Sodium Chloride and Dextrose Injection Preparation Cheat Sheet
This document outlines the precise formula, procedure, and quality control measures for preparing Sodium Chloride and Dextrose Injection IP, a fluid and electrolyte replenisher.
Core Principles
- The formula for 100ml of injection requires 0.45gm Sodium Chloride IP and 2.5gm Anhydrous Dextrose IP, with Water for Injection q.s.
- The preparation involves weighing, dissolving, filtering, and sterilizing the components.
- Quality control includes identification tests and pH measurement, with the final product containing between 9.5% and 105.0% of the stated amounts of sodium chloride and dextrose.
Action Steps
- Weigh 0.45gm Sodium Chloride IP and 2.5gm Anhydrous Dextrose IP.
- Boil and cool the required amount of Water for Injection.
- Dissolve the weighed sodium chloride and anhydrous dextrose in the cooled water.
- Filter the solution through a G4 filter and fill it into ampoules.
- Seal the ampoules and sterilize them by autoclaving.
Key Terms
- Sodium Chloride IP: A key ingredient for fluid and electrolyte replenishment in the injection.
- Anhydrous Dextrose IP: A key ingredient for fluid and electrolyte replenishment, providing energy.
- Water for Injection: Sterile water used as the solvent base for the injection.
- G4 filter: A type of filter used to remove particulate matter from the solution before filling.
- Autoclaving: A sterilization method using high-pressure steam to kill microorganisms.
Pro Tips
- To avoid dextrose degradation, ensure raw materials are free from impurities, maintain solution pH between 5.0-5.5, minimize exposure to high temperatures, and use a spray-cooled autoclave for sterilization.
Pitfalls to Avoid
- Dextrose degradation at alkaline pH can lead to brown pigment formation or conversion into formic and levulonic acid, affecting product quality.
Myth vs Reality
- Dextrose is stable under all pH conditions.: Dextrose undergoes transformation to methyl furfural, producing brown pigment or converting to formic and levulonic acid, especially at alkaline pH.
Real World Examples
- Preparing Sodium Chloride and Dextrose Injection IP for intravenous infusion.: The detailed formula and procedure ensure accurate preparation for therapeutic use as a fluid and electrolyte replenisher.
Statistics
- Dextrose Molar Mass: 180.16 g/mol
- Dextrose Density: 1.54 g/cm3
- Dextrose Solubility: 1:1 in water
- Sodium Chloride Solubility: Freely soluble in water
- Standard Content (Sodium Chloride & Dextrose): Not less than 9.5% & not more than 105.0% of stated amount
- pH Range: 3.5-6.5
- 5-Hydroxymethyl furfural limit (absorbance at 184 nm): Not more than 0.25
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