Last I R, Prebble K A
Analytical Development Laboratories, Wellcome Foundation Limited, Dartford, Kent, UK.
J Pharm Biomed Anal. 1993 Nov-Dec;11(11-12):1071-6. doi: 10.1016/0731-7085(93)80084-e.
A near-infrared reflectance (NIR) method for determination of moisture in an experimental freeze-dried injection product was developed and validated. NIR spectra were collected through the bases of unopened product vials using a horizontal instrument accessory, before generating primary reference data on the same individual vials by Karl-Fischer titration. Data were collected for product containing different concentrations of the active ingredient in the same matrix. NIR calibrations were developed with second derivative spectral data using regression facilities within the NIR software, and validated using independent test sets. An assessment is given of the applicability of moisture calibrations developed on product at one active ingredient level to the prediction of moisture contents in the product containing a different concentration of active ingredient.
开发并验证了一种用于测定实验性冻干注射产品中水分的近红外反射率（NIR）方法。使用水平仪器附件通过未开封产品小瓶的底部收集近红外光谱，然后通过卡尔费休滴定法在同一小瓶上生成主要参考数据。针对在相同基质中含有不同浓度活性成分的产品收集数据。使用近红外软件中的回归工具，利用二阶导数光谱数据建立近红外校准模型，并使用独立测试集进行验证。评估了在一种活性成分水平的产品上建立的水分校准模型对预测含有不同浓度活性成分的产品中水分含量的适用性。
