Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces.
Cleaning level acceptance criteria and a high pressure liquid chromatography procedure for the assay of Meclizine Hydrochloride residue in swabs collected from pharmaceutical manufacturing equipment surfaces.
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用于测定从制药设备表面收集的拭子中盐酸美其嗪残留量的清洁水平验收标准和高压液相色谱程序。
DOI：
10.1016/s0731-7085(98)00299-4
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发表时间：
1999
影响因子：
3.4
通讯作者：
J. R. Bodenmiller
中科院分区：
文献类型：
--
作者：
T. Mirza;Michael J Lunn;Frederick J Keeley;R. George;J. R. Bodenmiller
描述了一种方法，该方法使用基于HPLC的目视检测限标准来确定清洁后制药设备表面上盐酸美克洛嗪（MH）的可接受残留水平。使用公式来确定MH的安全清洁水平。该水平被称为特定残留清洁水平（SRCL），计算值为50 μg 100 cm−2。通过在不锈钢板上加标不同水平的MH并由一组观察员检查板来确定视觉检测限（VLOD）。大多数观察者可以目视检测到的最低水平，62.5微克100厘米−2，被认为是MH的最低检测限。因此，选择SRCL和VLOD值中的较低值（即50 μg 100 cm−2）作为清洁验收标准。开发并验证了一种灵敏的反相高效液相色谱法，用于测定用于测试设备表面的拭子中的MH。方法的平均回收率分别为87.0%和89.5%，相对标准偏差（RSD）分别为± 3.3%和± 2.4%。该方法成功地应用于从设备表面采集的实际拭子样品的测定。研究了MH在不锈钢板、清洁拭子和浸提液中的稳定性。
A method using pharmacologically based and visual limit of detection criteria to determine the acceptable residue level for Meclizine Hydrochloride (MH) on pharmaceutical manufacturing equipment surfaces after cleaning is described. A formula was used in order to determine the pharmacologically safe cleaning level for MH. This level was termed as specific residual cleaning Level (SRCL) and calculated to be 50 μg 100 cm−2. The visual limit of detection (VLOD) was determined by spiking different levels of MH on stainless steel plates and having the plates examined by a group of observers. The lowest level that could be visually detected by the majority of the observers, 62.5 μg 100 cm−2, was considered as the VLOD for MH. The lower of the SRCL and VLOD values, i.e. 50 μg 100 cm−2, was therefore chosen as the cleaning acceptance criterion. A sensitive reversed-phase HPLC method was developed and validated for the assay of MH in swabs used to test equipment surfaces. Using this method, the mean recoveries of MH from spiked swabs and ‘180-Grit’ stainless steel plates were 87.0 and 89.5% with relative standard deviations (RSD) of ±3.3 and ±2.4%, respectively. The method was successfully applied to the assay of actual swab samples collected from the equipment surfaces. The stability of MH on stainless steel plates, on cleaning swabs and in the extraction solution was investigated.