Sorbitol yog ib qho siab -purity polyol synthesized los ntawm kev tswj catalytic hydrogenation ntawm D-glucose, ua ib qho tseem ceeb bulk sweetener, humectant, thiab texturizing tus neeg sawv cev nyob rau hauv kev tswj cov formulations. Muaj nyob rau hauv dawb - ntws crystalline hmoov thiab ruaj khov aqueous kua tov, nws muab kev tswj qab zib thiab noo noo tuav tsis muaj kev cuam tshuam rau cov hniav caries. Ua raws li kev tswj hwm kev tswj hwm nruj, txhua pawg ua kom ntseeg tau tias kev ua tau zoo thiab txhim khu kev qha downstream ua tau zoo rau cov neeg tsim khoom thoob ntiaj teb.
Ntsiab Specifications
|
Parameter |
Crystalline Qib |
Qib Qib |
|
Assay (D-Sorbitol) |
99.0% min. (qhuav qhuav) |
70.0% min. |
|
Txo Qab Zib |
0.05% max. |
0.05% max. |
|
Cov ntsiab lus noo noo |
1.0% max. |
N/A |
|
Heavy Metals (raws li Pb) |
10 ppm max. |
10 ppm max. |
|
Residue ntawm Ignition |
0.1% max. |
0.1% max. |
Ua raws li & Cov Qauv Zoo
Pharmacopeial Monograph:Ua raws li USP, BP, thiab EP specifications rau cov tshuaj excipients thiab ncaj qha compression.
Khoom noj khoom haus Chemical Codex:Ua raws li FCC cov qauv rau kev nyab xeeb khoom noj thiab dej haus.
Khoom noj khoom haus & Allergen Status:Tsis yog -GMO, allergen-dawb, Kosher, thiab Halal tau ntawv pov thawj rau kev xa tawm thoob ntiaj teb.
Functional Properties
Moisture Retention & Plasticizing:Tswj dej ua haujlwm kom zoo los tiv thaiv desiccation, hardening, thiab crystallization tshaj lub neej txee ntev.
Thermal Stability:Withstands siab ua kub thaum extrusion thiab ci yam tsis muaj caramelization los yog degradation.
Tsis yog -Cariogenic Profile:Tiv thaiv los ntawm qhov ncauj micro- kab mob, tiv thaiv kev tsim cov quav hniav hauv qhov ncauj thiab cov khoom noj khoom haus.
Kev daws Rheology:Muab pov thawj qis ambient viscosity, tso cai seamless pumping thiab sib xyaw ua ke hauv cov kua tshuab.
Technical Focus & Manufacturing Control
Particle Loj Distribution:Crystalline qib tswj nruj mesh sizing (100% dhau los ntawm 40 mesh) kom ntseeg tau tias cov hmoov zoo flowability.
Hydrogenation Precision:Kev soj ntsuam cov reactor Advanced tshem tawm cov nickel residual catalysts thiab txwv tsis pub anhydrosorbitol los ntawm - khoom.
Kev Tiv Thaiv Microbial:Tag nrho cov suav aerobic microbial raug txwv qis dua 100 CFU / g ntawm kev ua kom tsis muaj menyuam thiab tswj kom qhuav.
Pyrogen Control:Pharmaceutical grades undergoed depyrogenation validation rau siab -kev nyab xeeb ntawm qhov ncauj thiab txhaj tshuaj- cov kev daws teeb meem nyob ib sab.
Daim phiaj siv
Khoom qab zib:Ua raws li qhov txias txias - cuam tshuam tus neeg sawv cev hauv qab zib - cov pos hniav dawb thiab cov khoom qab zib nyuaj.
Pharmaceuticals:Ua haujlwm raws li crystallization inhibitor thiab viscosity modifier hauv syrups, elixirs, thiab ncaj qha - cov ntsiav tshuaj compression.
Nutraceuticals:Ua hauj lwm raws li ib tug thawj cab kuj thiab chewable binder nyob rau hauv cov vitamin thiab mineral ntsiav tshuaj.
Cov khoom ci:Khaws cov dej noo hauv cov khoom noj khoom haus thiab cov khoom muag muag, tiv thaiv staling thaum khaws cia.
Kev Tswj Xyuas Zoo & Kev Xeem
Chromatographic Assay:Siab -Kev Ua Haujlwm Ua Kua Dej Chromatography (HPLC) ntsuas cov isomer purity thiab kab tsis huv ntawm ib qho ntau.
