Product Description

Orlistat is currently the best-selling weight loss products.
Orlistat is a potent and long-acting specific inhibitor of gastrointestinal lipase, by directly blocking the body’s absorption of fat in the food intake of energy consumption and fat than once, natural reduction of body fat, so as to achieve the purpose of weight loss. It is safe to lose weight, the active ingredient does not enter the blood circulation, do not act on the central nervous system, with fewer side effects, no dizziness, palpitation, insomnia, dry mouth, and so on.

Test Items	Specifications
Specific Rotation	-48° ~ -51.0°(on the anhydrous, solvent-free basis)
Identification	A.HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution.
	B.IR: The IR spectrum of sample is consistent to the reference
Related Substances
Total impurity	Not more than 1.0%
Related Compound A	Not more than 0.2%
Related Compound B	Not more than 0.05%
Related Compound C	Not more than 0.05%
Related Compound D	Not more than 0.2%
Related Compound E	Not more than 0.2%
Formyl leucine	Not more than 0.2%
Orlistat open ring epimer	Not more than 0.2%
D-Leucine orlistat	Not more than 0.2%
Orlistat open ring amide	Not more than 0.1%
Individual unidentified impurity	Not more than 0.1%
Residual Solvents
n-Hexane	Not more than 5000ppm
Isopropyl ether	Not more than 5000ppm
Residual on ignition	Not more than 0.1%
Heavy Metal	Not more than 20ppm
Water	Not more than 0.2%
Assay	98.0%~101.5% (on the anhydrous, solvent-free basis)
Conclusion	Conform with USP35

 

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