|
Sl. No. |
Tests |
Limits |
Protocol |
| 1. |
Description |
Yellowish brown powder |
| 2. |
Identification |
To pass the test |
By TLC |
| 3. |
Physico-chemical analysis |
< 7.0 |
As per USP <921>
Method II |
| Moisture (%w/w) |
| Acid insoluble Ash
(%w/w) |
< 4.0 |
As per USP <561> |
| Total soluble solids (%w/w) |
> 60.0 |
| 4. |
Particle Size |
> 90.0 |
As per USP <786>
Particle Size distribution |
| Material passing
through 30# BS/35 ASTM
(%w/w) |
| 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.
|
Residual solvent analysis |
< 3000 |
As per USP |
| As per ICH Guidelines |
| Methanol (ppm) |
| Acetone (ppm) |
< 5000 |
| 10. |
Pesticide residue analysis |
To comply with USP |
As per AOAC / USP |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 11. |
Phytochemical analysis |
³ 10.0 |
By HPLC |
| Total Gingerols (%w/w) |