Chemische Werke Hommel GmbH & Co. KG  

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Im Wirrigen 25
D-45731 Waltrop
Tel.: +49 2309 60699-0
Fax: +49 2309 60699-30
www.hommel-pharma.com
info@hommel-pharma.com

Spezifikation

Produktbezug:
Produktnummer 68199APEUL
Handelsname / Bezeichnung Vitamin B12, EP, USP
(Cyanocobalmin)
CAS Nummer 68-19-9
Andere Bezeichnungen / Synonyme•Cyanocobalamin; •Vitamin B12; •cyanocobalamin;
EG Nummer200-680-0
Zolltarifnummer / CN-Code29362600
Molekulargewicht [g/mol]1355.37 g/mol
FormelC63H88CoN14O14P


Parameter Methode Spezifikation Einheit

Sensorische Prüfung
Farbe Monograph:0547 Visual dunkelrot

Physikalische Parameter
Form (Agregatzustand) Monograph:0547 Visual kristallines Pulver
Trocknungsverlust EP ≤ 10,0 %

Identifikation
Gehalt EP 97,0  –  102,0 %
Identifizierung EP 2.2.25 A (UV: A361nm/A278nm): 1,70  –  1,90
Identifizierung EP 2.2.25 A (UV: A361nm/A547-559nm): 3,15  –  3,45
Identifizierung EP 2.2.27 B (TLC): entspricht den Anforderungen

Verunreinigungen
Verwandte Substanzen EP 2.2.32 34-Methylcyanocobalamin: ≤ 0,5 %
Verwandte Substanzen EP 2.2.32 7β,8β- Lactocyanocobalamin: ≤ 1,0 %
Verwandte Substanzen EP 2.2.32 8-Epi-cyanocobalamin: ≤ 0,32 %
Verwandte Substanzen EP 2.2.32 jede andere Verunreinigung: ≤ 0,2 %
Verwandte Substanzen EP 2.2.32 Verunreinigungen gesamt: ≤ 3,0 %

Restlösemittel
Restlösemittel Acetone ≤ 0,5 %

Mikrobiologische Daten
Gesamtkeimzahl Ph. 2.6.12 ≤ 1000 CFU/g
Schimmel und Hefe Ph. 2.6.12 ≤ 100 CFU/g

Regulatorische Informationen:

Hinweis zu Allergenen: Allergen frei

GVO Hinweis: Das Produkt ist kein GVO, enthält oder besteht aus GVO.

Bestrahlungs Status: Nicht bestrahlt


Zusätzliche Angaben:

Mindesthaltbarkeit: 60 Monate

Lagerbedingungen: An einem kühlen und trockenen Ort aufbewahren. Vermeiden Sie starkes Licht und Hitze.

Verpackung: Verpackt in Papierfässern und zwei Plastiktüten im Inneren, 0,1 kg / Dose.

regionaler Ursprung: China


Chemische Werke Hommel GmbH & Co.KG
Dieses Dokument wurde elektronisch erzeugt und ist ohne Unterschrift gültig.
Waltrop, 28. Apr. 2020
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