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Active Pharmaceuticals

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Product name: Lorcaserin Hydrochloride
Synonym : Belviq, Apd 356, (1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine
CAS : 846589-98-8
MF : C11H15Cl2N
Assay : 99% min
Boiling point : 288.125°C at 760 mmHg
Flash point: 128.054°C
Quality Standards : USP
Appearance : White to almost white crystalline powder

Lorcaserin HCl is an FDA-approved prescription weight-loss medication that, when used with diet and exercise, can help some overweight adults with a weight-related medical problem, or obese adults, lose weight and keep it off.

Lorcaserin HCl a serotonin 2C receptor agonist. It hasbeen shown to decrease food consumption and promote SA tiety by selectivelyactivating serotonin 2C receptors in the brain.

Lorcaserin HCl is specifically indicated as an adjunct to a reduced-calorie diet andincreased physical activity for chronic weight management in clinically obeseadults (BMI of 30 kg/m2 or greater) and overweight adults (BMI of 27 kg/m2 orgreater) with at least one weight-related comorbid condition.

Lorcaserin HCl is supplied as a tablet designed for oral administration. The recommendeddose is one 10mg tablet twice daily. Use of Lorcaserin HCl should be discontinued if 5%weight loss is not achieved by week 12 of treatment.

Lorcaserin may be used in patients with mild-to-moderate hepatic impairment who require no dose adjustments; however, caution is recommended for patients with severe hepatic impairment, because the effects in this population have not been studied.Although lorcaserin may be used in patients with mild renal impairment, caution is advised for those with moderate renal impairment. The use of lorcaserin in patients with severe renal impairment or end-stage renal failure is not recommended.

Lorcaserin is contraindicated in pregnant women, and it is listed as a Pregnancy Category X medication. It was found to offer no known benefit in pregnant women, because it promotes weight loss.There are no data supporting the use of the medication in nursing mothers.

Items Standard Results
Description White to kind of white powder kind of white powder
Melting point 193.0-200 196.0-198.9
Water 5-6.5% 5.6%
Solubility Soluble in methanol Complies
PH 4.0-6.0 5
Heavy Metals <10ppm Complies
Assay >96% 96.21%
Residue on ignition <0.1% 0.03%
Single impurity <0.2% 0.19%
Conclusion Up to the Standard USP 32.

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