Somatostatin API CAS 38916-34-6

Somatostatin API CAS 38916-34-6|Loj hlob Inhibitor Acetate cGMP ntau lawm|Peptide API|Science-Peptide

Somatostatin API CAS 38916-34-6 - Peptide API rau kev kho mob esophageal variceal los ntshav, pancreatitis, thiab lwm yam. Science-Peptide muab Kev Loj Hlob Inhibitor Acetate raws li cGMP tus qauv, nrog cov txheej txheem paub tab, ntshiab impurity profiles, kev txhawb nqa rau Tuam Tshoj, Tebchaws USA thiab Europe tshaj tawm, thiab tuaj yeem tso cai DMF. txais tos hu rau peb.

Somatostatin muaj txoj haujlwm ruaj khov hauv plab hnyuv thiab cov tshuaj kho mob xwm txheej ceev - mob esophageal variceal los ntshav, mob hnyav pancreatitis, pancreatic fistula, plab hnyuv fistula, cov xwm txheej no, nws yog thawj - kab tshuaj. Nws tsis yog cov khoom "breakout", tab sis kev thov tau ruaj khov thiab kev siv thoob ntiaj teb tsis yog qhov tseem ceeb.

 

Nws cov txheej txheem ntawm kev ua haujlwm yog qhov tshwj xeeb: nws inhibits kev tso tawm ntawm ntau yam tshuaj hormones, suav nrog kev loj hlob hormone, insulin, glucagon, gastrin, pancreatin, thiab lwm yam. Nws kuj txo cov ntshav visceral thiab txo qis portal venous siab. Nws kuj tseem txo cov ntshav visceral thiab txo qhov siab hauv cov hlab ntsha portal. Nyob rau hauv cov ntaub ntawv ntawm los ntshav esophageal varices, nws yog lub ntsiab ntawm cov tshuaj vasoactive, xws li terlipressin.

 

Kev tshawb fawb-Peptide tau ua peptide APIs rau ntau tshaj 20 xyoo, thiab kev loj hlob inhibitor yog ib hom kab mob uas peb tau nkag mus rau thaum ntxov. Cov peptide no yog 14 amino acid cyclic peptide nrog ib khub ntawm disulfide bonds, thiab peb tau khiav cov txheej txheem synthesis rau ntau tshaj 10 xyoo. Tam sim no, peb tuaj yeem ruaj khov muab kev loj hlob inhibitor acetate APIs los ntawm grams mus rau 100 kilograms, thiab tau ua tiav FDA DMF cov ntaub ntawv, thiab txhawb Tuam Tshoj, Tebchaws Asmeskas thiab Europe tshaj tawm. Cov impurity profile yog qhov tseeb, thiab muaj cov tswv yim tswj kom paub tab rau cov impurities tseem ceeb xws li disulfide bond mismatch, oxidized impurities thiab ploj peptides.

Acute esophageal variceal hemorrhage:Ua ke nrog endoscopic ligation, nws txo cov ntshav visceral, txo qis portal siab, thiab muaj cov nyhuv hemostatic. Cov lus qhia pom zoo kom tsis tu ncua infusion rau 2-5 hnub.
Mob hnyav pancreatitis:inhibit pancreatic enzyme secretion, txo cov tshuaj tiv thaiv kab mob pancreatic. Txawm hais tias nws tsis yog ib qho tshuaj tshwj xeeb, nws tuaj yeem siv los ua kev kho mob kom txo qis cov teeb meem.
Adjuvant therapy rau pancreatic thiab plab hnyuv fistulas:txo qhov tso tawm ntawm cov kua txiv hmab txiv ntoo thiab txhawb kev kho ntawm fistulas.
Acromegaly (ntev- daim ntawv ua yeeb yam):inhibits kev loj hlob hormone secretion, tab sis qhov ntawd yog lub tsev ntawm octreotide thiab lanreotide, thiab kev loj hlob inhibitors siv tsawg dua vim lawv luv luv ib nrab- lub neej.

Los ntawm qhov kev xav ntawm APIs, kev loj hlob inhibitors yog tus cwj pwm los ntawm ib qho txheej txheem pib - 14 peptides, cyclization, qhov sib lawv liag ntawm ib tug xov tooj ntawm hydrophobic amino acids, synthesis thiab purification yog complex dua luv peptides. Txawm li cas los xij, vim yog qhov pib, cov neeg muag khoom ruaj khov thiab yuav tsis dhau los ntawm tus nqi qis. Cov kev paub uas peb tau sau rau hauv hom no tso cai rau peb kom ua tiav qib siab ntawm kev sib xws hauv impurity profiles nrog thawj cov kws tshawb fawb.

