1. Name: Amoxicillin sodium
2. CAS NO: 34642-77-8
3. packing: 5kg/tin 2tin/carton
4. Standard: in-house specification
5. Validity: 2years
|
Testing items
|
|
|
Characters
|
white or almost white powder or crystalline
|
|
Identification
|
The retention time for the main peaks of sample should be the same as the retention time for reference standard
|
|
Should show positive reaction of sodium
|
|
|
Specific rotation
|
+240°-+290°
|
|
PH
|
8.0-10.0
|
|
Turbidity of solution
|
clear or not more than opalescent than reference suspension Ⅰ
|
|
Color of solution
|
not more than reference solution Y5 or YG5
|
|
Water
|
≤4.0%
|
|
Related substances
|
Any individual impurity ≤3.0%
|
|
Sum of impurities ≤9.0%
|
|
|
Sterility
|
complies
|
|
Bacterial Endotoxins
|
≤0.15 EU/mg
|
|
Assay
|
≥80.0% calculated on anhydrous basis
|