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Fumed Colloidal Silicon Dioxide, Pharmaceutical Grade — Summary of Inspection Certificate Content
Created on 11.06
AEROSIL 200 (Fumed Colloidal Silicon Dioxide, Pharmaceutical Grade) — Summary of Inspection Certificate Content
1. Document Information
Item | Content |
Document title | Inspection Certificate |
Certificate type | 3.1, according to EN 10204 |
Date of issue | 23.02.2024 |
Number of pages | 4 |
Language | English |
Certificate number | Not stated (identified by delivery number and batch number) |
Addresses stated on the document
· Header: Evonik Operations GmbH, D-63403 Hanau
· Footer: Evonik Resource Efficiency GmbH, Rellinghauser Str. 1-11, 45128 Essen, Germany; Tel. (0201) 177-01, Fax (0201) 177-3475
· Board of Directors: Dr. Claus Retting (Chairman), Simone Hildmann, Andreas Fischer, Alexandra Schwarz
· Registered office: Essen, Register court: Essen local court, Commercial registry B 25793, Tax-Id.: 112/5708/0516
2. Product and Batch Information
Item | Content |
Product | AEROSIL® 200 |
Packaging | 18 x 10 KG / 22.00 lbs Paper Bag 5M1 / Plastic pallet |
Material | 99089631 |
Quantity | 3,600 KG = 360 BAG |
Batch | 614010581 |
Production date | Jan 5, 2024 |
Best before | Jan 4, 2026 |
Delivery date | Feb 19, 2024 (defined on the certificate as estimated time of dispatch / departure) |
Delivery Number / Item | 3010242807 / 900002 |
Order Number / Item | 46375262 / 000010 |
Spec. No. | K00, Vers. 15.09.2022 |
Product category | Silica |
3. Consignee and Parties
Item | Content |
Sold-to | Busan Sea Port, c/o Evonik Korea Ltd., Jungan-Dong 4ga 79-9, BUSAN 600-016, SOUTH KOREA |
Customer no. | 503047 |
Manufacturing site | Site Rheinfelden, Untere Kanalstrasse 3, 79618 Rheinfelden, Germany |
Signatory | Dr. Martina Altemöller, Inspector, Rheinfelden site (Tel. +49 7623 917252, e-mail RHE-QM-AE@evonik.com) |
4. Test Data
Note: "Conforms / pass" is the wording used on the original certificate, meaning the parameter meets the requirement without a separately reported measured value.
4.1 General parameters and European Pharmacopoeia (Ph. Eur.)
Property | Test method | Unit | Value | Target | Min. | Max. |
Specific surface area | ISO 9277, modified | m²/g | 195 | 200 | 175 | 225 |
Identification | tested acc. to Ph. Eur. | — | Conforms | pass | — | — |
Assay (SiO₂ content) | tested acc. to Ph. Eur. | % | 100.1 | — | 99.0 | 100.5 |
pH value | tested acc. to Ph. Eur. | — | 4.3 | — | 3.5 | 5.5 |
Chlorides ≤ 250 ppm | tested acc. to Ph. Eur. | — | Conforms | pass | — | — |
Loss on ignition | tested acc. to Ph. Eur. | % | 0.1 | — | — | 5.0 |
4.2 Japanese Pharmacopoeia (JP)
Property | Unit | Value | Limit |
Identification (1), (2) and (3) | — | Conforms | pass |
Loss on drying | % | 0.9 | ≤ 7.0 |
Loss on ignition | % | 0.5 | ≤ 12.0 |
Al content | — | Conforms | pass |
Fe content | ppm | Conforms | ≤ 500 |
Ca content | — | Conforms | pass |
As content | ppm | Conforms | ≤ 5 |
Cl content | % | Conforms | ≤ 0.011 |
Heavy metals | ppm | Conforms | ≤ 40 |
Assay (SiO₂ content) | % | 99.2 | ≥ 98.0 |
Volume test | ml | Conforms | ≥ 70 |
4.3 United States Pharmacopeia / National Formulary (USP/NF)
Property | Unit | Value | Limit |
As content | ppm | Conforms | ≤ 8 |
Loss on drying | % | 0.1 | ≤ 2.5 |
Loss on ignition | % | 0.3 | ≤ 2.0 |
Identification, A and B | — | Conforms | pass |
pH value | — | 4.3 | 3.5 – 5.5 |
Assay (SiO₂ content) | % | 100.0 | 99.0 – 100.5 |
4.4 Food Additive E551 / E551b (internal SOP methods)
Property | Method | Unit | Value | Max. |
As content (E551) | SOP AE_FQ01 | ppm | Conforms | ≤ 3.0 |
Pb content (E551) | SOP AE_FQ02 | ppm | Conforms | ≤ 5.0 |
Hg content (E551) | SOP AE_FQ03 | ppm | Conforms | ≤ 1.0 |
Na₂SO₄ content (E551) | SOP AE_FQ06 | % | Conforms | ≤ 5.0 |
