Ensuring vial packaging safety through sustainable analytics

01 Aug 2025

As the industry moves toward sustainable pharmaceutical packaging development, the role of robust analytical techniques in ensuring long-term product quality is more critical than ever.

During the stability testing of an aqueous drug product stored in vial and stopper packaging, an unexpected compound was detected – one not present in the original extractables profile. Given the product’s daily dose of 10 mL and a strict reporting threshold of 0.5 µg/mL, swift and accurate identification was essential to uphold vial product quality and ensure regulatory compliance.

To identify the unknown, high-resolution Liquid Chromatography-Mass Spectrometry (‘LC-MS’) analysis was employed. Results suggested the compound was a known fatty acid, previously detected in the packaging system in its derivatised form by using Gas Chromatography-Mass Spectrometry analysis after derivatisation. This was further confirmed by LC-MS through reference material comparison and quantification using the newly validated method.

The case underscored the value of applying multiple, complementary analytical techniques during stability monitoring. Not only did this approach enable accurate identification and resolution of the issue, but it also minimised the need for unnecessary reformulation or retesting, saving time, reducing waste and supporting sustainable pharmaceutical development through smarter packaging and lab decisions.

Key benefits

• Enhanced confidence in vial and stopper product quality and safety
• Avoidance of redundant testing and material waste
• Support for post-marketing surveillance and regulatory readiness
• Alignment with sustainability goals in sustainable pharmaceutical development

By combining science-driven approaches with practical lab solutions, this case highlights how analytical techniques can play a key role in advancing sustainable pharmaceutical development and protecting long-term product quality.

Explore more on sustainable pharmaceutical development, product quality, and analytical techniques:

Ask the expert feature: Sustainable Drug Development

Watch the full webinar on this topic: Sustainable Approaches in Analytical Method Development

Discover more: Analytical testing laboratory to GLP / GMP standards