| S. No. |
Parameters |
Specification |
Method |
| Physical |
| 1 |
Description |
Grey to white color Powder with Characteristic odor |
Visual/ Organoleptic |
| 2 |
Identification |
To comply by HPLC |
KVN/QC/STP-IN/029 |
| 3 |
Loss on drying |
NMT 2.0% w/w |
USP <731> |
| 4 |
Residue on Ignition |
NMT 5.0% |
USP <281> |
| 5 |
Tapped Bulk density |
0.50-0.80g/ml |
USP <616> |
| Sieve test (passes through) |
| 6 |
| # 40 mesh |
NLT 95.0%w/w |
| # 60 mesh |
NLT 90.0%w/w |
|
USP <786> |
| Chemical |
| 7 |
Assay By HPLC Content of 5-Hydroxtryphtophan [5-HTP]
|
NTL 95.0 % w/w on dry basis |
KVN/QC/STP-IN/029 |
| Others |
| 8 |
| Heavy Metals |
| Lead |
NMT 5.0ppm |
ICP-OES |
| Arsenic |
NMT 1.0ppm |
ICP-OES |
| Cadmium |
NMT 0.3ppm |
ICP-OES |
| Mercury |
NMT 0.1ppm |
ICP-OES |
|
| 9 |
Residual solvents |
Should comply by ICH/USP |
USP <467> |
| Microbiological Profile |
| 10 |
| Total plate count |
NNMT 3000cfu/g |
USP <2021> |
| Yeast and molds count |
NMT 100cfu/g |
USP <2021> |
| Escherichia coli |
Absent /10g |
USP <2022> |
| Salmonella |
Absent /10g |
USP <2022> |
| Staphylococcus aureus |
Absent /10g |
USP <2022> |
| Pseudomonas aeruginosa |
Absent /10g |
USP <62> |
|