LISINOPRIL DIHYDRATE

Lisinopril Dihydrate is a widely used angiotensin-converting enzyme (ACE) inhibitor primarily prescribed for the management of hypertension, heart failure, and post-myocardial infarction care. It works by inhibiting the conversion of angiotensin I to angiotensin II, leading to vasodilation, reduced blood pressure, and decreased cardiac workload.

At Bluepill Express, we manufacture and export pharmaceutical-grade Lisinopril Dihydrate API that complies with IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, crystalline consistency, and excellent stability, suitable for oral tablets and combination formulations.

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

Pharmacological Information:

• Therapeutic Class: Antihypertensive / ACE Inhibitor
• Pharmacological Category: Renin-Angiotensin System Modulator
• CAS Number: 83915-83-7
• Molecular Formula: C21H31N3O5·2H2O
• Molecular Weight: 405.45 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Soluble in water, slightly soluble in ethanol
• Melting Point: 108°C – 112°C (dihydrate)
• Storage: Store in a cool, dry place below 25°C, protected from light and moisture

Mode of Action:

Lisinopril Dihydrate inhibits ACE, reducing the formation of angiotensin II, a potent vasoconstrictor. This results in lowered blood pressure, decreased aldosterone secretion, and improved cardiac function, making it effective for hypertension and heart failure management.

Applications and Uses:

• Hypertension – Long-term blood pressure control
• Heart Failure – Reduces mortality and hospitalization
• Post-Myocardial Infarction – Improves survival and cardiac remodeling
• Diabetic Nephropathy – Slows progression of kidney damage in diabetics
• Pharmaceutical Formulations – Tablets, fixed-dose combinations

Technical Specifications:

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

Manufacturing & Quality Assurance – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• High-purity crystalline API suitable for oral formulations
• COA, MSDS, and TDS provided with each batch
• HPLC-tested for purity, impurity profiling, and stability
• Pharmacopeial compliance: IP / BP / USP / EP

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 with 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 & Allergen-Free Declarations