Hauj lwm lawm

Kev tsis

Osimertinib Mesylate yog thib peb - tiam, irreversible epidermal loj hlob yam receptor tyrosine kinase inhibitor engineered los xaiv lub hom phiaj activating thiab T790M tsis kam hloov pauv thaum khaws cia cov tsiaj qus- hom receptor profiles. Tsim los ntawm validated synthetic pathways uas ua kom siab chiral purity, no active tshuaj muaj nyob rau hauv lub core constituent rau qhov ncauj khoom noj cov ntaub ntawv uas tsim los rau tsom oncology kev kho mob.

Technical Parameters

Parameter	Specification nthuav dav
International Nonproprietary Name	Osimertinib Mesylate
CAS Nr	1421373-66-1
Molecular Formula	C₂₈H₃₃N₇O₂· CH₄O₃S
Molecular Luj	599,71 g / mol
Qauv Qauv	Aminopyrimidine derivative / Kinase inhibitor
Qhov tshwm sim	Dawb rau tawm -dawb crystalline hmoov
Solubility	Xyaum insoluble hauv dej; sparingly soluble nyob rau hauv polar organic solvents
Kev cia khoom	Khaws rau hauv cov thawv kaw nruj nreem hauv qab 25 degree, tiv thaiv los ntawm lub teeb thiab noo noo
Txee lub neej	36 lub hlis nyob rau hauv cov txheej txheem cia

Zoo thiab analytical Specifications

Kev txheeb xyuas:Ua raws li tus qauv siv los ntawm Infrared Absorption thiab HPLC tuav lub sijhawm.

Kev ntsuam xyuas:98.5% mus rau 101.5% xam los ntawm lub hauv paus tsis muaj dej los ntawm High-Kev Ua Haujlwm Liquid Chromatography.

Chiral Purity:Enantiomeric ntau tshaj los yog sib npaug rau 99.5% ntawm chiral chromatography.

Profile ntawm impurities:Tus neeg teev cov impurities txwv rau 0.10% siab kawg; tag nrho impurities capped ntawm 0.50%.

Residual Solvents:Ua raws li ICH Q3C txwv kev txheeb xyuas los ntawm headspace gas chromatography.

Cov ntsiab lus dej:Qhov siab tshaj plaws 1.0% txiav txim siab los ntawm volumetric Karl Fischer titration.

Residue ntawm Ignition:Qhov siab tshaj 0.1% ntawm kev ntsuas gravimetric.

Heavy Hlau:Qhov siab tshaj plaws 20 ppm ntsuas los ntawm inductively coupled plasma mass spectrometry.

Particle Loj Distribution:Kev tswj tsis tau (D90 hauv qab 50 µm), kho tau raws li tus neeg siv khoom xav tau.

Manufacturing thiab Quality Assurance

Kev tsim khoom ib puag ncig:Kev lag luam- nplai ntau- lub hom phiaj kev sib txuas ua tiav nyob rau hauv kaw- kab ke ua haujlwm thiab ISO Class 8 chav huv.

Purification thiab cais tawm:Multi-thev organic synthesis incorporating catalytic hydrogenation, controlled crystallization, and centrifugal filtration to cais cov polymorphic forms.

Containment Standards:High -cov khoom cais tawm siv thaum sib cais, ziab, thiab micronization kom muaj kev nyab xeeb thiab kev nyab xeeb ntawm tus neeg teb xov tooj.

Supply Chain Integrity:Validated dual -sourcing rau raw cov ntaub ntawv ua ke nrog kev ruaj ntseg Tshuag ntawm nruab nrab cov tebchaw kom paub meej lub sij hawm xa mus tas li.

Cov ntaub ntawv thiab kev tswj hwm kev txhawb nqa

Regulatory ntaub ntawv:Drug Master File tau muab tso ua ke hauv ICH hom npaj rau kev xa tawm thoob ntiaj teb.

