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.

Ingredients	Quantity given/Ampoule
Ascorbic acid
Disodium edentate
Sodium Hydroxide
Sodium bicarbonate
Water for injection q.s

Apparatus: beaker, measuring cylinder, syringe, needle, ampoules,whatman filter paper/membrane filter, Ph meter.

Procedure:

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.

Packing:

in a suitable ampoule box the ampoules are packed and labeled.

Storage:

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.

Uses:

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

Result:

Ascorbic acid injection ampoules prepared and submitted

Industrial Pharmacy I Practical

Third Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

T Y B Pharm Sem V	T Y B Pharm Sem VI
BP501T Medicinal Chemistry II Theory	BP601T Medicinal Chemistry III Theory
BP502T Industrial Pharmacy Theory	BP602T Pharmacology III Theory
BP503T Pharmacology II Theory	BP603T Herbal Drug Technology Theory
BP504T Pharmacognosy II Theory	BP604T Biopharmaceutics and Pharmacokinetics Theory
BP505T Pharmaceutical Jurisprudence Theory	BP605T Pharmaceutical Biotechnology – Theory
BP506P Industrial Pharmacy I Practical	BP606T Quality Assurance Theory
BP507P Pharmacology II Practical	BP607P Medicinal chemistry III Practical
BP508P Pharmacognosy II Practical	BP608P Pharmacology III Practical
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Preparation of Ascorbic Acid injection