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Physical Compatibility and Chemical Stability of Injectable and Oral Ranitidine Solutions.

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Summary

Ranitidine hydrochloride injectable solutions and oral syrup demonstrate good stability, with injectable solutions stable for up to 6 months and oral syrup stable for 12 months, establishing reliable beyond-use dates (BUDs).

Keywords:
drug stabilityglass vialshigh-performance liquid chromatographyranitidinesyringes

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Area of Science:

  • Pharmaceutical Science
  • Drug Stability
  • Formulation Development

Background:

  • Ranitidine hydrochloride is a widely used medication.
  • Establishing beyond-use dates (BUDs) is crucial for ensuring medication efficacy and safety.
  • Limited data exists on the long-term stability of ranitidine hydrochloride in various dosage forms and storage conditions.

Purpose of the Study:

  • To determine the physical compatibility and chemical stability of ranitidine hydrochloride injectable solutions and oral syrup.
  • To establish appropriate beyond-use dates (BUDs) for these formulations.

Main Methods:

  • Ranitidine hydrochloride injectable solutions (25 mg/mL in glass vials, 5 mg/mL in PP syringes) and oral syrup (15 mg/mL in amber PP syringes) were prepared.
  • Samples were stored under various conditions (refrigerated, 25°C, protected from light, exposed to light).
  • Physical parameters (pH, clarity, color) and chemical stability (HPLC) were assessed over time.

Main Results:

  • No significant changes in pH or clarity were observed in any formulation.
  • Yellowing occurred in some samples but did not correlate with decreased ranitidine hydrochloride concentration.
  • The 25 mg/mL injectable solution remained >98.6% stable for 6 months, the 5 mg/mL solution remained >93.5% stable for 91 days, and the oral syrup remained >98.8% stable for 12 months.

Conclusions:

  • Ranitidine hydrochloride injectable solutions are stable for 6 months (25 mg/mL) and 91 days (5 mg/mL) under specified storage conditions.
  • The oral syrup formulation is stable for 12 months when stored at 25°C and protected from light.
  • These findings support the established beyond-use dates for ranitidine hydrochloride formulations.