Excipients play a crucial role in the pharmaceutical industry, serving as the vehicle or medium for a drug or other therapeutic substance. They can aid in the processing of the drug delivery system during its manufacture, protect, support, or enhance stability, bioavailability, or patient acceptability, assist in product identification, and enhance any other attribute of the overall safety, effectiveness, or delivery of the drug during storage or use. However, the importance of excipients testing cannot be overstated, as the quality and performance of excipients directly impact the safety and efficacy of pharmaceutical products.
The Importance of Excipients Testing
Pharmaceutical and biotech companies are increasingly recognizing the importance of excipients testing to ensure the quality and performance of excipients. This involves engaging testing laboratories that specialize in the QC testing of raw materials, such as the UK’s Butterworth Laboratories. These laboratories apply the same level of attention to detail to both APIs and excipients, ensuring that all materials meet the required specifications.
Regulatory Requirements
Regulatory agencies around the world require testing to verify the identity and purity of excipients. In the United States, for example, the FDA stipulates a safety limit of 0.1% w/w DEG in products, and the USP has developed a Gas Chromatography (GC) method capable of separating and quantifying glycerine, ethylene glycol, and DEG. Similarly, in India, all excipient manufacturer sites and products require approval by the Indian FDA, and compliance to IP, USP, EP, BP, or JP monographs is mandatory.
Testing Requirements
Comprehensive excipient testing involves a range of tests to evaluate the quality and purity of excipients. These tests include:
Monograph Testing: This involves testing excipients to evaluate their safety in a drug delivery system. Nelson Laboratories performs full monograph testing for excipients routinely.
Pharmacopoeial Monographs: These monographs provide standardized methods for testing excipients. The USP, for example, has developed guidelines for submitting requests for revision to excipient monographs.
Certified Reference Materials (CRMs): CRMs are used to ensure the traceability of excipients. The USP has developed a process through which certification can be achieved.
Gas Chromatography (GC): GC is used to separate and quantify excipients. The USP has developed a GC method for separating and quantifying glycerine, ethylene glycol, and DEG.
Microbial Limit Tests: These tests are used to control microbial contamination. The USP provides guidelines for microbial limit tests, including tests for specified microorganisms and sterility tests.
Thin-Layer Chromatography (TLC): TLC is used for identification tests. The USP provides guidelines for TLC procedures, including the use of different solvent systems.
Benefits of Comprehensive Excipients Testing
Comprehensive excipients testing provides several benefits to pharmaceutical manufacturers and regulatory agencies. These include:
Ensuring Safety and Efficacy: Excipients testing ensures that pharmaceutical products are safe and effective for use.
Compliance with Regulatory Requirements: Compliance with regulatory requirements is essential for pharmaceutical manufacturers. Comprehensive excipients testing helps ensure compliance with pharmacopoeial monographs and regulatory guidelines.
Improved Quality Control: Comprehensive excipients testing improves quality control by ensuring that all materials meet the required specifications.
Enhanced Patient Safety: Comprehensive excipients testing enhances patient safety by ensuring that pharmaceutical products are free from contaminants and perform as intended.
Conclusion
Comprehensive excipients testing is essential for ensuring the safety and efficacy of pharmaceutical products. Pharmaceutical manufacturers and regulatory agencies must work together to develop and implement standardized testing methods and guidelines. By doing so, they can ensure that pharmaceutical products are of high quality and meet the required specifications, ultimately benefiting patients and the pharmaceutical industry as a whole.
“It is becoming increasingly important that excipients meet specifications set for them by the formulators and regulatory authorities. When clients approach us, we help them make full use of Pharmacopoeial Monographs and CRMs, along with our in-house knowledge of QC testing, to ensure all materials meet their required specification.” – John Welch, Associate Director – Business Operations, Butterworth Laboratories
References
- Nelson Labs. (n.d.). Excipient Testing. Retrieved from https://www.nelsonlabs.com/testing/excipient-testing/
- Pharmaceutical Technology. (2021, February 18). The Importance of Excipients Testing. Retrieved from https://www.pharmaceutical-technology.com/sponsored/the-importance-of-excipients-testing/
- Auriga Research. (n.d.). Pharmaceutical Excipients Testing Requirements & How Will it Help. Retrieved from https://www.aurigaresearch.com/pharmaceutical-testing/excipients-testing/
- US Pharmacopeia. (2021, October 2). CHAPTER 3 EXCIPIENTS. Retrieved from https://www.usp.org/sites/default/files/usp/document/get-involved/submission-guidelines/general-information-for-all-submissions.pdf
- US Pharmacopeia. (2018, April 3). excipient-verification-program-manual.pdf. Retrieved from https://www.usp.org/sites/default/files/usp/document/our-work/verification-services/excipient-verification-program-manual.pdf
