Alpha-Lipoic Acid Sodium yog ib qho siab -purity, dej siab heev-soluble sodium ntsev ntawm alpha-lipoic acid engineered rau kev noj zaub mov ntxiv formulations, xa cov aqueous solubility thiab superior physiological absorption piv rau cov qauv dawb acid variants.
Cov ntsiab lus tseem ceeb
|
Parameter |
Specification Standard |
|
Kev ntsuam xyuas (HPLC) |
>= 99.0% |
|
Tus nqi pH |
7.0 txog 9.5 (1% aqueous tov) |
|
Poob rau ziab |
<= 0.5% |
|
Hnyav Hlau |
< 10 ppm (as Pb) |
|
Residual Solvents |
ICH Q3C ua raws |
Chemical & Functional Profile
Aqueous Solubility:Dissolute sai sai hauv dej ntau tshaj 50 mg / mL ntawm 20 degrees Celsius, tshem tawm cov teeb meem dispersion inherent hauv cov qauv crystalline.
Thermal Stability:Kev teeb tsa ntsev muab kev ruaj ntseg zoo tiv thaiv kev ntxhov siab thaum lub sij hawm siab -kev sib xyaw ua haujlwm ceev.
Absorption Kinetics:Kev nrawm nrawm nrawm nrawm nrawm nrawm nrawm nrawm nrawm thiab ua kom lub cev muaj zog bioavailability hauv kev kho mob profile.
Cov khoom lag luam -Kev tsom xam tshwj xeeb
Moisture Control:Ua tiav los ntawm kev tswj lub tshuab nqus tsev kom qhuav los tiv thaiv kev ua ntej hydrolysis thiab caking tendencies thaum lub sij hawm ntev cia.
Particle Loj Distribution (PSD):Milled rau 90% dhau los ntawm 80-mesh npo, lav cov hmoov sib tov sib xyaw ua ke hauv cov tshuab compression ncaj qha.
Chiral Parameters:Tswj kev sib hloov kho qhov muag tsim los ua kom tau raws li cov kev ua tau zoo ntawm cov metabolic thiab stereospecific purity cov cai.
Formulation & Application Parameters
Excipient Compatibility:Ua tiav nrog cov qauv ncaj qha compression binders suav nrog microcrystalline cellulose thiab anhydrous lactose nrog rau cov alkaline stabilizers.
Hygroscopic Management:Yuav tsum tau ua ib puag ncig khaws cia hauv qab 45% txheeb ze av noo thaum lub sij hawm capsule filling thiab ntsiav tshuaj punching theem.
Liquid Delivery:Haum rau cov kua dej - sau cov tshuaj ntsiav thiab cov kev npaj ua haujlwm poob qis yam tsis muaj theem sib cais lossis teeb meem nag lossis daus.
Daim phiaj siv
Kev tswj qhov hnyav ntxiv:Kev koom ua ke rau hauv cov txheej txheem kev txhawb nqa metabolic uas tsom mus rau kev siv hluav taws xob ntawm tes thiab txoj hauv kev siv cov piam thaj.
Antioxidant Formulations:Siv rau hauv kev tiv thaiv kab mob - kev laus thiab kev noj qab haus huv mitochondrial cov tshuaj ntsiav.
Kev Noj Qab Haus Huv Kev Ua Si:Ntxiv rau cov ntawv tshaj tawm qib siab- kev ua haujlwm rov qab sib xyaw tsim los rau oxidative kev ntxhov siab txo.
Kev Tswj Xyuas Zoo & Cov Qauv Ntsuas
Assay Verification:Quantified los ntawm siab -kev ua tau zoo kua chromatography ua ke nrog diode- array detection.
Trace Elemental Screening:Kev ntsuas los ntawm inductively txuas nrog ntshav plasma huab hwm coj spectrometry kom ntseeg tau tias cov hlau hnyav nyob hauv qab qhov chaw ua tshuaj.
