I-Fumed Colloidal Silicon Dioxide, Izinga Lemithi — Isifinyezo Sokuqukethwe Kwesitifiketi Sokuhlolwa

Kwadalwa ngo 11.06

I-AEROSIL 200 (I-Fumed Colloidal Silicon Dioxide, I-Pharmaceutical Grade) — Isifinyezo Sokuqukethwe KweSitifiketi Sokuhlola

Isampula yempuphu emhlophe ye-silicon dioxide e-colloidal eyenziwe nge-fumed yezinga le-pharma ye-AEROSIL 200 elabhorathri

1. Ulwazi Lwedokhumenti

Into	Okuqukethwe
Isihloko sedokhumenti	Isitifiketi Sokuhlola
Uhlobo lwesitifiketi	3.1, ngokwe-EN 10204
Usuku lokukhishwa	23.02.2024
Inani lamakhasi	4
Ulimi	IsiNgisi
Inombolo yesitifiketi	Akushiwo (kukhonjwa ngenombolo yokulethwa kanye nenombolo yeqoqo)

Amakheli ashiwo kudokhumenti

· Isihloko: Evonik Operations GmbH, D-63403 Hanau

· Umsuka: Evonik Resource Efficiency GmbH, Rellinghauser Str. 1-11, 45128 Essen, Germany; Ucingo (0201) 177-01, Ifeksi (0201) 177-3475

· Ibhodi Labaqondisi: Dr. Claus Retting (Usihlalo), Simone Hildmann, Andreas Fischer, Alexandra Schwarz

· Indawo ebhalisiwe: Essen, Inkantolo yokubhalisa: Inkantolo yasendaweni yase-Essen, Irejista yezentengiselwano B 25793, Inombolo yentela: 112/5708/0516

2. Ulwazi Lomkhiqizo Ngeqembu

Into	Okuqukethwe
Umkhiqizo	AEROSIL® 200
Ukupakishwa	18 x 10 KG / 22.00 lbs Isikhwama Sephepha 5M1 / Ipallets yepulasitiki
Impahla	99089631
Inani	3,600 KG = 360 ISIKHWAMA
Iqoqo	614010581
Usuku lokukhiqiza	Jan 5, 2024
Kuphele ngaphambi	Jan 4, 2026
Usuku lokulethwa	Feb 19, 2024 (kuchazwe esitifiketini njengesikhathi esilinganiselwe sokuthunyelwa / ukusuka)
Inombolo Yokulethwa / Into	3010242807 / 900002
Inombolo Ye-oda / Into	46375262 / 000010
Inombolo ye-Spec.	K00, Vers. 15.09.2022
Isigaba somkhiqizo	I-Silica

3. Umamukeli Nezinhlangano

Into	Okuqukethwe
Othengisiwe	Busan Sea Port, c/o Evonik Korea Ltd., Jungan-Dong 4ga 79-9, BUSAN 600-016, SOUTH KOREA
Inombolo yekhasimende	503047
Indawo yokukhiqiza	Site Rheinfelden, Untere Kanalstrasse 3, 79618 Rheinfelden, Germany
Umsayini	Dr. Martina Altemöller, Inspector, Rheinfelden site (Tel. +49 7623 917252, e-mail RHE-QM-AE@evonik.com)

Indawo yokukhiqiza i-AEROSIL 200 eRheinfelden eJalimane kanye nokuthunyelwa kwe-logistics yempuphu ye-silica epakishwe

4. Idatha Yokuhlola

Qaphela: "Kuyavumelana / kuyaphasa" yigama elisetshenziswe esitifiketini sokuqala, okusho ukuthi ipharamitha ihlangabezana nemfuneko ngaphandle kwenani elikalwe elibikiwe ngokwehlukana.

Ukuhlolwa kwelabhorathri ye-QC yezemithi yokuhlola indawo engaphezulu ethile ye-fumed silica, i-pH kanye nokuhlolwa ngokwe-Ph. Eur. USP JP IP

4.1 Amapharamitha ajwayelekile kanye ne-European Pharmacopoeia (Ph. Eur.)

Impahla	Indlela yokuhlola	Iyunithi	Inani	Ithagethi	Okuncane	Okukhulu
Indawo yomhlaba ethize	ISO 9277, kushintshiwe	m²/g	195	200	175	225
Ukuhlonza	kuhlolwe ngokwe-Ph. Eur.	—	Kuyavumelana	kuyaphasa	—	—
Ukuhlola (okuqukethwe kwe-SiO₂)	kuhlolwe ngokwe-Ph. Eur.	%	100.1	—	99.0	100.5
Inani le-pH	kuhlolwe ngokwe-Ph. Eur.	—	4.3	—	3.5	5.5
Ama-chloride ≤ 250 ppm	kuhlolwe ngokwe-Ph. Eur.	—	Kuyavumelana	kuyaphasa	—	—
Kuhlolwe ngokwe-Ph. Eur.	%	0.1	—	—	—	5.0

