Lisinopril Dihydrate

Item

Specification

Result

Appearance

White crystalline powder

Conforms

Specific optical rotation [a]Hg25

-115.3-122.5°

-119.5°

Water

8.0~9.5%

8.2%

Residue on ignition

≤0.1%

<0.1%

Assay

98.0-102.0% (calculated on anhydrous basis)

98.9%

Residual solvents

Ethanol≤0.5%

0.018%

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%

0.08%

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%

0.15%