Carbetocin; cas 37025-55-1

Sijè

Spesifikasyon

Aparisyon

Blan poud ki lach

Idantifikasyon

HPLC: tan an retansyon nan pi gwo pik la nan solisyon an echantiyon koresponn ak sa yo ki an solisyon an estanda, jan yo jwenn nan épreuves la .

Klè ak koulè solisyon

Klè ak san koulè

Wotasyon espesifik

((anidrid ak acetic asid-gratis sibstans, c =2 mg/ml, 1%asid acetic))

-71.0 degre ~ -81.0 degre

Ph

4.5~6.5

Imidite

Mwens pase oswa egal a 6.0%

Trifuoroacetate ion

Mwens pase oswa egal a 0.25%

Sibstans ki gen rapò

Impurity2 mwens pase oswa egal a 0.5%

Impurity8 mwens pase oswa egal a 0.3%

Impurity9 mwens pase oswa egal a 0.3%

Impurity10 mwens pase oswa egal a 0.3%

Impurity11 mwens pase oswa egal a 0.3%

Impurity12 mwens pase oswa egal a 0.3%

Impurity20 mwens pase oswa egal a 0.3%

Sèl malpwòpte mwens pase oswa egal a 0.3%

Unspecified salte mwens pase oswa egal a 1.0%

Enpurte total mwens pase oswa egal a 2.5%

Solvang rezidyèl

Methanol mwens pase oswa egal a 3000ppm

Acetonitrile mwens pase oswa egal a 410ppm

N, n-dimethylformamide mwens pase oswa egal a 880ppm

Kontni asid acetic

Mwens pase oswa egal a 5.0%

Kontni asid amine

Asp 0.9-1.1

Glu 0.9-1.1

Tyr 0.9-1.1

Gly 0.9-1.1

Il 0.9-1.1

Leu 0.9-1.1

Pro 0.9-1.1

Egziste h-cys (tert-butoxycarnylpropyl) -OH

Endotoksin bakteri

<1000EU/mg

Total konte aerobic mikwòb

Mwens pase oswa egal a 100cfu/g

Levasyon & mwazi

Mwens pase oswa egal a 100cfu/g

Asay

(anidrid ak asid asid-sibstans ki sou)))

97.0%~ 103.0%