Description
SPECIFICATION
Sr. No. | Test Parameter | Specification | Reference |
1.0 | Description | White crystalline powder or flake crystal. | In-house |
2.0 | Identification Test | In-house | |
2.1 | IR identification | The IR spectrum of sample should be concordant with the IR spectrum of the MSM working standard. | In-house |
2.2 | Retention time | The retention time of sample assay peak corresponds to the standard peak. | In-house |
3.0 | Solubility | Soluble in water. | In-house |
4.0 | Water content | Not more than 0.1 % w/w. | In-house |
5.0 | Melting point | 108.50 to 110.50 0C. | In-house |
6.0 | Particle size | 100 % passing through 40 mesh. | In-house |
7.0 | Assay | 98.00 – 102.00 % w/w. | In-house |
8.0 | Chromatographic purity | Not less than 99.80 % w/w. | In-house |
9.0 | Dimethyl Sulfoxide | Not more than 0.1 % w/w. | In-house |
10.0 | Any other individual impurity (%) | Not more than 0.05 % w/w. | In-house |
11.0 | Heavy metals | Not more than 3 ppm | In-house |
12.0 | Total aerobic microbial count | Not more than 1000 CFU /gm. | In-house |
13.0 | Total combined yeast and mould count | Not more than 100 CFU /gm. | In-house |
14.0 | Enterobacteriaceae count | Not more than 10 CFU /gm. | In-house |
15.0 | Pathogen | ||
15.1 | E. coli. | To be absent. | In-house |
15.2 | S. typhi | To be absent. | In-house |
15.3 | S. aureus | To be absent. | In-house |
15.4 | P. aeruginosa | To be absent. | In-house |
Reviews
There are no reviews yet.