| Sl. No. |
Tests |
Specification |
Result |
Test Protocol |
| 1. |
Description |
Light brown to brown.
powder with characteristic odour
|
Brown Powder |
- |
| 2. |
Identification |
To pass the test |
Positive for Hydroxy
Citric Acid and
magnesium
|
By HPLC |
| 3. |
Solubility |
Soluble in water |
Soluble in water |
- |
| 4. |
Loss on drying (%w/w) |
< 9.0 |
5.6 |
As per USP <921> Method III |
| 5. |
pH ( 1% w/v solution) |
6.0 – 10.0 |
6.7 |
As per USP <791> |
| 6. |
Ash (% w/w) |
< 50.0 |
18.7 |
As per USP <561> |
| 7. |
Acid insoluble Ash (%w/w) |
< 2.0 |
1.1 |
As per USP <561> |
| 8. |
Bulk density (g/cc) |
0.20 – 0.80 |
0.33 |
As per USP <616> Method – I |
| 9. |
Tapped bulk density (g/cc) |
0.40 – 1.20 |
0.58 |
As per USP <616> Method – I |
| 10. |
Material passing through 30# BS/35 ASTM (%w/w) |
> 99.0 |
100 |
As per USP <786>
Particle size distribution |
| 11. |
Heavy Metals |
| |
Lead |
< 10 ppm |
0.2 |
|
| |
Arsenic |
< 2 ppm |
< 0.1 |
|
| |
Cadmium |
< 0.3 ppm |
0.1 |
|
| |
Mercury |
< 0.5 ppm |
< 0.1 |
ICP –MS |
| |
Antimony |
< 2 ppm |
< 2.0 |
|
| |
Copper |
< 30 ppm |
1.7 |
|
| |
Tin |
< 30 ppm |
< 5.0 |
|
| 12. |
Microbiology Test |
|
|
|
| |
Total viable aerobic count |
< 1 0 4 c f u g - 1 |
No growth |
|
| |
Total fungal count |
Negative g-1 |
No growth |
|
| |
Total enterobacteriaceae |
< 1 0 2 o r g g - 1 |
< 1 |
|
| |
E. coli |
A b s e n t / g |
A b s e n t |
As per USP <61> & <62> |
| |
Salmonella species |
A b s e n t / 2 5 g |
A b s e n t |
|
| |
Clostridium perfringens |
A b s e n t / g |
A b s e n t |
|
| 13. |
Test for preservatives |
| |
Benzoic acid, Sorbic acid and their salts |
< 200 mg/kg |
Complies |
By HPLC |
| 14. |
Aflatoxins (B1 + B2 + G1 + G2) |
< 5.0 ppb |
Complies |
As per USP (Test for Aflatoxins) |
| 15. |
Pesticide residue analysis |
To comply with USP |
Complies |
As per AOAC/USP |
| 16. |
Phytochemical Analysis |
| |
(-) Hydroxy Citric Acid (% w/w) |
50.0 |
51.6 |
|
| |
Lactone (% w/w) |
< 8.0 |
< 1.0 |
By HPLC |
| |
Citric acid (% w/w) |
< 5.0 |
< 3.0 |
|
