Addendum Common Functional Groups

ICH Guideliaes QID, Bracketing and matrixing designs for stability testing of new drug substances and products, Feb. 2002. 

Atsriku, D. G. Watson, J. N. A. Tettey, M. H. Grant, and G. G. SkeUern, Determination of diminazene aceturate in pharmaceutical formulations by HPLC and identification of related substances by LC/MS, J. Pharm. Biomed. Anal. 30 (2002), 979-986. 

Al-Omari, A. A. Badwan, A. M. Y. Jaber, Amlodipine besylate— excipients interactions in solid dosage form, Pharm. Dev. Technol. 9 (2004), 15-24. 

Parthiban, R. LoBrutto, R. Vivilecchia, M. Zheng, B. Reddy, and M. Dryfoos, NIR Practical implementation in tablet content uniformity measurement, PAT, October 2005. 

Moffat, D. R. Rees, and N. W. Broad, A procedure for calibration transfer between near-infrared instruments—a worked example using a transmittance single tablet assay for piroxicam in intact tablets. Analyst 129 

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All of the background information discussed in the addendum (Common Functional Groups) will help an analytical chemist with development of a stability-indicating method (SIM) that will assist in the development of an optimized formulation that will become a drug product in the marketplace. Remember, an analytical chemist must be able to provide knowledge, not just data. 

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