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Lisinopril 83915-83-7 Lisinopril Dihydrate
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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% | 8.30% | |
Residue on ignition | ≤0.1% | <0.1% | |
Assay (HPLC) | 98.0-102.0% (calculated on anhydrous basis) | 98.60% | |
Residual solvents | Ethanol≤0.5% | 0.02% | |
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 |
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