Kev Nyab Xeeb Microbiological:Tag nrho cov aerobic microbial suav tau khaws cia qis dua 1000 CFU / g nrog kev tsis tuaj yeem ua tiav ntawm cov kab mob hauv ib lub tshuaj pharmacopeial monographs.
Cov Lus Qhia Txog Kev Cia & Kev Tswj
Thawv Configuration:Muab ntim rau hauv ob lub- txheej zaub mov- qib polyethylene hnab nyob hauv cov nruas fiber ntau lossis aluminium foil noo noo- cov hnab thaiv.
Environmental Controls:Khaws hauv qab 25 degrees Celsius hauv qhov tsaus ntuj, qhuav ib puag ncig nrog cov ntim kaw kom nruj kom tiv thaiv huab cua noo noo.
Txee Lub neej Stability:Validated rau 24 lub hlis txij li hnub tsim khoom raws li teev tseg tsis tau qhib cia.
Cov ntaub ntawv & Kev Txhawb Kev Ua Raws Cai
Comprehensive Dossiers:Muab nrog tag nrho cov analytical batch nrog rau npe, pilot, thiab coj mus muag validation cov ntaub ntawv.
Kev nyab xeeb & Specifications:suav nrog GHS-raws li MSDS, cov khoom specifications, txoj kev tsom xam, thiab txoj kev ntawm cov ntaub ntawv synthesis.
Regulatory tshaj tawm:Cov lus tau lees paub tag nrho hais txog BSE/TSE- xwm txheej pub dawb, tsis yog -GMO ua raws, thiab kev tswj tsis haum.
Kev them nyiaj yug DMF & CEP:Kev txhawb nqa los ntawm cov koom tes ua lag luam tswj hwm cov ntaub ntawv tswj hwm thoob plaws thoob ntiaj teb cov thawj coj saib xyuas kev noj qab haus huv tseem ceeb.
Ntim & Logistics
Standard Ntim Ntim:25 kg net hnyav ib lub nruas fiber ntau uas muaj dual qis - ntom polyethylene inner liners; customized ntim muaj raws li qhov kev thov.
Kev faib khoom thauj:Tsis yog -Kev faib tshuaj lom neeg tsim nyog rau cov khoom thauj khoom thauj khoom qhuav tiv thaiv los ntawm tshav ntuj ncaj qha thiab ya raws.
Qauv Txheej Txheem:Kev soj ntsuam ntau npaum li ntawm 100 g mus rau 1 kg muaj tam sim ntawd rau kev kuaj R & D thiab analytical method validation.
Cov lus nug nquag
Q: Dab tsi yog qhov zoo ntawm sodium ntsev tshaj tus qauv alpha-lipoic acid?
A: Cov ntsev ntsev muab cov dej solubility ntau dua thiab muaj qhov nruab nrab - rau -alkaline pH profile, daws cov teeb meem hauv cov kua dej thiab txhim kho tus nqi nqus.
Q: Cov khoom siv no puas xav tau cov saw hlau txias shipping?
A: Tsis yog. Cov khoom yog thermally ruaj khov nyob rau hauv ambient shipping tej yam kev mob (15 degrees Celsius mus rau 30 degrees Celsius), txawm tias huab cua kub yuav tsum tau zam.
Q: Dab tsi yog lub sij hawm coj mus muag rau kev txiav txim coj mus muag?
A: Standard bulk orders ship in 10 mus rau 15 hnub ua hauj lwm tom qab kev txiav txim pom zoo thiab kev tso tawm pov thawj zoo.
Q: Puas yog cov txheej txheem tshuaj ntsuam xyuas tau raug xa mus rau cov neeg siv khoom kuaj?
A: Yog. Cov txheej txheem kuaj HPLC sab hauv thiab impurity profiles tau sau tag nrho thiab muaj rau kev txheeb xyuas cov txheej txheem hloov raws li kev thov.
Cim npe nrov: alpha-lipoic acid sodium, Tuam Tshoj alpha-lipoic acid sodium manufacturers, lwm tus neeg, Hoobkas
