English
Optimizing Quality Standards for Aeroperl® 300 Pharma Grade: Key Criteria and Recommendations for Alignment with Evonik's Premium Silica Product
Created on 03.11
Translation to English:
Quality Standard Alignment with Aeroperl® 300 Pharma Grade (Evonik)
Based on existing information and industry standards, the following is an analysis of key quality criteria and recommendations for alignment with Aeroperl® 300 Pharma Grade (Evonik):
1. Chemical Composition and Purity Requirements
- Silica ContentGB 5009.12-2023
- Moisture and Ignition Residue
2. Physical Properties
- Particle Size Distribution
- Specific Surface Area
- Bulk and Tapped Density
3. Microbial and Biosafety Requirements
- Microbial LimitsE. coliSalmonella
- EndotoxinsChinese Pharmacopoeia
4. Functional Performance
- Flowability
- Adsorption Capacity
5. Packaging and Labeling
- Protection StandardsGB/T 20138-2023
- Labeling Information
6. Quality Systems and Certifications
- Manufacturing Environment
- Stability Studies
Alignment Recommendations
- Testing MethodsGB 5009.12-2023
- Gap Mitigation
Notes
- As search results lack direct Aeroperl® 300 specifications, obtain Evonik’s technical documentation or pharmacopeial monographs (e.g., USP-NF "Colloidal Silicon Dioxide") for refinement.
- Reference Chinese Pharmacopoeia
For tailored alignment services, consult Evonik technical support or third-party labs (e.g., SGS, Intertek).
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