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Raw Materials

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Practical Pharmaceutics

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Abstract

Raw materials for pharmaceutical preparations are either active substances (or active pharmaceutical ingredients (APIs)) or excipients. The choice of excipients and the quality of all raw materials determine the quality of a medicinal product. In addition to purity and content, physical properties such as particle size can influence the manufacturing process and the therapeutic effectiveness. Changes in quality can have unforeseen consequences.

The source of the raw materials, as well as their suppliers, should be assessed and qualified adequately. Active substances have to be manufactured according to EU GMP. When manufactured outside the European Union, various countries excepted, they need a ‘written confirmation’ from the manufacturing country’s authorities that active substances are manufactured in compliance with the EU GMP.

The general properties of raw materials will be discussed: identity, physical, chemical and microbiological quality, nomenclature, labelling, stability and shelf life. Main excipients and groups are discussed, for their quality properties as well as their applications: solvents such as water, ethanol, glycols, fatty oils, filling agents for capsules and tablets, surfactants, viscosity enhancers, preservatives, anti Learning oxidants, complexing agents and herbal raw materials.

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Notes

  1. 1.

    Colony Forming Unit = One or more micro-organisms that produce a visible, discrete growth entity on a semisolid, agar-based microbiological medium.

  2. 2.

    Contributed by Herman J. Woerdenbag, Groningen, The Netherlands.

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Authors and Affiliations

  1. Ofichem Group, Ter Apel, The Netherlands

    Richard Lantink

  2. Deutscher Arzneimittel-Codex/Neues Rezeptur-Formularium (DAC/NRF), Avoxa-Mediengruppe Deutscher Apotheker GmbH, Eschborn, Germany

    Michael Hörnig

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  1. Richard Lantink
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  2. Michael Hörnig
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Correspondence to Richard Lantink .

Editor information

Editors and Affiliations

  1. Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands

    Paul Le Brun

  2. Pharmacy Department, MINT URM Inserm 1066 CNRS 6021, University of Angers, CHU Angers, Angers, France

    Sylvie Crauste-Manciet

  3. Apotheke der Universitätsmedizin, Mainz, Rheinland-Pfalz, Germany

    Irene Krämer

  4. JCS Pharma Consulting Ltd., Newport, Gwent, UK

    Julian Smith

  5. Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands

    Herman Woerdenbag

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Lantink, R., Hörnig, M. (2023). Raw Materials. In: Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_7

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