Finished goods preparation

Drug products contain active pharmaceutical ingredients (API) and other active ingredients, such as excipients, diluent, lubricants and adhesives.The active ingredients can promote drug by such as change the drug release or absorb these means, to optimize performance.Pharmaceutical preparations by APIs and active ingredients, both of these together.

APIs in the listing process, it is necessary to adopt some identification and analysis techniques for characterization, this link is indispensable.Nuclear magnetic resonance (NMR) is one of the commonly used technology, through a series of a peacekeeping 2 d NMR experiment, can be fully and accurately detect and validate the chemical structure of experimental materials.For drug production workshop production on a regular basis, usually provides a reference spectrum, to rapidly identify different batches the structure of the drug.

In the process of drug development, all drug products will be prepared for a specific dosage forms, such as oral tablet, capsule, injection, external use or inhalant), so that drugs that can be applied effectively to the patients.Dosage form, therefore, determines the formulation development way, and also determines its need to choose what kind of analysis technology to verify the quality of the finished product preparation.

Formulation development process to ensure production of drugs with chemical and physical stability, and the stability of sustainable throughout the shelf life.In order to ensure patient safety, recipe with biological effectiveness and in compliance with regulatory and quality requirements.

In some specific formula, physical and chemical properties of APIs must be compatible.Select the appropriate excipients usually is the first step on the formulation development.In addition, detection technology in the recent development enables people to the interaction of excipients and APIs have more clear understanding.

According to the different active/inactive ingredients and recipes, need to use different analysis technology, is used to verify the quality of the finished product preparation.If the quality deviation, but also learn to improve the production process.

Fourier transform infrared spectroscopy (FT - IR) can reveal the formula for the effect on the stability of the protein in biological agents.

XRD is an indispensable technology, it can detect by solid-state phase transformation (polycrystalline type), dehydration/dissolution, chemical reaction, and different storage environment/temperature/humidity recrystallization phenomenon, to characterize and control the stability of the product preparation.

X-ray fluorescence (XRF) can be used to accurately measure element (metal) concentration, covers a large number of small and trace concentration range, which can determine the purity of product elements.

In terms of solid product formulation, solid-state nuclear magnetic resonance (ssNMR) definitely belong to the preferred.Due to its high resolution, the same spectrum of different type polycrystalline can be detected.Therefore, excipients normally not noticeable interference analysis on it.If it still has interference can be selective experiment (1 h,19 f, 35 cl).Economical time domain nuclear magnetic resonance (TD - NMR) instrument, as the desktop version, solid-state nuclear magnetic resonance (NMR) can be used for monitoring the phase purity, and has a unique detection ability under the condition of LOQ is lower than 1% also can carry on the quantitative analysis of amorphous.

Desktop TD - NMR can also be for a small bottle and filled syringe for 100% of the high precision and fast fill the check.