Xi'an Huilin Bio-Tech Co., Ltd. yog ib qho ntawm cov ua lag luam thiab cov muag khoom ntawm d-calcium pantothenate hmoov (vitamin b5) hauv Suav teb. Nrog kev paub dhau los, peb tau cog lus los muab cov khoom lag luam zoo nrog cov nqi sib tw. Thov koj xav tias dawb rau cov lag luam wholesale bulk ntshiab d-calcium pantothenate hmoov (vitamin b5) rau muag ntawm no los ntawm peb lub hoobkas.
Dab tsi hloov thaum tib lub ntsev yog muag rau kev noj
Cov tshuaj tsis hloov pauv thaum d-calcium pantothenate hmoov txav los ntawm luv luv kom zoo nkauj rau ib qho luv luv ntxiv. Cov qib, cov pob hlau hnyav, cov ntaub ntawv teeb tsa thiab cov lej lej tom qab daim ntawv thov txhua qhov kev hloov pauv, thiab plaub yam khoom no yog dab tsi tus neeg yuav khoom ntxiv tau yuav.
Tus neeg yuav khoom kom zoo nkauj nug seb cov khoom puas puas thiab pH nws coj li cas. Ib tus neeg yuav khoom ntxiv nug seb qhov kev cai twg cov khoom raug tso tawm tawm tsam, qhov twg cov hlau hnyav txwv siv, thiab pes tsawg milligrams hmoov xa cov milligram daim duab luam tawm ntawm lub vaj huam sib luag. Cov lus qhia tshwj xeeb teb cov lus nug thawj zaug rau ob lub khw; tsuas yog lub thib ob txheej txiav txim siab seb ib pawg tuaj yeem siv rau hauv cov khoom uas nqos tau.
Txoj Cai Tswjhwm hauv Tebchaws Meskas
Hauv Tebchaws Meskas, d-calcium pantothenate hmoov zaum hauv cov saw hlau uas pib nrog kev tswj hwm, dhau los ntawm tus qauv siv, thiab xaus rau ntawm qib kev siv. Txhua qhov txuas yog ib daim ntawv uas tus neeg yuav khoom tuaj yeem nug los ntawm lub npe.
| Muab tso rau hauv 21 CFR 184.1212 | Nws hais li cas | Dab tsi nws txwv ntawm kev yuav khoom |
|---|---|---|
| Tus kheej | Calcium ntsev ntawm pantothenic acid, sau (C9H16NO5)2Ca, nrog CAS 137-08-6 hais rau D isomer | CAS tus lej ntawm daim ntawv xaj khoom |
| Isomer kev ua haujlwm | Tsuas yog D isomer ntawm pantothenic acid muaj cov tshuaj vitamin, thiab D isomer thiab DL racemic sib xyaw yog siv rau hauv cov khoom noj. | Seb puas yog qib racemic tuaj yeem nqa tib daim ntawv thov |
| Specification | Cov khoom muaj raws li Food Chemicals Codex, 3rd edition, 1981, page 56 | Tus qauv twg yog siv rau kev siv khoom noj hauv Asmeskas |
| Siv qib | Siv rau hauv cov khoom noj uas tsis muaj kev txwv lwm yam tshaj li tam sim no kev tsim khoom zoo | Tias tsis muaj tus lej qab nthab tswj cov khoom |
| Siv qeb | Siv los ua cov khoom noj ntxiv hauv qab 21 CFR 170.3(o)(20) | Lub hom phiaj ua haujlwm tau tso cai |
| Me nyuam mos mis | Tej zaum yuav siv tau rau hauv cov mis mos nyob rau hauv nqe lus 412(g) lossis cov cai hauv qab 412(a)(2) ntawm Txoj Cai | Tus me nyuam mos mis no ua raws ib txoj hauv kev |
Ob ntawm cov kab no tsim nyog nyeem ob zaug. Txoj cai lij choj hais tias tsuas yog D isomer nqa cov vitamin ua haujlwm thaum tso cai rau ob daim ntawv D thiab cov racemic sib xyaw hauv cov zaub mov, yog li cov lus nug isomer yog cov lus nug uas tsis yog cov lus nug raug cai. Qhov kev siv rau Food Chemicals Codex, tsis yog rau USP, kuj yog qhov tshwj xeeb: US cov qauv zaub mov raug suav nrog hauv kev cai yog FCC monograph.
