Variability in Content of Hydrocortisone Sodium Succinate.

Contact in context Pub Date : 2023-01-01 DOI:10.6084/m9.figshare.23573532

Margaret Felix, James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder

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Abstract

SOLU-CORTEF^Ⓡ Sterile Powder is a type of anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as its active ingredient. It can be administered intravenously or intramuscularly, and comes in several packages including 100 mg plain vials without diluent. The diluent, which is part of the ACT-O-VIAL system, contains only Water for Injection and no preservatives. The pH of each formula is adjusted with sodium hydroxide to ensure it falls within the specified range of 7 to 8 after reconstitution. Intralot variability was detected in lot GA6092. Measuring in the PC subspace using just PCs 4, 5 and 6, vial 12 plots 4.2 BEST SDs from the center of the cluster, and vial 7 is 3.7 SDs from the center. Vial 18 appears 3.1 SDS from the center of the cluster (3/18, 17%). Interlot variability was also found in the spectral library (lots GA6092, GK7048, GM6839, GR8925, FL8062, FN6860, FR1914, and FR5098) containing the spectra of 126 hydrocortisone sodium succinate vials.

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氢化可的松琥珀酸钠含量的变异性。

sol - cortefⓇ无菌粉末是一种抗炎糖皮质激素，含有氢化可的松琥珀酸钠作为其活性成分。它可以静脉注射或肌肉注射，有几个包装，包括100毫克普通小瓶，不含稀释剂。该稀释剂是ACT-O-VIAL系统的一部分，仅含注射用水，不含防腐剂。用氢氧化钠调节各配方的pH值，使其在重构后的pH值落在规定的7 - 8范围内。批次GA6092检测到批次内变异。在PC子空间中，仅使用pc4、5和6进行测量，第12瓶距集群中心的最佳SDs为4.2，第7瓶距中心的最佳SDs为3.7。样品18从聚类中心出现3.1 SDS(3/18, 17%)。在包含126支氢化可的松酸钠小瓶的光谱文库(编号GA6092、GK7048、GM6839、GR8925、FL8062、FN6860、FR1914和FR5098)中也发现了区间变异性。

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