Product Name:

Sulfadiazine

Batch No.:

20130301

Batch size:

5000kg

Date of Manufacture:

4.01.2014

Date of Analysis:

4.01.2014

Report No:

OC20140416

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.