standard test procedure metronidazole injection
Product Name : STANDARD TEST PROCEDURE METRONIDAZOLE INJECTION
Label Claim : 5 mg per ml
1. PROCEDURE
1.1 METRONIDAZOLE INJECTION :Metronidazole Intravenous Infusion Metronidazole Injection is a sterile isotonic solution of
Metronidazole in Water for Injection. It may contain suitable buffering agents.
1.2 Usual strength
1.2.1 5 mg per ml.
1.3 Description
1.3.1 Almost colourless to pale yellow solution.
1.4 Storage
1.4.1 Store in single dose, light-resistant containers.
1.5 STANDARDS
1.5.1 Metronidazole Injection contains not less than 90.0 per cent and not more than 110.0 per cent of the stated amount of metronidazole, C6H9N3O3.
1.6 Identification
1.6.1 A: Carry out the method for thin-layer chromatography, using silica gel GF254 as the coating substance and a mixture of 70 volumes of chloroform, 28 volumes of methanol, 4 volumes of water and 2 volumes of strong ammonia solution as the mobile phase. Apply separately to the plate 5 ml of each of the following solutions. For solution (1) dilute a suitable volume of the injection with sufficient mobile phase to produce a solution containing 5 mg of Metronidazole per ml. Solution (2) is a 0.5% w/v solution of metronidazole RS. After removal of the plate, allow it to dry in air until the odour of solvent is no longer detectable and examine under ultra-violet light (254 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
1.6.2 B: Heat 2 ml equivalent to 10 mg of Metronidazole in a water-bath for 5 minutes with 10 mg of zinc powder and 0.25 ml of 2M hydrochloric acid for 5 minutes and cool in ice. The solution gives the reaction of
1.7 pH
1.7.1 Between 4.5 and 7.0,
1.8 Bacterial endotoxins
1.8.1 Not more than 0.35 Endotoxin Unit per mg of metronidazole,
1.9 Other requirements
1.9.1 Complies with the requirements of tests stated under Injectable Preparations (Intravenous Infusions).
1.10 Assay
1.10.1 Dilute a suitable volume with sufficient 0.1M hydrochloric acid to produce a solution containing 0.001% w/v of Metronidazole. Measure
the absorbance of the resulting solution at the maximum at about 277 nm, using as the blank a solution prepared in the same manner omitting
the substance being examined. Calculate the content of C6H9N3O3 from the absorbance obtained by repeating the operation using
metronidazole RS in place of the substance being examined and from the declared content of C6H9N3O3 in metronidazole RS.
1.11 Labelling
1.11.1 The label states that the contents should not be used if they contain any visible solid particles.
2. HISTORY
| STP NO. | REASON FOR CHANGE | REVISION NUMBER | CHANGE CONTROL NUMBER | EFFECTIVE DATE |
| New STP | 00 | NA |
3. ABBREVIATIONS
STP : Standard test Procedure
QCD : Quality Control Department
NA : Not Applicable
No. : Number
IP : Indian Pharmacopoeia
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