Extractables-Leachables-E-L.pdf | Extractables & Leachables (E / L)
E / L test is a service that provides risk assessment for extractables to identify extractables that may need attention from manufacturers in their extractables research and help identify analytes for leachables method development. This evaluation is based on Measurable standard and evaluates each extractable identified in the extractable evaluation. This report simulates different solvents for extractable substances and reflects the release comparison of each extractable substance. E / L test of SHENGZOU helps our customers to conduct the potential assessment of the first stage extract, but it does not mean that there is no need to conduct a risk assessment on the specific Leachables from their drugs. | 38.36 KB | January 9th, 2023 | Download |
Skills-and-technical-knowledge.pdf | Shengzou analysis laboratory is developing and providing ingredient tests for various
Pharmacopoeia tests
YBB
USP<381> Elastic seal for injection
European Pharmacopoeia 3.2.9 rubber seals for containers of aqueous parenteral preparations, powders and lyophilized powders
JP 7.03 Test of rubber seals for infusion | 84.83 KB | January 9th, 2023 | Download |
Difference-between-Visible-Particles-and-Sub-visible-Particles-Insoluble-Particles.docx | According to the pharmacopoeia specification, the number of particles of the rubber plug needs to be tested, so what do the particles mean? | 15.34 KB | January 9th, 2023 | Download |