Product Overview
L-Leucineyog ib qho fermentation - muab tau qhov tseem ceeb branched - saw amino acid, siv raws li tus qauv raw khoom hauv cov khoom noj khoom haus thiab kev tsim tshuaj.
Technical Specifications
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Qeb |
Khoom Specification |
Tus nqi tsim nyog / txwv |
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Cov ntaub ntawv dav dav |
Tshuaj npe |
(S)-2-Amino-4-methylpentanoic acid |
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CAS Nr |
61-90-5 |
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Molecular Formula |
C₆H₁₃NO₂ |
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Molecular Luj |
131.17 |
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Physical & Commercial Properties |
Qhov tshwm sim |
Dawb crystalline hmoov los yog crystalline hmoov |
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tsw & saj |
Tsis muaj ntxhiab, me ntsis iab saj |
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Particle Loj (Mesh) |
Tsis tu ncua: 40-80 mesh; Micronized: 100-200 mesh (yeem) |
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Kev ceev ceev |
0.30-0.50 g / mL (Tapped: 0.50-0.70 g / mL) |
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Purity & Identification |
Kev Ntsuas (Purity) |
98.5% - 101.5% (ntawm qhuav hauv paus) |
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Kev hloov kho qhov muag tshwj xeeb ([ ]D20) |
+14.9℃– +17.3℃(C{2}}, 6 mol/L HCl) |
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Kev txheeb xyuas |
IR spectrum sib tw siv; Ninhydrin tshuaj tiv thaiv yog qhov zoo |
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State of Solution (Kev xa tawm) |
Ntshiab thiab tsis muaj xim; Transmittance Ntau dua lossis sib npaug li 98.0% (1.0 g hauv 20 mL ntawm 1 mol / L HCl ntawm 430 nm) |
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pH |
5.5-7.0 (1.0 g yaj hauv 100 mL ntawm H₂O) |
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Impurities & Cleanness |
Lwm Yam Khoom (Lwm Yam Amino Acids) |
Txhua tus neeg impurity Tsawg dua lossis sib npaug li 0.50%; Tag nrho impurities Tsawg dua lossis sib npaug li 1.0%; Isoleucine Tsawg dua lossis sib npaug rau 0.80% (Pharma Qib) |
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Chloride (Cl) |
Tsawg dua lossis sib npaug li 0.02% lossis 0.05% |
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Sulfate (SO₄) |
Tsawg dua lossis sib npaug li 0.02% lossis 0.03% |
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Ammonium (NH₄) |
Tsawg dua lossis sib npaug li 0.02% |
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Hlau (Fe) |
Tsawg dua lossis sib npaug li 10 ppm lossis 30 ppm |
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Poob rau ziab |
Tsawg dua lossis sib npaug li 0.20% (105 degree, 3 h) |
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Residue ntawm Ignition |
Tsawg dua lossis sib npaug li 0.10% |
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Kev Nyab Xeeb & Microbiological Control |
Heavy Metals (raws li Pb) |
Tsawg dua lossis sib npaug li 10 ppm (lossis Lead Tsawg dua lossis sib npaug li 3 ppm rau kev nyab xeeb khoom noj) |
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Arsenic (As) |
Tsawg dua lossis sib npaug li 1 ppm lossis 2 ppm |
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Cov kab mob endotoxins |
<6.0 EU/g (Pharmaceutical/Injectable Grade only) |
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Total Aerobic Microbial Count (TAMC) |
Tsawg dua los yog sib npaug rau 1,000 cfu / g (Qeb khoom noj khoom haus / Khoom noj khoom haus ntxiv) |
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Total Combined Pwm thiab Poov xab (TYMC) |
Tsawg dua lossis sib npaug li 100 cfu / g |
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E. coli / Salmonella |
Tsis zoo |
Quality Assurance & Certifications
ISO 22000 Amino Acid Kev Ua Haujlwm
Cov chaw kuaj xyuas ua haujlwm tau ntawv pov thawj kev tswj hwm kev tswj hwm zoo rau kev lag luam amino acid synthesis.
FSSC 22000 Fermentation Standards
Lub chaw tsim khoom ua raws li kev soj ntsuam kev nyab xeeb ntawm cov zaub mov nruj rau ceg -chain amino acids.
