Carbetocin API CAS 1631754-28-3

Carbetocin API CAS 1631754-28-3|Carbetocin acetate cGMP ntau lawm|Long-acting IUD API|Science-Peptide

Carbetocin API CAS 1631754-28-3 - ib koob tshuaj ntev ntev tiv thaiv tom qab yug me nyuam hemorrhage peptide API.Science-Peptide muab cGMP raws Carbetocin Acetate nrog cov txheej txheem paub tab, ntshiab impurity profile, txhawb rau Tuam Tshoj, Tebchaws USA thiab Europe tshaj tawm, thiab tuaj yeem tso cai DMF.Zoo siab txais tos hu rau peb.

Carbetocin yog ib daim ntawv "kho kom zoo dua" ntawm contractions. Txawm hais tias kev cog lus tsis tu ncua tuaj yeem siv sijhawm li ob peb teev los tswj hwm hauv chav saib xyuas poj niam cev xeeb tub, ib qho tshuaj intramuscular ntawm Carbetocin tuaj yeem ua rau cov qog nqaij hlav mus ntev li 24 teev. Rau kev tiv thaiv ntshav qab zib tom qab yug me nyuam, qhov no yooj yim heev - tshwj xeeb tshaj yog nyob rau hauv - thaj chaw muaj peev xwm - thiab tuaj yeem ua tiav hauv ib qho kev txhaj tshuaj, tsis tas yuav tsum muaj lub raj mis hangman.

Nws cov qauv zoo ib yam li kev cog lus, uas tseem yog lub nplhaib 9-peptide, tab sis nrog ob qhov kev hloov kho: cov cysteine ​​ntawm txoj hauj lwm 1 yog deaminated, thiab leucine ntawm txoj hauj lwm 8 yog hloov los ntawm homocysteine ​​(uas yog butyrylated). Cov kev hloov me me no tau ncua nws ib nrab ntawm lub neej los ntawm ob peb feeb mus rau ntau dua 40 feeb, tso cai rau nws ua haujlwm ntev dua.

Kev tshawb fawb-Peptide tau ua peptide APIs rau ntau tshaj 20 xyoo, thiab peb tau ua cabergoline tau ntev. Cov txheej txheem yog tib yam li ntawm IUD, tab sis cov kauj ruam cyclization yog qhov muag heev. Tam sim no, peb muaj cov khoom ruaj khov ntawm Kapecin acetate API los ntawm gram mus rau kilogram, FDA DMF tau raug foob, thiab peb txhawb Tuam Tshoj, Asmeskas thiab Europe tshaj tawm. Nyob rau hauv lub impurity spectrum, muaj cov paub tab tswj schemes rau disulfide daim ntawv cog lus mismatch, oxidized impurities thiab ploj lawm peptides.

Carbetocin yog 9-peptide cyclic daim ntawv, uas yog cyclized los ntawm disulfide daim ntawv cog lus ntawm cysteine ​​​​ntawm 1 thiab 6 txoj haujlwm. Qhov sib txawv tseem ceeb ntawm IUD yog tias N-terminus yog deamidated ( txhim kho enzyme stability) thiab 8-txoj hauj lwm hloov mus rau homocysteine ​​thiab butyylated (txhim kho receptor affinity).

Cov ntawv thov kev kho mob tau tsom mus rau:

• Prophylaxis ntawm postpartum hemorrhage (PPH): intramuscular los yog intravenous infusion nyob rau hauv peb theem ntawm kev ua hauj lwm, muab raws li ib koob tshuaj. Cov ntaub ntawv kho mob qhia tau hais tias nws tsis muaj txiaj ntsig tsawg dua li kev txhaj tshuaj tas li ntawm oxytocin hauv kev tiv thaiv hemorrhage thiab siv tau yooj yim dua.
• Elective caesarean seem: Pom zoo rau cov poj niam uas muaj kev pheej hmoo siab rau kev mob ntshav qab zib.
• Tsis siv los ntxias kev ua haujlwm: vim nws lub sijhawm ua haujlwm ntev, nws tsis haum rau kev pib ua haujlwm (thaum cov nyhuv muaj zog heev, nws tsis tuaj yeem thim rov qab).