1. Cov khoom siv tes ua tau ua haujlwm tau ntau dua kaum xyoo thiab kev nthuav dav tsis muaj kev txhawj xeeb
Qhov nyuaj hauv kev sib txuas ntawm kev loj hlob inhibitors nyob rau hauv qhov tseeb cyclization ntawm disulfide daim ntawv cog lus thiab kev ua kom huv ntawm ntau yam hydrophobic amino acids nyob rau hauv ib ntus. Peb siv txoj hauv kev ntawm "khoom-theem synthesis ntawm linear precursors + kua-theem cyclization":

• Linear precursor: Fmoc solid-the synthesis, optimized coupling conditions for hydrophobic region, ruaj khov yield ntawm crude peptide.
• Cyclization: Me me oxidation nyob rau hauv cov kua theem, meej tsim ntawm 3-14 disulfide daim ntawv cog lus, cyclization efficiency yog tswj saum toj no 95%, thiab cov ntsiab lus ntawm mismatch isomers yog tsawg heev.
• Kev lim dej: Muaj ntau-kauj ruam HPLC tau ua los cais cov peptides uas ploj lawm, oxidized impurities, dimers, thiab mismatched isomers ib los ntawm ib qho.
• Txias- ntim ntim kom qhuav: thaj chaw ua haujlwm huv, ob npaug- txheej aseptic hnab.

Peb tau khiav cov txheej txheem no los ntawm ob peb kaum grams ntawm kev sim me me mus rau ntau pua kilograms ntawm cov khoom lag luam. Cov txheej txheem validation cov ntaub ntawv qhia tau hais tias lub purity yog ruaj khov nyob rau hauv ntau tshaj 99% nrog heev overlapping impurity profiles nyob rau hauv ob peb pawg. Cov ntawv tso tawm yog sib xws los ntawm batch mus rau batch.

2. Kev tswj kom zoo, tsis yog purity xwb

Txhua batch ntawm kev loj hlob inhibitor API raug tso tawm raws li cGMP cov kev cai, cov khoom xeem npog cov tshuaj pharmacopoeia tib lub sijhawm, peb kuj them nyiaj ntxiv rau qee cov txheej txheem impurities:

• Cov ntsiab lus: 95.0%-105.0% raws li cov dej tsis muaj dej thiab hnyav, raws li USP/EP.
• Purity: HPLC Ntau dua lossis sib npaug rau 99.0%, qhov tseeb batch feem ntau yog 99.2% -99.5%.
• Cov khoom muaj feem xyuam: ib qho impurity Tsawg dua lossis sib npaug li 0.15%, tag nrho impurity Tsawg dua lossis sib npaug li 1.0%.
• Cov impurities tseem ceeb: disulfide daim ntawv cog lus mismatch isomers (hom sib txawv cyclization), oxidized methionine impurities (tsis Met hauv qhov sib lawv liag, tab sis tryptophan yog yooj yim oxidized), peptides ploj, dimers, tag nrho nrog kev tswj thiab quantification txoj kev.
• Kev nyab xeeb ntsuas: endotoxin<0.25 EU/mg, microbiological limits in accordance with the Pharmacopoeia, residual solvents in accordance with ICH Q3C.

Kev ruaj ntseg yog ntev -lub sij hawm thiab ceev, txhawb 24-36 lub hlis rov kuaj dua. Txoj kev tshuaj ntsuam xyuas tau raug lees paub kom ua tau raws li ICH Q2 thiab USP / EP cov cai.

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

Kev loj hlob inhibitors muaj qhov zoo- tsim txoj hauv kev, thiab cov ntaub ntawv peb muab tuaj yeem siv ncaj qha rau ANDA lossis cov ntaub ntawv hauv tsev:

• Txheej txheem kev txhim kho daim ntawv qhia (yuav ua li cas qhov tseem ceeb parameter raug txiav txim)
• Cov txheej txheem validation cov kev pab cuam thiab cov ntawv ceeb toom (ntau- cov ntaub ntawv batch) analytical method validation reports
• Cov ntaub ntawv ruaj ntseg (ntev-lub sijhawm, nrawm, cuam tshuam)
• Heterogeneous mass spectrometry report (nrog kev pom zoo)
• Cov ntaub ntawv pov thawj ntawm cov qauv (NMR, MS, IR)
• Batch ntau lawm cov ntaub ntawv (ua tiav thiab traceable)
• Ua ke nrog rau ntawm - kev tshuaj xyuas qhov chaw

Peb Txoj Kev Loj Hlob Inhibitor API tau ua tiav FDA DMF cov ntaub ntawv, thiab tuaj yeem tso cai siv hauv Suav teb, Tebchaws Meskas thiab Tebchaws Europe tshaj tawm. Yog tias koj xav tau European CEP, peb kuj tuaj yeem koom tes nrog koj.