Txoj Kev Ntsuas Hlau:Inductively Coupled Plasma Mass Spectrometry (ICP-MS) kuaj cov khoom siv raw thiab cov khoom tiav.
Inline Moisture Sensing:Ze ntawm -Infrared (NIR) sensors saib xyuas cov chav ziab kom qhuav tsis tu ncua kom tswj xyuas cov dej tsis zoo.
Kev Tshawb Fawb Microbiological:Phaj suav thiab xaiv cov xov xwm kuaj xyuas qhov tsis muaj kab mob ua ntej tso tawm.
Cov ntaub ntawv & Kev Txhawb Kev Ua Raws Cai
Ntau -COA tshwj xeeb:Cov khoom xa tuaj muaj xws li daim ntawv pov thawj qhia meej txog qhov tseeb, kev ntsuas dej noo, thiab kev ntsuas impurity.
Regulatory Dossiers:Tag nrho cov ntaub ntawv cov ntaub ntawv muaj xws li BSE / TSE nqe lus thiab cov lus tshaj tawm cov khoom hnyav.
Cov ntaub ntawv Traceability:Ua kom tiav rau pem hauv ntej thiab rov qab taug qab ntau yam khaws cia tsawg kawg tsib xyoos.
Hloov Tswj Kev cog lus:Kev ceeb toom ua ntej tshaj tawm rau kev hloov pauv hauv cov khoom siv raw lossis kev ua haujlwm.
Cov Lus Qhia Cia
Kev tswj qhov kub thiab txias:Khaws rau hauv cov thawv ntim ntawm 15℃thiab 30℃deb ntawm qhov chaw thermal ncaj qha.
Humidity Management:Khaws cov hmoov crystalline nyob rau hauv cov av noo qis dua 60% kom tshem tawm cov kev pheej hmoo ntawm kev tsim khoom.
Liquid Maintenance:Khaws cov kua dej saum toj no 20℃nrog rhuab cia tso tsheb hlau luam rau kev tuav ntau.
Ntim & Logistics
Crystalline Ntim:25 kg multi- txheej hnab ntawv nrog zaub mov- qib polyethylene inner liners ntawm fumigation-dawb pallets.
Ntim Ntim:250 kg HDPE drums lossis 1,000 kg Intermediate Bulk Containers (IBC) nrog tamper- pov thawj foob.
Kev tiv thaiv kev thauj mus los:Moisture-absorbent desiccants muab tso rau hauv cov thawv thauj khoom kom tiv thaiv kom tsis txhob muaj kuab paug thaum thauj dej hiav txwv.
Cov lus nug nquag
Q: Dab tsi txawv ntawm crystalline thiab kua sorbitol hauv cov ntsiav tshuaj?
A: Crystalline hmoov suits ncaj qha compression thiab qhuav granulation, thaum cov kua ua raws li ib tug plasticizer nyob rau hauv ntub granulation thiab syrup tsheb.
Q: Puas yog cov txheej txheem tsim khoom puas tsim cov polyol degradation los ntawm - cov khoom?
A: Tsis yog. Kev tshuaj xyuas nruj txwv tsis pub anhydrosorbitol thiab txo cov suab thaj kom tsawg, ua kom muaj kev ruaj ntseg hauv cov qauv siv tshuaj.
Q: Yuav tiv thaiv caking li cas thaum lub sij hawm xa nkoj thoob ntiaj teb?
A: Tsawg-kev ua cov dej noo, cov kab thaiv kab mob, thiab cov thawv ntim desiccants raug siv los tshem tawm cov kev pheej hmoo ntawm kev thauj mus los.
Q: Puas yog cov txheej txheem tshuaj ntsuam xyuas tau lees paub rau cov qauv kev lees paub?
A: Yog. Tag nrho cov txheej txheem kev sim sab hauv ua raws li USP thiab EP cov txheej txheem, nrog rau cov ntaub ntawv hloov chaw muaj nyob rau ntawm kev thov.
Q: Dab tsi yog daim ntawv pov thawj lub neej nyob rau hauv cov txheej txheem cia?
A: Crystalline hmoov tseem ruaj khov rau 24 lub hlis, thiab cov kua tshuaj tseem nyob ruaj khov rau 12 lub hlis hauv cov thawv ntim khoom qub uas tsis tau qhib.
Cim npe nrov: Suav teb sorbitol manufacturers, lwm tus neeg, Hoobkas
