- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Ferrous Fumarate and Folic Acid Tablets |
Vitamin B component.
Ferrous Fumarate and Folic Acid Tablets contain Ferrous Fumarate and Folic Acid. They are coated.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Carry out the tests avoiding exposure to actinic light.
90.0 to 105.0% of the stated amount.
90.0 to 115.0% of the stated amount.
A. In the Assay for folic acid, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).
B. Heat a quantity of the powdered tablets containing 0.77 g of Ferrous Fumarate with 25 mL of a mixture of equal volumes of hydrochloric acid and water on a water bath for 15 minutes, cool and filter. Retain the residue for test C. The filtrate yields reaction A characteristic of iron salts, Appendix VI.
C. Wash the residue reserved in test B with a mixture of 1 volume of 2m hydrochloric acid and 9 volumes of water and dry at 105°. Suspend 0.1 g of the residue in 2 mL of sodium carbonate solution and add potassium permanganate solution dropwise. The permanganate is decolourised and a brownish solution is produced.
Dissolve a quantity of the powder prepared for the Assay for ferrous fumarate containing 1.5 g of Ferrous Fumarate in a mixture of 100 mL of water and 10 mL of hydrochloric acid by heating rapidly to the boiling point. Boil for 15 seconds, cool rapidly, add 3 g of potassium iodide, stopper, allow to stand in the dark for 15 minutes and titrate the liberated iodine with 0.1m sodium thiosulfate VS using starch mucilage as indicator. Repeat the operation without the substance being examined. The difference between the titrations is not more than 13.4 mL (5% ferric iron in Ferrous Fumarate).
Tablets containing less than 2mg and/or less than 2% w/w of Folic Acid comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 135 volumes of methanol and 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate (solvent A).
(1) Place one tablet in 40 mL of solvent A, shake for a further 15 minutes, dilute to 50 mL with solvent A and filter (0.45 µm nylon filter is suitable).
(2) 0.0007% w/v of folic acid BPCRS in solvent A.
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 277 nm.
(f) Inject 20 µL of each solution.
135 volumes of methanol and 800 volumes of a solution containing 0.938% w/v of sodium perchlorate and 0.075% w/v of potassium dihydrogen orthophosphate adjusted to pH 7.2 with 0.1m potassium hydroxide and diluted to 1000 volumes with water.
Calculate the content of C19H19N7O6 in each tablet using the declared content of C19H19N7O6 in folic acid BPCRS.
Weigh and powder 20 tablets.
Disperse a quantity of the powder containing 0.3 g of Ferrous Fumarate in 7.5 mL of 1m sulfuric acid with gentle heating. Cool, add 25 mL of water and titrate immediately with 0.1m ammonium cerium(iv) sulfate VS using ferroin solution as indicator. Each mL of 0.1m ammonium cerium(iv) sulfate VS is equivalent to 16.99 mg of C4H2FeO4.
Use the average of the 10 individual results obtained in the test for Uniformity of content.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 135 volumes of methanol and 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate (solvent A).
(1) Mix a quantity of the powdered tablets containing 0.35 mg of Folic Acid in 40 mL of solvent A, shake for 5 minutes with the aid of ultrasound, shake for a further 15 minutes and dilute to 50 mL with solvent A and filter (0.45 µm nylon filter is suitable)
(2) 0.0007% w/v of folic acid BPCRS solvent A.
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silca gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 277 nm.
(f) Inject 20 µL of each solution.
135 volumes of methanol and 800 volumes of a solution containing 0.938% w/v of sodium perchlorate and 0.075% w/v of potassium dihydrogen orthophosphate adjusted to pH 7.2 with 0.1m potassium hydroxide and diluted to 1000 volumes with water.
Calculate the content of C19H19N7O6 in the tablets using the declared content of C19H19N7O6 in folic acid BPCRS.
Ferrous Fumarate and Folic Acid Tablets should be protected from light.
304 mg of ferrous fumarate is equivalent to 100 mg of ferrous iron.