Cia peb txiav cov generic marketing hais lus. Yog tias koj tab tom import Huperzine A rau hauv EU lossis Asmeskas, cov qauv kuaj xyuas purity yuav tau txais koj cov khoom txeeb ntawm kev lis kev cai. Nws yog qhov yooj yim. Koj tab tom cuam tshuam nrog microgram-dosed acetylcholinesterase (AChE) inhibitor. Ib qho kev hloov me ntsis hauv cov active alkaloid profile tsis tsuas yog ua kom puas batch; Nws ua rau mob hnyav cholinergic toxicity.

NtawmXi'an Tihealth (Xi'an Tihealth Biotechnology Co., Ltd.), peb tshawb xyuas tsis lees paub cov qauv kev paub thoob ntiaj teb. Tus thawj culprit? Qhov muag tsis pom kev ntseeg hauv cov ntaub ntawv pov thawj ntawm Kev Tshawb Fawb (COA) yooj yim. Cov lus qhia kev tshaj tawm no qhia tias vim li cas tus qauv chromatography tsis ua rau cov khoom siv dag siv dag zog, qhov tseeb nyuaj txog kev kuaj xyuas cov hlau hnyav, thiab yuav ua li cas cov tub ceev xwm yuav tsum tau nyeem cov chromatogram zoo li forensic chemist.

Qhov tshwm sim 99% purity ntawm tus qauv C18 HPLC kem yog qhov kev xav tsis zoo. Vim li cas? Vim tias cov kua chromatography yooj yim tsis tuaj yeem cais cov enantiomers. Pheej yig manufacturers synthesize Huperzine A tshuaj, yielding ib 50/50 racemic sib tov. Tus (+)-isomer yog dab ntxwg nyoog lom neeg. Nws tsis muaj dab tsi kiag li rau kev txawj ntse.

Txawm li cas los xij, ntawm tus qauv HPLC nyeem ntawv, ob qho tib si lub cev muaj zog (-)-isomer thiab tsis muaj txiaj ntsig hluavtaws (+)- isomer elute ntawm tib lub sijhawm khaws cia. Koj pom ib lub ncov loj heev. Koj xav tias koj yuav 99% ntshiab API. Koj yeej yuav 50% qhov hnyav tuag. Txhawm rau tiv thaiv EU / Asmeskas kev ua raws cai, kev yuav khoom yuav tsum tau thov kom meej meejChiral HPLClos yog ib qho kev sib hloov polarimetry. Peb tswj hwm nruj Enantiomeric Excess (ee) cov txheej txheem kom lav qhov kev sib cais ntawm cov qhabnias (-)-Huperzine A alkaloid.

Nyeem cov khoom lag luam blogs kom zoo. Ntau tus neeg thov tias HPLC kuaj pom cov hlau hnyav thiab cov kuab tshuaj seem. Qhov no yog scientifically tsis paub ntawv. HPLC nruj me ntsis ntsuas cov organic molecules. Lub sijhawm. Nws tsis tuaj yeem "pom" cov hlau lead lossis kab ethanol.

Yog tias koj xav tau kom tshem tawm EU / EFSA lossis US FDA kev lis kev cai, koj tus neeg muag khoom API yuav tsum siv ntau yam - instrumental mus kom ze. Thaum HPLC lees paub qhov kev them nyiaj alkaloid, lub Hoobkas yuav tsum tau muab tso ua keICP-MS (Inductively Coupled Plasma Mass Spectrometry)txhawm rau txheeb xyuas cov hlau hnyav (Pb, As, Cd, Hg) qis dua 1.0 ppm. Rau residual extraction kuab tshuaj? Koj yuamGC-HS (Gas Chromatography-Headspace). COA tso siab rau HPLC nkaus xwb tsis yog ib daim ntawv zoo. Nws yog ib tug loj txoj cai lav.

Tsis txhob saib qhov feem pua ​​​​ntawm qhov kawg ntawm daim ntawv qhia txog kev sim. Saib cov ntaub ntawv nyoos analytical. Qhov tiag 99% siab-purity Huperzine A batch yuav tso tawm ib rab chais-ntse, symmetrical Gaussian ncov.

