Crystalline Sorbitol Crystalline Sorbitol 50-70-4
ITEM |
QUALITY STANDARD |
RESULT |
APPERANCE |
WHITE CRYSTAL POWDER; SCENTLESS, SWEET; MISCIBLE WITH WATER; DISSOLVE EASILY IN WATER, SLIGHTLY IN ALCOHOL AND HARDLY DISSOLVE IN ETHER. |
CONFORM |
MELTING POINT |
≥95°C |
98.2°C |
IDENTIFICATION |
CONFORMED TO THE STANDARD |
CONFORM |
SPECIFIC ROTATION |
+4.0°~+7.0° |
+4.8° |
ACIDITY |
≤0.30ml |
0.12 ml |
CLARITY AND COLOR OF SOLUTION |
CONFORMED TO THE STANDARD |
CONFORM |
CHLORIDE |
≤0.005% |
<0.005% |
SULFATE |
≤0.01% |
<0.01% |
REDUCING SUGARS |
≤67mg |
17.9mg |
TOTAL SUGARS |
≤50mg |
14.1mg |
LOSS ON DRYING |
≤1.0% |
0.5% |
RESIDUE ON IGNITION |
≤0.1% |
0.03% |
HEAVY METALS |
≤0.001% |
<0.001% |
ARSENIC |
≤0.0002% |
<0.0002% |
ASSAY |
≥98.0% |
99.5% |
Solid dosage forms:
Diluent in tablet, capsule and powder formulations (wet granulation)
Sweetening agent in tablets and sachets
Plasticizer for gelatin capsules
Medicated confectionery:
Chewing gum
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