Phenibut Ntxiv Capsulesmuaj ib koob tshuaj Phenibut ({0}}phenyl- -aminobutyric acid), ib qho hluavtaws nootropic thiab GABA-mimetic compound. Tsim los kom yooj yim thiab meej qhov ncauj kom tsawg, cov tshuaj ntsiav no muaj cov hmoov zoo sib xws, hla qhov saj ntawm cov khoom nyoos.
Leej twg yog tus tsim nyog siv Phenibut Supplement Capsule?
- Rau siab - cov neeg ua haujlwm hauv chaw ua haujlwm siab: Tshem tawm kev ntxhov siab thiab kev ntxhov siab ua haujlwm, txhim kho kev ua haujlwm zoo.
- Rau cov uas npaj rau kev xeem / kev kawm: Pab txhim kho kev xav thiab daws kev ntxhov siab ua ntej - xeem.
- Rau cov neeg uas pw tsaug zog: Maj mam txhim kho kev pw tsaug zog zoo yam tsis muaj kev cia siab rau cov tshuaj sedatives.
- Rau cov neeg uas muaj kev ntxhov siab: Pab txo kev ntxhov siab hauv kev sib raug zoo thiab txhim kho kev sib raug zoo.
Ceeb Toom: Contraindicated rau cov menyuam yaus, cov poj niam cev xeeb tub, cov poj niam pub niam mis, cov neeg uas muaj lub siab tsis zoo lossis lub raum ua haujlwm, thiab cov tib neeg tam sim no noj cov tshuaj puas hlwb.
Cov txiaj ntsig tseem ceeb ntawm Phenibut Supplement Capsule
- Txhawb txoj kev xav so thiab txhawb kom muaj kev thaj yeeb nyab xeeb.
- Pab txo qis kev ntxhov siab thiab ntxhov siab qee zaus.
- Tej zaum yuav nce kev nplij siab hauv kev sib raug zoo.
- Txhawb kev puas siab puas ntsws clarity thiab kev txawj ntse muaj nuj nqi.
Lymall Bpanda muab tau dab tsi?
1. Formula meej: Cov khoom xyaw uas sib xyaw ua ke ua kom muaj kev sib npaug ntawm kev ua tau zoo thiab kev nyab xeeb.
2. Daim ntawv yooj yim Dosage: Daim ntawv Capsule yog ib qho yooj yim mus nqa thiab nqa, muab cov koob tshuaj meej thiab tsis txhob muaj qhov cuam tshuam ntawm kev npaj hmoov.
3. Quality Assurance: Kev tsim khoom ua tau raws li cov qauv xws li GMP, thiab cov khoom siv raw tau raug kuaj xyuas nruj thiab kuaj.
4.Kev siv dav dav: Npog ntau yam kev xav tau suav nrog kev tswj hwm txhua hnub, tswj kev pw tsaug zog, thiab txo kev ntxhov siab.
Txheej txheem ntau lawm
1.API Synthesis
Cov tshuaj formula ntawm Phenibut yog C₁₀H₁₃NO₂, nrog ib tug molecular hnyav ntawm 179.22 thiab CAS naj npawb 1078-21-3. API feem ntau yog tsim los ntawm kev siv tshuaj lom neeg:
| Theem | Kauj ruam npe | Kev ua haujlwm tseem ceeb | Tso zis |
|---|---|---|---|
| 1 | Pib Kev Npaj Khoom | Siv benzaldehyde thiab malonic acid ua cov khoom pib | Nruab nrab |
| 2 | Condensation Reaction | Condensation los ua -phenylacrylic acid | -Phenylacrylic acid |
| 3 | Ntxiv Reaction | Cov tshuaj tiv thaiv nrog nitromethane | -Phenyl- -nitrobutyric acid |
| 4 | Txo cov tshuaj tiv thaiv | Catalytic hydrogenation los txo cov pab pawg nitro rau amino pawg | Phenibut Crude |
| 5 | Kev huv huv | Recrystallization rau purification | Siab -Phenibut API |
Los ntawm recrystallization purification, siab -purity Phenibut API yog tau rau cov formulation tom ntej.
