ITEM
|
SPECFICATION
|
METHOD
|
Assay
|
97.7%-100.5%
|
USP
|
Characters
|
White crystalline powder
|
Visual
|
Identification
|
||
IR
|
Match with the reference IR spectrum
|
UPS
|
Specific optical rotation
|
+89°-+93°
|
USP
|
Reaction time
|
Be similar to the reference solution
|
USP
|
Loss on drying
|
≤0.4%
|
USP<731>
|
Related substances
|
||
Any impurity
|
≤1.0%
|
USP
|
Total impurities
|
≤2.0%
|
USP
|
Microbial Test
|
||
Total Plate Count
|
<1000cfu/g
|
USP<61>
|
Yeast & Mold
|
<100cfu/g
|
USP<61>
|
Escherichia coli
|
Negative/g
|
USP<62>
|
Staphylococcus aureus
|
Negative/g
|
USP<62>
|
Pseudomonas aeruginosa
|
Negative/g
|
USP<62>
|
Entericbacteria
|
Negative/g
|
USP<62>
|
Salmonella
|
Negative/10g
|
USP<62>
|