GMP Raws li Crystallization
Cov txheej txheem crystallization thiab kev sib cais ua haujlwm raws li cov kev coj ua zoo tam sim no.
BRCGS Cov Khoom Siv Tshawb Fawb
Cov kab ua haujlwm ua tau raws li Tus Txheej Txheem Ntiaj Teb rau Kev Nyab Xeeb Khoom Noj Khoom Noj rau cov khoom xyaw noj.
ISO 17025 Thib Peb-Party Testing
Thib peb-chaw kuaj xyuas cov chaw kuaj xyuas qhov kev sib hloov kho qhov muag thiab cov qauv ntsuas rau txhua pawg.
Manufacturing & Supply Capacity
Isomer -Tshwj xeeb Chiral Separation
Lub chaw siv tshwj xeeb muaj chromatography cais leucine los ntawm nws cov qauv isomer, isoleucine.
Siab -Yield Fermentation Strains
Validated Corynebacterium glutamicum strains txhawb kev ruaj khov fermentation yields thaum lub sij hawm submerged fermentation txheej txheem.
Hydrophobic Crystal Milling
Kev lag luam micronization milling muab qhov loj me me, txhim kho cov tshuab sib xyaw ua ke hauv qhuav- sib xyaw cov qauv.
Nitrogen-Planketed Ntim Kab
Inline nitrogen-flushing raws tu qauv tiv thaiv cov qauv crystalline tiv thaiv ambient nqus noo noo thaum lub sij hawm ntev cia.
5,000-Ton Submerged Fermentation
Dedicated bioreactor arrays muaj peev xwm txhua xyoo ntawm 5,000 metric tons rau cov khoom no.
Decomplexing Purification Systems
Multi-theem decolorization thiab crystallization loops txo kev tsim cov organic impurities thiab ammonium ntsev seem.
Daim ntawv thov
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Daim ntawv thov teb |
Yuav Siv Li Cas |
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Kev Noj Qab Haus Huv Kev Ua Si |
Blended rau hauv pre/post- workout BCAA hmoov formulas. |
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Pharmaceuticals |
Formulation muaj nyob rau hauv kev kho mob IV amino acid infusions. |
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Khoom noj khoom haus |
Capsulated los yog ntsiav tshuaj nrog lwm yam tseem ceeb amino acids. |
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Khoom noj khoom haus |
Fortified rau hauv lub zog tuav thiab noj mov hloov shakes. |
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Tsiaj Pub |
Ntxiv rau qhov tshwj xeeb porcine thiab nqaij qaib pub rations. |
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Tshuaj pleev ib ce |
Integrated rau hauv daim tawv nqaij thiab tu cov plaub hau formulations thiab cov khoom tu plaub hau. |
Ua raws li & Cov ntaub ntawv txhawb nqa
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Cov ntaub ntawv / Cov khoom txhawb nqa |
Kev piav qhia |
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DMF Type II Archival |
Lub chaw tswj xyuas cov ntaub ntawv Drug Master rau kev tswj xyuas kev lag luam tshuaj. |
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Batch-Cov Ntawv Qhia Tshwj Xeeb HPLC |
Txhua qhov khoom xa tuaj suav nrog cov chromatographic profiles txheeb xyuas enantiomeric purity thiab isomer sib cais. |
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TSE/BSE Free Statements |
Cov ntaub ntawv tseem ceeb tau lees paub qhov tshwj xeeb ntawm kev siv cov nroj tsuag -raws li fermentation substrates. |
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REACH & RoHS Kev Sau Npe |
Cov ntawv sau tshuaj ua raws cai tau khaws cia rau European kev ua raws cai rau European kev lag luam thiab kev siv tshuaj pleev ib ce. |
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Hloov Cov Ntawv Pom Zoo Tswj |
Cov ntawv cog lus zoo tau lees paub ua ntej sau ntawv ceeb toom txog kev hloov kho cov txheej txheem tsim khoom. |
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Keeb kwm Traceability Mapping |
Tag nrho cov khoom siv saw hlau cov ntaub ntawv taug qab cov khoom noj los ntawm qhov chaw ua liaj ua teb mus rau cov siv lead ua tiav. |
FAQ
Cim npe nrov: l-leucine, Tuam Tshoj l-leucine manufacturers, hoobkas
