Tsis yog -Kev puas tsuaj Raman Raw Material Identification Solution

Tsis yog -Kev puas tsuaj Raman Raw Material Identification Solution

Handheld thiab ntawm - kab Raman spectroscopy kom ceev, tsis yog -kev puas tsuaj pov thawj ntawm cov khoom siv raw thiab cov khoom ntim, tsis qhib lub thawv kaw. Cov khoom siv raw khoom yog qhov yuav tsum tau kuaj xyuas GMP, tab sis cov tsoos ntub dej - chemistry lossis cov qauv kev puas tsuaj yog qeeb thiab yuav tsum tau qhib txhua lub thawv, muaj kev pheej hmoo. Raws li cov saw hlau txuas ntxiv ntev thiab cov khoom cuav lossis cov khoom tsis raug cai yuav loj tuaj, cov tuam txhab tsim khoom xav tau txoj hauv kev nrawm, tsis yog - puas tsuaj los lees paub tus kheej los ntawm kev ntim ntim ntawm daim ntawv txais nyiaj.

USP General Tshooj<1120>(Raman Spectroscopy) muab kev taw qhia txog kev tsim nyog ntsuas thiab kev siv tau zoo rau Raman-raws li kev ntsuas tus kheej. Tam sim no Kev Tswj Xyuas Kev Tswj Xyuas Zoo (21 CFR 211.84) yuav tsum tau kuaj xyuas tus kheej ntawm txhua feem ntau, thiab FDA's Process Analytical Technology (PAT) kev taw qhia txhawb nqa tsis yog -kev puas tsuaj, ntawm - kab spectroscopic txoj kev ua ib feem ntawm cov txheej txheem zoo niaj hnub no.

Peb Raman identification system txheeb xyuas cov ntaub ntawv raw khoom los ntawmnkag mus nrhiav tau los ntawm iav vials, hnab yas, HDPE fwj thiab cov hnab ntim khoom sib xyawtsis qhib lub thawv, siv lub tsev qiv ntawv spectral npogPharmaceutical APIs, excipients, hmoov, granules, cov kuab tshuaj thiab cov khoom siv tshuaj nruab nrab. Hom ntawv tuav los yog lub rooj zaum txhawb nqaCov khoom xa tuaj sai sai ntawm cov chaw tau txais cov khoom lag luam, kev tshuaj xyuas cov khoom xa tuaj thiab kev kuaj QC kuaj pom zoo, nrog cov txiaj ntsig thiab spectral match kev ntseeg siab sau tseg rau cov ntaub ntawv batch. Raws li cov chaw tsim khoom peb muabkev cai database tsev raws li tus neeg siv khoom tus kheej cov khoom siv ntau yam, kev tsim khoom luv luv & lub sijhawm xa tuaj, ntawm - qhov chaw ntsuas kev ua haujlwm, spectral lub tsev qiv ntawv tsis tu ncua pub dawb hloov tshiab thiab ntev - lub sijhawm tom qab - muag calibration & kev cob qhia kev txhawb nqa.

NeuronBC Raman Spectrometer Core Nta

• Ua raws nraim nrogFDA 21 CFR Part 11, EP 2.2.48, PIB<1120>thiab Suav Pharmacopoeia General Rule 0421, txhawb kev tshawb nrhiav txoj hauv kev, kos npe hluav taws xob, kev tso cai tus neeg siv hierarchical thiab tamper-cov ntaub ntawv pov thawj export

• Tsis yog -kev puas tsuaj los ntawm- kev ntsuas lub thawv: nkag mus rau iav vials, hnab yas, HDPE fwj thiab cov ntim khoom sib xyaw yam tsis qhib cov qauv rau kev txheeb xyuas cov khoom tuaj

• Batch xeem muaj nuj nqi, QR / barcode scanning rau cov ntaub ntawv ceev hu, tsis siv neeg Pass / Fail kev txiav txim thiab batch PDF daim ntawv qhia export rau GMP batch ntaub ntawv

• Ua kom tiav ALCOA + cov ntaub ntawv kev ntseeg siab lees paub, cov khoom siv raw, sib piv kev ntseeg siab tus nqi thiab cov ntaub ntawv teev cia ua ke mus tas li

• Ib qho - nres kev daws teeb meem: wavelength configuration, sojntsuam accessories, software muaj nuj nqi kev txhim kho tus kheej

• Kev tsim khoom luv luv & sijhawm xa khoom xa tuaj, thoob ntiaj teb ntawm - qhov chaw ua haujlwm thiab ntsuas ntsuas qhov kev pabcuam

• Ua kom tiav cov ntaub ntawv pov thawj CSV / IQ / OQ / PQ rau kev tshuaj xyuas tshuaj

• Ntev - lub sij hawm tsis tu ncua calibration, kev cob qhia thiab tej thaj chaw deb tom qab - kev muag khoom

Q1: Raman spectroscopy puas tuaj yeem txheeb xyuas cov ntaub ntawv los ntawm cov ntim xim lossis opaque?

A1: Raman feem ntau tuaj yeem nkag mus rau iav ntshiab thiab ntau lub thawv yas; Kev ua tau zoo los ntawm cov xim, opaque, lossis cov fluorescent ntim ntau sib txawv thiab yuav tsum tau lees paub rau ib yam khoom.

Q2: Kev txheeb xyuas Raman zoo li cas piv rau cov tsoos ntub dej -Chemistry ID xeem?

A2: Raman muab cov txiaj ntsig sai dua, tsis yog - puas tsuaj yam tsis muaj kev siv tshuaj reagent, txawm hais tias nws txheeb xyuas cov khoom siv raws li molecular spectral ntiv tes thiab yuav tsum muaj lub tsev qiv ntawv siv tau rau txhua yam khoom siv kuaj.

Q3: Puas yog txhua yam khoom siv raw xav tau nws tus kheej spectral siv nyob rau hauv lub tsev qiv ntawv?

A3: Yog - kev txheeb xyuas txhim khu kev qha yog nyob ntawm qhov kev siv tau zoo ntawm cov khoom siv tshwj xeeb thiab, feem ntau, txhua tus neeg xa khoom lossis qib sib txawv.

Q4: Puas yog handheld Raman haum rau GMP cov chaw kuaj xyuas?

A4: Yog lawm, cov khoom siv tes tuav feem ntau yog siv los ntawm kev txais cov docks rau kev tshuaj ntsuam xyuas tus kheej sai, nrog cov txheej txheem ntawm lub rooj zaum siv hauv QC labs kom siab dua - kev lees paub tseeb lossis kev txhim kho.