Qib Qib
Qib ntawm d-calcium pantothenate hmoov tsis txawv purities ntawm tib cov lus cog tseg. Lawv yog cov pob khoom sib txawv ntawm kev ua raws, kev sim thiab cov ntaub ntawv, thiab tus nqi sib txawv taug qab lub pob es tsis yog daim duab ntsuas ib leeg.
| Qib | Dab tsi ntxiv rau saum qhov kev ntsuam xyuas | Dab tsi nws feem ntau ua haujlwm |
|---|---|---|
| Qib zaub mov | FCC conformity, hnyav hlau pob, allergen thiab keeb kwm nqe lus | Khoom noj khoom haus fortification, ntxiv blends |
| Pharmaceutical qib | Ph. Eur. los yog USP conformity, muaj feem xyuam rau cov khoom thiab residual hnyav cov ntaub ntawv, tag nrho batch ntaub ntawv traceability | Cov ntsiav tshuaj, tshuaj ntsiav, tshuaj formulations |
| Pub qib | Assay thiab calcium thiab nitrogen cov nuj nqis, cov ntaub ntawv them nqi coj | Premix thiab compound pub |
Qhov loj tshaj qhov sib txawv ntawm qib zaub mov thiab qib tshuaj tsis yog qhov ntsuas qab nthab tab sis cov ntaub ntawv impurity. Cov tshuaj muaj feem cuam tshuam ntawm 1.2% tag nrho hauv Ph. Eur. 0470 txhais tau tias tsis muaj dab tsi rau tus neeg yuav khoom uas tsis tuaj yeem pom chromatogram, thiab qib tshuaj yog qhov uas chromatogram tau muab raws li qhov tseeb.
Label Claim Arithmetic: Los ntawm Pantothenic Acid rau Input Nyhav
Ib daim ntawv tshaj tawm hais tias pantothenic acid; lub nruas muaj d-calcium pantothenate hmoov. Kev hloov dua siab tshiab ntawm ob yog cov kauj ruam uas cov mis ntxiv feem ntau poob ob peb feem pua ntawm nws cov nqi tshaj tawm, thiab nws yog lej lej tsis yog kev txiav txim.
| Lub hom phiaj ntawm lub vaj huam sib luag, raws li pantothenic acid | Ntsev sib npaug ntawm 100% purity | Tawm tswv yim ntawm 93.1% raws li muab | Input nrog 10% overage |
|---|---|---|---|
| 5 mg | 5.43 mg | 5.84 mg | 6.42 mg |
| 10 mg | 10.87 mg | 11.67 mg | 12.84 mg |
| 25 mg | 27.17 mg | 29.18 mg | 32.10 mg |
| 100 mg | 108.68 mg | 116.73 mg | 128.41 mg |
Thawj kab mus rau kab thib ob kauj ruam rau d-calcium pantothenate hmoov siv qhov piv ntawm pantothenic acid ntawm 219.24 mus rau ib nrab ntsev ntawm 238.27, uas muab 0.920 g ntawm pantothenic acid ib gram ntawm d-calcium pantothenate hmoov. Cov kab thib peb siv 93.1% raws li cov khoom siv concentration, uas yog dab tsi 98.0% ntawm lub hauv paus qhuav dhau los ntawm 5.0% poob ntawm ziab qab nthab ntawm USP thiab FCC monographs. Pawg plaub yog kev txiav txim siab ua lag luam, tsis yog kev tswj hwm.
