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  • Paracetamol

Paracetamol

Certificate of Analysis

产品分析单

 

Product Name

PARACETAMOL

Batch Number

201101068

Quantity

5MT

Manufactured Date

Jan.10,2011

Expiry Date

Jan. 09,2015

Date of Test

Jan.10,2011

Quality Standard

BP2007/USP30

 

Items

Specification

Result

Appearance

White   crystalline powder

White   crystalline powder

Identification

Positive

Positive

Assay(anhydrous   basis)

99.0-101.0%

100.2%

Moisture

0.5%

0.06%

Melting   point

168-172℃

169.3-171.2℃

Related   substance

Impurity   J(Chloroacetanilide)10ppm

3.68ppm

Impurity   K(4-aminophenol)50ppm

4.52ppm

Impurity   F(4-nitrophenol)0.05%

0.02%

Any   other impurity0.05%

0.02%

Total   of other impurity0.1%

0.06%

Residue   on ignition

0.1%

0.08%

Chloride

0.014%

0.014%

Sulfate

0.02%

0.02%

Sulfide

Conforms

Conforms

Heavy   metals

0.001%

0.001%

Free   p-aminophenol

0.005%

0.001%

Limit   of P-chloroacetanilide

0.001%

0.001%

Readily   carbonizable substances

Conforms

Conforms

Organic   volatile impurity

Conforms

Conforms

Conclusion

Complies   with BP2007/USP30


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