Lisinopril Dihydrate is the dihydrate form of lisinopril, a synthetic peptide-derived angiotensin-converting enzyme (ACE) inhibitor used in cardiovascular medicine. It reduces the formation of angiotensin II and decreases the secretion of aldosterone, resulting in vasodilation and reduced blood pressure.
Lisinopril is a long-acting, orally active ACE inhibitor used primarily for the management of hypertension and heart failure. It is also used to improve outcomes following acute myocardial infarction in appropriate patients.
Lisinopril Dihydrate is a crystalline pharmaceutical substance with the molecular formula C21H31N3O5·2H2O and a molecular weight of approximately 441.52 g/mol. The CAS Number is 83915-83-7.
The dihydrate form contains two molecules of water of crystallization. Lisinopril is structurally related to lysine and is designed to inhibit the angiotensin-converting enzyme involved in the renin-angiotensin-aldosterone system.
Lisinopril competitively inhibits angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to the potent vasoconstrictor angiotensin II.
Reduced angiotensin II levels decrease vasoconstriction and aldosterone secretion. This promotes vasodilation, reduces sodium and water retention and lowers systemic blood pressure.
Lisinopril also reduces degradation of bradykinin, which may contribute to its vasodilatory activity.
Lisinopril Dihydrate is used in pharmaceutical formulations for the treatment of hypertension and heart failure. It is also used in selected patients following acute myocardial infarction to reduce cardiovascular complications and support ventricular function.
It is commonly formulated as an oral tablet.
Lisinopril Dihydrate API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Because the material is a hydrate, control of water content and solid-state characteristics is particularly important. Chromatographic and spectroscopic techniques may be used for identity, assay and impurity determination.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Lisinopril Dihydrate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
As a hydrate, appropriate control of environmental moisture is important to maintain the specified solid form. Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Lisinopril Dihydrate API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Lisinopril Dihydrate API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |