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Support

Skills and technical knowledge

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   other component tests include: Elastomer moisture Silicon analysis Conduct material characterization analysis by TGA-FTIR、DSC and UV Analysis of Microparticles Endotoxin Elastomer stability test Cytotoxicity test

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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. Analysis technology The analytical techniques commonly performed during extraction studies include: GC-FID, HS-GC-MS GC-MS LC-PDA, LC-MS ICP-OES Additional technology new product development Shengzou can use systematic database for material analysis(PY-GC-MS) according to the products provided by customers    

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Difference between Visible Particles and Sub-visible Particles/Insoluble Particles

According to the pharmacopoeia specification, the number of particles in the rubber stopper should be detected. Then how to define the “particle”?   Visible Particles Refer to an insoluble substance that is present in injection or eye drops and can be visually observed with naked eyes under specified conditions. Its particle size or length is usually greater than 50um. Inspection Method:Usually inspected with naked eyes under light.   Sub-visible particles/ Insoluble particles Refer to the small particles and impurities contaminated by various ways during the production or application of drugs. The particle size ranges from 1 to 50 um. They are invisible, movable, non-metabolic harmful particles (hereinafter referred to as particles). Numerous animal tests and human autopsies have shown that particles can cause potentially serious harm that is difficult to detect at the moment.   Usually inspected by Light Obscuration Particles Count Test and Microscopic Particles Count Test   Parenteral Infusion or Injection EP Standard (EP 3.2.9) pcs/ml USP Standard (USP 381) pcs/ml Shengzou Standard pcs/ml ≧ 10 um ≦25 ≦25 ≦25 ≧ 25 um ≦ 3 ≦ 3 ≦ 3  

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