Appearance

White to slightly yellow granule

Pass

Identification

Positive

Pass

Clarity of solution

Clear, ≤BY₆

Clear, ≤BY₆

Assay

96.0-98.0%

97.52%

Loss on drying

≤0.20%

0.13%

Heavy metals (as Pb)

≤10ppm

<10ppm

Arsenic

≤3ppm

<3ppm

Particle size

≥95% through 20 mesh

100.0%

≤25% through 100 mesh

24.2%

Total plate count

≤1000cfu/g

<1000cfu/g

Yeast ＆molds

≤100cfu/g

<100cfu/g

Escherichia.coli

Absence

Pass

Salmonella

Absence

Pass

Staphylococcus

Absence

Pass