PARAMETERS |
Specification |
Test Method |
Physical Control |
|
|
Description |
Brown colour Powder with characterstic odor & taste |
Organoleptic/In house |
Identification |
By TLC |
TLC |
Sieve Analysis |
100% pass 20 mesh |
USP<786> |
Solubility in water |
NLT 80% |
In House Method |
Loss on Drying |
<5% |
USP<731> |
Bulk Density |
0.3-0.7 gm/ml |
USP<616> |
ASSAY |
|
|
Morindins |
5% to 10% |
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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