Spezifikation
|
Produktbezug: |
| Produktnummer | 7447407MEE |
| Handelsname / Bezeichnung | Kaliumchlorid EP, USP, E 508, pyrogen fr |
| CAS Nummer | 7447-40-7 |
| Andere Bezeichnungen / Synonyme | •Kaliumchlorid;
•potassium chloride; |
| EG Nummer | 231-211-8
|
| Zolltarifnummer / CN-Code | 310420 |
| Molekulargewicht [g/mol] | 74,55 |
| Formel | KCl
ClK |
| Parameter |
Methode |
Spezifikation |
Einheit |
Sensorische Prüfung |
| Aussehen der Lösung |
|
klar und farblos |
| Aussehen |
E 508 |
farblose, längliche, prismatische oder würfelförmige Kristalle oder weiß, körniges Pulver |
| Aussehen |
EP |
fast weißes oder weißes, kristallines Pulver oder farblose Kristalle |
| Geruch |
|
geruchlos |
|
Physikalische Parameter |
| Säuregehalt |
USP |
entspricht |
|
| Säuregehalt |
EP |
Max. 0.5 ml of 0.01 M HCl / NaOH |
| Trocknungsverlust |
EP |
≤ 1 |
% |
| Trocknungsverlust |
E 508 |
@ 105°C, 2h: ≤ 1 |
% |
| Trocknungsverlust |
USP |
@ 105°C, 2h: ≤ 1 |
% |
| Löslichkeit |
EP |
gut löslich in Wasser, praktisch unlöslich in wasserfreiem Ethanol |
| Löslichkeit |
E 508 |
leicht löslich in Wasser, unlöslich in Ethanol |
Identifikation |
| Gehalt |
EP |
99,0 – 101,0 |
% |
| Gehalt |
USP |
99,0 – 100,5 |
% |
| Gehalt |
E 508 |
on dry basis ≥ 99 |
% |
| Identifizierung |
|
(Cl): entspricht |
| Identifizierung |
|
(K): entspricht |
|
Verunreinigungen |
| Sulphat (SO4) |
|
≤ 300 |
ppm |
| Verunreinigung |
|
Mg und Alkalimetalle (berechnet als Ca) ≤ 200 |
ppm |
Restlösemittel |
| Restlösemittel |
|
Da bei der Herstellung keine organischen Lösungsmittel verwendet werden, erfüllt das Produkt die Anforderungen der USP, EP und EMA/CHMP/ICH/82660/2006 für Restlösungsmittel |
Elementare Verunreinigungen |
| Aluminium (Al) |
|
≤ 1 |
ppm |
| Arsen (As) |
|
≤ 3 |
ppm |
| Brom (Br) |
|
≤ 0,1 |
% |
| Calcium (Ca) |
|
entspricht |
% |
| Cadmium (Cd) |
|
≤ 1 |
ppm |
| Eisen (Fe) |
|
≤ 20 |
ppm |
| Quecksilber (Hg) |
|
≤ 1 |
ppm |
| Jod (I2) |
USP |
≤ 0,005 |
% |
| Jod (I2) |
EP |
entspricht |
|
| Magnesium (Mg) |
|
entspricht |
% |
| Natrium (Na) |
EP |
≤ 0,1 |
% |
| Natrium (Na) |
USP |
entspricht |
% |
| Natrium (Na) |
E 508 |
negativ |
% |
| Blei (Pb) |
|
≤ 2 |
ppm |
Mikrobiologische Daten |
| Bakterielle Endotoxine |
|
≤ 5 |
I.E./g |
| Gesamtkeimzahl |
|
≤ 1000 |
CFU/g |
| Schimmel und Hefe |
|
≤ 100 |
CFU/g |
Chemische Werke Hommel GmbH & Co.KG
Dieses Dokument wurde elektronisch erzeugt und ist ohne Unterschrift gültig.
|
Waltrop, 21. Jul. 2023
|
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takeover are not totally excluded. Some or all parts off the document may be translated due to our best knowledge from the original
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