|
Sl. No. |
Tests |
Limits |
Protocol |
| 1.
|
Description |
Reddish brown to Dark brown powder.
|
| 2.
|
Solubility |
Soluble
in water |
1g
in 100 ml |
| 3.
|
Identification
|
To
pass the test |
By HPLC |
| 4.
|
Physico-chemical
analysis |
<
8.0 |
As per USP <921>
Method II |
| Moisture (%w/w) |
| Ash
content (%w/w) |
<
15.0 |
As
per USP<561> |
| Acid insoluble Ash (%w/w) |
< 5.0 |
| pH of 5% w/v solution |
4.0 – 7.0 |
As per USP<791> |
| Total soluble solids (%w/w) |
> 90.0 |
- |
| 5.
|
Particle
Size |
>
95.0 |
As
per USP <786>
Particle Size distribution
|
| Material passing through
60# (%w/w) |
| 6.
|
Heavy
metal analysis |
< 10 ppm |
AAS / ICP –ES |
| Lead |
| Arsenic |
< 2 ppm |
| Cadmium |
< 1 ppm |
| Mercury |
< 0.1 ppm |
| 7.
|
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 |
| 8.
|
Test
for Specific Pathogen |
|
| As
per FIP Guidelines |
|
| E.coli (1g) |
Absent |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 9.
|
Mycotoxin
anal ysis |
<
5 ppb |
As
per USP |
| Aflatoxins (B1 + B2
+ G1 + G2)
|
| 10. |
Residual solvent
analysis |
< 3000 |
As per USP |
| As per ICH Guidelines |
| Methanol (ppm) |
| 11. |
Pesticide residue
analysis |
To comply with
USP |
As per AOAC / USP |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 12. |
Coumarin content |
< 100.0 |
By HPLC |
| Coumarin content (ppm) |
| 13. |
Bio-Assay |
< 100.0 |
[NR/BSY/SOP/004/002] |
| a-amylase
Inhibition IC50
(mcg/ml) |
| 14. |
Phytochemical analysis |
|
|
| Total Polyphenols (%w/w) |
³ 10.0 |
By Spectrophotometry |