SANA hmoov

SANA hmoov(CAS 42571-07-3) yog ib qho kev sim me me molecule compound tam sim no nyob rau hauv kev kho mob thaum ntxov. Nws qhov chaw tseem ceeb yog thawj -hauv-chav kawm creatine-dependent thermogenesis activator rau kev poob rog thiab kev txhim kho metabolic. Nws txhawb kev siv hluav taws xob los ntawm kev ua kom muaj qhov tshwj xeeb thermogenesis hauv cov ntaub so ntswg adipose uas yog ywj pheej ntawm UCP1 protein. Hauv kev tshawb fawb tsiaj, nws tau pom tias muaj kev poob phaus zoo dua thiab kev tswj ntshav qab zib hauv cov ntshav piv rau salicylic acid thiab metformin, nrog rau cov koob tshuaj zoo li 40 npaug qis dua salicylic acid. Kev ua tiav Phase 1A / B tib neeg kev soj ntsuam kuaj tau ua ntej tau lees paub nws txoj kev nyab xeeb thiab kev ua haujlwm ntev, thiab kev txhim kho qhov hnyav thiab kev tiv thaiv insulin raug pom nyob rau hauv 15-hnub lub sijhawm tswj qhov ncauj.

1. Raw Material Testing (Incoming Inspection)

Kev tshuaj xyuas tuaj yeem ntiav HPLC thiab MS los txheeb xyuas qhov sib xyaw ntawm tus kheej, purity (R&D qib siab dua lossis sib npaug li 98%), thiab cov impurities tseem ceeb, ua kom cov khoom zoo raws li cov qauv ntawm lub hauv paus.

2. Hauv - txheej txheem QC

Tiag -Lub sijhawm saib xyuas cov txheej txheem tsis ua haujlwm thiab cov khoom nruab nrab yog ua thaum sib txuas. Hauv Kev sim Phaj I, kev nce koob tshuaj (200–800 mg), ob npaug - qhov muag tsis pom cov placebo- tswj kev tswj hwm, thiab kev tshuaj xyuas PK los ntawm cov qauv ntshav tau txais txiaj ntsig zoo li hauv - cov txheej txheem tswj kom muaj kev nyab xeeb thiab kev kwv yees raug.

3. Cov khoom tiav

• Kev Ntsuas Purity Test: High-performance liquid chromatography (HPLC) is used to determine the purity of the finished product, with a research-grade standard requirement of >98%.
• Microbiological thiab Endotoxin Test: Kev ntsuam xyuas cov kab mob endotoxin (BET) yog ua raws li cov txheej txheem pharmacopoeia (gel method lossis dynamic turbidimetric method) kom ua raws li cov kev txwv microbiological rau kev txhaj tshuaj lossis qhov ncauj formulations.
• Heavy Metals thiab Residual Solvents: Kev soj ntsuam kev pheej hmoo thiab kev txwv tswj tau ua rau muaj peev xwm genotoxic impurities, cov hlau hnyav, thiab cov txheej txheem residual solvents, ua raws li cov lus qhia xws li ICH Q3D, kom ua raws li cov qauv kev nyab xeeb tshuaj.

4. Cov khoom siv kuaj (HPLC/GC-MS)

Hais txog cov khoom siv kuaj, HPLC yog lub hauv paus tseem ceeb rau kev txiav txim siab purity ntawm lub ntsiab Cheebtsam thiab tshuaj xyuas impurity profiles. GC-MS yog siv los ua ib txoj hauv kev pabcuam rau kev tshawb nrhiav kom muaj nuj nqis ntawm cov organic residual cov kuab tshuaj tsis zoo thiab muaj peev xwm genotoxic impurities. ICP-MS thiab endotoxin detectors yog siv ntxiv los tshuaj xyuas cov hlau hnyav thiab cov ntsuas microbial.

1. Chemical Synthesis thiab Purification: Npaj los ntawm kev siv tshuaj tua kab mob siv cov tshuaj salicylic acid derivatives, muaj cov tshuaj tiv thaiv xws li nitration thiab condensation, tom qab ntawd los ntawm kev sib cais thiab purification siv extraction, crystallization, los yog chromatography cov tswv yim.
2. Lim/Concentration/Drying Process: Insoluble impurities raug tshem tawm los ntawm cov khoom siv -kua sib cais, hnyav tau zoo los ntawm lub tshuab nqus tsev concentration, thiab thaum kawg, cov hmoov qhuav yog tsim los ntawm cov tshuaj tsuag kom qhuav lossis khov kom qhuav.
3. Mixing / Homogenesis / Standardization txheej txheem: API qhuav yog tov nrog excipients nyob rau hauv ib qho piv txwv thiab homogenized. Cov ntsiab lus yog txiav txim los ntawm HPLC kom paub meej batch-rau-batch sib xws.
4. Filling and Packaging: Dispensing, sealing, labeling, and outer packaging yog ua tiav nyob rau hauv ib puag ncig, aseptic ib puag ncig kom ntseeg tau cov khoom ruaj khov.
5. Process Parameter Control: Key parameters such as temperature, time, solvent ratio, and pH are precisely set and monitored, with HPLC purity (>98%) siv los ua tus txheej txheem kawg.
6. Automated Control System: PLC automated control system, ua ke nrog SCADA system, ua kom muaj tseeb - lub sijhawm saib xyuas, cov ntaub ntawv kaw, thiab lub tswb tswj cov ntsuas tsis xws li kub, siab, thiab ntws tus nqi, ua haujlwm raws li SOP specifications.

1.Cov khoom siv tam sim no

Raws li kev tshawb nrhiav kev tshawb fawb, SANA Powder yog tam sim no muab nkag rau hauv lub chaw soj nstuam thiab cov chaw tshawb fawb soj ntsuam los ntawm cov tshuaj synthesis. Peb lub tuam txhab muab cov qauv milligram- qib ntim (5mg, 10mg, 50mg, 100mg) thiab tuaj yeem txais kev txiav txim ntau.

2.Supply Stability thiab Inventory

Peb muaj cov khoom muag loj thiab tuaj yeem xa khoom sai.

3.R&D Progress thiab Long -Term Cooperation Prospects

SANA Powder txoj kev loj hlob tau nce mus rau Phase I kev sim tshuaj, nrog rau Phase 1A/B kev sim siab yuav tsum ua kom tiav hauv 2025. Loj dua -scale Phase II kev sim tshuaj yog npaj. Qhov no txhais tau hais tias los ntawm qhov ntev - txoj kev koom tes hauv lub sijhawm, raws li kev sim tshuaj kho mob tau zoo, cov txheej txheem synthesis yuav raug nce mus ntxiv thiab ua kom zoo dua qub, thiab yav tom ntej muaj peev xwm tsim tau thiab cov saw hlau loj yuav tsum txhim kho.

4.Tsom ntsoov rau cov teeb meem

• Puas yuav muaj kev cuam tshuam ntawm kev xa khoom? - Peb tam sim no muaj cov khoom muag txaus, yog li qhov kev pheej hmoo ntawm kev cuam tshuam ntawm cov khoom siv rau kev sim xav tau hauv lub sijhawm luv luv yog tsawg. Txawm li cas los xij, kev lag luam loj loj - yuav tsum tau muaj kev sab laj ua ntej.
• Puas yog qhov zoo ruaj khov? - Purity Ntau dua lossis sib npaug li 98% (HPLC)
• Puas yog kev koom tes ntev - ua tau? -Kev yuav khoom tam sim no yog rau kev tshawb fawb hauv chav kuaj. Yog xav tau loj -scale, thov hu rau peb.