Analysis method of Itraconazole Solution
1.1 To lay down a procedure for analysis of Itraconazole Solution.
2.1 This procedure is applicable to the analysis of Itraconazole Solution quality control laboratory
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 Identification by chemical method.
Each 1.0 ml contains:
Itraconazole B.P. 20 mg.
Method of Itraconazole:
Diluent: 4ml concentrated hydrochloric acid. Produced to 1000 ml methanol.
Standard preparation: Weight 50 mg Standard wt. of Iitraconazole diluted to 100 ml with diluent. further dilution 2 ml to 50 ml volumetric flask with diluent.
sample preparation: Weight accurately equivalent to 50 mg sample wt. in 100 ml volumetric flask with diluent. further dilution 2 ml to 50 ml volumetric flask with diluent.
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
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