Description
Function
Angiotensin Converting Enzyme Inhibitor (ACE-I), a lysine derivative of Enalapril, is the third non-sulfhydryl group in the world to be marketed. ACE-I. Long-acting, once a day, and the dosage is only 1/20 of captopril, 1/4 of enalapril, oral bioavailability is better. The curative effect is remarkable. For moderate and severe patients, the Chemicalbook should be better than captopril and enalapril. It has no direct effect on the heart, does not cause arrhythmia, has no central effect, and has no adverse reactions such as blood pressure rebound. It can be used for diseases accompanied by diabetes, asthma, peripheral vascular disease, psychosis and congestive heart failure, and for other diseases Patients with hypertension who are contraindicated in the treatment of drugs. It is effective for short-term and long-term congestive heart failure.
| Product Name | Lisinopril dlhydrate | ||
| Reference | USP | ||
| Test | Specification | Results | |
| Characters | White crystalline powder. | White crystalline powder. | |
| Identification | 1) Infrared absorption spectrum concordant with spectrum obtained with Lisinopril dihydrate RS. | Conform | |
| 2) The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay. | Conform | ||
| Specific optical rotation [a]Hg25 | -115.3—122.5° | -119.6° | |
| Water | 8.0~9.5% | 8.3% | |
| Residue on ignition | ≤0.1% | <0.1% | |
| Assay (HPLC) | 98.0-102.0% (calculated on anhydrous basis) | 98.6% | |
| Residual solvents | Ethanol≤0.5% | 0.017% | |
| Related substances (HPLC) | DL-Homophenylalanine ≤0.30% | <RL(RL:0.05%) | |
| Related compound A ≤0.3% | <RL(RL:0.05%) | ||
| R,S,S-Diketopiperazine ≤0.3% | <LOD(LOD:0.01%) | ||
| Lisinopril epimer ≤0.3% | 0.07% | ||
| Lisinopril cyclohexyl analogue ≤0.30% | 0.08% | ||
| N-Alkyl-L-lysine ≤0.3% | 0.09% | ||
| N-Alkyl lisinopril ≤0.15% | <LOD(LOD:0.01%) | ||
| Any individual unspecified impurity≤0.10% | <RL(RL:0.05%) | ||
| Total imp. does not include lisinopril epimer≤0.5% | 0.17% | ||
| Conclusion | Complies with USP | ||
