Theophylline Anhydrous USP Other Bulk Chemicals Test Specification Min Max COPPER

Test Specification Min Max COPPER (Cu) 995 - 1005 ppm 995 - 1005 ppm TRACEABLE TO NIST EXPIRATION DATE

01% PHOSPHORUS 0

00% VISCOSITY OF A 0

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

Theophylline Anhydrous USP Other Bulk Chemicals Test Specification Min Max COPPERTest 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