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QC 351

1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

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Rana Tayyab
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309 views1 page

QC 351

1) The certificate of analysis is for Diclofenac Potassium BP 2020 batch number DFK/10070088 manufactured in July 2020. 2) Tests results show the batch meets British Pharmacopoeia 2020 specifications for appearance, solubility, identification, appearance of solution, related substances by HPLC, loss on drying, assay by potentiometry, and pH. 3) The quality control manager approved the batch as meeting all BP 2020 specifications.

Uploaded by

Rana Tayyab
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

CORPORATE OFFICE : Ptot No.

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QUALITY CONTROL
CERTIFICATE OF ANALYSIS

PRODUCT NAME : DICLOFENAC POTASSIUM BP 2020


BATCH NO. : DFK/'10070088
MFG. DATE July'2020 A.R.NO, : FP12011644

EXP. DATE : June' 2025 RELEASE DATE 2910812020


sR. TESTS SPECIFICATION RESULTS
NO.
1 Appearance White or slightly yellowish, slightly hygroscopic, White crystalline powder, slightly
crystalline powder, hygroscopic,

2 Solubility Sparinqly soluble in water, freely soluble in methanol, Sparingly soluble in water, freely
soluble in Ethanol (96%), slightly soluble in acelone. soluble in methanol, soluble in
Ethanol (96%), slightly soluble in
acetone.
3 ldentilication
A. L R Spectrum The lnfrared absorption speclrum of sample is Concordant with lR absorplion
concordant with lnfrared absorption spectrum of spectrum of Diclofenac potassium
Diclofenac potassium WS. ws.
B. TLC The principal spot obtained in test solulion is similar The principal spot obtained in test
in position and size to the principal spot obtained with solulion is similar to the principal spot
reference solution (a). obtained with reference solution (a).

C. As per IH/BP/EP A blue color develops and a precipitate is form A blue color develops and a
precipitate is form.

D. Reaction (b) of potassium A yellow or orange yellow precipitate is formed Gives reaction for potassium
4 Appearance of solution The solution is clear and absorbance measured at Solution is clear and absorbance is
440 nm is not greater than 0.05 0.0154
5 Related substances by HPLC
. lmpurity A Not more than 0.15 % Not detected.
r lmpurity F Not more than 0.15 % Not detected.
. Unspecifiedlmpurities Not more than 0.'10 % Not detected
. Total impurities Not more than 0.4 % Not detected
6 Loss on drying Maximum 0.9 %, determined on '1.0 g by drying in an o.28./.
uC
oven at 105 for 3 hrs.
7 Assay by potentiometrically Not less than 99 % and not more than 10'l % of
C Hro ClzKNOz, calculated with reference to lhe 99.85 %
dried substance
8 pH. Between 6.5 and 8.5, determined on a 1% Wv 7.25
solulion.
Opinion The above material passes as per BP 2020 Specification

Analyzed By

QC Officer
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Checked By

QC Asst. Manager
I
Approved By

OC Manager
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Date r-r\u[\Tar.r Date Date


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