S P E C I F I C A T I O N S

QUININE SULFATE DIHYDRATE USP

Synonyms:					Quinine sulfate; Quinine bisulfate; Quinine 							hydrogen sulfate

CAS No.:					6119-70-61

Chemical Formula:				(C20H24N2O2)2*H2SO4*2H2O  

Formula Weight:				782.94

Description:					White, fine, needle-like crystals. Odorless, 	has a persistent, very bitter taste. It darkens 	on exposure to light.

Identification A,B,C:			To pass tests

Specific Rotation:				Between -235 and -245 degrees 
 
Water:						4.0% to 5.5%

Residue on Ignition:			0.1% maximum

Heavy metals:				0.001% maximum

Assay (anhydrous basis):			99.0% to 101.0%

Chloroform-Alcohol insoluble
Substances:					< 0.1%

Chromatographic Purity:			To pass test

Limit of Dihydroquinine Sulfate:	<10.0%

Residual Solvents (Toluene)		890 ppm maximum

Solubility (5% in 95% ethanol):		Clear, colorless to very faint yellow solution

Effective Date: 12/29/08