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Non-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 more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Standardized 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 been standardized by the FDA include the northern pasture grasses (Timothy, June, Meadow Fescue, Orchard, Redtop, Perennial Rye, Sweet… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Extract Formulations

Extract Formulations

Allergen extract

s are available in a variety of formulations. An extract’s formulation directly impacts the stability of the allergenic proteins in solution and therefore the shelf life of the product. The FDA has determined maximum expiration dates for each formulation based on the estimated loss of potency over time. All extracts can be… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Basics of Extract Manufacture

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 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Latest Topics

Home  >  Latest Topics Mixing Concerns: Cross-Reactivity & Proteolytic Enzymes Use of

Allergen extract

s  >  Mixing Allergens  >  Mixing Concerns: Cross-Reactivity & Proteolytic Enzymes Mixing Concerns: Cross-Reactivity & Proteolytic Enzymes Some patients who present with numerous sensitivities may require treatment with a mixture of different allergens. In the United States, it is standard practice to mix… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

Popular Topics

Home  >  Popular Topics Extract Formulations Extract Formulations

Allergen extract

s are available in a variety of formulations. An extract’s formulation directly impacts the stability of the allergenic proteins in solution and therefore the shelf life of the product. The FDA has determined maximum expiration dates for each formulation based on the estimated loss of potency… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.

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.… read more 705357C1-B577-4332-A248-2D41FB183786Created with sketchtool.