ASCORBIC ACID Vitamin C; L-Ascorbic Acid

C6H8O6 Mol. Wt. 176.13 Ascorbic Acid is (R)-5-[(S)-1,2-dihydroxyethyl)-3,4- dihydroxy-5(H)-furan-2-one. Category: Vitamin (antiscorbutic) and pharmaceutical aid (antioxidant). Dose: Prophylactic, 25 to 75 mg daily; therapeutic, not less than 250 mg daily, in divided doses. Description: Colourless crystals or white to very pale yellow crystalline powder; odourless. On exposure to light it gradually darkens. Solubility: Freely soluble in water; sparingly soluble in ethanol (95%); insoluble in chloroform, in ether and in benzene. Storage: Store in tightly-closed, light-resistant containers and avoid contact with metals. It undergoes rapid decomposition in solutions in contact with air.

STANDARDS Ascorbic Acid contains not less than 99.0 per cent and not more than 100.5 per cent of C6H8O6.

Identification Test A may be omitted if tests B, C and D are carried out. Tests C and D may be omitted if tests A and B are carried out. A: The infra-red absorption spectrum is concordant with the reference spectrum of ascorbic acid or with the spectrum obtained from ascorbic acid RS. B: Add 2 ml of a 2% w/v solution to a few ml of 2,6-dichlorophenolindophenol solution; the solution is decolorised. C: Dilute 1 ml of a 2% w/v solution with 5 ml of water and add 1 drop of a freshly prepared 5% w/v solution of sodium nitroprusside and 2 ml of dilute sodium hydroxide solution. Add 0.6 ml of hydrochloric acid dropwise and stir; the yellow colour turns blue. D: To 2 ml of a 2% w/v solution add 2 ml of water, 0.1 g of sodium bicarbonate and about 20 mg of ferrous sulphate, shake and allow to stand; a deep violet colour is produced. Add 5 ml of 1M sulphuric acid; the colour disappears. pH: Between 2.2 and 2.5, determined in a 5.0% w/v solution. Clarity and colour of solution: A 5.0% w/v solution in carbon dioxide-free water is clear, and not more intensely coloured than reference solution BYS7. Specific optical rotation: Between +20.5o and +21.5o, determined in a 10% w/v solution. Light absorption: Absorbance of a 0.001% w/v solution in 0.01M hydrochloric acid at the maximum at about 244 nm, about 0.56. Oxalic acid: Dissolve 0.25 g in 5 ml of water and neutralise to litmus paper with 2M sodium hydroxide. Add 1 ml of 2M acetic acid and 0.5 ml of 0.5M calcium chloride. Any opalescence, after 60 minutes, is not more intense than that produced by treating 5 ml of a solution prepared by dissolving 70 mg of oxalic acid in 500 ml of water in a similar manner (0.3%). Heavy metals: Not more than 20 ppm, determined by Method A on 1.0 g dissolved in 25 ml of water. Sulphated ash: Not more than 0.1%. Assay: Weigh accurately about 0.1 g and dissolve in a mixture of 100 ml of freshly boiled and cooled water and 25 ml of 1M sulphuric acid. Immediately titrate with 0.05M iodine, using starch solution as indicator until a persistent blue-violet colour is obtained. Each ml of 0.05M iodine is equivalent to 0.008806 g of C6H8O6.

ASCORBIC ACID INJECTION

Vitamin C Injection; L-Ascorbic Acid Injection Ascorbic Acid Injection is a sterile solution of Sodium Ascorbate or of Ascorbic Acid prepared with the aid of Sodium Hydroxide, or Sodium Carbonate or Sodium Bicarbonate in Water for Injection. Usual strength: 500 mg in 2 ml. Description: Clear, colourless liquid. Storage: Store in single dose, light-resistant containers in a cold place.

STANDARDS Ascorbic Acid Injection contains not less than 95.0 per cent and not more than 115.0 per cent of the stated amount of ascorbic acid, C6H8O6. Identification: A: To a volume equivalent to 5 mg of Ascorbic Acid add 0.5 ml of 0.1M hydrochloric acid and 3 drops of sodium nitroprusside solution followed immediately by 1 ml of 0.1M sodium hydroxide; a transient blue colour is produced. B: To a volume equivalent to 40 mg of Ascorbic Acid add 4 ml of 0.1M hydrochloric acid and 4 drops of methylene blue solution and warm to 40o; the deep blue colour becomes appreciably lighter or is completely discharged within 3 minutes. C: The solution responds to the flame test for sodium salts, . pH: Between 5.5 and 7.0. Oxalic acid: Dilute a volume equivalent to 0.25 g of Ascorbic Acid in 5 ml of water and neutralise to litmus paper with 2M sodium hydroxide. Add 1 ml of 2M acetic acid and 0.5 ml of 0.5M calcium chloride. Any opalescence, after 60 minutes, is not more intense than that produced by treating 5 ml of a solution prepared by dissolving 70 mg of oxalic acid in 500 ml of water in a similar manner (0.3%). Other requirements: Complies with the requirements of tests stated under Injectable Preparations (Injections). Assay: Measure accurately a volume equivalent to about 50 mg of Ascorbic Acid and transfer to a 250-ml volumetric flask. Add 20 ml of metaphosphoric-acetic acids solution, dilute with water to 250.0 ml and mix. Pipette 10.0 ml into a 50-ml Erlenmeyer flask, add 5 ml of metaphosphoric-acetic acids solution and titrate with standard 2,6-dichloro- phenolindophenol solution, until the pink colour persists for at least 10 seconds, the titration occupying not more than 2 minutes. Repeat the operation with a mixture of 5.5 ml of metaphosphoric-acetic acids solution and 15 ml of water omitting the preparation being examined. From the difference calculate the ascorbic acid in each ml of the injection from the ascorbic acid equivalent of the standard 2,6-dichloro- phenolindophenol solution.

ASCORBIC ACID TABLETS Vitamin C Tablets; L-Ascorbic Acid Tablets Usual strengths: 50 mg; 100 mg; 500 mg. Storage: Store in tightly-closed, light-resistant containers avoiding contact with metals.

STANDARDS Ascorbic Acid Tablets contain not less than 95.0 per cent and not more than 115.0 per cent of the stated amount of ascorbic acid, C6H8O6. The tablets may contain permitted colouring and flavouring agents. Labelling: For tablets containing 500 mg or more of Ascorbic Acid the label states that the tablets should be chewed before swallowing. Identification: A: Shake a quantity of the powdered tablets with sufficient water to make approximately the equivalent of a 2% w/v solution of Ascorbic Acid and filter. The filtrate (solution A) is acid to litmus solution. B: Solution A complies with test B described under Ascorbic Acid. C: To 1 ml of solution A, add about 0.1 ml of 2M nitric acid and 0.05 ml of silver nitrate solution; a grey precipitate is produced. Disintegration: The requirement for Disintegration does not apply to Ascorbic Acid Tablets containing 500 mg or more of Ascorbic Acid. Other requirements: Comply with the requirements of tests stated under Tablets. Assay: Weigh and powder 20 tablets. Weigh accurately a quantity of the powder equivalent to 0.15 g of Ascorbic Acid and dissolve as completely as possible in a mixture of 30 ml of water and 20 ml of 1M sulphuric acid. Titrate with 0.1M ceric ammonium sulphate using ferroin sulphate solution as indicator. Each ml of 0.1M ceric ammonium sulphate is equivalent to 0.008806 g of C6H8O6.