- Information on USP compliance available at INTERPHEX 2016
- Clariant assists USP in development of new standards
- Guidelines govern quality, efficacy of drop-in desiccant products
The US Pharmcopeia and The National Formulary (USP-NF is a compendium of pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. Chapter is dedicated to “Auxiliary Packaging Components” and until now has mainly addressed requirements for pharmaceutical packaging coil. Previous guidance for desiccant quality were only covered in other chapters within the USP-NF as they applied to pharmaceutical ingredients and usually was not applicable to packaging applications.
Thus, the USP decided to develop a new “Desiccants” section within USP and invited Clariant (and others) to provide input. After a lengthy process, a draft chapter was published in November 2015 and becomes official on May 1, 2016 in the latest issuance of the USP-NF (USP 39–NF 34 2016).
“The new guidelines will only have meaning and industry support if it is based on real data,” explains Desmond G. Hunt, M.S., Ph.D., Sr. Scientific Liaison, USP, Rockville, Maryland. “Clariant was a major contributor to the effort, providing materials for testing and answering key questions along the way. They helped make development of the new Chapter section extremely easy.”
The new desiccant section officially sets forth specific quality standards for desiccants used in pharmaceutical packaging, and includes sub-sections on desiccant substance appearance, identification, inorganic impurities, specific test methods, and moisture adsorption capacity. It covers the major desiccant materials used in pharmaceutical packaging including silica gel and molecular sieve.
USP’s drug standards are enforceable in the United States by the Food and Drug Administration (FDA) and are also used in more than 140 countries. The standards leave it up to pharmaceutical packager to determine how best to demonstrate compliance, but generally that involves testing and obtaining certificates of compliance from their suppliers.
“We have been working internally and with our suppliers to ensure that we are prepared to help our customers understand and comply with the new standards,” explains Frédéric Gaire, Global Head of Quality, Clariant Healthcare Packaging. “Verification and testing has been completed by a 3rd party laboratory to certify that our standard silica gel and molecular sieve desiccants are compliant.”
Accordingly, Statements of Compliance will be made available to customers certifying that its standard desiccants meet applicable requirements of USP , and Clariant will now begin an ongoing process to ensure the compliance is maintained.