Extending calibrations for near infrared assay of tablets using synthetic modeling and variance from placebos

• Published in: Pharmaceutical Technology Vol. 33; no. 3; p. 120
• Main Authors: Mattes, Robert, Root, Denise
• Format: Magazine Article Trade Publication Article
• Language: English
• Published: Monmouth Junction Intellisphere, LLC 01-03-2009; MultiMedia Healthcare Inc
• Subjects: Assaying; Calibration; Evaluation; Ingredients; Methods; Pharmaceutical industry; Pharmaceuticals; Placebos; Prescription drugs; Principal components analysis; Process controls; Product development; R&D; Research & development; Software; Spectrum analysis; Technology adoption; United States; United States > US
• ISSN: 1543-2521; 2150-7376

The range of a near-infrared calibration model for tablet assay is extended using production "seed" spectra and synthetic spectra generated from placebos and "pure" active pharmaceutical ingredient (API) spectra. This method resolves the problem of not being able to obtain a range of production samples with ±15% of the label claim of API concentration on-line. The authors develop a synthetic model using five real production samples and 70 samples synthesized from fractions of "pure" API spectra added to placebo spectra. A synthetic calibration model with R^sup 2^ = 0.9987 and a standard error of calibration of 0.0037 mg was developed with this method for an API with 1.0-mg label claim in a 100-mg tablet. [PUBLICATION ABSTRACT]