Standardized
An extract that has approved methods for measuring and assigning potency using an FDA standard reference. These extracts are labeled in Bioequivalent Allergy Units (BAU), Allergy Units (AU) and Amb a 1 (AgE) units.
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Non-standardized
An extract that is not analyzed for lot-specific biological potency. No FDA standardization protocol has been defined. Therapeutic dosing also has not been defined. Formulations for non-
Standardized
extracts include: weight-to-volume (w/v) and Protein Nitrogen Unit (PNU) designations. read moreNon-Standardized Extracts
Non-
Standardized
Extracts Allergenic extracts that are considered non-Standardized
do not undergo additional laboratory testing to verify relative biologic strength. Instead, non-Standardized
extracts are assigned potency values based on either the product’s extraction ratio (source material-to-extracting solution) or on an estimated measure of total protein. Weight-to-Volume (w/v): This is simply a ratio of grams of dry… read moreStandardized Extracts
Standardized
Extracts The FDA has mandated standardization testing for a limited number of extracts. The purpose of standardization is to minimize the amount of variability between lots and manufacturers of the same extract. Extracts that have beenStandardized
by the FDA include the northern pasture grasses (Timothy, June, Meadow Fescue, Orchard, Redtop, Perennial Rye, Sweet… read moreEffect of Storage Conditions on Stability
Effect of Storage Conditions on Stability Allergenic extracts should be stored in a refrigerator when not in use. The proper storage temperature is 2-8°C (36-46°F). It is recommended to include a recording device in a refrigerator in order to monitor temperature and to note any deviations if they occur. In the event of a power…
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References
Home > References References General References Used Throughout Stability References Painful Injection From 50% Glycerin FDA Standardization Major Allergen And Standardization Regional Relevance Of Allergens Cross-Reactivity Management Of Anaphylaxis Coring & Syringe Technique Skin Testing USP 797 References – Beyond Use Date, Pharmacy Compounding Rules Allergen Information General References Used Throughout Cox, L, et al.…
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W/V
w/v, weight to volume. A ratio of the weight of dry raw material per volume of extracting fluid, expressed in grams per mL or kg per L. For example, 1:10 w/v implies that one gram of dry allergenic material (e.g. pollen) was extracted in 10 mL of extracting solution. A 1:20 w/v extract is half…
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PNU
PNU, Protein Nitrogen Unit. A measurement of protein concentration, which is analyzed in all lots of aqueous, non-
Standardized
extracts. PNU is derived from the nitrogen content of the extract solution. One milligram of nitrogen is equivalent to 100,000 PNU. read moreBAU
BAU, Bioequivalent Allergy Unit. A potency unit used to characterize biological activity of select
Standardized
allergen extracts. BAU was defined using skin prick test titrations in a sensitized patient population. Reference standards were then established by the FDA and utilized by extract manufacturers to maintain the defined relative potency for the specific,Standardized
extract. This… read moreAU
A potency unit that expresses the relative biologic activity of an allergenic extract compared to an FDA-issued standard. House Dust Mite extracts are the only extracts that are
Standardized
using AU. read more