Module 3 Presentations

07/05/2024

Different type of analytical methods

Analytical methods

Qualitative

Semi-quantitative

Quantitative

Quantitative low levels

 Example: Identification test by IR.

 Example: active assay in finished product. Dissolution. Content uniformity  Instrumentation: chromatographic HPLC/GC, titrations.

 Example: degradant in finished products. Elemental impurities.

 Example: limit test – old heavy metals.  Instrumentation: spectroscopy, simple chemical reaction, TLC.

 Instrumentation: spectroscopy, simple chemical reaction, TLC.

 Instrumentation: chromatographic HPLC/GC. High sensitivity may require hyphenated technique with MS

COMPLEXITY

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The method development process.

The sample.

The analytical technique.

 Nature and type of dosage form (Tablets, Capsules, Powder, Lozenges, Gummies, Syrup, etc).

 Matched to the requirement/specification. Stability indication requirement  Simplicity and robustness of the analytical technique.

 Extraction and Stability of the analyte.

 Change of formulation composition

 State of the art.

Method development

Institutional knowledge

The opportunities.

 Internal: Enovia, Veeva.

 Use modeling techniques such as Quality by Design to platform and speed up method development.  Incorporate partial validation elements as part of method development.

 External: Pharmacopoeia, Literature and International journals.

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