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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.… read more

Dose Calculations for the Maintenance Vial Theformulabelowoffersasimplifiedmethodforcalculatingthevolumeofan extract to add based on the target dose selected. Importantly, thiscalculationcanbeusedforanypotencyunit(AU, BAU,

PNU

, w/v, or µg). V = 10T/E V: Volume to be drawn up from the manufacturer’s bulk concentrate and added to the patient’s vial T: Target maintenance dose in 0.5cc injection (e.g., 2000BAU, 1000

PNU

, 7.5µg Der… read more

Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk… read more

Major Allergen Characterization The active ingredients of allergenic extracts are the proteins that the immune system responds to. Within an extract, there may be multiple allergenic proteins. Major allergens are those proteins to which at least 50% of a population are sensitized to. Some of these allergens, such as Fel d 1 in cat, are… read more

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 more

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 been standardized by the FDA include the northern pasture grasses (Timothy, June, Meadow Fescue, Orchard, Redtop, Perennial Rye, Sweet… read more