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Stability of Procainamide Injection in Clear Glass Vials and Polyvinyl Chloride Bags
1The Ottawa Hospital, Ottawa, Ontario, Canada.
Hospital Pharmacy
|December 26, 2017
Summary
Procainamide hydrochloride is stable for 193 days in glass vials or PVC bags under various storage conditions. This stability applies to both the concentrated 100 mg/mL form and a 3 mg/mL dilution, ensuring its integrity for extended periods.
Area of Science:
- Pharmaceutical Sciences
- Chemical Stability Studies
- Drug Repackaging and Dilution
Background:
- Procainamide hydrochloride is a critical medication requiring careful storage.
- Understanding the chemical stability of pharmaceutical preparations is essential for patient safety and therapeutic efficacy.
- Repackaging and dilution are common practices that necessitate stability assessments.
Purpose of the Study:
- To determine the chemical stability of procainamide hydrochloride (100 mg/mL) when repackaged into clear glass vials.
- To evaluate the stability of procainamide hydrochloride diluted to 3 mg/mL in normal saline and packaged in polyvinyl chloride (PVC) bags.
- To assess stability under different storage conditions: 23°C exposed to light (ETL) and 5°C protected from light (PFL).
Main Methods:
- Utilized a stability-indicating high-performance liquid chromatography (HPLC) method for accurate drug concentration assays.
- Collected samples from triplicate containers at multiple time points up to 193 days.
- Monitored physical parameters including color, clarity, and pH changes throughout the study.
Main Results:
- All samples maintained clarity with minimal pH fluctuations.
- Solutions stored at 23°C ETL showed color intensification without significant concentration loss.
- Procainamide hydrochloride demonstrated stability for 193 days in both repackaged glass vials and diluted PVC bags under all tested conditions.
Conclusions:
- Procainamide hydrochloride (100 mg/mL) is chemically stable for 193 days when repackaged in clear glass vials, irrespective of storage at 23°C ETL or 5°C PFL.
- Diluted procainamide hydrochloride (3 mg/mL in normal saline, PVC bags) also exhibits 193-day stability under both tested storage conditions.
- These findings support the extended stability of procainamide hydrochloride in common pharmaceutical packaging formats.
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