Abstract

1000 international units (IU) and less, whereas in higher doses it is considered an ethical pharmaceutical. Patients and physicians may rely upon the OTC preparations to manage metabolic bone disease and to optimize response to osteoporosis pharmaceuticals. Assurance of cholecalciferol content in commercial cholecalciferol preparations is of great importance to patient outcomes. OTC and ethical pharmaceutical preparations are handled differently with regulatory authorities. OTC preparations are assigned an NPN (natural products number) based on parameters which differ from ethical pharmaceutical preparations which are assigned a DIN (drug identification number). We assayed the cholecalciferol content of 22 supplements available as OTC pharmaceutical products obtained from retail pharmacies in Canada. We used HPLC with tandem mass spectrometry detection. Tablets were first pulverized in a mortar and pestle, then extracted with methanol. After centrifuging, the methanol extract was applied to the HPLC column and run with appropriate standards. Mean cholecalciferol content of the OTC pharmaceuticals was 55.4 % of the declared label amount (range 7 to 119%). 77% of the preparations contained less than 80% of the label amount. (Table) We conclude that OTC cholecalciferol preparations are generally at less than label indicated potency. Prescription cholecalciferol preparations aremore likely to contain the label amount of vitamin. This information is important to patients and prescribing physicians; consideration of more stringent monitoring of OTC preparations by health authorities is warranted.

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