1 | Description | White, odorless crystals. | White, odorless crystals. |
2 | Solubility | Complies | Soluble in water, in alcohol, and in glycerine; freely soluble in boiling water. |
3 | Identification (By IR) | Complies | The infrared spectrum should be concordant with that of succinic acid standard. It exhibits absorption at the wave numbers of about 1690 cm-1, 1424 cm-1, 1314 cm-1, 1206 cm-1, and 920 cm-1. |
4 | Identification (By Chromatographic identity) | Complies | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
5 | Assay(HPLC) | 99.7% | 99.0% - 100.5% |
6 | Residue on ignition | 0.012% | NMT 0.025% |
7 | Melting range | 186.1°C - 186.4°C | 185.0°C - 190.0°C |
8 | Potassium permanganate- reducing substances | Complies | The color of solution does not disappear within 3 min. |
9 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
10 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
11 | E.coli | Absent/gm | Should be absent /gm |
12 | Salmonella | Absent/10 gm | Should be absent /10 gm |
13 | Pseudomonas aeruginosa | Absent/gm | Should be absent /gm |
14 | Staphylococcus aureus | Absent/gm | Should be absent /gm |
15 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent /gm |
16 | Bacterial endotoxin test | Less than 2.5 EU/gm | NMT 2.5 EU/gm |