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Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:
Email & Skype: support@dideu.com Telephone:+86-29-89586682
Mobile:+86-15129568250; Whatsapp: +8615129568250
Ergocalciferol Tablets | |
| Action and use | Vitamin D analogue (Vitamin D2). |
Definition | Ergocalciferol Tablets contain Ergocalciferol. The tablets comply with the requirements stated under Tablets and with the following requirements. |
Content of ergocalciferol, C28H44O | 90.0 to 125.0% of the stated amount. |
| Identification | A. In the test for Uniformity of content, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (1). B. Extract one tablet, in powder, with 5 ml of dichloromethane, filter and to 1 ml of the filtrate add 9 ml of antimony trichloride solution. A brownish red colour is produced. |
Tests Related substances | Uniformity of content Tablets containing less than 2 mg of Ergocalciferol comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) 0.001% w/v of ergocalciferol BPCRS in hexane (2) For tablets containing more than 0.25 mg of ergocalciferol prepare the solution in the following manner. Add 4 ml of water to one tablet in an amber flask and disperse with the aid of ultrasound. Add 12 ml of dimethyl sulphoxide, mix, extract with 100 ml of hexane by shaking for 30 minutes, centrifuge the hexane layer and use the clear supernatant liquid. For tablets containing 0.25 mg or less carry out the same procedure but using 2 ml of water, 6 ml of dimethyl sulphoxide and 25 ml of hexane. (3) Dissolve 0.5 g of cholecalciferol for performance test EPCRS in 2 ml of toluene and dilute to 10 ml with the mobile phase; heat under a reflux condenser in a water bath at 90° for 45 minutes and cool. chromatographic conditions (a) Use a stainless steel column (20 cm × 4.6 mm) packed with silica gel for chromatography (5 µm) (Partisil is suitable). (b) Use isocratic elution and the mobile phase described below. (c) Use a flow rate of 2 ml per minute. (d) Use an ambient column temperature. (e) Use a detection wavelength of 254 nm. (f) Inject 20 µl of each solution. Inject a suitable volume of solution (1) and record the chromatogram using a sensitivity such that the height of the peak due to ergocalciferol is more than 50% of full-scale deflection. Repeat the operation using solution (2) and injecting the same volume. mobile phase 8 volumes of pentan-1-ol and 992 volumes of hexane. system suitability Inject 20 µl of solution (3) and record the chromatogram using a sensitivity such that the height of the peak due to colecalciferol is more than 50% of full-scale deflection. When the chromatogram is recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol. The test is not valid unless the resolution factor between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0. If necessary, adjust the proportions of the constituents and the flow rate of the mobile phase to obtain this resolution. determination of content Calculate the content of ergocalciferol, C28H44O, in each tablet using the declared content of C28H44O in ergocalciferol BPCRS and using peak heights. |
| Assay | For tablets containing 2 mg or more of ergocalciferol Carry out the following procedure in subdued light. Weigh and powder 25 tablets, or more if necessary. To a quantity of the powdered tablets containing 6 mg of Ergocalciferol add 50 ml of ethanol (96%), 14 ml of glycerol and 20 ml of a 50% w/v solution of potassium hydroxide. Boil under a reflux condenser for 30 minutes, swirling occasionally, add 110 ml of water and allow to stand for 10 minutes with occasional stirring. Cool and add sufficient ethanol (96%) to produce 250 ml. Shake 5 ml with 25 ml of petroleum spirit (boiling range, 40° to 60°) for 3 minutes and evaporate duplicate 5 ml portions of the extract to dryness in a current of oxygen-free nitrogen. Dissolve each residue in 1 ml of ethanol-free chloroform, add rapidly 9 ml of antimony trichloride solution and measure the absorbance of each solution at 500 nm and at 550 nm, 90 to 120 seconds after adding the reagent, Appendix II B. Repeat the operations using duplicate 1 ml portions of a solution containing a known amount of ergocalciferol BPCRS in ethanol-free chloroform and beginning at the words 'add rapidly 9 ml of antimony trichloride solution…'. Subtract the absorbance at 550 nm from that at 500 nm and calculate the content of ergocalciferol in mg from the average value so obtained and from the amount of ergocalciferol in the reference solution using the declared content of C28H44O in ergocalciferol BPCRS. For tablets containing less than 2 mg of ergocalciferol Use the average of the 10 individual results obtained in the test for Uniformity of content. |
| Labelling | The label states the equivalent number of IU (units) of antirachitic activity (vitamin D) per tablet. Each μg of ergocalciferol is equivalent to 40 IU of antirachitic activity (vitamin D). When calciferol tablets are prescribed or demanded, Colecalciferol Tablets or Ergocalciferol Tablets shall be dispensed or supplied. |
Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:
Email & Skype: support@dideu.com Telephone:+86-29-89586682
Mobile:+86-15129568250; Whatsapp: +8615129568250
Ergocalciferol Tablets | |
| Action and use | Vitamin D analogue (Vitamin D2). |
Definition | Ergocalciferol Tablets contain Ergocalciferol. The tablets comply with the requirements stated under Tablets and with the following requirements. |
Content of ergocalciferol, C28H44O | 90.0 to 125.0% of the stated amount. |
| Identification | A. In the test for Uniformity of content, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (1). B. Extract one tablet, in powder, with 5 ml of dichloromethane, filter and to 1 ml of the filtrate add 9 ml of antimony trichloride solution. A brownish red colour is produced. |
Tests Related substances | Uniformity of content Tablets containing less than 2 mg of Ergocalciferol comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) 0.001% w/v of ergocalciferol BPCRS in hexane (2) For tablets containing more than 0.25 mg of ergocalciferol prepare the solution in the following manner. Add 4 ml of water to one tablet in an amber flask and disperse with the aid of ultrasound. Add 12 ml of dimethyl sulphoxide, mix, extract with 100 ml of hexane by shaking for 30 minutes, centrifuge the hexane layer and use the clear supernatant liquid. For tablets containing 0.25 mg or less carry out the same procedure but using 2 ml of water, 6 ml of dimethyl sulphoxide and 25 ml of hexane. (3) Dissolve 0.5 g of cholecalciferol for performance test EPCRS in 2 ml of toluene and dilute to 10 ml with the mobile phase; heat under a reflux condenser in a water bath at 90° for 45 minutes and cool. chromatographic conditions (a) Use a stainless steel column (20 cm × 4.6 mm) packed with silica gel for chromatography (5 µm) (Partisil is suitable). (b) Use isocratic elution and the mobile phase described below. (c) Use a flow rate of 2 ml per minute. (d) Use an ambient column temperature. (e) Use a detection wavelength of 254 nm. (f) Inject 20 µl of each solution. Inject a suitable volume of solution (1) and record the chromatogram using a sensitivity such that the height of the peak due to ergocalciferol is more than 50% of full-scale deflection. Repeat the operation using solution (2) and injecting the same volume. mobile phase 8 volumes of pentan-1-ol and 992 volumes of hexane. system suitability Inject 20 µl of solution (3) and record the chromatogram using a sensitivity such that the height of the peak due to colecalciferol is more than 50% of full-scale deflection. When the chromatogram is recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol. The test is not valid unless the resolution factor between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0. If necessary, adjust the proportions of the constituents and the flow rate of the mobile phase to obtain this resolution. determination of content Calculate the content of ergocalciferol, C28H44O, in each tablet using the declared content of C28H44O in ergocalciferol BPCRS and using peak heights. |
| Assay | For tablets containing 2 mg or more of ergocalciferol Carry out the following procedure in subdued light. Weigh and powder 25 tablets, or more if necessary. To a quantity of the powdered tablets containing 6 mg of Ergocalciferol add 50 ml of ethanol (96%), 14 ml of glycerol and 20 ml of a 50% w/v solution of potassium hydroxide. Boil under a reflux condenser for 30 minutes, swirling occasionally, add 110 ml of water and allow to stand for 10 minutes with occasional stirring. Cool and add sufficient ethanol (96%) to produce 250 ml. Shake 5 ml with 25 ml of petroleum spirit (boiling range, 40° to 60°) for 3 minutes and evaporate duplicate 5 ml portions of the extract to dryness in a current of oxygen-free nitrogen. Dissolve each residue in 1 ml of ethanol-free chloroform, add rapidly 9 ml of antimony trichloride solution and measure the absorbance of each solution at 500 nm and at 550 nm, 90 to 120 seconds after adding the reagent, Appendix II B. Repeat the operations using duplicate 1 ml portions of a solution containing a known amount of ergocalciferol BPCRS in ethanol-free chloroform and beginning at the words 'add rapidly 9 ml of antimony trichloride solution…'. Subtract the absorbance at 550 nm from that at 500 nm and calculate the content of ergocalciferol in mg from the average value so obtained and from the amount of ergocalciferol in the reference solution using the declared content of C28H44O in ergocalciferol BPCRS. For tablets containing less than 2 mg of ergocalciferol Use the average of the 10 individual results obtained in the test for Uniformity of content. |
| Labelling | The label states the equivalent number of IU (units) of antirachitic activity (vitamin D) per tablet. Each μg of ergocalciferol is equivalent to 40 IU of antirachitic activity (vitamin D). When calciferol tablets are prescribed or demanded, Colecalciferol Tablets or Ergocalciferol Tablets shall be dispensed or supplied. |
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