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Potency Labeling The biologic strength (potency) of an allergenic extract can be expressed in a variety of ways. In general, all allergenic extracts are divided into 2 categories: Standardized (BAU /AU) The FDA has mandated standardization testing for a limited number of extracts. The purpose of standardization is to minimize the amount of variability between… read more

Source Material Collection The manufacture of an allergenic extract begins with the identification and procurement of a natural source material. 1 Source material collection is a process that results in a relatively pure sample of allergenic substances (e.g., pollen, dander/epithelium, fungal cultures, whole insects, foods, etc.). A successful collection of allergenic material can depend on… read more