D-(+)-Trehalose Dihydrate cGMP Manufactured Pharmaceutical Chemical Ingredients DRIED BASIS) 98

DRIED BASIS) 98

DRIED BASIS) 98 101

Test Specification Min Max CADMIUM (Cd) 9950 - 10050 ppm 9950 - 10050 ppm EXPIRATION DATE

10% RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST BACTERIAL ENDOTOXINS 2

[a] 20D +5

D-(+)-Trehalose Dihydrate cGMP Manufactured Pharmaceutical Chemical Ingredients DRIED BASIS) 98Test Specification Min Max APPEARANCE TO PASS TEST TO PASS TEST APPEARANCE COLOR OF SOLUTION TO PASS TEST TO PASS TEST ASSAY (HPLC, ANHYDROUS) 97 102. 00% pH (10% AQUEOUS) 4. 5 6. 5 SPECIFIC ROTATION @ 20?? (ANHYDROUS) +197 to +201?? td> +197 to +201?? 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% RESIDUAL