Patent ID: 7831393

Claim:
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: df =  y + z + … ( x + y + z + … ⁢ ) 2  ⁢ dx +  - x ( x + y + z + … ⁢ ) 2  ⁢ dy +  - x ( x + y + z + … ⁢ ) 2  ⁢ dz + … ⁢ ⁢ σ f 2 ≅ σ x 2 ⁡ ( ∂ f ∂ x ) 2 + σ y 2 ⁡ ( ∂ f ∂ y ) 2 + σ z 2 ⁡ ( f z ) 2 + … df f = y + z + … x · dx ( x + y + z + … ⁢ ) + dy + dz + … ( x + y + z + … ⁢ ) ⁢ ⁢ and ⁢ / ⁢ or ⁢ ⁢ σ f f = [ ( y + z + … x ) 2 · σ x 2 ( x + y + z + … ⁢ ) 2 + σ y 2 + σ z 2 + … ( x + y + z + … ⁢ ) 2 ] 1 / 2 where df and σ f are an absolute variation of concentration of a ingredient in the pharmaceutical formula, df/f and σ f /f are a relative variation of a dosage percentage of an ingredient in the pharmaceutical formula, x, y, z, . . . are quantities of ingredients of the dosage form, dx, dy, dz, . . . are sensitivities of the analytical instruments; 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.