|Melting point||230 to 240|
|Dry weight loss||less than 0.5%|
|PH||(10% aqueous solution) 4-7|
|Heavy metal||less than 10ppm|
|TLC||only one spot|
|Character||white or white crystalline powder, soluble in methanol.|
|Packing specification||1kg/ aluminum foil bag; 25kg/ cardboard drum|
|Storage||avoid light, sealed, placed in a cool place to store.|
|Test Items||Specification||Test Results|
|Description||White crystalline powder||White crystalline powder|
|Identification||IR , UV conform||Conform|
|Loss on drying||≤0.5ml||0.21ml|
|Residue on ignition||Not more than 0.2%||0.06ml|
|Iron||Not more than 0.005%||0.0018%|
|Heavy metals||Not more than 0.001%||0.0006%|
|Related substances||Total: Not more than 1.0%
Individual: Not more than 0.5%
|E-isomer||Not more than 0.3%||0.19%|
|Organic volatile impurities||Conforms||Conforms|
|Conclusion||Conform with USP30|
It is expected that the usual dose of rimonabant will be 20 mg once daily before breakfast. No dosage adjustment is recommended for the elderly, but this agent should be used with caution in patients older than 75 years of age.
Although rimonabant can be used in patients with mild hepatic impairment, caution is advised in patients with moderate impairment. This medication is not recommended for those with severe hepatic impairment.
Rimonabant may be used cautiously in patients with mild-to-moderate renal impairment, but it is not recommended for patients who are severely renally impaired.
There are no data supporting the use of rimonabant in pediatric populations.
Rimonabant should not be given to patients with a known hypersensitivity to the agent or any compound found in the tablet formulation.
The drug is contraindicated in lactat-ing women and is not recommended for use in women who are pregnant.