S. No. |
Parameters |
Specification |
Method |
Physical |
1 |
Description |
Green to dark green powder with bitter taste |
Visual/ Organoleptic |
2 |
Identification |
To comply by TCL |
KVN/QC/STP-TLC/003 |
3 |
Loss on drying |
NMT 6.0% w/w |
USP <731> |
4 |
Water soluble extractives |
NLT 90.0% w/w |
KVN/QC/STP-GT/039 |
5 |
Alcohol soluble extractives |
NLT 50.0% w/w |
KVN/QC/STP-GT/026 |
6 |
Residue on Ignition |
NMT 5.0% |
USP <281> |
7 |
Tapped bulk density |
0.40 -0.70g/ml |
USP <616> |
Sieve test (passes through) |
8 |
# 40 mesh |
NLT 95.0%w/w |
# 60 mesh |
NLT 90.0%w/w |
|
USP <786> |
Chemical |
9 |
Assay By Gravimetry Content of Gymnemic acids
|
NLT 75.0% w/w on dry basis |
KVN/QC/STP-GT/024 |
Others |
10 |
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 |
|
11 |
Residual solvents |
Should comply by ICH/USP |
USP <467> |
Microbiological Profile |
12 |
Total plate count |
NNMT 5000cfu/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> |
|