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Normal Saline Solution Pharmaceutics Lab Practical Manual PDF

Aim: To Prepare, Evaluate and Submit Normal Saline Solution

Requirements:

  • Chemicals: Sodium Chloride, Water for Injection
  • Apparatus: Glass Bottle, Beaker, Rubber Closure, Aluminum Seal, Crimping Machine, Autoclave, Funnel, Volumetric Flask, Glass Rod.

Theory:

Saline solution is a mixture of salt and water. The normal saline solution contains 0.9 percent sodium chloride (salt), which is similar to the sodium concentration in blood and tears. Saline solution is usually called normal saline, but it’s sometimes referred to as physiological isotonic saline. It contains no antimicrobial agent; as it is a large volume and single-dose parenteral preparation. Sodium Chloride Injection contains not less than 0.85% w/v and more than 0.95% w/v of sodium chloride.

Procedure:

1) Accurately weigh all the ingredients.

2) Add sodium chloride in a suitable sterile container and add a sufficient quantity of water for injection to make the required volume. Stir to dissolve.

3) If the solution is clear or not, filter the solution by using sintered glass filter.

4) Fill the clear filtrate solution into the stainless steel pressure tank and aseptically pass-through membrane filter of 0.22 im.

5) Fill the solution aseptically into a sterilized container and close with a sterilized rubber closure and seal it with aluminium cap.

6) Check the leakage and reject the leaking container.

7) Examine the solution critically for particulate matter.

8) Then sterilized by autoclave at temperature121°C and pressure 15 lbs /sq. inch for 20 mins.

9) Switch off the autoclave. Allow it to cool and the pressure to come to zero, then remove containers.

10) Polish the container and re-examine for the particulate matter and leakage.

11) Label it and submit.

Category: Fluid and Electrolyte replenisher.

Dose: As directed by a physician. To be used with non-pyrogenic I. V. administration set with aseptic technique.

Storage: It should be stored in a cool dark place, protect from light.

Direction: For I.V. use only.

Precautions: Only for single-use, discard any unused portion immediately. Even invisible damage to the container may result in contamination. Do not use if the container is found to leak or the solution contains visible solid particles.

Definitions:

Electrolyte: 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.

Vehicle: Vehicles or solvents are the medium in which ingredients of a formulation are dissolved, suspended or dispersed.

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