Goserelin Acetate CAS 145781-92-6

Goserelin Acetate CAS 145781-92-6|Goserelin acetate Kg mov|Science-Peptide

Goserelin Acetate CAS 145781-92-6 qib kev tshawb fawb peptide - txhawb nqa txheej txheem cog, kev tshawb fawb dav dav, kev tswj tsis huv. Goserelin Acetate muaj nyob rau hauv grams mus rau kilograms ntawm purity siab, nrog ua tiav cov qauv kev pom zoo, ntshiab impurity profiles, thiab ntau-rau-ntaus stability. Cov khoom no tseem tsis tau dhau cov ntaub ntawv ntawm kev siv tshuaj, thiab tsuas yog siv rau kev tshawb fawb. Txais tos tiv tauj peb.

Goserelin (goserelin acetate) yog lwm tus tswv cuab tseem ceeb ntawm tsev neeg GnRH agonist. Tsis zoo li leuprolide thiab treprostinil, goserelin paub zoo tshaj plaws nyob rau hauv lub tsev kho mob rau nws ncua - tso implant - ib tug pas nrig me me uas muab faus rau hauv daim tawv nqaij thiab tso tawm maj mam dhau peb lub sijhawm - hli. Cov txheej txheem thev naus laus zis rau daim ntawv ntau npaum no tseem siab dua li ntawd rau microspheres, yog li ntau tus neeg uas ua cov qauv ntawm goserelin ua li ntawd rau kev cog qoob loo.

 

Peb kuj tau nqis peev ntau ntawm kev siv zog rau ntau yam ntawm Goserelin. Zoo li leuprolide thiab treprostinil, peb cov goserelin tseem tsis tau raug xa mus rau kev siv tshuaj thiab tsis tuaj yeem muag raws li API. Txawm li cas los xij, yog tias koj tab tom ua cov txheej txheem txhim kho rau kev cog qoob loo, ua ntej- tshawb fawb cov tshuaj generic, los yog xav tau ntau npaum li cas ntawm peptide rau pilot scale-up, ces peb cov kev tshawb fawb-qib cov khoom yog ncaj nraim - los ntawm grams mus rau kilograms, peb muaj peev xwm muab ib tug ruaj khov khoom, tsis muaj kev hloov pauv nyob rau hauv nruab nrab, thiab cov ntaub ntawv yuav tsum tau mus txog rau thaum xaus.

Goserelin (Goserelin Acetate) yog ib qho decapeptide uas nws txoj hauj lwm thib kaum yog AzGly (azaglycine), cov qauv tsis pom muaj nyob hauv cov amino acids ntuj, uas tau qhia tawm dag zog, feem ntau los txhim kho metabolic stability. Kev cog qoob loo (Zoladex) yog daim ntawv tseem ceeb thiab muaj nyob rau hauv ob qhov ntau thiab tsawg: 1 hli thiab 3 lub hlis.

Hauv R & D lub voj voog, goserelin tau txais kev saib xyuas tsawg dua li lwm tus GnRH agonists:

• Kev txhim kho kev cog qoob loo: Vim tias cov txheej txheem cog ntoo yog qhov nyuaj dua li microspheres, cov kev cai rau APIs kuj tseem siab dua - batch- rau -batch sib xws, impurity profile stability, solubility thiab cov ntsuas no ncaj qha cuam tshuam rau kev tso tawm profile ntawm cov cog cog.
• Kev tshawb fawb dav dav: cov tuam txhab tsim khoom lag luam hauv tsev los ua goserelin generic kuj tsawg, tab sis qhov kev sib tw toj roob hauv pes yog pom tseeb, thawj lub sijhawm tseem muaj.
• Impurities thiab kev kawm zoo: Nws AzGly site thiab tert-butyl tiv thaiv pab pawg yuav qhia txog qee qhov tshwj xeeb degradation cov khoom thiab cov txheej txheem impurities, thiab cov synthesis thiab characterization ntawm impurities no yog cov teeb meem nyob rau hauv txoj kev kawm zoo.

Peb cov goserelin yog qhov chaw los txhawb cov xwm txheej R&D no - tsis yog rau kev kho mob, tab sis yeej txaus rau R&D, thiab nws tuaj yeem khaws los ntawm milligrams mus rau kilograms.

1. Kilogram muaj peev xwm rau cov txheej txheem cog cog
Cov txheej txheem kev txhim kho ntawm cov tshuaj implantable muaj qhov xav tau zoo rau APIs. Ib qho kev sim ntsuas yuav xav tau kaum grams lossis ntau pua grams, thiab tom qab peb daim ntawv pov thawj, ob peb puas grams yuav tawm mus. Hauv Goserelin, peb kuj tau qhib qhov ntsuas - nce txheej txheem, thiab peb tuaj yeem muab cov khoom hnyav hnyav hnyav nrog kev tswj hwm purity, impurity profile, thiab tawm los ntawm pawg. Yog tias koj tab tom ua qhov kev sim sim ntawm tus neeg sawv cev implantable, koj tsis tas yuav txhawj txog cov khoom siv ntxiv lawm.