4.2 I-Pharmacopoeia yaseJapane (JP)

Impahla	Iyunithi	Inani	Umkhawulo
Ukuhlonza (1), (2) kanye no-(3)	—	Kuyavumelana	kuyaphasa
Ukulahlekelwa ngesikhathi sokomisa	%	0.9	≤ 7.0
Ukulahleka lapho kushiswa	%	0.5	≤ 12.0
Okuqukethwe kwe-Al	—	Kuyavumelana	kuyaphasa
Okuqukethwe kwe-Fe	ppm	Kuyavumelana	≤ 500
Okuqukethwe kwe-Ca	—	Kuyavumelana	kuyaphasa
Okuqukethwe kwe-As	ppm	Kuyavumelana	≤ 5
Okuqukethwe kwe-Cl	%	Kuyavumelana	≤ 0.011
Izinsimbi ezisindayo	ppm	Kuyavumelana	≤ 40
Assay (SiO₂ content)	%	99.2	≥ 98.0
Ukuhlolwa kwevolumu	ml	Kuyavumelana	≥ 70

4.3 I-United States Pharmacopeia / National Formulary (USP/NF)

Impahla	Iyunithi	Inani	Umkhawulo
Njengokuqukethwe	ppm	Kuyavumelana	≤ 8
Ukulahlekelwa ngokoma	%	0.1	≤ 2.5
Ukulahlekelwa ngokushiswa	%	0.3	≤ 2.0
Ukuhlonza, A kanye no-B	—	Kuyavumelana	kuyaphasa
Inani le-pH	—	4.3	3.5 – 5.5
Ukuhlola (okuqukethwe kwe-SiO₂)	%	100.0	99.0 – 100.5

4.4 Isengezo Sokudla E551 / E551b (izindlela zangaphakathi ze-SOP)

Impahla	Indlela	Iyunithi	Inani	Okuphezulu
Njengokuqukethwe (E551)	SOP AE_FQ01	ppm	Kuyavumelana	≤ 3.0
Okuqukethwe kwe-Pb (E551)	SOP AE_FQ02	ppm	Kuyavumelana	≤ 5.0
Okuqukethwe kwe-Hg (E551)	SOP AE_FQ03	ppm	Kuyavumelana	≤ 1.0
Okuqukethwe kwe-Na₂SO₄ (E551)	SOP AE_FQ06	%	Kuyavumelana	≤ 5.0
Okuqukethwe kwe-Cd (E551b)	SOP AE_FQ04	ppm	Kuyavumelana	≤ 2.0
Okuqukethwe kwe-Pb (E551b)	SOP AE_FQ05	ppm	Kuyavumelana	Ukulahleka ngesikhathi sokushiswa

4.5 Indian Pharmacopoeia (IP)

Impahla	Iyunithi	Inani	Umkhawulo
Ukuhlonza	—	Kuyavumelana	kuyaphasa
Ukuhlolwa (okuqukethwe kwe-SiO₂)	%	100.1	99.0 – 100.5
Inani le-pH	—	4.3	3.5 – 5.5
Ukulahleka lapho kushiswa	%	0.1	≤ 5.0
Njengokuqukethwe	ppm	Kuyavumelana	≤ 8
Izinsimbi ezisindayo	ppm	Kuyavumelana	≤ 25
Ama-Chloride	ppm	Kuyavumelana	≤ 250

5. Izitatimende ZoHlelo Lwekhwalithi Nokuhambisana (Ikhasi 3)

1. Ubunikazi bomkhiqizo: AEROSIL® 200 Pharma — I-Colloidal Silicon Dioxide ehlolwe ngokusho kwe-Ph. Eur., USP/NF, JP kanye ne-IP (inguqulo yamanje).

2. I-Microbiology: I-TAMC (inani eliphelele lamagciwane asebenzayo emoyeni), i-TYMC (inani eliphelele elihlanganisiwe lemvubelo nesikhunta) kanye namagciwane e-Gram-negative kuhlolwa njalo ngokusho kwe-USP.

3. Uhlelo lokukhiqiza: kukhiqizwa futhi kupakishwe ngohlelo olukhethekile lokuphikha oluvaliwe ngokwemihlahlandlela ye-GMP eyasungulwa yi-International Pharmaceutical Excipients Council (IPEC/PQG) yezithako zamakhambi amaningi.

4. Izinhlelo zokudla nokudla kwezilwane: kukhiqizwa kusetshenziswa uhlelo lwe-HACCP kanye ne-FAMI-QS; kuqinisekiswa umhloli wangaphandle ozimele, kubhalwe embikweni, okuqinisekisa ukuthi lolu hlelo lwe-HACCP luyazifeza izidingo zomthetho we-European Union (EC) No 852/2004.

