Physical characterization of solid form of drug is of paramount importance as its biopharmaceutical properties and/or its processing behavior may be altered. Early identification and monitoring of solid state transformation is a critical requirement for pharmaceutical product development. In combination with chemometrics, a non destructive and non invasive technique like NIR is a powerful tool for solid state characterization. Main focus of this review is application of NIR for qualitative and quantitative analysis of solid forms of drugs and excipients. In addition, this review also sheds light on recent advancement in NIR, such as NIR chemical imaging and NIR based hyphenated techniques.

药物的固体形式的物理表征至关重要，因为它的生物药物特性和/或其加工行为可能会改变。早期识别和监测固态转化是药物产品开发的关键要求。与化学计量学相结合，像NIR这样的非破坏性和非侵入性技术是进行固态表征的强大工具。这篇综述的主要重点是将近红外光谱技术用于药物和赋形剂固体形式的定性和定量分析。此外，本综述还阐明了近红外技术的最新进展，例如近红外化学成像和基于近红外的联用技术。