enhances cardiac function post-myocardial infarction
• Diabetic Nephropathy (off-label): Protects kidney function in type 1 diabetes
• Combination Therapy: Can be combined with diuretics or other antihypertensives

Technical Specifications:

• Assay (Purity): ≥ 99.0%
• Identification: IR spectrum complies with reference standard
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Heavy Metals: ≤ 10 ppm
• Related Substances: ≤ 0.2% (individual impurity)
• Particle Size: Optimized for tablet and capsule formulation
• Microbial Limits: Complies with pharmacopeial specifications

Manufacturing & Quality Assurance – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• High-purity crystalline API with stable maleate content
• COA, MSDS, and TDS provided for each batch
• HPLC-tested for purity and impurity profiling
• Pharmacopeial compliance: IP / BP / USP / EP
• Suitable for tablets, capsules, and combination formulations

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: Export-compliant, including batch number and origin
• Export Markets: Africa, Asia, Europe, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO and Allergen-Free Declarations