Description
SPECIFICATION
Sr. No. | Test Parameter | Specification | Reference |
1.0 | Description | Yellow or yellowish brown colored crystalline powder. | In-house |
2.0 | Solubility (10 % w/v) | Soluble in water. | In-house |
3.0 | pH (1 % w/v) | 4.00 – 6.50 at 27 0C. | In-house |
4.0 | Loss on drying | 4.00 – 13.50 % w/w. | In-house |
5.0 | Assay | Not less than 98.00 % w/w.(Dried basis) | In-house |
6.0 | Free Sodium EDTA | 1.00 % Maximum. | In-house |
7.0 | Heavy Metal | 1.00 % Maximum. | |
8.0 | Arsenic | Not more than 3 ppm. | In-house |
Mercury | Not more than 3 ppm. | In-house | |
Lead | Not more than 25 ppm. | In-house | |
Cadmium | Not more than 25 ppm. | In-house | |
Copper | Not more than 60 ppm. | ||
Zinc | Not more than 150 ppm. | ||
9.0 | Total aerobic microbial count | Not more 1000 CFU /gm. | In-house |
10.0 | Total combined yeast and mould count | Not more 100 CFU /gm. | In-house |
11.0 | Enterobacteriaceae count | Not more 10 CFU /gm. | In-house |
12.0 | Pathogen | ||
12.1 | E. coli. | To be absent. | In-house |
12.2 | S. typhi | To be absent. | In-house |
12.3 | S. aureus | To be absent. | In-house |
12.4 | P. aeruginosa | To be absent. | In-house |
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