Yog tias chromatogram qhia qhov tseem ceeb"peak tailing"los yog pom tau"lub xub pwg nyom"ntawm qhov nkhaus, koj muaj teeb meem co-elution. Unpurified cog matrix los yog ze ze alkaloids (xws li Huperzine B) yog nkaum hauv qab lub ncov thawj. Tsis tas li ntawd, qhov tsis zoo, tsis muaj suab nrov hauv paus qhia tias cov theem nyob ruaj khov tsis zoo lossis tsis muaj qhov ntsuas UV, ua rau muaj kev cuam tshuam hnyav rau qhov txwv ntawm Quantitation (LOQ). Xi'an Tihealth muab tag nrho, pob tshab chromatograms los ua pov thawj qhov siab tshaj plaws symmetry.

Cov kws tshaj lij QA pab pawg nrhiav los ntawm Xi'an Tihealth tswj hwm cov ntoo khaub lig tshwj xeeb no -cov txheej txheem siv:

Thauj tog rau koj cov saw hlau QA raws tu qauv hauv cov ntaub ntawv txheeb xyuas tau lees paub:

• Phau ntawv Journal of Pharmaceutical thiab Biomedical Analysis: Kev txiav txim siab ntawm huperzine A hauv cov khoom tsim los ntawm HPLC.(Tsim lub hauv paus ntawm UV nrhiav tsis tau).
  URL:https://pubmed.ncbi.nlm.nih.gov/11274112/
• Acta Pharmacologica Sinica: Huperzine A: Cov tshuaj pheej hmoo rau Alzheimer's disease.(Pharmacokinetic pov thawj ntawm qhov tsim nyog ntawm qhov tshwj xeeb (-)-isomer).
  URL:https://pubmed.ncbi.nlm.nih.gov/16872547/
• US Pharmacopeia (USP): General Tshooj<467>Residual Solvents.(Cov txheej txheem tswj xyuas qhov tseeb rau GC-HS kuaj).
  URL:https://www.uspnf.com/

Tsis yog kiag li. UV-Vis ​​yog ib txoj kev tsis yog- tshwj xeeb. Nws ntsuas tag nrho absorbance, lub ntsiab lus keeb kwm yav dhau los cog flavonoids yuav ua kom lub siab dawb huv nyeem ntawv. Rau cov khoom xyaw nquag dosed hauv micrograms, HPLC yog tib txoj kev tiv thaiv raug cai los cais cov alkaloid ncov tshwj xeeb.

Q: Vim li cas EU / Asmeskas cov neeg yuav khoom yuav tsum thov kev ywj pheej thib peb - tog neeg kuaj?

Txhawm rau txo cov khoom lag luam kev dag ntxias. Thaum cov tuam txhab muaj koob npe zoo li Xi'an Tihealth muab pob tshab hauv -COAs hauv tsev, kev lees paub ywj pheej los ntawm Eurofins, SGS, lossis Alkemist Labs tau lees paub qhov tsis ncaj ncees rau kev txheeb xyuas HPLC thiab nruj EU / US hnyav hlau ua ntej kev xa khoom ntau.

Kev Txiav Txim Siab: Tshawb xyuas koj cov ntaub ntawv txheeb xyuas

Rau EU thiab Asmeskas cov neeg yuav khoom, qhov kev thov "99% Purity" yog qhov tsis muaj qab hau yam tsis muaj kev nruj, ntau yam - ntsuas qhov tseeb. Tus qauv HPLC lees paub cov organic concentration, tab sis kev nyab xeeb, bio- nquag Huperzine A yuav tsum tau kuaj xyuas chiral, ntsuas chromatogram meej, thiab ntxiv ICP- MS kuaj.

Tsis txhob pheej hmoo rau koj cov qauv ntawm cov ntaub ntawv kuaj tsis tiav.Npaj txhij los muab cov ntaub ntawv pov thawj, kws tshuaj - qib kev paub APIs? Hu rau pab pawg Xi'an Tihealth QA hnub no rau tag nrho HPLC chromatograms thiab nruj EU-cov qauv ua raws Huperzine A.