Storage container for weakly acidic solution formulation...

Details Storage container for weakly acidic solution formulation... Storage container for weakly acidic solution formulation...

A - Human Necessities

61

J

A61J 1/06 (2006.01) A61M 5/315 (2006.01)

Patent

CA 2368189

The invention has the purpose of offering a storage container wherein flocculation and nebulation of hGH does not occur during storage of an hGH solution. A rubber stopper is formed of rubber such that when one such rubber stopper is immersed in 1ml of a buffer solution having a pH of approximately 5.5 to 6.5 and containing a surfactant, stored while shaking for one week at a temperature of 25 ~C, then the metal ion elution rate in the buffer solution is measured using atomic absorption spectrophotometry, the elution rate of polyvalent metal ions is 50 ppm or less.

Lobjet de l'invention est un récipient de stockage qui empêche la floculation ou la nébulisation de l'hormone de croissance humaine (HCH) pendant le stockage d'une solution contenant cette HCH. Un bouchon en caoutchouc est formé d'un élastomère tel que, lorsque le bouchon est immergé dans 1 ml d'une solution tampon présentant un pH d'environ 5,5 à 6,5 et contenant un tensioactif, puis stocké pendant le secouage durant une semaine à une température de 25 ·C, le taux d'élution d'ions de métaux polyvalents dans la solution tampon mesuré par spectrophotométrie d'absorption atomique est d'au plus 50 mg/l.

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