Tablet identification using near-infrared spectroscopy (NIRS) for pharmaceutical quality control

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Regulatory bodies like the International Conference on Harmonisation (ICH) emphasize the need for reliable and rapid analytical methods for active pharmaceutical ingredient (API) identification in finished pharmaceutical products.
• Infrared spectroscopy, particularly near-infrared spectroscopy (NIRS), offers advantages for large-scale tablet production due to its high-throughput and accurate multiparametric data collection capabilities.
• Limited regulatory approval of NIRS identification methods may stem from challenges in clearly documenting and auditing these procedures.

Purpose of the Study:

• To propose a standardized process for developing reliable near-infrared spectroscopy (NIRS) methods for API identification.
• To illustrate the proposed process with a specific NIRS method for identifying thiamazole in coated tablets.
• To ensure the developed method meets regulatory validation requirements and is suitable for cGMP environments.

Main Methods:

• Development of a novel protocol for building robust NIRS identification methods.
• Application of the protocol to create an NIRS method for thiamazole identification in coated tablets with varying concentrations (2%, 4%, 8%).
• Validation of the NIRS method according to ICH Q2 (2005) guidelines for analytical procedure validation.

Main Results:

• Successful development and validation of a NIRS method for thiamazole identification in coated tablets.
• The method demonstrated reliability and adherence to stringent validation criteria set by the ICH.
• The NIRS method was approved by European national authorities, confirming its suitability for regulatory compliance.

Conclusions:

• The proposed process enables the development of reliable NIRS identification methods for pharmaceutical applications.
• The validated NIRS method for thiamazole is suitable for use in current Good Manufacturing Practice (cGMP) environments.
• This work addresses the need for clear protocols, facilitating regulatory acceptance of NIRS technology in pharmaceutical quality control.