Tus kheej thiab tag nrho cov impurities tswj raws li pharmacopeia txwv (xws li USP / EP), txheeb xyuas los ntawm HPLC nrog cov kev txwv impurity.
Txhais Particle Size Distribution
Particle loj tis tswj los ntawm sieving los yog laser diffraction (xws li D90 nyob rau hauv cov kev cai ntau yam) los xyuas kom meej uniform blending kev ua tau zoo.
Tswj cov dej noo
Cov ntsiab lus noo noo tswj tau raws li cov kev txwv (xws li Tsawg dua lossis sib npaug li 0.5%–1.0%) siv Karl Fischer lossis poob ntawm txoj kev ziab.
Residual Solvent Compliance
Cov kuab tshuaj residual tswj raws li ICH Q3C cov lus qhia, txheeb xyuas los ntawm GC tsom xam rau txhua pawg ntau lawm.
Hnyav Hlau Tswj
Pb, As, Cd, thiab Hg tswj nyob rau hauv pharmacopeia lossis ICH Q3D txwv, txheeb xyuas los ntawm ICP-MS lossis sib npaug.
Ua raws li & Zoo
GMP{0}}Aligned Manufacturing System
Ua raws li kev tswj hwm tshuaj zoo raws li GMP cov cai nrog cov ntaub ntawv SOP tswj.
Validated Analytical Methods
Kev soj ntsuam, impurities, residual solvents, thiab ya raws kuaj siv txoj kev siv tau xws li HPLC, GC, thiab KF.
Raw Material Qualification
Cov ntaub ntawv nkag tau txheeb xyuas qhov tseeb ntawm tus kheej thiab cov lus qhia zoo ua ntej tsim khoom.
Batch Traceability System
Ua kom tiav traceability npog cov khoom siv raw khoom, txheej txheem tsim khoom, thiab kev tso tawm zaum kawg.
Kev Muag Khoom & Kev Lag Luam
Tej API Supply Capability
Muaj nyob rau hauv kilogram- nplai thiab ntau dua rau kev ua lag luam tsis tu ncua.
Standard Pharmaceutical Ntim
Ntim hauv cov nruas fiber ntau nrog ob lub hnab PE sab hauv lossis cov chaw muag tshuaj - qib ntim ntim.
Export Cov ntaub ntawv txhawb nqa
COA, MSDS, thiab cov ntaub ntawv tswj hwm tau muab rau kev xa khoom thoob ntiaj teb.
Stable Lead Time Management
Kev tsim khoom teem caij raws li kev txiav txim ntim thiab cov kev xav tau tshwj xeeb.