Glasgow Maria, Dressman Shawn, Brown William, Foster Thomas, Schuber Stefan, Manning Ronald G, Wahab Samir Z, Williams Roger L, Hauck Walter W
United States Pharmacopeia, Rockville, MD 20852, USA.
Pharm Res. 2008 May;25(5):1110-5. doi: 10.1007/s11095-007-9482-2. Epub 2008 Jan 3.
Periodic performance verification testing (PVT) is used by laboratories to assess and demonstrate proficiency and for other purposes as well. For dissolution, the PVT is specified in the US Pharmacopeia General Chapter Dissolution <711> under the title Apparatus Suitability Test. For Apparatus 1 and 2, USP provides two reference standard tablets for this purpose. For each new lot of these reference standards, USP conducts a collaborative study.
For new USP Lot P Prednisone Tablets, 28 collaborating laboratories provided data. The study was conducted with three sets of tablets: Lot O open label, Lot O blinded, and Lot P blinded. The blinded Lot O data were used for apparatus suitability testing.
Acceptance limits were determined after dropping data due to failure of apparatus suitability, identification of data as unusual on control charts, or protocol violations.
Results yielded acceptance criteria of (47, 82) for Apparatus 1 and (37, 70) for Apparatus 2. Results generally were similar for Lot P compared to results from Lot O except that the average percent dissolved for Lot P is greater than for Lot O with Apparatus 2.
实验室使用定期性能验证测试（PVT）来评估和证明其专业能力，也用于其他目的。对于溶出度测试，PVT在美国药典通则第<711>章“溶出度”的“仪器适用性测试”标题下有规定。对于仪器1和仪器2，美国药典为此提供了两种参比标准片。对于这些参比标准品的每个新批次，美国药典都会进行一项协作研究。
对于美国药典新批次P泼尼松片，28个协作实验室提供了数据。该研究使用了三组片剂：O批次开放标签、O批次盲法以及P批次盲法。O批次盲法数据用于仪器适用性测试。
在因仪器适用性不合格、在控制图上识别出异常数据或违反方案而剔除数据后，确定了验收限度。
得出仪器1的验收标准为（47，82），仪器2的验收标准为（37，70）。与O批次的结果相比，P批次的结果总体相似，只是在仪器2中，P批次的平均溶出百分比高于O批次。
