Description

Lisinopril Dihydrate is the dihydrate form of a potent, long-acting angiotensin-converting enzyme (ACE) inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of first-line antihypertensive and heart failure medications, ensuring consistent therapeutic efficacy and patient safety. It is essential for global pharmaceutical manufacturers engaged in the production of solid oral dosage forms, such as tablets and capsules, for cardiovascular disease management.

Application

• Primary Active Pharmaceutical Ingredient (API) in antihypertensive drug formulations.
• Key component in medications for the treatment of congestive heart failure (CHF).li>- Used in post-myocardial infarction therapy to improve survival rates.
  • Essential raw material for generic and branded pharmaceutical manufacturers.
  • Intermediate in advanced pharmaceutical research and development (R&D).
  • Reference standard for quality control and analytical testing in laboratories.

Basic Information

Product Name	Lisinopril Dihydrate
CAS No.	83915-83-7
Molecular Formula	C21H31N3O5·2H2O
Molecular Weight	441.52 g/mol
Synonyms	Lisinopril Dihydrate; (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline Dihydrate; MK-521 Dihydrate; Prinivil (brand); Zestril (brand); N2-[(1S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline Dihydrate; Lisinopril Hydrate
EINECS	Contact for details

Quality Control

Our Lisinopril Dihydrate is manufactured under strict quality management systems. It is tested to meet or exceed the rigorous standards of major pharmacopoeias, including USP and EP. Every batch is supported by a comprehensive Certificate of Analysis (COA) that details identity, purity, and impurity profiles, ensuring full traceability and compliance for GMP-driven pharmaceutical production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and ensure stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.2%
Specific Rotation	-40.0° to -47.0° (c=1 in water)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.