优化Aeroperl 300药用级的质量标准：与Evonik的优质硅产品的一致性关键标准和建议

Utworzono 03.11

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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. Composición química y requisitos de pureza

Silica ContentGB 5009.12-2023
Moisture and Ignition Residue

2. Propiedades Físicas

Particle Size Distribution
Specific Surface Area
Bulk and Tapped Density

3. 微生物和生物安全要求

``` msgid "Microbial Limits" msgstr "微生物限度" msgid "E. coli" msgstr "大肠杆菌" msgid "Salmonella" msgstr "沙门氏菌" ```
EndotoxinsChinese Pharmacopoeia

msgid "4. Functional Performance" msgstr "4. 功能性能"

Flowability
Adsorption Capacity

5. 包装和标签

Protection StandardsGB/T 20138-2023
Labeling Information

6. Sistemas de Calidad y Certificaciones

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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