Item

Specification (FCC4/E202)

Test Results

1. Appearance

White granule

conforms

2. Identification

Conforms

Conforms

3. Heat stability

No change in color (105, 3h)

No change in color (105, 3h)

4. Assay

≥99%

99.9%

5. Loss on drying

≤1%

0.52%

6. Acidity or alkalinity

≤1%

0.57%

7. Aldehydes

≤0.1%

<0.1%

8. Arsenic (as As)

≤3ppm

<3ppm

9. Lead

≤2ppm

<2ppm

10. Mercury

≤1ppm

<1ppm

11. Heavy metal (as Pb)

≤10ppm

<10ppm

12. Conclusion

Complies with USP/FCC4/E202 grade