standard test procedure paracetamol infusion

Product Name : STANDARD TEST PROCEDURE PARACETAMOL INFUSION
Label Claim : 10 mg per ml

1. PROCEDURE
1.1 Paracetamol Infusion :Acetaminophen Infusion Paracetamol Infusion is a sterile isotonic buffered solution for intravenous infusion consisting of

paracetamol with the aid of a suitable auxiliary substances and alkali or acid. Paracetamol Infusion contains not less than 90.0 per cent and not more

than 110.0 per cent of the stated amount of paracetamol
1.2 Usual strength.
1.2.1 10 mg per ml.
1.3 Description.
1.3.1 A clear, colourless solution.
1.4 Identification
1.4.1 In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with reference solution.
1.5 pH
1.5.1 4.5 to 6.5.
1.6 Light absorption.
1.6.1 The absorbance of the infusion at 500 nm is not more than 0.04.
1.7 Related substances.
1.7.1 Determine by liquid chromatography Test solution. Use the infusion.
Reference solution (a). Dilute 1.0 ml of the test solution to 100.0 ml with the mobile phase.
Reference solution (b). A solution containing 0.002 per cent w/v each of 4-aminophenol and paracetamol RS in the mobile phase. Reference solution (c). A 0.00002 per cent w/v solution of
4- chloroacetanilide in the mobile phase. Chromatographic system – a stainless steel column 25 cm 4.0 mm, packed with octylsilane bonded to porous silica (5 pm), column temperature: 35C,
– mobile phase: a mixture of 25 volumes of methanol containing 0.115 g of tetrabutylammonium hydroxide solution (40 per cent w/v), with 37.5 volumes of 0.05 M disodium hydrogen orthophosphate and 37.5 volumes of 0.05 M sodium dihydrogen orthophosphate, – flow rate: 1.5 ml per minute,- spectrophotometer set at 245 nm, – injection volume: 20 pl. Inject reference solution (b). The test is not valid unless the resolution between the two principal peaks is not less than
4.0. Inject reference solutions (a), (c) and the test solution. Run the chromatogram 12 times the retention time of the principal peak. In the chromatogram obtained with the test solution the area of any peak corresponding to 4-atninophenol is not more than 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent), the area of any peak corresponding to 4- chloroacetanilide is not more than 0.001 times the area of the principal peak in the chromatogram obtained with reference solution (a) (10 ppm) and the area of any other secondary peak is not more than 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.25 per cent).
1.8 Bacterial endotoxins
1.8.1 Not more than 2.0 Endotoxin Units per ml of paracetamol.
1.9 Other tests.
1.9.1 Comply with the tests stated under Parenteral Preparation (Infusions).
1.10 Assay.
1.10.1 Determine by liquid chromatography. Test solution. Dilute a volume of injection with the mobile phase to obtain a solution containing 0.01 per cent w/v of
Paracetamol.Reference solution. A 0.01 per cent w/v solution of paracetamol RS in the mobile phase. Chromatographic system- a stainless steel column 20 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (10 tun) – mobile phase: 0.01 M sodium butanesulphonate in a mixture of 85 volumes of water, 15 volumes of methanol and 0.4 volume of formic acid, – flow rate: 2 ml per minute,- spectrophotometer set at 245 nm, injection volume: 20 pl.Inject the reference solution. The test is not valid unless the column efficiency is not less than 1500 theoretical plates, the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the reference solution and the test solution.Calculate the content of paracetamol in the infusion.
1.11 Storage.
1.11.1 Store protected from light

STP NO.	REASON FOR CHANGE	REVISION NUMBER	CHANGE CONTROL NUMBER	EFFECTIVE DATE
	New STP	00	NA

standard test procedure paracetamol infusion

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