Buspirone Hydrochloride USP size:25 GM 916 IDENTIFICATION TO PASS TEST

916 IDENTIFICATION TO PASS TEST TO PASS TEST RETEST DATE

670 mg/g APPROX

Test Specification Min Max APPEARANCE TAN TO BROWN PWD TAN TO BROWN PWD PARTICLE SIZE 40 - 80 MESH 40 - 80 MESH MOISTURE 10% MICROBIAL LIMITS: TOTAL PLATE COUNT 5000/g YEAST AND MOLD 100/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE

3 C RANGE) 231 242�C SPECIFIC ROTATION [a][@D@] +29

01% SUBSTANCES NOT PPTD BY (NH[@4@]OH) 0

Buspirone Hydrochloride USP size:25 GM 916 IDENTIFICATION TO PASS TESTTest Specification Min Max ASSAY 97. 5 102. 50% WATER DETERMINATION 0. 50% RESIDUE ON IGNITION 0. 50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES DETECTED AT (UV 240 nm): Bispirone related compound A 0. 10% Spiroammonium salt 0. 10% Bispyrimidinylpiperazinyl butane 0. 10% Bispyrimidinylpiperazinyl butyl ether 0. 10% Buspirone open ring 0. 30% Buspirone open ring dimer 0. 10% Buspirone related compound G 0. 10% Buspirone diester