Spezifikation
|
Produktbezug: |
| Produktnummer | 58617WPEG |
| Handelsname / Bezeichnung | Adenosin, pharma |
| CAS Nummer | 58-61-7 |
| Andere Bezeichnungen / Synonyme | •2-(6-aminopurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol;
•9-beta-D-Ribofuranosyladenin;
•9-beta-D-ribofuranosyladenine;
•Adenosin;
•adenosine; |
| EG Nummer | 200-389-9
607-743-5
|
| Zolltarifnummer / CN-Code | 29349990 |
| Molekulargewicht [g/mol] | 267.24132 |
| Formel | C10H13N5O4 |
| Parameter |
Methode |
Spezifikation |
Einheit |
Sensorische Prüfung |
| Aussehen der Lösung |
c = 3.3 %, w/v, in H 2 O |
farblos |
|
| Aussehen |
|
weißes kristallines Pulver, geruchlos |
Physikalische Parameter |
| Säuregehalt |
|
blau-violette Farbe (mit nmt 0,3 ml 0,01 M NaOH)
gelbe Farbe (mit nmt 0,1 ml 0,01 M HCl) |
| Trocknungsverlust |
|
@ 105°C, 2h: ≤ 0,5 |
% |
| Spezifische optische Drehung |
(acc. to Ph.Eur.): (c = 2,5 %, in 1 M HCl) |
45,0 – 49,0 |
° |
| Spezifische optische Drehung |
(acc. to USP): (c = 2 %, in 5 % NaOH) |
68,0 – 72,0 |
° |
| Schmelzbereich |
|
233,0 – 238,0 |
°C |
| Löslichkeit |
|
praktisch unlöslich in Aceton,
Methylenchlorid, Alkohol und Ether, in Wasser bei 20 °C schwer löslich,
löslich in kochendem Wasser, gut löslich in verdünnten Säuren |
Identifikation |
| Gehalt |
HPLC |
≥ 99,5 |
% |
| Gehalt |
aus Titration (HClO 4 ) |
auf Trockenbasis 99,0 – 101,0 |
% |
| Identifizierung |
IR Spektrum |
entspricht |
|
Verunreinigungen |
| Ammonium |
|
≤ 4 |
ppm |
| Glührückstand |
|
≤ 0,1 |
% |
| Schwermetalle (als Pb) |
|
≤ 10 |
ppm |
| Sulphat (SO4) |
|
≤ 200 |
ppm |
| Verwandte Substanzen |
|
Adenine ≤ 0,1 |
% [w/w] |
| Verwandte Substanzen |
TLC |
each single ≤ 1,0 |
% [w/w] |
| Verwandte Substanzen |
|
Guanosine ≤ 0,1 |
% [w/w] |
| Verwandte Substanzen |
|
in sum: ≤ 0,5 |
% [w/w] |
| Verwandte Substanzen |
|
Inosine ≤ 0,1 |
% [w/w] |
| Verwandte Substanzen |
TLC |
jede einzelne ≤ 1,0 |
% [w/w] |
| Verwandte Substanzen |
|
Unspecified impurities ≤ 0,1 |
% [w/w] |
| Verwandte Substanzen |
|
Uridine ≤ 0,1 |
% [w/w] |
Elementare Verunreinigungen |
| Chloride (Cl) |
|
≤ 70 |
ppm |
Mikrobiologische Daten |
| Escherichia Coli. |
|
neg. in 1 g |
CFU/g |
| Endotoxintest (LAL) |
|
≤ 20,0 |
EU/100 mg |
| Pseudomonas aeruginosa |
|
neg. in 1 g |
|
| Salmonellen |
|
neg. in 10 g |
|
| Staphylococcus Aureus |
|
neg. in 1 g |
|
| Gesamtkeimzahl |
|
(TAMC): ≤ 100 |
CFU/g |
| Schimmel und Hefe |
|
(TYMC): ≤ 100 |
CFU/g |
Zusätzliche Angaben:
Lagerbedingungen:
bei RT stabil, wenn sie fest verschlossen gelagert werden Behälter, vor Licht und Feuchtigkeit geschützt
Entspricht der Monographie:
EP, USP,
Chemische Werke Hommel GmbH & Co.KG
Dieses Dokument wurde elektronisch erzeugt und ist ohne Unterschrift gültig.
|
Waltrop, 08. Feb. 2022
|
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accordingly. Despite careful working, errors in the
takeover are not totally excluded. Some or all parts off the
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