Semaglutide hmoov

Semaglutide hmoov,Raws li tus neeg sawv cev noj tshuaj ntawm ib tiam tshiab ntawm GLP-1 receptor agonists, nws muaj nws cov txiaj ntsig tseem ceeb hauv kev tswj hwm cov metabolism hauv ntau txoj hauv kev:ntawm ib sab tesCov khoom xyaw nquag no tuaj yeem nkag siab txog qib ntshav qabzib, ua rau cov tshuaj insulin tsuas yog thaum cov ntshav qabzib nce siab, txo qis kev pheej hmoo ntawm hypoglycemia;ntawm qhov tod tes, nws prolongs satiety lub sij hawm los ntawm ncua lub plab zom mov motility thiab ncaj qha ua nyob rau hauv lub hlwb lub chaw noj mov kom tsis muaj zog lub siab xav noj, yog li ua kom tiav ob lub hom phiaj ntawm cov ntshav qabzib homeostasis thiab tswj qhov hnyav.

Cov koob tshuaj xws li 10 mg thiab 20 mg feem ntau yog tsim los rau kev txhawb nqa tshwj xeeb - tso tawm cov qauv lossis siab - cov qauv kev sib xyaw ua ke, txhawm rau ua kom lub sijhawm ntev ntawm cov nyhuv tshuaj, txo qhov zaus ntawm kev tswj hwm, thiab txhim kho qhov yooj yim thiab ua raws li kev siv tshuaj ntev - rau cov neeg mob. Nws yog tam sim no dav siv hauv kev kho mob kev pab cuam rau cov neeg laus mob ntshav qab zib hom 2 thiab rog rog.

1. High -purity active ingredient:Raws li polypeptide cov khoom siv tshuaj nquag, nws khav theeb purity tshaj 99%, bioactivity siab, thiab tswj nruj me ntsis ntawm impurities thiab endotoxins, ua tau raws li cov kws tshuaj - qib cov qauv zoo.
2. ruaj khov thiab yooj yim -rau- khaws daim ntawv lyophilized:Muaj nyob rau hauv daim ntawv lyophilized hmoov, semaglutide hmoov qhia tau zoo heev thermal thiab cia ruaj khov, yooj yim rau ntev - lub sij hawm cia thiab txias saw tsheb thauj mus los, zoo txuas lub neej txee.
3. High dosage form adaptability:Daim ntawv hmoov muab kev ua haujlwm zoo, tso cai rau kev tsim ua ntau hom tshuaj xws li txhaj tshuaj, ntsiav tshuaj ntawm qhov ncauj, thiab cov yeeb yaj kiab hauv qhov ncauj, ntsib ntau yam R & D thiab kev xav tau ntau lawm.
4. Precise thiab controllable ntau npaum:Raws li cov khoom siv tshuaj nquag, cov tuam txhab tshuaj tuaj yeem ntsuas qhov hnyav thiab tsim cov kev qhia tshwj xeeb ntawm kev npaj (piv txwv li, 5mg, 10mg, 40mg, thiab lwm yam) raws li kev tsim qauv, ua tiav cov kev hloov pauv hloov tau yooj yim thiab ua kom cov batch- mus rau -batch sib xws.

1. Raw Material Testing (Incoming Inspection)

Cov ntaub ntawv pib thiab cov khoom tseem ceeb raug kuaj xyuas kom pom, kev txheeb xyuas (HPLC / MS), purity (HPLC Ntau dua lossis sib npaug li 98%), thiab cov ntsiab lus noo noo. Txhua batch ntawm raw cov ntaub ntawv yuav tsum tau muab ib tug Supplier's Certificate of Account (COA) thiab tau mus kuaj sampling. Tsuas yog cov ntaub ntawv uas dhau qhov kev pov thawj raug tso tawm rau kev siv.

