Calcium Gluconate Injection Pharmaceutics Practical Lab Manual PDF
Aim: To Prepare, Evaluate and Submit Calcium Gluconate Injection
Requirement:
Chemicals: Calcium Gluconate, Calcium D-Saccharate, Water for Injection, Sodium Hydroxide
Apparatus: Membrane Filtration Assembly, Syringe, Gloves, Face Mask, Forceps
Theory:
Calcium gluconate injection is the supersaturated solution of calcium gluconate which acts as electrolytes and source of calcium. Calcium gluconate is slowly soluble in about 30 parts of water and soluble in about 5 parts of boiling water. Calcium in the form of calcium gluconate is used in the strength of 10% w/v. In fact, 10% solution of calcium gluconate in water gives a saturated solution. Any temperature fluctuations during storage yield crystallization of calcium gluconate. Therefore, IP prescribes to replace a part of calcium gluconate (not more than 5% of the total) by an equal amount of more soluble calcium salt, such as calcium D-saccharate or calcium lactobionate. These soluble calcium salts are called stabilizing agents. The pH of the calcium gluconate injection can be adjusted from 6.0 to 8.2 using sodium hydroxide or hydrochloric acid solutions. It is prepared in a single dose container, preferably a Type I glass container.
Procedure:
1) Accurately weigh all the ingredients.
2) Dissolve calcium gluconate in water for injection.
3) Then dissolve calcium D-saccharate in the above solution.
4) Adjust the pH of above solution to 6 – 8,2 using 10% sodium hydroxide solution.
5) Filter the above solution through 0.45 um membrane filter.
6) Fill the solution in ampoules and seal it using burner and forceps.
7) Sterilize the ampoule by using autoclave at 121°C, 15 lbs for 30 minutes.
8) Observe the ampoule for particulate matter
Category: Fluid and electrolyte, Source of Calcium
Dose: Calcium gluconate by Intramuscular or Intravenous injection 1 to 2 g.
Storage: Keep in cool and dry place. If any particulate matter observed in the ampoule, then discard the preparation.
Precaution: If visible particles are present should not be used.
Definitions:
- Fluid and Electrolytes: Electrolytes are mineral substances which become ions in solution and have the capacity to carry an electrical charge. It regulates the osmotic pressure in cells and helps to maintain the function of muscle and nerve cells.
- Stabilizing agent / Stabilizers: A stabilizer is any substance that is used to preserve the physical and chemical properties of a material and prevent degradation. At a chemical level, these stabilizers work by inhibiting chemical reactions.
- Vehicle: A carrier or inert medium used as a solvent (or diluent) in which the medicinally active agent is formulated.
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