Das Gupta V, Odom C, Bethea C, Plattenburg J
University of Houston, TX 77030.
J Clin Pharm Ther. 1990 Oct;15(5):331-6. doi: 10.1111/j.1365-2710.1990.tb00393.x.
Levothyroxine sodium tablets from two different manufacturers were analysed using the USP-NF method of analysis, a stability-indicating high pressure liquid chromatographic (HPLC) procedure. The results indicate that one particular manufacturer's 0.2-mg pink tablets contain some excipient(s) which act as a catalyst to hasten decomposition after extraction of levothyroxine for analysis. The same tablets from a different batch showed an additional long peak in the chromatogram, which indicated that the excipient(s) may have been changed. The same manufacturer has also used three different types of bottles/lids for the same product during the last year. Good manufacturing practice requires that new compatibilities/stability studies be conducted to assure the quality of the product. Ongoing stability studies are required by the Food and Drugs Administration (FDA). The use-life of 0.2-mg pink tablets of this manufacturer may be short.
采用美国药典-国家处方集（USP-NF）分析方法，即一种稳定性指示高效液相色谱（HPLC）程序，对来自两个不同制造商的左甲状腺素钠片进行了分析。结果表明，某一特定制造商生产的0.2毫克粉色片剂含有一些赋形剂，这些赋形剂在提取左甲状腺素用于分析后起到催化剂的作用，加速分解。来自不同批次的相同片剂在色谱图上显示出一个额外的长峰，这表明赋形剂可能已发生变化。在过去一年中，同一制造商还为同一产品使用了三种不同类型的瓶子/瓶盖。良好生产规范要求进行新的相容性/稳定性研究，以确保产品质量。美国食品药品监督管理局（FDA）要求进行持续的稳定性研究。该制造商生产的0.2毫克粉色片剂的有效期可能较短。
