Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Analytical Chemistry

Background:

• Pharmaceutical excipients are crucial for drug manufacturability and performance.
• Ensuring consistent excipient quality is vital, necessitating robust quality control strategies.
• Qualifying new suppliers requires methods to detect subtle product variations.

Purpose of the Study:

• To compare calcium hydrogen phosphate (CaHPO4) from two different suppliers.
• To evaluate the effectiveness of multivariate data analysis (MVA) for detecting supplier-specific differences in excipients.
• To develop an enhanced strategy for second supplier qualification based on risk assessment.

Main Methods:

• Utilized Raman spectroscopy, laser diffraction, and X-ray powder diffraction to analyze CaHPO4.
• Applied multivariate data analysis (MVA) to extract information from analytical data.
• Compared classical one-parameter-at-a-time monitoring with MVA.

Main Results:

• Significant chemical and physical differences were identified between CaHPO4 from the two suppliers.
• MVA successfully discriminated between CaHPO4 batches from different suppliers.
• Lot-to-lot variability within each supplier was also detectable using MVA.

Conclusions:

• MVA offers a more powerful approach than traditional methods for excipient quality control.
• The study provides a framework for enhanced second supplier qualification strategies.
• This approach aligns with regulatory guidelines demanding risk-based quality control for pharmaceutical excipients.