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00% HEAVY METALS (by ICP-OES) 5 ppm IRON (Fe) 5 ppm POTASSIUM (K) 0
DRIED BASIS) 98
DRIED BASIS) 98 101
Test Specification Min Max APPEARANCE
[a] 20D +5
D-(+)-Trehalose Dihydrate cGMP Manufactured Pharmaceutical Chemical Ingredients 00% HEAVY METALS (by ICP-OES)Test 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
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