Patent ID: 7831393
Filing Date: 2010-11-09
Classification: A61K

Abstract:
1. A program product for determining an error in an ingredient's quantities in a multi-component pharmaceutical formula measured by multiple analytical instruments, said error being a value of variation of concentration for a validation under an assay standard, the program product including a computer readable computer program encoded in a non-transitory tangible storage medium, said program product employing the steps of: setting a computing mode according to a selection by a user on a type of error analysis; receiving a value for a quantity of an ingredient of a composition to be measured by an instrument; receiving a value for a sensitivity of the analytical instrument measuring the quantity of the ingredient; repeating the two receiving steps for any remaining ingredients to be measured that compose the pharmaceutical formula; executing an algorithm based on the following equations to relate: the quantities of measurements and sensitivities of instruments to a value of variation of the final concentration of any ingredient in the pharmaceutical formula: optionally plotting a relationship between quantities measurements of an ingredient, sensitivities of the instruments measuring the ingredient and a variation of a final concentration of the ingredient in a mixture in 2D or 3D chart; and outputting said value of variation of concentration for a validation under an assay standard as the error.