Pharmaceutical analysis

Pharmaceutical analysis guarantees drug safety by providing information on the identity, content, quality, purity, and stability of pharmaceutical products using analytical chemistry. Metrohm offers you a broad range of instruments and applications for quality control and for monitoring and improving drug manufacturing. With myriads of pharmacopeia-compliant analysis methods, we are your qualified partner for all chemical-pharmaceutical analysis issues and analytical method validations.

In accordance with international pharmacopeias and various guidelines, Metrohm offers you analysis for active pharmaceutical ingredients (APIs), excipients, impurities, pharmaceutical solutions as well as pharmaceutical starting materials, and finished pharmaceutical products (FPPs). Additionally, we provide numerous wet chemical methods for atline and online process control as well as inline monitoring methods for assuring cost-effective manufacturing processes that satisfy all regulatory demands.

Active pharmaceutical ingredients (APIs)

APIs are used to cure, alleviate, prevent, or identify illnesses and diseases. They are present in small quantities and aim at restoring physiological functions in human beings. In international pharmacopeias, a list of monographs provides detailed descriptions of test methods, tests, and requirements.

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Impurities are mainly introduced from the starting materials used and/or during synthesis of the active pharmaceutical ingredients. They are monitored according to both the directives of the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the pharmacopeias. Even small concentrations of impurities can have significant side effects.

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Pharmaceutical manufacturing process

Successful process monitoring relies to a great extent on the latest methods of ion analysis and spectroscopy. While the former – mostly wet chemical methods – are preferably measured online and atline, near-infrared spectroscopy (NIRS) is the ideal tool for inline monitoring, particularly in the light of the FDA’s PAT and QbD initiatives.

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