Analysis according to Pharmacopoeia

farmacopeaThe suitability of bottles, ampoules, syringes and other glassware for use in pharmaceutical applications must be verified by means of a series of specific procedures, detailed in special collections of regulations called Pharmacopoeia. Each national market refers to its own body of legislation, but at a global level the European (Ph. Eur.), United States (U.S.P.) and Japanese (J.P.) Pharmacopoeia have particular relevance as a model of reference.

In Stazione Sperimentale del Vetro a specific laboratory is dedicated to the preparation and segregated handling of pharmaceutical samples, and is equipped with advanced analytical instrumentation, capable of reaching the extremely low limits of detection and quantification prescribed by the Pharmacopoeia.

SSV offers analytical support to manufacturers and users of pharmaceutical glass for the execution of various types of tests according to Pharmacopoeia:

  • Hydrolytic resistance tests on powders and surfaces according to European, American, Japanese Pharmacopoeia;
  • Surface hydrolytic resistance tests, Arsenic release, according to European and American Pharmacopoeia;
  • Chlorides determination according to European Pharmacopoeia;
  • Light transmission tests according to European, American, Japanese Pharmacopoeia;
  • Protocol for determining elementary impurities according to USP 232 and USP 233 (extractables).

For the above mentioned analytical activities destined to the pharmaceutical sector, SSV has adapted its operating and management procedures to the prescriptions of reference Good Manufacturing Practices (GMP).

2019-01-16T17:06:40+00:00