P-test verification of Equate cold tablets and comparison with Alka-Seltzer

Significance of the Topic

Ensuring the chemical identity and uniformity of generic over the counter cold tablets is critical for consumer safety and regulatory compliance. Raman spectroscopy offers a rapid, nondestructive method to verify that budget brands match the active ingredient profile of established name brands without compromising quality.

Objectives and Study Overview

This study aimed to demonstrate the use of a p test based on multivariate Raman spectroscopy to compare Equate brand cold relief tablets with Alka Seltzer Plus. A robust training set was developed to capture sample heterogeneity and instrument variability. Verification experiments assessed the statistical similarity of generic and name brand formulations.

Methodology

A representative training set was created by collecting 60 spectra from Equate tablets using three integration settings (high, low, auto). Spectra were acquired at multiple surface locations to account for inhomogeneity. A p test was applied to measure how sample spectra fit within the statistical model. The acceptance threshold was set at a confidence level of 0.95 and match score of 0.85.

Applied Instrumentation

• Mira P Advanced handheld Raman spectrometer
• Excitation wavelength 785 nm with short working distance attachment
• Orbital Raster Scan ORS technology for enhanced sampling area
• MiraCal software for spectral processing and p test analysis

Main Results and Discussion

The Equate training set produced p values well above the 0.05 failure limit, confirming its statistical robustness. When Alka Seltzer samples were tested against this model, p values typically fell below the threshold with ORS enabled, indicating a chemical difference in ingredient distribution. Disabling ORS yielded inconsistent pass results, demonstrating the impact of surface heterogeneity on verification. Raman spectra comparison also revealed subtle peak differences supporting these findings.

Benefits and Practical Applications

• Rapid and nondestructive confirmation of drug identity and homogeneity
• Capability to distinguish generic and name brand formulations
• Minimal sample preparation and compliance with regulatory protocols
• Portable solution for on site quality control in manufacturing and supply chains

Future Trends and Opportunities

• Integration of machine learning for improved spectral classification
• Expansion of training libraries for a wider range of pharmaceutical products
• Combination with complementary techniques such as Near IR for broader chemical coverage
• Deployment in field operations for remote quality assurance and counterfeit detection

Conclusion

Multivariate Raman spectroscopy with p test analysis on a handheld Mira P instrument effectively verifies the chemical similarity and homogeneity of effervescent cold tablets. The technique distinguishes generic from name brand products, providing a powerful tool for routine quality control and regulatory compliance.