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> |
|