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|
Parameter
|
Specification
|
Test Result
|
Method
|
|---|---|---|---|
|
Appearance
|
White or almost white crystalline powder
|
Complies
|
Visual
|
|
Identification (HPLC)
|
Complies with reference standard
|
Complies
|
USP/EP
|
|
Assay (on dried basis)
|
98.0% - 101.0%
|
99.5%
|
HPLC
|
|
Loss on Drying
|
0.5%
|
0.2%
|
USP <731>
|
|
Residue on Ignition
|
0.1%
|
0.05%
|
USP <281>
|
|
Heavy Metals (as Pb)
|
10 ppm
|
< 5 ppm
|
ICP-MS
|
|
Arsenic (As)
|
3 ppm
|
< 1 ppm
|
ICP-MS
|
|
Microbial Total Plate Count
|
1000 CFU/g
|
120 CFU/g
|
USP <61>
|
|
Yeast & Mold
|
100 CFU/g
|
< 10 CFU/g
|
USP <61>
|
|
Escherichia coli
|
Absent
|
Absent
|
USP <62>
|
|
Salmonella
|
Absent
|
Absent
|
USP <62>
|
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