2. Hauv -Kev QC

Kev tshuaj xyuas yog siv nyob rau hauv cov theem tseem ceeb: Thaum lub sij hawm synthesis, coupling efficiency thiab condensing tus neeg sawv cev residue raug saib xyuas; Thaum lub sij hawm purification, purity thiab rov qab tus nqi ntawm cov khoom seem yog tswj; Thaum lub sij hawm khov- ziab, noo noo thiab cov kuab tshuaj seem raug saib xyuas, nrog rau kev saib xyuas tshwj xeeb rau kev tshem tawm cov txiaj ntsig ntawm condensing agents (DIC, DCC) thiab catalysts (DMAP) los xyuas kom meej cov txheej txheem tswj.

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4.Testing Equipment thiab Laboratory muaj peev xwm

Cov khoom siv kuaj Core:

• HPLC (High Performance Liquid Chromatography): Siv rau kev txiav txim siab purity, txheeb xyuas cov khoom siv, thiab kev txheeb xyuas.
• GC-MS/MS (Gas Chromatography-Tandem Mass Spectrometry):Siv rau kev tshawb nrhiav cov khoom seem (DIC, DCC) thiab cov catalysts (DMAP). Txoj kev precision RSD <6.0%, rov qab tus nqi 97.6% ~ 99.2%.
• LC-Q-TOF/MS (Liquid Chromatography-Quadrupole Time- ntawm- Davhlau Mass Spectrometry):Siv rau kev paub meej peptide thiab kev txheeb xyuas qhov tsawg- nplua nuj tsis huv.
• 2D-LC-MS (Ob-Dimensional Liquid Chromatography-Mass Spectrometry):Siv rau hauv - qhov tob tus yam ntxwv ntawm lub ntsiab ncov thiab nyuaj - rau - cais impurities.

Laboratory Txuj Ci:QC lub chaw soj nstuam yuav tsum muaj CNAS / ISO 17025 kev lees paub, muaj cov neeg ua haujlwm nrog cov kws tshuaj ntsuam xyuas, thiab ua kom tiav SOP system thiab kev tswj hwm cov ntaub ntawv (raws li ALCOA + cov hauv paus ntsiab lus).

Thib peb-Kev Sib Koom Tes Sib Koom Tes:Kev tshuaj xyuas ywj pheej thiab kev lees paub ntawm txoj hauv kev, kev txiav txim siab qhov hnyav ntxiv, thiab kev tshawb fawb kev ruaj ntseg tuaj yeem raug xa mus rau thib peb -cov koom haum xeem nrog CMA/CNAS kev lees paub (xws li CGC).

1. Lub Hoobkas Thaj Chaw:Semaglutide hmoov puag yog nyob rau hauv Xi'an High-tech Zone / Xixian New Area, npog thaj tsam ntawm kwv yees li 90,000 square metres (134 ev kawj), nrog GMP kev cob qhia thiab cov chaw txhawb nqa tag nrho kwv yees li 50,000-80,000 square meters.
2. GMP Rhiav Qib:Qhov chaw sib xyaw / lim dej yog Chav Kawm 10,000 (ISO 7), qhov khov kho- qhov chaw ziab / ntim khoom yog Chav Kawm 100,000 (ISO 8), thiab lub hauv paus laminar ntws mus txog Chav Kawm 100 (ISO 5). Nws tau dhau los ntawm GMP kev soj ntsuam ntawm Shaanxi Provincial Drug Administration.
3. Kev Muaj Peev Xwm Txhua Xyoo:50-200 kg / xyoo ntawm cov khoom xyaw tshuaj nquag (kwv yees li 5 lab-20 lab vials ntawm cov khoom tiav), 20 lab ntsiav tshuaj / xyoo ntawm qhov ncauj ntau npaum li cas, nrog 30% muaj peev xwm hloov tau.
4. Cov kab ntau lawm thiab Automation:2-3 kab synthesis (50L-1000L reactors), 2-3 purification kab, 2-3 freeze dryers, thiab 1 qhov ncauj ntau npaum li cas daim ntawv ntau lawm kab. Cov txheej txheem tseem ceeb automation tus nqi yog tshaj 85%.
5. Cov khoom siv tseem ceeb:1000L synthesis reactor, npaj HPLC (300mm kab inch), freeze dryer (15m² shelf area), GC-MS/MS thiab ntau HPLC units, txhawb ntau lawm los ntawm gram mus rau pua pua kilograms.