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Effect of Dilution on Stability As extracts become more dilute their shelf life declines. So when preparing a series of dilutions, it is best to assign shorter dating to the most dilute solutions (>1:1000 v/v) since their potency cannot be guaranteed over time. When making dilutions, use of the diluent Human Serum Albumin (HSA) is… 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

Formulation Concern – Glycerin Source ALK uses glycerin that is derived from plant materials and is over 99% pure. Occasionally patients may have a concern that there could be corn allergens present in the glycerin, since corn is one of the likely source materials; however, there is a lack of adequate evidence to support the… read more

Formulation Concern – Phenol Does phenol have a negative impact on extract stability? Many extracts contain phenol (0.4%) as a preservative. There have been some reports that phenol can impact the stability of allergenic extracts. However, more recent data has shown that phenol does not appear to have a significant impact on the long term… read more

Formulation Concern – Alum Does aluminum (alum) have a negative impact on patient health? Aluminum has been used as an adjuvant in numerous vaccines for over 70 years with no severe adverse effects reported. Despite suggestions, made decades ago, that alum may contribute to conditions such as Alzheimer’s disease or other neurological disorders, there has… read more

Diluents & Preservatives When making dilutions from the concentrate vial, a number of diluents can be used. Normal Saline with Phenol (NSP) NSP is the same solution that is used to extract Aqueous extracts. It is a buffered solution of sodium chloride (0.9%) with phenol (0.4%) as a preservative. NSP offers limited stability protection for… read more

Quality Concern – Precipitation Proteins that come out of solution and become visible are said to have precipitated. Precipitation occurs when the protein configurations get altered due to factors such as improper storage conditions, freezing or prolonged heat exposure. As the protein structures change, they may clump together to form larger particles that are visible… read more

Quality Concern – Color Variation Since extracts are produced from biological materials that can be highly variable, the color of one manufactured lot may be different from a previous lot of the same product. An extract’s color comes from the pigmentation found in the source materials, which can vary significantly between lots. Since an extract’s… read more

Regional Panels An important decision for your practice will be the selection of allergenstobestockedinyourofficeforskintesting.Anappropriatediagnosticpanel willreflectnot onlytherelevantallergens inyourregion butalsothe unique profiles of patients who regularly visit your practice. Somepatients travel frequently or live in multiple locations. In these cases,significant allergens from each region the patient is exposed to should beconsidered. The number and diversity of allergens… read more

Warning indications Hyposensitization therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, animal danders and various other inhalants in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing.… read more