JYMed's CRO&CMO ee mashruucaaga peptide

Halkee JYMed ka taageeri kartaa mashruucaaga peptide?

CRO & adeegga CMO

JYMed waxay bixin kartaa peptides'API iyo peptide waxay dhameeyeen horumarinta qiyaasta mashruucaaga, sida hoos ku qoran:

[Horumarinta Shacabka]

CQA

QBD

Horumarinta iyo go'aaminta habka

Hagaajinta habka

3 qaybood oo wax soo saar ah si loo qiimeeyo suurtogalnimada in kor loo qaado

1-3 dufcadood wax soo saarka miisaanka tijaabada

Astaamaha

3 wax soo saarka dufcadaha ansaxinta

Daraasadda xasilloonida ICH

Wax soo saarka muunadda bukaan-socodka

[Horumarinta Analytical]

Horumarinta hababka falanqaynta ee walaxda la xidhiidha iyo qiimaynta

Barashada wasakhnimada

Horumarinta hababka falanqaynta: GC, IC, falanqaynta amino acid, ions counter iyo hababka nadaafadda

Samaynta Tilmaamaha

Diyaarinta Heerka Shaqada

Xaqiijinta habka gorfaynta

[Dukumentiyada Xeerarka]

Soo koobida xogta iyo buuxinta DMF

Taageerada sharciyeynta ee hor taal US FDA/EDQM


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