Ascorbic Acid Injection

General Notices

Action and use

Vitamin C.

Definition

Ascorbic Acid Injection is a sterile solution of Ascorbic Acid in Water for Injections containing Sodium Bicarbonate.

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

Content of ascorbic acid, C6H8O6

95.0 to 105.0% of the stated amount.

Characteristics

A colourless liquid.

Identification

A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in water.
(1) Dilute the injection, if necessary, to contain 0.5% w/v of Ascorbic Acid.
(2) 0.5% w/v of ascorbic acid BPCRS.
chromatographic conditions
(a) Use a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 2 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).
mobile phase

20 volumes of water and 120 volumes of ethanol (96%).

confirmation

The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).

B. To a volume containing 50 mg of Ascorbic Acid add 0.2 mL of 2m nitric acid and 0.2 mL of 0.1m silver nitrate. A grey precipitate is produced.

Tests

Acidity

pH, 5.0 to 6.5, Appendix V L.

Oxalic acid

Dilute a volume containing 0.25 g to 5 mL with water, neutralise to litmus paper with 2m sodium hydroxide, add 1 mL of 2m acetic acid and 0.5 mL of calcium chloride solution and allow to stand for 1 hour. Any opalescence produced is not more intense than that in a solution prepared at the same time and in the following manner. Dissolve 70 mg of oxalic acid in 500 mL of water and to 5 mL of the resulting solution add 1 mL of 2m acetic acid and 0.5 mL of calcium chloride solution (0.3%).

Assay

To a volume containing 0.2 g add 5 mL of 2m sulfuric acid and titrate with 0.05m iodine VS using starch mucilage as indicator. Each mL of 0.05m iodine VS is equivalent to 8.806 mg of C6H8O6.

Storage

Ascorbic Acid Injection should be protected from light and stored at a temperature of 2° to 8°.

When vitamin C injection is prescribed or demanded, Ascorbic Acid Injection shall be dispensed or supplied.