SPDS Meeting Book

Regulatory Guidance • Evaluation of the Joint FAO/WHO Expert Committee on Food  Additives (JECFA), 2004 • The FDA has confirmed the Joint Expert Committee on Food  Additives’ (JECFA) ruling (Sept 8, 2004) that free lutein and  hi f f h i zeaxant n are sa e or uman consumpt on. • Vitamin status in some countries

General Method Requirements

1 Q i i . uant tat ve extract on rom matr ces a. Raw materials from which dosage forms are formulated b. Finished products (e.g., softgels, beadlets) including proteolytic or  other matrix release methods 2. Ensure against losses (e.g., oxidation, photolysis) during  extraction, workup and analysis 3. Separation from matrix interferent for accurate and  reproducible quantitation 4. The analytical range of the chosen method must encompass  below 1 mg i f i

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