If no validated condition is available, temporary storage of unopened lyophilized material at approximately 20C in a tightly sealed, dry, light-protected container may be used as a conservative laboratory holding condition, but it must not be presented as a validated shelf-life claim
Markenhersteller sollten die genaue Form der Inhaltsstoffe, den Gehalt an Schwermetallen, die mikrobiellen Grenzwerte, die Restlsungsmittel, die Lslichkeit, die Hygroskopizitt, den Geschmack, das Herkunftsland, die Eignung fr Veganer, die Angabe von Allergenen und die Eignung fr die vorgesehene Darreichungsform prfen
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