Los ntawm API qhov kev xav, kev ua lag luam rau cabazitaxel tau loj hlob sai - raws li nws tau suav nrog hauv WHO Cov Tshuaj Tseem Ceeb, thiab ntau lub tebchaws tau hloov kho lawv cov kev yuav khoom los ntawm kev cog lus rau cabazitaxel. Cov kev cai rau APIs kuj tseem muaj cov ncauj lus kom ntxaws: cov impurity profile yuav tsum huv si, tshwj xeeb tshaj yog kev tswj ntawm disulfide daim ntawv cog lus mismatch thiab 8-txoj hauj lwm homocysteine- cuam tshuam los ntawm cov khoom.

1. Cov thev naus laus zis zoo ib yam li cov tshuaj indomethacin, tab sis cov cyclization yog qhov tseeb dua
Txoj kev sib txuas ntawm carbenoxolone zoo ib yam li kev cog lus: kev sib txuas ntawm cov kab hluav taws xob ua ntej hauv cov theem khoom thiab cyclization los tsim ib daim ntawv cog lus disulfide hauv cov kua theem. Txawm li cas los xij, qhov kev teeb tsa spatial ntawm cyclization yog txawv me ntsis vim hais tias 8-txoj hauj lwm yog homocysteine ​​(ib qho CH2 ntau dua li cov cysteine ​​li qub).

• Linear precursor: Fmoc solid-phase synthesis, N-terminal deamidation yuav tsum tau tshwj xeeb raw cov ntaub ntawv (deaminated cysteine ​​derivatives), uas peb tau siv ntau xyoo nrog kev sib txuas ruaj khov.
• Cyclization: me me oxidation hauv cov kua theem. Lub cyclization efficiency ntawm cov disulfide daim ntawv cog lus ntawm cabergoline yog ntau tshaj 95%, tab sis cov mismatch isomers (xws li, 1-1, 6-6 intermolecular disulfide daim ntawv cog lus) yuav tsum tau nruj me ntsis tswj los ntawm pH thiab concentration.
• Purification: Ntau-pab HPLC kev npaj: Peb ua kom zoo dua qhov kev ua kom huv si tshwj xeeb rau cabergoline kom cais cov isomers tsis sib xws, peptides ploj, thiab oxidized impurities.
• Cov ntaub ntawv pov thawj cov txheej txheem: Lub purity tau ruaj khov ntawm ntau dua 99.0% thiab qhov tsis sib xws isomer yog<0.10% in several successive batches.

2. Kev tswj kom zoo, nrog rau qhov tseem ceeb ntawm cov isomers tsis sib xws

Txhua pawg raug tso tawm rau kev sim raws li cGMP, suav nrog USP / EP cov qauv, thaum peb them nyiaj ntxiv rau ob peb qhov tseem ceeb impurities:

• Purity: HPLC Ntau dua lossis sib npaug rau 99.0%, qhov tseeb batch 99.2% -99.5%.
• Disulfide bond mismatch isomer: qhov tseem ceeb tshaj plaws impurity ntawm cabergoline. Peb cais nws los ntawm HPLC tshwj xeeb txoj kev thiab tswj nws ntawm<0.10%.
• Oxidizing impurities: tyrosine, tryptophan nyob rau hauv ib theem zuj zus? Carbetocin tsis muaj tryptophan, tab sis tyrosine tej zaum yuav oxidized, peb tswj<0.10%.
• Peptides ploj lawm: qhov chaw uas ploj lawm uas muaj kev tswj hwm, tag nrho cov peptides ploj lawm<0.5%.
• Tsis tiav homocysteine ​​butyrylation: Yog hais tias sab saw butyrylation ntawm 8-txoj hauj lwm homocysteine ​​tsis tiav, ib tug debutyryl impurity yog generated, uas peb tswj ntawm<0.15%.
• Endotoxin:<0.25 EU/mg, microbial limit according to Pharmacopoeia.

