Orlistat

Details:

CAS NO:96829-58-2

MF: C29H53NO5

Other name: TERAHYDROLIPSTATIN

Grade: medicine grade 

Specification:

Appearance: white crystalline powder.

Solubility:very soluble in methanol and ethanol,freely soluble in chloroform,practically insoluble in water.

Melting point  42~44°C.

Specific rotation:-48~-51°

Identification  HPLC:The retention time of principal peak should comply with its RS.

IR spectrum should comply with that of its RS.

Related substance.

Total impurities NMT  0.1%

Related Compound A: ND

Related Compound B: ND

Related Compound C: 0.019%

Related Compound D: ND

Related Compound E: 0.08%

Formylleucine  ND

Orlistat open ring epimer  ND

D-Leucine orlistat     ND

Orlistat open ring epimer   ND

Individual unidentified impurity  0.01%

Residual solvents

n-Heptane  820ppm

Isopropyl ether   ND

Methanol    ND

Tetrahydrofuran   ND

Residual on Ignition   0.06%

Heavy metal   not more than 20ppm

Assay     99.5%

Water    0.02%

Conclusion L  Confirms with USP35

Usage:

Orlistat is a drug designed to treat obesity.

Its primary function is preventing the absorption of fats from the human diet by acting as a lipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervised reduced-calorie diet.

Orlistat is the saturated derivative of lipstatin, a potent natural inhibitor of pancreatic lipases isolated from the bacterium Streptomyces toxytricini. However, due to its relative simplicity and stability, orlistat was chosen over lipstatin for development as an anti-obesity drug. The effectiveness of orlistat in promoting weight loss is definite, though modest.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between

 59-86 degrees F (15-30 degrees C) is permitted.