Abstract
The European Pharmacopeia (Ph. Eur.) surface test to analyze the hydrolytic resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with 12 mm diameter electrode was calibrated with 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis. Limit of quantification at 1 μS/cm was determined as having a signal to noise ratio of 3 compared with the water blank. The conductivity method was selective for glass composing elements (boron, sodium, aluminum, silicon, potassium, and calcium) within the vial extract. Accuracies of spiked conductivity standard within the range of 1 to 100 μS/cm were ± 7% and had linearity with coefficient of determination (R2) of ≥ 0.9999. Intraday precision had RSD (n=5) of ≤ 6% for spiked conductivity standard within the range of 1 to 100 μS/cm. Interday precision had RSD (n=4) of ≤ 6% for ten vials from three glass vial lots. Conductivity of water extracts from nine sets of seven lots of glass vials had a precise linear relationship [R2 = 0.9876, RSD = 1% (n=9)] with titration volumes of the same lots. Conductivity results in μS/cm could be converted to titration values in mL by conversion factor of 0.0275. The simplicity, sample stability, and individual vial analysis of the conductivity technique were advantageous than the current titration technique.
- Received June 20, 2016.
- Accepted August 15, 2016.
- Copyright © 2016, Parenteral Drug Association
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