Overage thiab Premix Behavior
Rau d-calcium pantothenate hmoov, overage yog qhov txawv ntawm daim ntawv lo thiab lub nkoj hnyav, thiab nws qhov loj nyob ntawm seb ntev npaum li cas cov khoom zaum hauv premix ua ntej cov tshuaj tiav lawm. Ob qhov kev hloov pauv uas txav mus rau nws feem ntau yog kev khaws dej noo thiab cais tawm.
| Theem | Yuav ua li cas rau cov khoom | Yam tus formulator tswj |
|---|---|---|
| Qhov hnyav | me ntsis noo noo khaws nyob rau hauv huab cua ntub; hmoov yog hygroscopic | Chav tsev av noo, lub sijhawm ntawm lub rooj ntev zaum, resealing |
| Premix sib tov | Uniform faib nyob rau hauv ib tug diluent ntawm tsawg inclusion theem | Diluent xaiv, blending lub sij hawm, particle loj match |
| Kev ruaj ntseg ntawm premix | Moisturizing ntawm cov khoom | Ntim barrier, desiccant, thawv loj |
| Tableting los yog encapsulation | Kev poob rau cov khoom siv ntawm qhov chaw qis | Yam tsawg kawg nkaus batch loj, yaug thiab rov ua cov kauj ruam |
| Cov khoom tiav txee lub neej | Assay drift dhau lub sijhawm tshaj tawm | Tshaj dhau, ntim khoom, kev cia khoom |
Qhov laj thawj rau qhov overage ntawm d-calcium pantothenate hmoov yog nyob rau hauv cov ntaub ntawv batch, tsis nyob rau hauv kev lag luam: ib tug overage loj txaus los npog ib tug ob-xyoo drift yog ib tug formulation kev txiav txim siab uas yuav tsum tau ua ncaj ncees tiv thaiv cov ntaub ntawv stability rau cov matrix tshwj xeeb. Luam ib feem pua ntawm lwm cov khoom lag luam yog vim li cas ib txwm ua haujlwm ua ntej kev ruaj ntseg tsis ua haujlwm.
Cov ntaub ntawv teev tom qab ib pawg
Rau d-calcium pantothenate hmoov muag rau hauv ib qho ntxiv lossis cov khoom noj khoom haus, daim ntawv pov thawj ntawm kev soj ntsuam yog ib daim ntawv ntawm ob peb, thiab tus neeg muag khoom uas xa daim ntawv pov thawj nkaus xwb tau tso tus neeg yuav khoom thov tus lej email ib zaug.
| Cov ntaub ntawv | Lo lus nug nws teb | Tshaj tawm los ntawm |
|---|---|---|
| Daim ntawv pov thawj ntawm kev soj ntsuam | Cov batch no puas ua tau raws li qhov pom zoo specification | Chaw tsim tshuaj paus |
| Daim ntawv qhia tshwj xeeb | Qhov kev txwv thiab txoj hauv kev yog dab tsi | Chaw tsim tshuaj paus |
| Daim ntawv qhia kev nyab xeeb | Yuav ua li cas cov khoom siv thiab muab faib rau kev thauj mus los | Chaw tsim tshuaj paus |
| Allergen hais lus | Txawm hais tias muaj kev ua xua rau ntawm lub khw muag khoom cov npe muaj nyob | Chaw tsim tshuaj paus |
| Keeb kwm thiab lus hais txog kev noj haus | Seb cov khoom puas yog tsiaj-derived, thiab seb nws tsis yog-GMO | Chaw tsim tshuaj paus |
| Residual solvent nqe lus | Seb organic volatile impurities ua tau raws li cov tshuaj pharmacopoeia | Chaw tsim tshuaj paus |
Ob qho no tsis tu ncua thiab ob qho tib si tseem ceeb. Cov lus qhia txog kev ua xua yog cov ntaub ntawv tshwj xeeb hauv kev lag luam thiab tsis tuaj yeem suav tau los ntawm cov lus qhia tshwj xeeb, thiab cov ntsiab lus tseem ceeb ntawm cov kuab tshuaj yog qhov sib txawv ntawm qib tshuaj thiab qib zaub mov ntawm tib cov ntsev.
