D-(+)-Trehalose Dihydrate cGMP Manufactured Pharmaceutical Chemical Ingredients Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE

01% SODIUM (Na) 0

00% HEAVY METALS (by ICP-OES) 5 ppm IRON (Fe) 5 ppm POTASSIUM (K) 0

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

D-(+)-Trehalose Dihydrate cGMP Manufactured Pharmaceutical Chemical Ingredients Test Specification Min Max APPEARANCETest 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