Theophylline Anhydrous USP Other Bulk Chemicals 02% SULFATES (SO[@4@]) TO PASS

02% SULFATES (SO[@4@]) TO PASS TEST RETEST DATE

1 mg/ml) 10

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

10% TRIMETHYLAMINE HCL 0

Test Specification Min Max ABSORPTION MAX 548 nm 548 nm

Theophylline Anhydrous USP Other Bulk Chemicals 02% SULFATES (SO[@4@]) TO PASSTest Specification Min Max ASSAY 97 102. 00% LOSS ON DRYING @ 105 C 0. 50% ORGANIC IMPURITIES: . . THEOPHYLLINE RELATED COMPOUND C 0. 10% THEOPHYLLINE RELATED COMPOUND B 0. 10% THEOPHYLLINE RELATED COMPOUND D 0. 10% CAFFEINE 0. 10% ANY OTHER INDIVIDUAL UNSPECIFIED IMPURITY 0. 10% TOTAL IMPURITIES 0. 50% RESIDUE ON IGNITION 0. 15% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION (B) RETENTION