Yam Daim Ntawv Pov Thawj Yuav Tsum Qhia Ua Ntej Tshaj Tawm
Daim ntawv pov thawj rau d-calcium pantothenate hmoov tuaj yeem tshaj tawm qhov kev ntsuam xyuas sab hauv lub qhov rais thiab tseem piav qhia txog cov khoom siv uas yuav ua tsis tiav ntawm cov kauj ruam tom ntej, vim qhov kev ntsuam xyuas yog qhov tsawg tshaj plaws ntawm cov lej ntawm nplooj ntawv. Plaub daim duab ua ke muab kev txiav txim siab tso tawm siv tau.
| Yam khoom ntawm daim ntawv pov thawj | Qhov rai | Dab tsi ua tsis tiav |
|---|---|---|
| Kev soj ntsuam ntawm d-calcium pantothenate, qhuav hauv paus | 98.0–102.0% (USP); 98.0–101.0% (Ph.Eur.) | Hauv qab lub qhov rais: dilution los yog undercharge |
| Calcium, qhuav hauv paus | 8.2-8.6% (USP, FCC) | Sab nraum lub qhov rais: tsis ncaj ncees lawm counter-ion los yog muab tub lim |
| Nitrogen, qhuav hauv paus | 5.7-6.0% (USP) | Sab nraum lub qhov rais: tsis muaj nitrogen dilution |
| Poob rau ziab | Tsis ntau tshaj 3.0% (Ph. Eur.); 5.0% (USP, FCC) | Tshaj 3.0%: tsis yog Ph. Eur. pawg |
| Kev sib hloov tshwj xeeb | +25.0 rau +27.5 (USP, FCC); +25.5 rau +27.5 (Ph. Eur.) | Tsawg nyeem ntawv: cov khoom siv racemic lossis ib nrab racemised |
| Chlorides | Tsis ntau tshaj 200 ppm (Ph. Eur.) | Saum toj no txwv: txheej txheem nqa-over |
Cov calcium thiab nitrogen khub yog tus kheej txheeb xyuas qhov kev soj ntsuam ntawm d-calcium pantothenate hmoov tsis tuaj yeem ua. Theoretical calcium rau C18H32CaN2O10 ntawm 476.54 yog 8.41% thiab theoretical nitrogen yog 5.88%, thiab ob lub qhov rais pharmacopoeial bracket cov duab. Cov khoom siv diluted nrog cov neeg nqa khoom tsis muaj nitrogen tuaj yeem ua kom dhau qhov kev ntsuam xyuas tawm tsam tus qauv fortified, tab sis nws tsis tuaj yeem nqa calcium thiab nitrogen rov qab rau hauv lawv lub qhov rais tib lub sijhawm.
Specification
| Yam khoom | txwv | Txoj kev |
|---|---|---|
| Qhov tshwm sim | Dawb mus yuav luag dawb crystalline hmoov | Pom kev |
| Kev txheeb xyuas | Infrared spectrum conforms; calcium tshuaj tiv thaiv zoo | Infrared; pharmacopoeial calcium test |
| Assay | 98.0–102.0% qhuav hauv paus (USP) lossis 98.0–101.0% (Ph. Eur.) | Perchloric acid titration |
| Kev sib hloov tshwj xeeb | +25.0℃rau +27.5℃(USP, FCC) lossis +25.5℃rau +27.5℃(Ph. Eur.) | Polarimetry |
| Poob rau ziab | Tsis ntau tshaj 5.0% (USP, FCC) lossis 3.0% (Ph. Eur.) | 1.000 g ntawm 105 degree |
| Calcium | 8.2-8.6%, qhuav hauv paus | Complexometric titration |
| Nitrogen | 5.7-6.0%, qhuav hauv paus | Kjeldahl |
| pH | 6.8 rau 8.0 | 5% w/v daws |
| Chlorides | Tsis ntau tshaj 200 ppm | Ph. Eur. txwv kuaj |
| Tag nrho cov khoom muaj feem xyuam | Tsis ntau tshaj 1.2% | Ph. Eur. kua chromatography |
| Coj | Raws li pom zoo specification | ICP-MS los yog sib npaug |
| Tag nrho cov phaj suav | Raws li pom zoo specification | Pharmacopoeial method |
Cov lus nug nquag nug (FAQ)
Q: Puas yog d-calcium pantothenate hmoov zoo ib yam li vitamin B5 hmoov?