Daim ntawv pov thawj ntau:Daim Ntawv Pov Thawj Kev Tshawb Fawb tau muab rau txhua qhov kev lag luam batch, nthuav qhia tag nrho cov kab kos chromatographic impurity.

Cov pob khoom ua raws:Kev Ua Haujlwm Zoo Ua Raws Li Cov Lus Qhia, kev tshawb fawb kev ruaj ntseg cov ntsiab lus suav nrog cov ntaub ntawv nrawm thiab ntev -, thiab cov ntawv tsis muaj rau kis tau tus mob spongiform encephalopathy.

Cov ntaub ntawv kev nyab xeeb:Cov Ntaub Ntawv Kev Nyab Xeeb Kev Nyab Xeeb Cov Ntaub Ntawv piav qhia txog cov kab mob toxicological, cov khoom siv tiv thaiv tus kheej, thiab cov txheej txheem tuav.

Ntim thiab Logistics

01/

Ntim Ntim:Food-grade, double-layer low-density polyethylene bags heat-sealed under positive pressure nitrogen purge.

02/

Secondary Ntim:Rigid fiber nruas los yog txhuas-laminated tiv thaiv canisters muab puncture kuj thiab lub teeb shielding.

03/

Moisture Control:Pharmaceutical-qib silica gel desiccant packets sib xyaw ua ke ntawm thawj thiab theem nrab liners.

04/

Labeling Standards:Barcoded ntau daim ntawv cim qhia pom tus lej CAS, qhov hnyav hnyav, qhov hnyav tag nrho, kev cia khoom tshwj xeeb, rov- hnub xeem, thiab qhov chaw tsim khoom.

Kev siv tshuaj

Oncology Formulations:Cov khoom siv tshuaj nquag siv rau hauv cov tshuaj hauv qhov ncauj tsom rau hauv zos qib siab lossis metastatic tsis yog -mob qog noj ntshav nrog EGFR T790M kev hloov pauv.

Thawj -Cov kab ke:Muab tso rau hauv kev kho mob hauv qhov ncauj txhua hnub rau cov neeg mob uas muaj kev ua kom exon 19 tshem tawm lossis exon 21 L858R hloov pauv.

Adjuvant Protocols:Siv nyob rau hauv post-kev kho mob kev kho mob dosing regimens rau theem IB mus rau IIIA cov neeg mob cohorts.

Tableting Efficiency:Optimized hmoov flowability thiab compressibility yam ntxwv txhawb ncaj qha blending los yog ntub granulation manufacturing txheej txheem.

FAQ

Q: Tam sim no txoj cai tswjfwm ntawm Cov Ntaub Ntawv Tshuaj Yeeb Tshuaj yog dab tsi?

A: Cov ntaub ntawv tus thawj tswj hwm tau khaws cia hauv ICH hom, muaj rau kev tso cai siv raws li kev thov.

Q: Polymorphic daim ntawv twg yog xa hauv cov khoom xa tuaj?

A: Cov khoom xyaw nquag yog muab los ua ib daim ntawv thermodynamically ruaj khov crystalline daim ntawv pov thawj ntawm X-ray hmoov diffraction thiab sib txawv scanning calorimetry.

Q: genotoxic impurities tswj tau li cas?

A: Tag nrho cov txheej txheem muaj peev xwm - cov seem seem raug saib xyuas los ntawm cov kua chromatography validated -tandem mass spectrometry txoj kev thiab khaws cia hauv qab qhov kev txwv ntawm kev ua raws li cov lus qhia thoob ntiaj teb.

Q: Dab tsi yog qhov muaj piv txwv loj rau kev ntsuam xyuas?

A: Kev ntsuas cov qauv ntsuas pib ntawm 100g rau kev tshuaj ntsuam xyuas, nrog rau kev txiav txim coj mus muag hauv tus qauv 5kg lossis 25kg nruas teeb tsa.

Cim npe nrov: Tuam Tshoj osimertinib mesylate manufacturers, lwm tus neeg, Hoobkas