4. Cov saw hlau, peb muaj ib txoj kev npaj

Ntawm cov amino acid raw cov ntaub ntawv siv rau kev loj hlob inhibitors, muaj ntau yam amino acids tshwj xeeb (xws li, Fmoc-Asn(Trt)-OH, Fmoc-Trp(Boc)-OH) uas muaj lub sij hawm mus yuav khoom ntev. Peb tau ua ntau yam:

• Tsawg kawg yog ob tus neeg tsim khoom tsim nyog rau cov ntaub ntawv tseem ceeb, kev tshawb xyuas lub Hoobkas tsis tu ncua.
• Cov khoom siv sij hawm ntev ua cov khoom siv, tsim kom muaj kev ruaj ntseg cov khoom lag luam, tsis muaj kev lag luam nres vim kev thauj mus los hauv hiav txwv qeeb.
• Ntau cov kab ntau lawm tso cai rau kev teem caij sib luag thiab kev txiav txim nrawm tuaj yeem tso rau hauv kab.

Ntawm hom kev koom tes, peb tuaj yeem muag API, lossis tso cai DMF, lossis hloov cov thev naus laus zis mus rau tus neeg siv khoom qhov chaw. Packing specification yog raws li qhov yuav tsum tau ntawm kev npaj.

• Chaw tsim khoom 10 daim av, cGMP tus qauv, FDA, EMA, NMPA raws, ISO 9001: 2015 tau ntawv pov thawj.
• Synthesis cog: automated solid-phase synthesis, 100 kg peev
• Purification Rhiav: ntau yam ntawm HPLC npaj, txaus tus nqi npog 50mL-1000mL / min
• 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

Nyob rau hauv cov nqe lus ntawm kev ua tau zoo, kev hloov pauv, kev tswj kev sib txawv, CAPA, kev tshuaj xyuas tus neeg muag khoom, kev tshuaj xyuas txhua xyoo yog txhua yam haujlwm niaj hnub. Peb tau koom tes nrog FDA, EMA, NMPA ntawm - kev tshuaj xyuas qhov chaw, thiab muaj ntau yam kev paub.

Client A, lub tuam txhab kws tshuaj hauv tsev, tau koom nrog kev tshuaj xyuas qhov sib xws ntawm kev loj hlob inhibitor txhaj tshuaj. Lub impurity profile ntawm tus neeg muag khoom yav dhau los tsis ruaj khov, tshwj xeeb tshaj yog cov disulfide daim ntawv cog lus mismatch isomer siab. Peb muab peb pawg ntawm cov ntaub ntawv pov thawj uas tau lees paub nrog tag nrho cov ntaub ntawv tsis huv ntawm cov ntaub ntawv, thiab cov isomer tsis sib haum tau tswj hauv qab 0.05%. Lawv tau siv peb cov ntaub ntawv raw los npaj, uas dhau qhov kev ntsuam xyuas tiav, thiab tam sim no lawv tab tom yuav tsis tu ncua txhua lub hlis.

Client B, Lub tuam txhab kws tshuaj nyob sab hnub tuaj Asia: kev sau npe hauv zos xav tau kev loj hlob inhibitor API uas ua tau raws li tus qauv EP. Peb tau muab plaub pawg ua ke, thiab qhov purity ntawm txhua batch yog siab dua 99.2% nrog tib impurity profile. Lawv siv peb cov ntaub ntawv raw los ua qhov kev npaj thiab tau txais kev pom zoo rau npe hauv zos.

Kev loj hlob inhibitor tsis yog hom "explosive" ntau yam, tab sis qhov kev thov kho mob yog qhov ruaj khov, tus neeg muag khoom yuav tsum tau siab heev - cov txheej txheem yuav tsum paub tab, impurities yuav tsum tau tswj, cov ntaub ntawv yuav tsum sawv ntsug rau kev soj ntsuam. Peb tau ua haujlwm ntawm hom no rau ntau tshaj 10 xyoo, thiab peb xav tias peb tau teb cov lus teb zoo. Yog tias koj tab tom ua kev npaj kev loj hlob inhibitor, xav nrhiav API cov neeg muab khoom, txais tos tham.