Test Item | Specification |
Characters | White or off-white crystals or crystalline powder |
Identification (HPLC) | The retention time of the major peak of the Sample solution corresponds to that of the D-chiro-inositol peak of the Standard solution. |
Loss on drying | ≤ 2.0% |
Residue on Ignition | ≤ 0.5% |
Heavy Metals | ≤ 10ppm |
Chlorides | ≤ 0.5% |
Sulphates | ≤ 0.5% |
Related compounds (HPLC, %) (Calculated on the dried basis) |
Total impurities ≤ 2.0% |
Sucrose ≤ 1.0% | |
Pinitol ≤ 1.0% | |
Glucose(dextrose) ≤ 1.0% | |
Fructose ≤ 1.0% | |
myo-Inositol ≤ 1.0% | |
Any unknown impurity ≤ 0.1% | |
Optical Rotation (c=1.0, H2O) |
+63.0° ~ +67.0° |
Assay (by HPLC) | 97.0% ~ 103.0% |
Total Plate Count | ≤ 100CFU/g |
Yeast and Moulds | ≤ 100CFU/g |
Salmonella | Absence/10g |
Enterobacteria | Absence/g |