Analysis method of Cholecalciferol Drops
1.1 To lay down a procedure for analysis of Cholecalciferol Drops (vitamin D3).
2.1 This procedure is applicable to the analysis of Cholecalciferol Drops (vitamin D3) in quality control
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 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained obtained with the reference solution.
Each ml contains
Cholecalciferol 400 IU
Estimation of Cholecalciferol (Vitamin D3):
Method of Cholecalciferol (vitamin D3)
Diluted solvent: Methanol
Mobile phase: METHANOL: ACETONITRILE
Standard preparation: Weight accurately about 25 mg std wt. of vitamin D3 in 100 ml
volumetric flask. Further dilution 2.0 ml to 100 ml volumetric flask with methanol.
Test preparation: Weight accurately Equivalent to 5ppm and dilute with methanol.
Flow rate – 1.0 ml /mint.
Column -c18 (150 x4.6) 5µm.
Temp – 350c
Retention time – about 5.70 mint
Injection volume – 100µl.
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|1.0||STP||Standard Testing Procedure|
7.0 ATTACHMENTS (ANNEXES)
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