Lisinopril

Lisinopril is an angiotensin-converting enzyme inhibitor used in formulations targeting essential hypertension, renovascular hypertension, and symptomatic heart failure. By suppressing the conversion of angiotensin I to angiotensin II, it reduces plasma angiotensin II levels, decreases vasopressor activity, and lowers aldosterone secretion. Production adheres to current Good Manufacturing Practice guidelines, ensuring precise assay compliance and consistent solid-state properties suitable for direct compression and wet granulation tableting processes.

 

 

Parameter	Specification Details
International Nonproprietary Name	Lisinopril
Chemical Name	(S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate
CAS Registry Number	83915-83-9
Molecular Formula	C21H31N3O5
Molecular Weight	405.49 g/mol
Structural Class	Dicarboxylate-containing ACE inhibitor
Pharmacopeial Compliance	USP / EP / BP
Storage Conditions	Store in tight containers at 15°C to 30°C, protected from moisture and light
Shelf Life	36 months from the date of manufacture

 

 

Test Parameter	Acceptance Criteria
Description	White or almost white, crystalline powder
Solubility	Sparingly soluble in water, freely soluble in methanol, practically insoluble in ethanol
Identification	Infrared absorption spectrum matches reference standard; retention time conforms to reference solution
Specific Optical Rotation	-47.0° to -52.0° calculated on the anhydrous substance
Water Content	8.5% to 10.5% determined by Karl Fischer titration
Residue on Ignition	Maximum 0.1%
Heavy Metals	Maximum 10 ppm
Related Substances	Individual impurity $\le$ 0.10%; Total impurities $\le$ 0.5%
Assay	98.5% to 101.5% calculated on the dried basis

 

 

Synthesis Route: Liquid-phase and stereoselective catalytic hydrogenation processes ensuring high chiral purity.

 

Purification Process: Multi-stage crystallization, controlled temperature filtration, and vacuum drying to achieve targeted particle size distribution profiles.

 

Cleanroom Environment: Isolation, milling, and packaging executed inside ISO Class 8 cleanrooms equipped with continuous differential pressure and high-efficiency particulate air filtration.

 

Equipment Trains: Reaction trains utilizing glass-lined and stainless steel reactors, automated centrifuge systems, and agitated nutsche filter-dryers.

 

In-Process Controls: Automated monitoring of pH, temperature, agitation speed, and residual solvent concentrations using gas chromatography and high-performance liquid chromatography.

 

Supply Capacity: Scalable production capacity ranging from pilot validation batches to commercial multi-metric ton supplies per annum.

 

 

Primary Packaging	Double-layer low-density polyethylene bags heat-sealed under positive pressure.
Secondary Packaging	Rigid, moisture-tight fiber drums or high-density polyethylene drums containing tamper-evident seals.
Desiccant Integration	Silica gel packets positioned between primary and secondary layers to prevent moisture degradation during transit.
Standard Dimensions	Net weight 25 kg per drum with customized configurations available upon validated request.
Labeling Compliance	Outer drums labeled with product name, CAS number, batch number, manufacturing date, retest date, net weight, gross weight, storage requirements, and hazard warnings.

 

 

Essential Hypertension: Formulated into oral tablets for monotherapy or combination therapy to lower systemic arterial blood pressure by decreasing vascular resistance.

 

Congestive Heart Failure: Utilized as adjunctive pharmacological therapy to reduce cardiac preload and afterload, improving myocardial survival and functional capacity.

 

Acute Myocardial Infarction: Administered in hemodynamically stable patients within 24 hours of infarction to prevent ventricular remodeling and preserve left ventricular systolic function.

 

Diabetic Nephropathy: Applied in patients with type 2 diabetes mellitus to lower intraglomerular pressure, mitigate microalbuminuria, and slow the progression of renal disease.

 

 

 

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