standard test procedure ornidazole injection

Product Name : STANDARD TEST PROCEDURE ORNIDAZOLE INJECTION
Label Claim : 5 mg per 3 ml

1. PROCEDURE
1.1 Ornidazole Injection Omidazole Injection is a sterile solution of Omidazole in propylene glycol or other suitable glycol,

in a suitable mixture of these. It contains suitable alcohols. Ornidazole Injection contains not less than 90.0 per cent and

not more than 110.0 per cent of the stated amount of ornidazole, C4110C1N303
1.2 Usual strength.
1.2.1 500 mg per 3 ml.
1.3 Description.
1.3.1 A clear, light yellow coloured solution.
1.4 Identification
1.4.1 In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to peak in the chromatogram obtained with reference solution.

1.5 Appearance of solution. A solution containing 0.5 g Omidazole per 3 ml in a mixture of equal volumes of propylene glycol

and ethanol is clear (2.4.1) and not more than intensely coloured than YS5
1.6 Related substances. Determine by liquid chromatography . NOTE – Use freshly prepared solutions and carry out the test protected from light.
1.7 Test solution. Dilute a volume of injection with the mobile phase to obtain a solution containing 0.1 per cent w/v of Omidazole. Reference solution (a). A 0.5 per cent w/v solution of 2-methyl-5-nitroimidazole RS in the mobile phase. Reference solution (b). A 0.001 per cent w/v solution of
ornidazole RS in the mobile phase.Reference solution (c). Dilute 20.0 ml of reference solution (a)
and 1.0 ml of reference solution (b) to 200.0 ml with the mobilephase.Chromatographic system
– a stainless steel column 25 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 pm),- mobile phase: a mixture of 70 volumes of 0.01 M potassium dihydrogen phosphate and 30 volumes of methanol,- flow rate: 1 ml per minute,- spectrophotometer set at 318 nm,- injection volume: 20 pl.Inject reference solution (c). The test is not valid unless the resolution between the peaks corresponding to 2-methyl-5-nitroimidazole and omidazole is not less than 1.5.Inject reference solutions (a), (b) and the test solution. In the chromatogram obtained with the test solution, the area of any peak corresponding to 2-methyl-5-nitroirnidazole is not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent) and the sum of the areas of all the secondary peaks is not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent).
1.8 Bacterial endotoxins
1.8.1 Not more than 0.7 Endotoxin Unit per mg of ornidazole.
1.9 Other tests.
1.9.1 Comply with the tests stated under Parenteral Preparation (Injections).
1.10 Assay.
1.10.1 Determine by liquid chromatography . Solvent mixture. 50 volumes of methanol and 50 volumes of water.
1.10.2 Test solution. Dilute a volume of injection with the solvent mixture to obtain a solution containing 0.0033 per cent w/v of Ornidazole.

Reference solution. A 0.0033 per cent w/v solution of ornidazole RS in the solvent mixture. Chromatographic system – a stainless

steel column 15 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 pm), – mobile phase: a mixture of 90 volumes of a 0.136 per cent
w/v solution of potassium dihydrogen orthophosphate in water, adjusted to pH 3.0 with orthophosphoric acid and 10 volumes of acetonitrile,

– flow rate: 2 ml per minute,
– spectrophotometer set at 300 nm,- injection volume: 20 pl.Inject the reference solution. The test is not valid unless the column efficiency is

not less than 2000 theoretical plates, the tailing factor is not more than 2.0 and the relative standard
deviation is not more than 2.0 per cent.Inject the reference solution and the test solution. Calculate the content of C4110CIN303 in the injection.
1.11 Storage.
1.11.1 Store protected from light and moisture.

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

standard test procedure ornidazole injection

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