Variability in Content of Hydrocortisone Sodium Succinate

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry

Background:

• Solu-Cortef (hydrocortisone sodium succinate) is an anti-inflammatory glucocorticoid administered intravenously or intramuscularly.
• The product is available in various formulations, including 100 mg vials, with a diluent system (ACT-O-VIAL) containing Water for Injection without preservatives.
• Formulation pH is adjusted with sodium hydroxide to a range of 7-8 post-reconstitution.

Purpose of the Study:

• To assess intralot and interlot variability in hydrocortisone sodium succinate vials.
• To identify potential deviations in product quality and consistency.

Main Methods:

• Utilized principal component (PC) subspace analysis (PCs 4, 5, and 6) to measure variability within a specific lot (GA6092).
• Quantified deviations of individual vials from the cluster center in terms of Standard Deviations (SDs).
• Analyzed a spectral library of 126 hydrocortisone sodium succinate vials from multiple lots to evaluate interlot variability.

Main Results:

• Significant intralot variability was detected in lot GA6092, with specific vials showing deviations of 4.2, 3.7, and 3.1 SDs from the center.
• Interlot variability was confirmed across multiple lots (GA6092, GK7048, GM6839, GR8925, FL8062, FN6860, FR1914, FR5098) within the spectral library.

Conclusions:

• The study identified both intralot and interlot variability in hydrocortisone sodium succinate vials.
• These findings highlight potential inconsistencies in product quality that may require further investigation and control measures.