USP <788>, <787> and EP2.9.19
Defining allowable limits of sub-visible particulates in parenteral formulations
Chapters <788> and <787> of the United States Pharmacopeia (USP), Particulate Matter in Injections, and chapter 2.9.19 of the European Pharmacopoeia apply to most small- and large-volume parenteral products, particularly ready-to-use solutions for intramuscular, subcutaneous or intravenous (IV) injection.
USP defines particulate matter as mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. Further, it provides 2 tests for detecting subvisible particulates—light obscuration technology and microscopic assay. USP<788>, <787> and EP2.9.19 are harmonized and state a preference for using the light obscuration counter, deferring only to the microscopic method when the light obscuration instrument cannot be used for some reason. These instruments are generally accepted for use in testing:
- Small-volume parenteral infusions/injectables (ampules and vials)
- Large-volume parenteral infusions/injectables (IV solutions)
Although light obscuration technology is generally the preferred testing method, it may be necessary to test some formulations using light obscuration and a microscopic particle count test to confirm compliance with applicable requirements.
Note that USP <788> does not apply for:
- Radiopharmaceutical preparations
- Parenterals for use only as irrigating solutions
- Parenterals requiring use of a filter prior to administration (provided scientific data justifies an exemption)