2. AzGly site, peb paub txog nws
Txoj hauj lwm thib 10 ntawm Goserelin yog AzGly (azaglycine), uas tsis yog tus qauv amino acid thiab yuav tsum tau ua ke nrog cov khoom siv raw tshwj xeeb. Peb tau ua ntau peptides nrog AzGly, thiab peb paub nws cov kev sib txuas thiab kev ruaj ntseg, yog li peb yuav tsis tau daig ntawm txoj haujlwm no. Lub purity ntawm cov khoom tsis tu ncua yog ntau dua lossis sib npaug li 98%, thiab cov khoom tseem ceeb tuaj yeem ua tau ntau dua lossis sib npaug li 99% lossis ntau dua.

3. Lub impurity spectrum yog qhov tseeb, thiab tshwj xeeb impurities tuaj yeem tswj tau
Muaj ntau ntau yam impurities nyob rau hauv impurity profile ntawm Goserelin: degradation cov khoom txuam nrog AzGly site, impurities los ntawm tert-butyl shedding, thiab dimers. Peb tau ua qhov kev soj ntsuam zoo thiab tuaj yeem muab cov npe ua tiav ntawm impurities thiab kev tswj hwm. Yog tias koj xav tau cov impurities tshwj xeeb kom phim koj txoj kev, peb tuaj yeem kho lawv.

Zaj Dab Neeg 1: Lub tuam txhab biotech, pilot scale-up of an implant
Lawv tab tom txhim kho goserelin cog thiab xav tau kilos API los khiav peb qhov kev tsav tsheb. Cov neeg muag khoom lawv tau pom yav dhau los tsis tuaj yeem ua tau tom qab muab ob peb lub kaum os grams xwb. Lawv pom peb, thiab peb muab 1 kilogram ntawm Goserelin ncaj qha nrog 99.2% purity hauv peb pawg. Lawv siv cov batch ntawm peptide no los ua kom tiav qhov kev sim ntsuas, qhov kev tso tawm nkhaus yog qhov ruaj khov, thiab tom qab ntawd ua kom yooj yim rau hauv cov khoom tsim tawm. Tus thawj coj ntawm txoj haujlwm tau hais tias, "Qhov kev cog ntoo yog qhov ntshai tshaj plaws ntawm kev hloov pauv ntawm cov khoom siv raw, koj cov ntaub ntawv peb pawg yog tib yam nkaus, peb tau txais kev nplij siab."

Zaj 2: Cov tuam txhab tshuaj hauv tsev, AzGly impurity kawm
Lawv tau tshaj tawm cov ntawv tshaj tawm ntawm Goserelin, thiab pom tias nws nyuaj rau kev tswj hwm rau ntau yam impurities ntsig txog AzGly site. Peb pab lawv tsim peb AzGly-txog impurities nrog purity tshaj 95%, nrog NMR thiab MS cov ntaub ntawv lees paub. Lawv siv cov impurities no los tsim ib txoj kev, thiab cov impurity ib feem ntawm daim ntawv thov tau ua tiav pom zoo.

Zaj Dab Neeg 3: Lub tsev muag tshuaj hauv tsev kawm ntawv qib siab, kev cog lus tso tawm mechanism kawm
They were studying the release kinetics of goserelin implant and needed peptides of different purity levels for comparison. We provided two specifications of crude peptide (>80%) and high purity peptide (>99%), thiab pab lawv ua kom tiav txoj kev kawm ntawm kev tso tawm mechanism. Daim ntawv tau luam tawm nyob rau hauv ib phau ntawv xov xwm loj hauv kev lag luam tshuaj, thiab peb tau suav nrog kev lees paub.

Peb tau ua haujlwm rau ntau yam ntawm Goserelin no tau ntau xyoo, los ntawm kev sim me me mus rau kilograms. Tshwj xeeb tshaj yog rau AzGly, peb muaj kev nplua nuj nyob rau hauv synthesizing qhov chaw tshwj xeeb, thiab peb kuj muaj kev nkag siab zoo ntawm impurity profile. Yog tias koj tab tom ua kev cog qoob loo lossis kev tshawb fawb dav dav, thiab xav tau cov ntaub ntawv ruaj khov, ua tiav, thiab kev tshawb fawb -qib goserelin uas tuaj yeem muab tau me me mus rau ntau qhov ntau, thov koj xav nrog peb tham.