|
Product Name:
|
Sulfadiazine
|
Batch No.:
|
20130301
|
Batch size:
|
5000kg
|
|
|
Date of Manufacture:
|
March.01.2013
|
Date of Analysis:
|
March.01.2013
|
Report No:
|
QCCY033201006
|
|
|
Reference:
|
USP28
|
|||||
|
Items
|
Acceptance criteria
|
Results
|
||||
|
Description
|
White or off-white color crystals or powder; odorless., practically insoluble in water, slightly soluble in acetone,very slightly soluble in alcohol.
|
white powder, odorless; Complise
|
||||
|
Identification
|
A: tests(1)
|
Complise
|
||||
|
B: tests(2)
|
Complise
|
|||||
|
C: tests(3)
|
Complise
|
|||||
|
Acidity
|
Not more than 0.2 ml of 0.1M sodium hydroxide is required to produce a pink color.
|
Complise
|
||||
|
Clarity and color of solution
|
The solution is clear and not more deeply colored than pale yellow
|
Complise
|
||||
|
Acidity
|
not more than 0.20mLis required to produce a pink color
|
0.1mL
|
||||
|
Loss on drying
|
not more than 0.5%.
|
0.1%
|
||||
|
Residue on ignition
|
not more than 0.1%.
|
0.06%
|
||||
|
Selenium
|
not more than 0.003%
|
Complise
|
||||
|
Limit of Heavy metals
|
not more than 0.002%
|
Complise
|
||||
|
Assay
|
not less than 98.0~102.0% of C10H10N4O2S,
calculated on the dried basis.
|
99.3%
|
||||
|
Conclusion:
|
This batch of Sulfadiazine meets the specification of USP 28.
|
|||||
