Preparation of Ascorbic Acid injection
Ascorbic acid (vitamin c) is a water-soluble vitamin. It occurs as a white or slightly yellow
Crystal or powder with a slight acidic taste. It is an antiscorbutic product. On exposure to Light, it gradually darkens. In the dry state, it is reasonably stable in air, but in solution it Rapidly oxidizes. Ascorbic acid is freely soluble in water; sparingly soluble in alcohol;
Insoluble in chloroform, in ether, and in benzene. The chemical name of ascorbic acid is lascorbic acid. The empirical formula is c6h806, and the molecular weight is 176.13. The ascorbic acid injection is a sterile solution.
Each ml contains: Edetate disodium 0.025% in water for injection qs. Prepared with the aid of sodium Bicarbonate. Sodium hydroxide and/or hydrochloric acid may have been used to adjust ph.
|Water for injection q.s|
Apparatus: beaker, measuring cylinder, syringe, needle, ampoules,whatman filter paper/membrane filter, Ph meter.
- Type I glass ampoules are selected and clean. The formulation is carried out in clean area.
- Weigh accurately ascorbic acid.
- Dissolve ascorbic acid in water for injection in a beaker with application of heat then add calcium d saccharate to it.
- adjust the ph in between 6-8 with 10% sodium hydroxide solution.
- Keep the solution for cooling.
- cooling filter the solution through whatman filter paper/ 0.45 μmmembrane filter to remove
any particulate matter.
- Fill the prepared injection in ampoules (type i) with the help of syringe.
- Seal the ampoules by pull seal technique.
- Sterilize the ampoules by autoclaving at 121°c for 30 minutes.
in a suitable ampoule box the ampoules are packed and labeled.
store below 40 °c, preferably between 2∘ and 8 °c, unless otherwise specified by manufacturer. No preservative added. Store in a well closed container and use only if solution is clear and seal intact.
Vitamin C is recommended for the prevention and treatment of scurvy
QUALITY CONTROL TEST:
- Particulate test
- Leaker test
- Sterility test
- Content uniformity test
- Pyrogen test
Ascorbic acid injection ampoules prepared and submitted
Industrial Pharmacy I Practical
- Preformulation studies on paracetamol/aspirin/or any other drug
- Preparation and evaluation of Paracetamol tablets
- Preparation and evaluation of Aspirin tablets
- Coating of tablets- film coating of tables/granules
- Preparation and evaluation of Tetracycline capsules
- Preparation of Calcium Gluconate injection
- Preparation of Ascorbic Acid injection
- Quality control test of (as per IP) marketed tablets and capsules
- Preparation of Eye drops/ and Eye ointments
- Preparation of Creams (cold / vanishing cream)
- Evaluation of Glass containers (as per IP)
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