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Stability of ranitidine syrup re-packaged in unit-dose containers
Rakhi B Shah1, Hullahalli R Prasanna, Barry Rothman
1Office of Testing and Research, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-002, USA.
Summary
Re-packaged ranitidine syrup remains stable for up to 52 weeks under standard conditions and 13 weeks under accelerated conditions. This study confirms the stability of unit-dose ranitidine hydrochloride packaging.
Area of Science:
- Pharmaceutical Science
- Drug Stability
- Packaging Technology
Background:
- Ranitidine hydrochloride is a widely used medication.
- Ensuring the stability of liquid formulations in alternative packaging is crucial for maintaining drug efficacy and safety.
- Unit-dose packaging offers advantages in medication management and administration.
Purpose of the Study:
- To evaluate the stability of ranitidine hydrochloride syrup when re-packaged into unit-dose amber-colored glass bottles.
- To assess the impact of storage conditions on the chemical integrity and physical properties of the re-packaged syrup.
Main Methods:
- Ranitidine hydrochloride syrup was re-packaged into unit-dose containers and subjected to long-term (52 weeks at 25°C/40% RH) and accelerated (13 weeks at 40°C/25% RH) stability testing.
- Stability was assessed using high-performance liquid chromatography (HPLC) to quantify ranitidine hydrochloride and its impurities.
- Changes in pH and sample weight were also monitored.
Main Results:
- Ranitidine hydrochloride syrup in unit-dose packaging demonstrated stability under both long-term and accelerated storage conditions.
- No significant changes in pH or weight were observed that would compromise product quality.
- Impurity profiles remained within acceptable limits throughout the study period.
Conclusions:
- Re-packaged ranitidine hydrochloride syrup maintains its stability for up to 52 weeks at 25°C/40% RH and 13 weeks at 40°C/25% RH.
- Unit-dose amber glass bottles are suitable for the storage of ranitidine syrup.
- The findings support the use of re-packaged ranitidine syrup in unit-dose formats for clinical use.
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