1 | Appearance | White crystalline powder. Is odorless, and has a sweet taste. | Colorless crystals or white, crystalline or granular powder. Is odorless, and has a sweet taste. |
2 | Solubility | Complies | Very soluble in boiling water; freely soluble in water; soluble in boiling alcohol; slightly soluble in alcohol. |
3 | Assay (anhydrous substance) | 99.51% | 97.5% - 102.0% |
4 | Identification (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of standard. |
5 | Identification (By HPLC) | Complies | The principal peak from the sample solution is similar in retention time and size to the principal peak from standard solution A. |
6 | Identification (By Water) | 0.86% | NMT 1.0% |
7 | Appearance of solution | Complies | The solution should clear and not more intensely coloured than reference solution BY7 |
8 | Color and Clarity of solution | Complies | The Sample solution should clear and not more intensely coloured than reference solution. |
9 | Titrable acid | Less than 0.002 meq/g | NMT 0.002 meq/g |
10 | Conductivity | 15 µS/cm | NMT 20 µS/cm |
11 | Specific rotation[a]D25° | 52.6° | 52.5 – 53.0° |
12 | Insoluble matter in water | 0.002% | NMT 0.005% |
13 | Chloride (Cl) | Less than 0.01% | NMT 0.01% |
14 | sulfate (as SO4) | Less than 0.005% | NMT 0.005% |
15 | Heavy metals (as Pb) | Not detected | NMT 5ppm |
16 | Iron (Fe) | Not detected | NMT 5ppm |
17 | Related substances: sum of impurities A (maltose) and B (isomaltose) | 0.11% | NMT 0.4% |
18 | Related substances: Impurity C (maltotriose) | 0.02% | NMT 0.2% |
19 | Related substances: Impurity D (fructose) | Not detected | NMT 0.15% |
20 | Related substances: unspecified impurity | 0.01% | NMT 0.10% |
21 | Related substances: the total amount of all other impurities | 0.14% | NMT 0.5% |
22 | Dextrins | Complies | The sample dissolve completely |
23 | Soluble starch, sulfite | Less than 15ppm | NMT 15ppm |
24 | Water (By KF) | 0.86% | NMT 1.0% |
25 | Sulfated ash | 0.01% | NMT 0.02% |
26 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
27 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
28 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
29 | Escherichia coli | Absent/gm | should be absent/gm |
30 | Pseudomonas aeruginosa | Absent/gm | should be absent/gm |
31 | Staphylococcus aureus | Absent/gm | should be absent/gm |
32 | Candida albicans | Absent/gm | should be absent/gm |
33 | Salmonella | Absent/10gm | should be absent/10gm |
34 | Bacterial endotoxins | Less than 10 IU/gm | NMT 10 IU/gm |