BP2013/USP35 powder Paracetamol (Acetaminophen) CAS NO.103-90-2

Product  name

Paracetamol (Acetaminophen)

Batch NO.

1604055

Packing

25kg / drum

MFG. Date

2016.4.23

Quantity

6000Kg

EXP. Date

2020.3.21

Analysis Date

2016.4.26

Standard

BP2013/USP35

Contents

Specification

Results

Characters

White crystalline powder,sparingly soluble in water,freely soluble in alcohol,very slightly soluble in ether and in methylene chloride.

Conforms

Identification

A:Melting range168-172℃

169.9-170.4℃

B.C.D.E Positive

B.C.D.E Positive

Related substance

Impurity J (chloracetanilide)≤ 10ppm

<10ppm

Impurity K (4-aminophenol)≤ 50ppm

<50ppm

Impurity F (4-nitrophenol)≤ 0.05%

<0.05%

Any other impurity≤ 0.05%

<0.05%

Total of other impurity≤ 0.1%

<0.1%

Chloride

≤0.014%

<0.014%

  Sulfate

≤0.02%

<0.02%

Sulfide

Complies

Complies

Heavy metals

≤0.001%

<0.001%

Free p-Aminophenol

≤0.005%

<0.005%

Chloracetanilide

≤0.001%

<0.001%

Readily carbonizable substances

Complies

Complies

Residual solvent

Residual content of acetic acid≤0.5%

<0.16%

Organic volatile impurities

Complies

Complies

Water

≤0.5%

0.16%

Residueon igniton

≤0.1%

0.03%

Assay

99.0%-101.0%

100.3%

Conclusion: It complies with the requirements of the BP2013/USP35

Approved by

01

Checked by

02

Analyzed by

Twin