Cd content (E551b) | SOP AE_FQ04 | ppm | Conforms | ≤ 2.0 |
Pb content (E551b) | SOP AE_FQ05 | ppm | Conforms | ≤ 30.0 |
4.5 Indian Pharmacopoeia (IP)
Property | Unit | Value | Limit |
Identification | — | Conforms | pass |
Assay (SiO₂ content) | % | 100.1 | 99.0 – 100.5 |
pH value | — | 4.3 | 3.5 – 5.5 |
Loss on ignition | % | 0.1 | ≤ 5.0 |
As content | ppm | Conforms | ≤ 8 |
Heavy metals | ppm | Conforms | ≤ 25 |
Chlorides | ppm | Conforms | ≤ 250 |
5. Quality System and Compliance Statements (Page 3)
1. Product identity: AEROSIL® 200 Pharma — Colloidal Silicon Dioxide tested according to Ph. Eur., USP/NF, JP and IP (current version).
2. Microbiology: TAMC (total aerobic microbial count), TYMC (total combined yeast and mould count) and Gram-negative bacteria are tested on a regular basis according to USP.
3. Manufacturing system: manufactured and packaged in a dedicated closed production system according to GMP guidelines established for bulk pharmaceutical excipients by the International Pharmaceutical Excipients Council (IPEC/PQG).
4. Food and feed systems: manufactured applying a HACCP system and FAMI-QS; verified by an independent external auditor, documented by a report, confirming that this HACCP system fulfils the requirements of European Union regulation (EC) No 852/2004.
5. E551 compliance: the purity criteria for E 551 according to (EU) 231/2012 (specifications for food additives regarding (EG) 1333/2008, Annex II and III) are met.
6. Appearance: white, fine, amorphous powder.
7. Sieve residue: typical sieve residue (Grit, 45 µm) is < 0.025% (according to ISO 787-18).
8. Elemental impurities: elemental impurities are not intentionally added to the production process; elemental impurities under ICH Q3D are tested on a regular basis according to USP 233 and Ph. Eur. 5.20.
9. Residual solvents: no organic solvents are used in manufacture, therefore no residual solvents are present; class 1 residual solvents cited in USP/NF (USP chapter 467) — carbon tetrachloride, 1,2-dichloroethane, 1,1,1-trichloroethane and benzene — are tested on a regular basis according to USP.
10. TSE/BSE and materials of plant origin: no raw materials of animal or plant origin (as mentioned in EMEA/410/01, current version) are used in the production process; AEROSIL® Pharma products have not been in contact with, and constitutionally do not include, any material of animal or plant origin; products are not contaminated with material of animal or plant origin when they leave the production and warehouse facilities.
11. Manufacturing location: Site Rheinfelden, Untere Kanalstrasse 3, 79618 Rheinfelden, Germany.
12. Signature: Dr. Martina Altemöller, Inspector, Rheinfelden site.
6. Document Validity Statement (Page 4)
· This document is computer printed and therefore without signature.
· All warranty claims with respect to the conformity of the product are subject to Evonik's General Terms and Conditions of Sale and Delivery.
· The data listed reflect the results of internal quality tests.
· No express or implied warranty is given as to specific properties or fitness for any particular application or purpose.
· All values are valid for the product when despatched from the works.
· The document ends with the marker "*** End ***".
7. Notes on Document Structure
· Page 1 is headed "Page 1 of 4"; pages 3 and 4 are headed "Page 3 of 4" and "Page 4 of 4".
· Page 2 is headed "Page 2 of 2" (inconsistent with the other pages); its content covers the USP/NF, E551 and IP test items.
· Pages 2, 3 and 4 each repeat the product name, material number (99089631), batch number (614010581), date (23.02.2024) and delivery number / item (3010242807 / 900002).
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.
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