semaglutide; CAS 910463-68-2

Aparans

Poud blan oswa -blan

Idantifikasyon

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

Kat peptides

Kat peptide solisyon tès la koresponn ak solisyon referans lan, jan yo jwenn nan tès la.

Molekilar Isou Mass(MS)

4112.58 ~ 4114.58Da

Solibilite

Libète idrosolubl nan dlo

Klè ak koulè solisyon

Klè ak san koulè

Wotasyon espesifik[]_D²⁰

-15.0 degre ~-10.0 degre

(sou sibstans anidrid ak sodyòm ion-gratis)

Aktivite espesifik

0.7 ~ 1.3Inite/mg

PH

7.0-9.0

Imidite (KF)

Mwens pase oswa egal a 8.0%

Kontni asid amine

Asp: 0.9-1.1

Sèr: 2.7-3.3

Glu: 4.5-5.5

Gly: 3.6-4.4

Li: 0.9-1.1

Arg: 1.8-2.2

Thr: 1.8-2.2

Ala: 2.7-3.3

Aib: 0.9-1.1

Tyr: 0.9-1.1

Val: 1.8-2.2

Lys: 0.9-1.1

Ile: 0.9-1.1

Leu: 1.8-2.2

Phe: 1.8-2.2

AEEA: Yo ta dwe detekte

Pwoteyin Molekilè Segondè

Mwens pase oswa egal a 0.3%

Pwoteyin Selil Lame

Mwens pase oswa egal a 0.01%

ADN selil lame

Mwens pase oswa egal a 10.0ng/mg

Trifluoroacetate Ion

Mwens pase oswa egal a 0.1%

Acetate Ion

Mwens pase oswa egal a 0.1%

Fosfat Ion

Mwens pase oswa egal a 0.1%

Sodyòm Ion

Mwens pase oswa egal a 3.0%

Sibstans ki gen rapò (HPLC)

Enpurte idrofil mwens pase oswa egal a 0.6%

Enpurte idrofob 1 Mwens pase oswa egal a 0.3%

Enpurte idrofob 2 Mwens pase oswa egal a 0.5%

Total enpurte mwens pase oswa egal a 1.0%

Solvang rezidyèl

Acetonitrile Mwens pase oswa egal a 410 ppm

Isopropyl Etè Mwens pase oswa egal a 5000ppm

Endotoxins bakteri

< 10EU/mg

Konte total mikwòb aerobic

Mwens pase oswa egal a 100cfu/g

Ledven & Mwazi

Mwens pase oswa egal a 100cfu/g

Kontni Peptid

Pi gran pase oswa egal a 85.0%

Pite (HPLC)

Pi gran pase oswa egal a 99.0%

Esè

95.0%~105.0%