Company

Glaxo smith kline company

Name

Rev # 12345
Paracetamol Implementation
Title 12/2022
specification /effective Date
Page # 1 of 2

Sr# Specification Results Limits

1 Appearance white or almost
white crystalline
powder
2 Sparingly soluble in
Solubility water ,freely
soluble in alcohol

Tests

1 identification identical

2 Related substance(HPLC) passes test Impurity J max.10 ppm

Impurity K max.50 ppm
Impurity F max.0,05 %
Other impurities max.0,05 %
Total impurities max.0,1 %

3 Loss on drying (105 ÇC) Pass max.0,5 %

4 Sulphated ash pass max.0,1 %

5 Assay (T, dried subst.) 99,0-101,0 %

 • Storage condition :

protected from light

• The maximum period of storage before re-examination:

Re-examination must be done after one year from production under
appropriate storage condition

• Supplier

Rochem International Inc

Prepared By iqbal Checked by numan Approved By Maher

Date 6/4/2019 Date 9/4/2019 Date 10/4/2019

For the distribution of this document ,a need for three copy to be distributed to other
department while saving the orginal in R&D department
Copy must delivered to the intended person who must sign to approve the delivery .