5. Ukuhambisana kwe-E551: izindinganiso zokuhlanzeka ze-E 551 ngokwe-(EU) 231/2012 (izincazelo zezithako zokudla mayelana ne-(EG) 1333/2008, Isengezo II kanye ne-III) ziyafezwa.

6. Ukubukeka: impuphu emhlophe, ecwebezelayo, engenasimo.

7. Insalela yesihlungi: insalela yesihlungi ejwayelekile (i-Grit, 45 µm) ingaphansi kuka-0.025% (ngokwe-ISO 787-18).

8. Ukungcola kwama-elementi: ukungcola kwama-elementi akufakwa ngamabomu enqubweni yokukhiqiza; ukungcola kwama-elementi ngaphansi kwe-ICH Q3D kuhlolwa njalo ngokusho kwe-USP 233 kanye ne-Ph. Eur. 5.20.

9. Izincibilikisi ezisele: awekho izincibilikisi eziphilayo ezisetshenziswayo ekukhiqizeni, ngakho-ke azikho izincibilikisi ezisele; izincibilikisi ezisele zesigaba 1 ezishiwo ku-USP/NF (isahluko se-USP 467) — i-carbon tetrachloride, i-1,2-dichloroethane, i-1,1,1-trichloroethane kanye ne-benzene — zihlolwa njalo ngokusho kwe-USP.

10. I-TSE/BSE kanye nezinto zokwakha ezivela ezitshalweni: azikho izinto zokusetshenziswa eziwumsuka wezilwane noma wezitshalo (njengoba kushiwo ku-EMEA/410/01, inguqulo yamanje) ezisetshenziswayo enqubweni yokukhiqiza; imikhiqizo ye-AEROSIL® Pharma ayikaze ithintane nayo, futhi ngokwakheka kwayo ayifaki, noma iyiphi into yokwakha evela ezilwaneni noma ezitshalweni; imikhiqizo ayikho engcoliswe into yokwakha evela ezilwaneni noma ezitshalweni lapho ishiya izikhungo zokukhiqiza nezokugcina impahla.

11. Indawo yokukhiqiza: Isiza saseRheinfelden, Untere Kanalstrasse 3, 79618 Rheinfelden, Germany.

12. Isiginesha: Dr. Martina Altemöller, Umhloli, isiza saseRheinfelden.

6. Isitatimende Sokusebenza Kwencwadi (Ikhasi 4)

· Le ncwadi ishicilelwe ngekhompyutha ngakho-ke ayinasiginesha.

· Zonke izimangalo zewaranti maqondana nokuvumelana komkhiqizo zingaphansi kweMibandela Jikelele Yokuthengisa Nokulethwa yakwa-Evonik.

· Idatha eshiwo ibonisa imiphumela yokuhlolwa kwekhwalithi kwangaphakathi.

· Akukho siqinisekiso esicacile noma esisetshenzisiwe esinikezwayo mayelana nezakhiwo ezithile noma ukufaneleka kwanoma yiluphi uhlelo lokusebenza noma injongo ethile.

· Wonke amanani ayasebenza kumkhiqizo lapho uthunyelwa usuka emsebenzini.

· Idokhumenti iphetha ngophawu "*** End ***".

7. Amanothi Ngesakhiwo Sedokhumenti

· Ikhasi 1 linesihloko esithi "Page 1 of 4"; amakhasi 3 no-4 anesihloko esithi "Page 3 of 4" kanye no-"Page 4 of 4".

· Ikhasi 2 linesihloko esithi "Ikhasi 2 kwangu-2" (akuhambisani namanye amakhasi); okuqukethwe kwayo kuhlanganisa izinto zokuhlola ze-USP/NF, E551 kanye ne-IP.

· Amakhasi 2, 3 kanye no-4 ngamunye aphinda igama lomkhiqizo, inombolo yempahla (99089631), inombolo yebhetshi (614010581), usuku (23.02.2024) kanye nenombolo yokulethwa / into (3010242807 / 900002).

Izindaba nolwazi olukhishwe yiZhonglian Chemical kunikezwa ngenjongo yokwazisa kuphela futhi kuhloselwe ukuba kube yireferensi nokuxhumana phakathi kochwepheshe bomboni. Akusiqinisekisi ukunemba nokuphelela kwalolu lwazi. Akufanele usebenzise lolu lwazi ukuthatha isikhundla sokwahlulela kwakho okuzimele; ngakho-ke, uzothwala izingozi ezivela ekusetshenzisweni kwalo lwazi, futhi iZhonglian Chemical ngeke ibe nesibopho. Uma kunesiphambeko, sicela uxhumane nathi ukuze sisuse.

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