Finished Products

Drug products contain an active pharmaceutical ingredient (API) and other inactive ingredients, such as excipients, diluents, lubricants, and binders. The purpose of the inactive ingredients is to optimize the drug’s performance, for example by modifying drug release or facilitating absorption. The API together with these ingredients makes up the drug formulation.

APIs also require characterisation as part of their release and several identification and analytical characterisation techniques may be employed. NMR is very commonly used, and a raft of 1D and 2D NMR experiments may be employed to ensure full and unambiguous assignment of the chemical structure of the material being studied as well as proof of structure. For batches that are regularly manufactured on a production plant there will frequently be a reference spectrum available to allow quick confirmation of structure between batches.

During drug development, all drug products are formulated to particular dosage forms – such as oral tablets, capsules, injections, topical and inhaled – in order to be delivered effectively to the patient. Formulation development, therefore, depends on the dosage form, as will the analytical technology required to verify the quality of the finished product.

配方开发的过程可确保制造的药物在化学和物理上是稳定的，并且在整个保质期间保持如此稳定。配方也必须是生物利用的，并满足监管要求和质量标准，以确保患者安全。

APIs must be physically and chemically compatible with the excipient within a given formulation. Selecting the right excipient is usually the first stage of formulation development and recent technological advances have provided a clearer picture of the interactions of excipients with APIs.

To verify the finished product quality and learn from potential quality-deviation to improve the manufacturing process, various analytical techniques are being used, depending on the active and inactive ingredients as well as the formulation.

Fourier Transfer Infrared (FT-IR) spectroscopy, elucidates the influence of the formulation on protein stability in biopharmaceutical drug products.

XRD是通过检测固态相变（多态性），脱水/脱溶剂，化学反应和重结晶在环境以及储存期间的非验证（温度，湿度）条件下的固态相变（多态性），化学反应和重结晶，来表征和控制最终产物稳定性的关键方法。。

X-ray fluorescence (XRF), is used to accurately measure elemental (metal) concentrations at major, minor, and trace levels and, thus, to determine the elemental purity of the product.

固态NMR（SSNMR）用作测试固态最终产品的优质技术。因为它是一个高分辨率，可以在相同的频谱中检测几个多晶型物。赋形剂通常不会显着干扰分析。如果他们这样做，可以进行选择性实验（¹H;¹⁹F,³⁵Cl). An affordable, benchtop version of ssNMR istime-domain NMR(TD-NMR), used to monitor phase purity and unique for the capability of quantifying amorphous form with LOQ < 1%.

Benchtop TD-NMR还用于高精度，快速100％填充小瓶和填充注射器。