QP-QC-001-A/WI-0018 Page 1 of 2CONTROLLED COPY NO. 01

Department Quality Control Issue No. 0 1

Issue Date 0 5 - 2 0 0 6

STANDARD TESTING PROCEDUREFOR

DICLOFENAC POTASSIUM

PURPOSE & SCOPE:It is established to ensure the quality of incoming raw material. It is applicable for analysis of DICLOFENAC POTASSIUM.

RESPONSIBILITY:1. Manager Quality Control.2. Assistant Manager Quality Control.3. Quality Control Analyst.

DESCRIPTION:A white or slightly yellowish, crystalline powder.

SOLUBILITY:Sparingly soluble in water, freely soluble in methanol, soluble in alcohol, slightly soluble in acetone.

IDENTIFICATION:1. Dissolve about 10 mg in 10 ml of alcohol. To 1 ml of the solution add 0.2 ml of a mixture, prepared

immediately before use, of equal volumes of a 6 g/l solution of potassium ferricyanide and a 9 g/l solution of ferric chloride. Allow to stand protected from light for 5 min. Add 3 ml of a 10 g/l solution of hydrochloric acid. Allow to stand protected from light for 15 min. A blue color develops and a precipitate is formed.

2. Prepare 10µg per ml solution of both standard and sample in 0.1N NaOH. The absorbance spectrum of both standard and sample solution is same and has maximum absorbance at 276nm.

3. Suspend 0.5 g of the substance to be examined in 10 ml of water. Stir, add water until the substance is dissolved. Add 2 ml of hydrochloric acid R1, stir for 1 h and filter with the aid of vacuum. Neutralise the solution with sodium hydroxide solution R. To about 40 mg of the substance being examined dissolved in 1 ml of water or to 1 ml of the prescribed solution add 1 ml of 2M acetic acid and 1 ml of a freshly prepared 10% w/v solution of sodium cobaltinitrite. A yellow or orange-yellow precipitate is produced immediately.

TESTS:Loss on drying: Not more than 0.5 per cent, determined on 1.000 g by drying in an oven at 100°C to 105°C for 3 hour.

Prepared By Reviewed By Approved By

QP-QC-001-A/WI-0018 Page 2 of 2CONTROLLED COPY NO. 01

Department Quality Control Issue No. 0 1

Issue Date 0 5 - 2 0 0 6

STANDARD TESTING PROCEDUREFOR

DICLOFENAC POTASSIUM

ASSAY:Dissolve 0.100 g in 50 ml of anhydrous acetic acid. Titrate with 0.1M perchloric acid, determining the end-point potentiometrically. Each ml of 0.1M perchloric acid is equivalent to 33.42 mg of Diclofenac potassium.

Limit: 99 ~ 101 %

Prepared By Reviewed By Approved By