|
SL. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Light yellowish brown to Dark brown powder |
| 2.
|
Identification |
To pass the test |
By TLC |
| 3.
|
Physico-chemical
analysis |
< 5.0 |
As per USP <921> Method III |
| Loss on drying (%w/w) |
| Ash content (%w/w) |
< 16.0 |
As per USP<561> |
| Acid insoluble Ash (%w/w) |
< 2.0 |
| 4.
|
Particle
Size |
0.20 - 0.50 |
As per USP <616> Method -
I |
| Bulk Density (g/cc) |
| Tapped bulk density |
0.25 - 0.70 |
| Material passing through 30# BS/35
ASTM (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 5.
|
Heavy
metal analysis |
< 10 ppm |
AAS / ICP -ES |
| Lead |
| Arsenic |
< 2 ppm |
| Cadmium |
< 1 ppm |
| Mercury |
< 0.1 ppm |
| 6.
|
Microbiological
analysis |
< 104 cfu g-1 |
As per
WHO/PHARMA/92.559/Rev.1
Pg.49-52 / As
per USP <61>
& <62> |
| As per FIP
Guidelines |
| Total Viable Aerobic Count |
| Total Enterobacteriaceae |
< 102 org g-1 |
| Total Fungal Count |
< 102 fs g-1 |
| 7.
|
Test
for Specific Pathogen |
Absent |
| As per FIP
Guidelines |
| E.coli (1g) |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 8.
|
Mycotoxin
analysis |
< 5 ppb |
As per USP Test for Aflatoxins |
| Aflatoxins (B1 + B2 + G1 + G2) |
| 9.
|
Pesticide
residue analysis |
To comply with USP |
As per AOAC / USP. |
| As per USP
& BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical
analysis |
> 30.0 |
By Spectrophotometry |
| Total tannins (%w/w) |