A: Hauv cov khoom lag luam, ob lub npe xa mus rau tib yam khoom, CAS 137-08-6, calcium ntsev ntawm D-pantothenic acid. Vitamin B5 yog vitamin tooj; d-calcium pantothenate hmoov yog cov khoom xyaw raws li muab. Dawb pantothenic acid ntawm CAS 79-83-4 yog ib yam khoom sib txawv thiab tsis tshua muaj los ua cov hmoov qhuav.
Q: Cov qib racemic puas tuaj yeem siv rau hauv cov zaub mov?
A: Yog lawm, hauv Tebchaws Meskas . 21 CFR 184.1212 hais tias D isomer thiab DL racemic sib xyaw ntawm calcium pantothenate yog siv hauv cov zaub mov, thaum sau tseg tias tsuas yog D isomer ntawm pantothenic acid muaj cov vitamin ua haujlwm. Cov ntawv sau npe thiab kev suav ua haujlwm tseem nyob ntawm D cov ntsiab lus.
Q: Tus qauv twg yog US zaub mov siv siv?
A: Cov kev cai hais txog Food Chemicals Codex, 3rd edition, 1981, page 56, es than the USP. Rau kev siv khoom noj hauv Asmeskas lossis kev siv ntxiv, FCC monograph yog tus qauv muaj npe nyob rau hauv txoj cai, thiab FCC qhov rai qhov ntsuas yog 97.0 txog 103.0% tom qab ziab.
Q: Ntau npaum li cas hmoov xa 10 mg ntawm pantothenic acid?
A: Kwv yees li ntawm 10.87 mg ntawm ntshiab d-calcium pantothenate hmoov, vim hais tias ib gram ntawm ntsev sib raug rau 0.920 g ntawm pantothenic acid. Ntawm 93.1% raws li muab cov tswv yim nce mus rau 11.67 mg. Ib qho overage ntxiv rau saum daim duab ntawd dua li hloov nws.
Q: Vim li cas qhov poob ntawm qhov ziab kom qhuav ntau dua li qhov ntsuas ntsuas?
A: Vim tias qhov kev ntsuam xyuas tau hais tawm ntawm cov khoom qhuav. Ntawm 5.0% poob ntawm ziab, 98.0% assay txhais tau tias 93.1% ntawm cov hmoov raws li muab. Cov ntsiab lus dej kuj yog cov khoom uas cais Ph. Eur. batch, capped ntawm 3.0%, los ntawm ib pawg uas tsuas yog ua tau raws li USP lossis FCC.
Q: Qib no puas haum rau cov menyuam mos mis?
A: 21 CFR 184.1212 tso cai calcium pantothenate nyob rau hauv cov mis mos nyob rau hauv nqe lus 412(g) ntawm Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj thiab Tshuaj pleev ib ce, los yog raws li cov kev cai uas tau muab nyob rau hauv nqe lus 412(a)(2). Qib thiab cov ntaub ntawv rau kev siv tau pom zoo cais los ntawm qib zaub mov dav dav.
Q: Cov ntaub ntawv dab tsi yuav tsum tuaj nrog thawj cov khoom xa tuaj?
A: Rau d-calcium pantothenate hmoov daim ntawv pov thawj ntawm kev soj ntsuam, daim ntawv qhia tshwj xeeb thiab cov ntaub ntawv kev nyab xeeb yog qhov tsawg kawg nkaus, ntxiv rau cov lus qhia tsis haum thiab cov lus qhia keeb kwm. Rau qib kws kho mob, ntxiv cov ntaub ntawv muaj feem xyuam nrog cov ntaub ntawv thiab cov lus hais txog cov kuab tshuaj residual. Nug tag nrho cov txheej txheem ua ntej thawj qhov kev txiav txim, tsis yog tom qab.
