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).

The news and information released by Zhonglian Chemical is provided solely for informational purposes and is intended only for reference and communication among industry professionals. It does not guarantee the accuracy and completeness of such information. You should not use this information to replace your own independent judgment; therefore, you shall bear the risks arising from any use of the information, and Zhonglian Chemical shall not be held liable. In case of any infringement, please contact us for removal.

Contact

Leave your information and we will contact you.