Ukuhlela Izinga Lezinga le-Aeroperl 300 Pharma Grade: Izinkomba Eziyinhloko Nezincazelo Zokuvumelanisa Ne- Evonik's Premium Silica Product

Kwadalwa ngo 03.11
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Quality Standard Alignment with Aeroperl 300 Pharma Grade (Evonik)
Ngokusekelwe kulwazi olukhona kanye nezindinganiso zezimboni, okulandelayo kuyisifundo sezinga elibalulekile lokuhlola kanye neziphakamiso zokuhambisana ne-Aeroperl 300 Pharma Grade (Evonik):

1. Ikomposition yeChemicals kanye nezidingo zokuhlanzeka

  • Silica ContentGB 5009.12-2023
  • Moisture and Ignition Residue

2. Izakhiwo zomzimba

  • Particle Size Distribution
  • Specific Surface Area
  • Bulk and Tapped Density

3. Microbial and Biosafety Requirements

  • Microbial LimitsE. coliSalmonella
  • EndotoxinsChinese Pharmacopoeia

4. Umsebenzi Wokusebenza

  • Flowability
  • Adsorption Capacity

5. Ukupakisha nokumaka

  • 保护标准GB/T 20138-2023
  • Labeling Information

6. Izinhlelo Zokwakhiwa Kwekhwalithi Neziqinisekiso

  • Manufacturing Environment
  • Stability Studies

Alignment Recommendations

  • Testing MethodsGB 5009.12-2023
  • Gap Mitigation

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  • Njengoba imiphumela yokusesha ingenayo imininingwane ethile ye-Aeroperl 300, thola imibhalo yezobuchwepheshe ye-Evonik noma ama-monographs e-pharmacopeial (isb., USP-NF "Colloidal Silicon Dioxide") ukuze uthuthukise.
  • 参考中国药典
Ngokuhlinzekwa kwezinsizakalo zokuhambisana ezikhethekile, xhumana nosizo lwezobuchwepheshe lwe-Evonik noma amalabhorethri angaphandle (isb., i-SGS, i-Intertek).
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