| PARAMETERS |
Specification |
Test Method |
| Physical Control |
|
|
| Description |
Light Brown colour Powder with characterstic odor & taste |
Organoleptic |
| Identification |
By TLC |
TLC |
| Solubility in water |
NLT 80% |
In House method |
| Sieve Analysis |
100% pass 40 mesh |
USP<786> |
| Loss on Drying |
<5% |
USP<731> |
| Bulk Density |
0.3-0.7 gm/ml |
USP<616> |
| ASSAY |
|
|
| Saponins |
20% to 40% |
Gravimetry |
| Chemical Control |
|
|
| Arsenic (As) |
NMT 1ppm |
USP<231> |
| Cadmium(Cd) |
NMT 1ppm |
USP<231> |
| Lead (Pb) |
NMT 3ppm |
USP<231> |
| Mercury |
NMT 0.1 ppm |
USP<231> |
| Heavy Metals |
NMT 10ppm |
USP<231> |
| Residual Solvent |
As Per< USP> |
USP<467> |
| Microbiological Control |
|
|
| Total Plate Count |
<1,000cfu/g by Heat & Steam |
USP<31> |
| Yeast & Mold |
<1,00cfu/g by Heat & Steam |
USP<31> |
| Salmonella |
Negative |
USP<31> |
| E.Coli |
Negative |
USP<31> |
| Staphylococcus aureus |
Negative |
USP<31> |
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