2.Capsule Formulation Production Process
Cov txheej txheem kev tsim tshuaj ntsiav tshuaj yog ncaj qha sib xyaw thiab txhaws:
| Theem | Kauj ruam npe | Kev ua haujlwm tseem ceeb | Kev piav qhia |
|---|---|---|---|
| 1 | Raw Khoom Pretreatment | Crushing thiab sieving Phenibut API | Tswj particle loj, xyuas kom meej flowability |
| 2 | Sib tov | Sib tov nrog fillers, lubricants thiab lwm yam excipients | Xyuas kom cov ntsiab lus sib xws |
| 3 | Capsule filling | Tsis siv neeg capsule filling tshuab | Tswj qhov hnyav variation |
| 4 | Polishing & Tshuaj xyuas | Tshem tawm cov hmoov av, tsis lees txais cov tshuaj tsis zoo | Kev tshuaj xyuas qhov muag |
| 5 | Ntim | Blister ntim los yog lub raj mis | Airtight sealing |
Kev Tswj Xyuas Zoo
1.API Kev Tswj Xyuas Zoo
|
Test Parameter |
Specification |
Kev piav qhia |
|---|---|---|
|
Qhov tshwm sim |
Dawb crystalline hmoov |
Tsis pom impurities |
|
Kev txheeb xyuas |
IR yam ntxwv peaks raws li tus qauv siv |
Paub meej cov qauv tshuaj |
|
Assay (Cov ntsiab lus) |
Ntau dua lossis sib npaug li 98.5% (feem ntau tshaj 99%) |
Kev txiav txim los ntawm HPLC |
|
Poob rau ziab |
Tsawg dua los yog sib npaug li 0.5% |
Tswj cov dej noo |
|
Residue ntawm Ignition |
Tsawg dua lossis sib npaug li 0.1% |
Tswj inorganic impurities |
|
Hnyav Hlau |
Tsawg dua los yog sib npaug li 10 ppm |
Xws li txhuas, arsenic, mercury, thiab lwm yam. |
|
Yam khoom muaj feem |
Ib qho impurity Tsawg dua lossis sib npaug li 0.1%, Tag nrho cov impurities Tsawg dua lossis sib npaug rau 0.5% |
Tswj cov synthesis los ntawm -cov khoom thiab cov khoom degradation |
|
Residual Solvents |
Ua raws li ICH Q3C cov cai |
Tswj cov kuab tshuaj organic siv hauv kev tsim khoom |
2. Capsule Formulation Quality Control
|
Test Parameter |
Specification |
Txoj Kev Xeem |
|---|---|---|
|
Qhov tshwm sim |
Lub plhaub plhaub tsis zoo, tsis muaj kev tawg lossis tawg; cov ntsiab lus yog dawb los tawm -cov hmoov dawb |
Kev tshuaj xyuas qhov muag |
|
Fill Weight Variation |
Txhua lub ntsiav tshuaj hnyav hauv ± 7.5% ntawm daim ntawv thov (rau qhov nruab nrab sau qhov hnyav Tsawg dua lossis sib npaug li 300mg) |
Qhov hnyav txoj kev |
|
Cov ntsiab lus tsis sib xws |
Ua raws li cov cai hauv pharmacopoeia (A+2.2S Tsawg dua lossis sib npaug rau 15.0) |
Cov ntsiab lus uniformity xeem |
|
Assay (Cov ntsiab lus) |
Txhua capsule muaj 90%-110% ntawm cov ntawv sau npe Phenibut |
HPLC txoj kev |
|
Kev tawg |
Dissolution rate Ntau dua lossis sib npaug li 80% hauv lub sijhawm teev tseg (xws li 45 feeb) |
Kev Ntsuas Kev Ntsuas (paddle / lub tawb nqa khoom) |
|
Cov ntsiab lus noo noo |
Tsawg dua lossis sib npaug li 9.0% (rau gelatin capsules) |
Poob rau ziab |
|
Lub Sijhawm Disintegration |
Tsawg dua lossis sib npaug li 30 feeb |
Kev kuaj kev puas tsuaj |
|
Microbial txwv |
Tag nrho aerobic suav Tsawg dua lossis sib npaug rau 1000 CFU / g; Cov poov xab & pwm Tsawg dua lossis sib npaug rau 100 CFU / g; Tsis zoo rau Salmonella, E. coli, S. aureus |
Microbial limit test |
3. Kev tshawb fawb txog kev ruaj ntseg
Txhawm rau kom ntseeg tau tias cov khoom lag luam zoo nyob ruaj khov thoob plaws hauv nws lub neej txee, kev tshawb fawb kev ruaj ntseg yuav tsum:
|
Kawm Hom |
Cov xwm txheej |
Lub Sijhawm Ntsuas Cov Ntsiab Lus |
Test Parameters |
|---|---|---|---|
|
Ntev - Lub Sij Hawm Stability |
25℃± 2 degree, 60% RH ± 5% RH |
0, 3, 6, 9, 12, 18, 24 hli |
Assay, dissolution, ya raws, yam khoom, microbiology, thiab lwm yam. |
|
Accelerated Stability |
40℃± 2 degree, 75% RH ± 5% RH |
0, 1, 2, 3, 6 hli |
Ib yam li saum toj no |
|
Kev Ntsuas Kev Nyuaj Siab |
Kev kub siab (60 degree), high humidity (75% RH / 92.5% RH), lub teeb (4500 Lx) |
0, 5, 10 hnub |
Ib yam li saum toj no |
R & D Muaj peev xwm
1.R&D cov zis
|
Hom tso zis |
Cov ntsiab lus tshwj xeeb |
|---|---|
|
Khoom Specifications |
Ntau yam khoom tshwj xeeb muaj (xws li MT2, Phenibut, Berberine, Astaxanthin, thiab lwm yam) |
|
Cov ntawv xeem |
COA, MSDS, HPLC purity tsom xam cov ntaub ntawv muaj |
|
Customization Services |
OEM customization txhawb, specifications thiab ntim adjustable ib tus neeg yuav tsum tau |
|
Cov ntaub ntawv ua raws cai |
tuaj yeem pab cov neeg siv khoom nrog cov ntawv pov thawj thoob ntiaj teb thiab kev tshuaj xyuas cov cai |
2.Tus nqi tsim nyog ntawm R & D muaj peev xwm
Rau cov neeg yuav khoom, peb lub tuam txhab R & D muaj peev xwm yog qhov tseem ceeb hauv:
- Quality Assurance: ISO/GMP system ua kom batch-rau-batch sib xws ntawm cov khoom.
- Teeb meem teb: Pab pawg R & D tuaj yeem pab daws cov teeb meem zoo tshaj tawm los ntawm cov neeg siv khoom.
- Kev tsim kho kev cai: Khoom specifications (xws li particle loj, purity, thiab ntim) tuaj yeem hloov kho raws li cov neeg siv khoom xav tau.
- Kev Pabcuam Ua Raws Cai: Muab cov ntaub ntawv thev naus laus zis thiab cov ntawv xeem uas xav tau rau kev xa tawm.
Cim npe nrov: Tuam Tshoj phenibut ntxiv capsule manufacturers, lwm tus neeg, Hoobkas
