Analysis method of Cholecalciferol Drops
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Cholecalciferol Drops (vitamin D3).
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Cholecalciferol Drops (vitamin D3) in quality control
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
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 Identification:
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.
5.5 ASSAY:
Each ml contains
Cholecalciferol 400 IU
(vitamin D3)
Estimation of Cholecalciferol (Vitamin D3):
Method of Cholecalciferol (vitamin D3)
BY HPLC
Diluted solvent: Methanol
Mobile phase: METHANOL: ACETONITRILE
90: 10
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.
Chromatographic condition:
Wavelength -290nm
Flow rate – 1.0 ml /mint.
Column -c18 (150 x4.6) 5µm.
Temp – 350c
Retention time – about 5.70 mint
Injection volume – 100µl.
6.0 ABREVIATIONS
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | NM | Nano Meter |
7.0 ATTACHMENTS (ANNEXES)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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