sulfadiazine SD pharmaceutical
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Product Name: |
Sulfadiazine |
Batch No.: |
20130301 |
Batch size: |
5000kg |
|
Date of Manufacture: |
March.01.2014 |
Date of Analysis: |
March.01.2014 |
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. |
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