Scopolamine Hydrobromide Trihydrate USP size:5 KG Test Specification Min Max ASSAY

Test Specification Min Max ASSAY 97 - 100% 97 - 100%

17 % MOISTURE 12% FAT 9% ENZYME ACTIVITY NEGATIVE MICROBIAL LIMITS: TOTAL PLATE COUNT 10000/g YEAST AND MOLD 500/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE

30% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0

02% NITRATE (NO[@3@]) 0

Scopolamine Hydrobromide Trihydrate USP size:5 KG Test Specification Min Max ASSAYTest Specification Min Max ASSAY (ANHYDROUS BASIS) 98. 5 102. 00% SPECIFIC ROTATION 24?? to 26?? td> 24?? to 26?? td> pH (1 in 20 solution) 4 5. 5 WATER DETERMINATION 13. 00% RESIDUE ON IGNITION 0. 10% ORGANIC IMPURITIES: TROPIC ACID 0. 20% NORSCOPOLAMINE 0. 50% HYOSCYAMINE 0. 20% APOHYOSCINE 0. 20% APOATROPINE 0. 20% ANY OTHER INDIVIDUAL IMPURITY 0. 10% TOTAL IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS