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Sampling Considerations

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Sample Preparation of Pharmaceutical Dosage Forms

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Abstract

Accurate analytical data for pharmaceutical dosage forms are dependent on adequate sample preparation and appropriate sample analysis methods. In addition, in order for the results to truly reflect the quality of the overall batch, the sample tested must be representative of the batch. Sampling is the first step and a critical aspect of the overall analysis process. Many analysts, however, are not as familiar with sampling techniques and principles as they are with analytical techniques or even sample preparation techniques. This chapter covers some fundamental sampling considerations and strategies relevant to pharmaceutical dosage forms. Both the theoretical aspects and applications in the development, manufacture, and quality control of pharmaceutical products are discussed. Examples of issues caused by sampling bias/errors are also given.

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Authors and Affiliations

  1. Pharmaceutical and Analytical R&D, Hoffmann La-Roche Inc., 340 Kingsland Street, Nutley, NJ, 07110, USA

    Dawen Kou Ph.D.

  2. Pharmaceutical and Analytical R&D, Hoffmann-La Roche Inc., Nutley, NJ, USA

    Hua Ma Ph.D., Shangdong Zhan Ph.D. & Hitesh P. Chokshi Ph.D.

  3. Quality Laboratory Operations, Celgene Corporation, Summit, NJ, USA

    Edmund J. Bishop Ph.D.

Authors
  1. Dawen Kou Ph.D.
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  2. Hua Ma Ph.D.
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  3. Edmund J. Bishop Ph.D.
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  4. Shangdong Zhan Ph.D.
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  5. Hitesh P. Chokshi Ph.D.
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Corresponding author

Correspondence to Dawen Kou Ph.D. .

Editor information

Editors and Affiliations

  1. Pfizer Global Research & Development, Analytical Research & Development Dept., Pfizer Inc., Eastern Point Road 4086, Groton, 06340, Connecticut, USA

    Beverly Nickerson

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Kou, D., Ma, H., Bishop, E.J., Zhan, S., Chokshi, H.P. (2011). Sampling Considerations. In: Nickerson, B. (eds) Sample Preparation of Pharmaceutical Dosage Forms. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9631-2_2

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