Q: Tib batch puas tuaj yeem ua haujlwm rau cov tshuaj pleev ib ce thiab cov neeg siv khoom ntxiv?
A: Tsuas yog cov lus qhia tshwj xeeb tau sau los npog ob qho tib si. Cov khoom siv thiab CAS tus naj npawb zoo ib yam, tab sis cov pob hlau hnyav, cov ntaub ntawv teeb tsa thiab qib tau teev nyob rau hauv daim ntawv pov thawj txawv. Ib pawg tso tawm tawm tsam cov lus qhia kom zoo nkauj tsis tau tso tawm tawm tsam ib qho khoom noj.
Vim li cas thiaj xaiv peb?
Koj tus kws tshaj lij kev tsim khoom & Sourcing tus khub
Peb yog ntau tshaj li tus neeg xa khoom - peb yog cov khoom siv sib txuas sib txuas rau cov khoom xyaw zoo, cov qauv kev cai, thiab cov khoom tiav thoob plaws ntau qhov kev lag luam.
Cov kws tshaj lij
Nrog rau ntau xyoo ntawm kev paub hauv cov nroj tsuag extracts, khoom noj khoom haus additives, cosmetic raw cov ntaub ntawv, thiab khoom noj khoom haus cov khoom xyaw, peb pab neeg coj cov kev txawj ntse txawj ntse thiab kev ua lag luam kev pom zoo rau txhua qhov kev koom tes.
01
Ntau Yam Khoom Muag
Peb muab ntau yam khoom lag luam, suav nrog cov khoom noj khoom haus ntxiv, cov khoom siv cog qoob loo, txiv hmab txiv ntoo & zaub hmoov, tshuaj pleev ib ce, thiab cov khoom xyaw ua zaub mov.
02
Ib-Stop Shop
Raw Khoom:High-purity cov khoom xyaw rau zaub mov, dej haus, ntxiv, thiab daim ntawv thov kom zoo nkauj.
Cov khoom tiav:Hauv tsev tsim cov tshuaj ntsiav, mos gels, gummies, kua tee, thiab hmoov sib tov.
03
Kev pabcuam OEM / ODM / OBM
Label Design & Ntim:Custom branding tailored rau koj lub hom phiaj kev lag luam.
Formulation & R & D:Cov kws tshaj lij kev txhawb nqa los tsim cov kev cai sib xyaw, cov qauv tsim muaj, thiab cov khoom tsim tshiab.
Ntiaj teb no Logistics:Txhim khu kev xa khoom, cov ntaub ntawv, thiab kev pabcuam kev lis kev cai.
04
Quality Assurance
Kev nruj nruj raws li GMP cov qauv thiab tag nrho cov kev cai pob tshab. Peb nyob twj ywm tam sim no nrog cov kev cai thoob ntiaj teb, suav nrog FDA GRAS, EFSA, thiab lwm yam kev cai hauv cheeb tsam, kom ntseeg tau tias koj cov khoom ua tau raws li cov qauv kev nyab xeeb siab tshaj plaws thiab kev ua raws cai.
05
Ua tam sim no
Npaj kom elevate koj cov khoom formulation nrog high-zooD-Calcium Pantothenate?
- Thov Tus Qauv Dawb - Ua kom zoo ua ntej koj cog lus.
- Thov Kev Tso Cai - Tau txais tus nqi sib tw raws li koj qhov xav tau ntim.
- Thov Cov Ntaub Ntawv - Tau txais COA, MSDS, TDS, thiab nqe lus ua raws tam sim.
Koom tes nrog peb rau qhov sib xws, ua raws, thiab ua tau zoo koj tuaj yeem nyob ntawm-batch tom qab batch.
Thov hu rau peb ntawmella.zhang@huilinbio-tech.com.
Cov ntaub ntawv
Cim npe nrov: d-calcium pantothenate hmoov (vitamin b5), Tuam Tshoj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, ntshiab, ntuj, zoo, Tshuag, kev muag
