Phentolamine Mesylate USP CLP Inorganic Chemical Standards Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (KCl

Test Specification Min Max APPEARANCE BEIGE GRANULES BEIGE GRANULES BULK DENSITY 600 g/I WATER ADSORPTION 19% WATER 1

2 % MELTING POINT WITHIN 3 C WITHIN 3 C RESIDUE AFTER IGNITION 0

/td> WATER CONTENT (KF) 9 11 RELATED SUBSTANCES TO PASS TEST TO PASS TEST HEAVY METALS 5 ppm SULFATE 200 ppm CHLORIDE 125 ppm SOLUBLE STARCH TO PASS TEST TO PASS TEST SULFATED ASH 0

10% INSOLUBLE MATTER TO PASS TEST TO PASS TEST CHLORIDE (Cl) 0

Phentolamine Mesylate USP CLP Inorganic Chemical Standards Test Specification Min Max ASSAYTest Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0. 50% RESIDUE ON IGNITION 0. 10% SULFATE 0. 20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST