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