Kev ruaj ntseg yog ua tiav ob lub sijhawm ntev thiab nrawm, txhawb nqa 24-36 lub hlis rov kuaj dua. Cov txheej txheem raug lees paub.

3. Ua tiav cov ntaub ntawv thiab DMF ua ntaub ntawv

• Kev tshaj tawm cov ntaub ntawv tuaj yeem siv ncaj qha: cov txheej txheem kev txhim kho cov ntaub ntawv, cov txheej txheem validation cov kev pab cuam thiab cov ntaub ntawv, analytical method validation, stability cov ntaub ntawv, impurity profiling (mismatched isomers, debutanoyl impurities, thiab lwm yam), cov qauv kev pom zoo (NMR, MS, IR), batch ntau lawm cov ntaub ntawv. Koom tes nrog rau ntawm - kev tshuaj xyuas qhov chaw.

DMF tau raug xa mus rau US FDA thiab tuaj yeem tso cai siv hauv Suav teb, Asmeskas thiab Europe.

4. Cov khoom siv ruaj khov
Carbetocin siv ntau cov amino acids tshwj xeeb: deaminocysteine ​​thiab homocysteine ​​derivatives. Muaj ob peb tus neeg muag khoom ntawm cov ntaub ntawv no, yog li peb tau tsim cov khoom ruaj ntseg ua ntej thiab yuav los ntawm ob qhov chaw, kom tsis txhob muaj cov khoom tsis txaus.
 

• Chaw tsim khoom 10 daim av, cGMP tus qauv, FDA / EMA / NMPA ua raws, ISO 9001: 2015.
• Synthesis cog: automated solid-phase synthesis, 100 kg peev
• Purification Rhiav: ntau yam kev npaj HPLC
• Txias-rhiav tshuab ziab khaub ncaws: 30 square meters +, industrial khov- tshuab ziab khaub ncaws
• Qhov chaw huv: ISO 7/8
• QC Lab: HPLC, UPLC, LC-MS, GC, thiab lwm yam
• Kev Tswjhwm Zoo: Kev Hloov Kho, Kev Tswj Xyuas Kev Sib Dev, CAPA, Kev Tshawb Fawb Txog Kev Lag Luam, Kev Ntsuam Xyuas Txhua Xyoo. Koom tes nrog FDA, EMA, NMPA ntawm -kev tshuaj xyuas qhov chaw.

Kev lag luam kws tshuaj hauv tsev, Cabergoline txhaj tshuaj zoo sib xws: yav dhau los tab tom nrhiav rau cov neeg muag khoom ntawm cov isomer fluctuations (0.05%-0.25%). Peb muab peb pawg ntawm cov khoom siv pov thawj, thiab qhov tsis sib haum xeeb isomer tau ruaj khov ntawm li 0.06%, thiab peb kuj tau muab cov khoom tswj xyuas thiab cov qauv kev pom zoo. Lawv dhau qhov kev ntsuam xyuas tiav, thiab tam sim no tab tom yuav khoom tsis tu ncua txhua lub hlis.

Lub tuam txhab tshuaj South American: kev sau npe hauv zos yuav tsum ua kom tau raws li USP tus qauv ntawm cabergoline. Peb muab peb pawg ua ke, qhov purity siab tshaj 99.3% thiab cov impurity profile tau zoo ib yam. Lawv tau txais kev tso npe tso npe.

Carbetocin yog ib qho ntev - kev xaiv ua rau obstetrics, nrog rau ib hnub - raj uas yooj yim thiab siv tau. Peb tau sau ntau xyoo ntawm kev paub hauv cov khoom zoo li no, nrog cov txheej txheem ruaj khov, kev tswj xyuas zoo ntawm impurities thiab ua tiav cov ntaub ntawv. Yog tias koj tab tom tsim kev npaj ntawm Cabergoline thiab xav tau API, thov koj xav nrog peb tham.