Spezifikation
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Produktbezug: |
| Produktnummer | 1115704PPEBU |
| Handelsname / Bezeichnung | Metformin HCl EP/BP/USP |
| CAS Nummer | 1115-70-4 |
| Andere Bezeichnungen / Synonyme | •1,1-DIMETHYLBIGUANIDE;
•1,1-DIMETHYLBIGUANIDE HYDROCHLORIDE;
•1,1-Dimethylbiguanide Hydrochloride;
•1,1-Dimethylbiguanide hydrochloride;
•1,1-Dimethylbiguanide, Hydrochloride;
•1-carbamimidamido-N,N-dimethylmethanimidamide hydrochloride;
•3-(diaminomethylidene)-1,1-dimethylguanidine hydrochloride;
•METFORMIN;
•METFORMIN HCL;
•Metformin HCL; |
| EG Nummer | 214-230-6 |
| Zolltarifnummer / CN-Code | 29252900 |
| Molekulargewicht [g/mol] | 165.62458 |
| Formel | C4H12ClN5 |
| Parameter |
Spezifikation |
Einheit |
Sensorische Prüfung |
| Aussehen der Lösung |
klar und farblos |
| Aussehen |
weißes, kristallines Pulver |
Physikalische Parameter |
| Trocknungsverlust |
(105° C/5h): ≤ 0,5 |
% [w/w] |
| Löslichkeit |
in Wasser: löslich
in Alkohol: kaum löslich
in Aceton und Methylen Chlorid: unlöslich |
Identifikation |
| Gehalt |
98,5 – 101,0 |
% [w/w] |
| Identifizierung |
B. (IR): IR Spektrum entspricht |
| Identifizierung |
E. Chloride: entspricht |
Verunreinigungen |
| Schwermetalle (als Pb) |
≤ 10 |
ppm |
| Sulphatasche |
≤ 0,1 |
% [w/w] |
| Verunreinigung |
F.: ≤ 0,05 |
% [w/w] |
| Verwandte Substanzen |
Impurity A: ≤ 0,02 |
% [w/w] |
| Verwandte Substanzen |
Impurity B: ≤ 0,05 |
% [w/w] |
| Verwandte Substanzen |
unbestimmte Verunreinigung: ≤ 0,05 |
% [w/w] |
| Verwandte Substanzen |
Verunreinigungen gesamt: ≤ 0,2 |
% [w/w] |
Partikelgrößenverteilung |
| Partikel |
< 100 µm ≥ 90 |
% |
| Partikel |
< 180 µm ≤ 100 |
% |
Regulatorische Informationen:
BSE/TSE Hinweis:
Das Produkt enthält keine tiereischen Inhaltsstoffe oder wird aus Rohstoffen tierischen Ursprungs hergestellt.
Registrationsstatus:
CEP
Restlösemittel:
Methanol: ≤ 1000 ppm
Xylene: ≤ 500 ppm
Zusätzliche Angaben:
Mindesthaltbarkeit:
5 Jahre
Herleitung:
synthetisch
Entspricht der Monographie:
PhEur-9.0, BP-2018, USP-40
regionaler Ursprung:
IND
Chemische Werke Hommel GmbH & Co.KG
Dieses Dokument wurde elektronisch erzeugt und ist ohne Unterschrift gültig.
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Waltrop, 24. Jul. 2019
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