|
ITEMS |
SPECIFICATION |
METHOD |
TEST RESULTS |
|
Physical&Chemical Data |
|||
|
Color |
White |
Organoleptic |
Conform |
|
Odour |
Characteristic |
Organoleptic |
Conform |
|
Appearance |
Fine Powder |
Organoleptic |
Conform |
|
Analytical Quality |
|||
|
Identification |
Identical to R.S.sample |
HPTLC |
Identical |
|
Assay |
≥99% |
HPLC |
99.9% |
|
Sieve analysis |
100 % through 80 mesh |
USP36 |
Conform |
|
Loss on Drying |
≤5.0 % |
Eur.Ph.7.0 [2.8.17] |
0.12 % |
|
Total Ash |
≤10.0 % |
Eur.Ph.7.0 [2.4.16] |
0.20 % |
|
Bulk density |
40~60 g/100mL |
Eur.Ph.7.0 [2.9.34] |
45 g/100mL |
|
Tap density |
60~90g/100mL |
Eur.Ph.7.0 [2.9.34] |
68 g/100mL |
|
Contaminants |
|||
|
Lead (Pb) |
≤3.0 mg/kg |
Eur.Ph.7.0 |
0.0446 mg/kg |
|
Arsenic (As) |
≤2.0 mg/kg |
Eur.Ph.7.0 |
0.0324 mg/kg |
|
Cadmium (Cd) |
≤1.0 mg/kg |
Eur.Ph.7.0 |
<0.01 mg/kg |
|
Mercury (Hg) |
≤0.1 mg/kg |
Eur.Ph.7.0 |
0.0414 mg/kg |
|
Solvents Residue |
Meet Eur.Ph.7.0 |
Eur.Ph 7.0 |
Conform |
|
Pesticides Residue |
Meet USP Requirements |
USP36 |
Conform |
|
Microbiological |
|||
|
Total Plate Count |
≤1000 cfu/g |
USP36 |
Conform |
|
Yeast &Mold |
≤100 cfu/g |
USP36 |
Conform |
|
E.Coli. |
Negative |
USP36 |
Conform |
|
Salmonella |
Negative |
USP36 |
Conform |