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Evaluation of density variations to determine impact on sterile compounding
Lindsey B Amerine1,2, Tyler Pasour3, Shannon Jj Johnson4
1UNC Health, Morrisville, NC.
Summary
Manual density calculations for sterile injectable ingredients are comparable to measured densities. Density variations between different lots and manufacturers are minimal, supporting gravimetric compounding methods.
Area of Science:
- Pharmaceutical Sciences
- Compounding Pharmacy
- Quality Control
Background:
- Gravimetric compounding methods are crucial for preparing sterile injectable products (CSPs).
- Accurate drug density is essential for precise gravimetric calculations.
- Variations in drug density due to manufacturing processes can impact compounding accuracy.
Purpose of the Study:
- To evaluate density variations in sterile injectable ingredients.
- To compare measured drug density with manually calculated density.
- To assess density differences across different drug lots and manufacturers to support gravimetric compounding.
Main Methods:
- Seventeen frequently used sterile injectable drug vials were selected.
- Drug density was measured using a density meter and calculated manually.
- Density differences were analyzed between measured vs. calculated values, different lots, and different manufacturers.
Main Results:
- The average difference between measured and calculated drug density was 0.022.
- Average density differences for non-hazardous drugs were 0.005 (lots) and 0.008 (manufacturers).
- Average density differences for hazardous drugs were 0.0001 (lots) and 0.001 (manufacturers).
Conclusions:
- Manual density calculation is clinically equivalent to using a density meter.
- Minimal density variation exists between lots and manufacturers for sterile injectable drugs.
- These findings support the reliability of gravimetric compounding methods.
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