Carnosine ntsiav tshuaj

Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm carnosine ntsiav tshuaj hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo carnosine ntsiav tshuaj muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.

Carnosine ntsiav tshuajyog cov khoom noj khoom haus zoo tshaj plaws uas muaj cov dipeptide tshwm sim ib txwm muaj -alanyl-L-histidine, ib qho chaw nrog zoo -cov ntaub ntawv antioxidant, tiv thaiv-glycation, thiab pH-buffering zog. Bloomtechz manufactures kws tshuaj -qib Carnosine Tablets nyob rau hauv standardized 250mg thiab 500mg lub zog, ua nyob rau hauv nruj GMP tej yam kev mob nrog tag nrho cov batch traceability thiab thib peb - tog kuaj rau purity, hnyav hlau, thiab microbial txwv. Peb cov ntsiav tshuaj yog tsim los rau kev ruaj ntseg zoo thiab bioavailability, nrog enteric -cov kev xaiv coated muaj los txo qis degradation los ntawm serum carnosinase thiab ua kom cov khoom xa tuaj.

Certificate of Analysis
Compound npe	Carnosine
Qib	Pharmaceutical qib
CAS Nr.	305-84-0
Ntau	18g
Ntim txheem	PE hnab + Al foil hnab
Chaw tsim tshuaj paus	Shaanxi BLOOM TECH Co., Ltd
Ntau No.	202601090055
MFG	Peb 9, 2026
EXP	Peb 8, 2029
Qauv
Yam khoom	Enterprise txheem	Kev txheeb xyuas qhov tshwm sim
Qhov tshwm sim	Dawb los yog yuav luag dawb hmoov	Ua raws
Cov ntsiab lus dej	Tsawg dua lossis sib npaug li 5.0%	0.88%
Poob rau ziab	Tsawg dua lossis sib npaug li 1.0%	0.54%
Hnyav Hlau	Pb Tsawg dua lossis sib npaug li 0.5ppm	N.D.
	Tsawg dua lossis sib npaug li 0.5ppm	N.D.
	Hg Tsawg dua lossis sib npaug li 0.5ppm	N.D.
	Cd Tsawg dua lossis sib npaug li 0.5ppm	N.D.
Purity (HPLC)	Ntau dua lossis sib npaug li 99.0%	99.66%
Ib leeg impurity	<0.8%	0.63%
Tag nrho microbial suav	Tsawg dua lossis sib npaug li 750cfu / g	637
E. Coli	Tsawg dua lossis sib npaug li 2MPN / g	N.D.
Salmonella	N.D.	N.D.
Ethanol (los ntawm GC)	Tsawg dua lossis sib npaug li 5000ppm	655ppm ua
Cia	Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree

Kev ruaj ntseg ntawm L-carnosine nyob rau hauv cov ntaub ntawv ntawm qhov ncauj khoom noj yog tswj hwm los ntawm nws cov khoom muaj txiaj ntsig physicochemical raws li zwitterionic dipeptide.

Lub -alanyl-L-histidine daim ntawv cog lus yog raug rau hydrolytic cleavage, tshwj xeeb tshaj yog nyob rau hauv tej yam kev mob ntawm siab kub thiab av noo, yielding lub constituent amino acids -alanine thiab L-histidine. Tsis tas li ntawd, lub nplhaib imidazole ntawm histidine residue yog nquag oxidative degradation thaum lub sij hawm raug rau atmospheric oxygen thiab lub teeb, muaj peev xwm tsim histamine thiab lwm yam degradation byproducts. Cov txheej txheem degradation no yuav tsum muaj kev qhia dav dav, ntau- txheej txheem tswj kev ruaj ntseg los ntawm cov khoom siv raw los ntawm cov khoom tiav txee lub neej.

Intrinsic Degradation MechanismsL-carnosine nthuav tawm pH- nyob ruaj khov nyob rau hauv ib puag ncig aqueous, nrog kev ruaj khov siab tshaj plaws nyob rau hauv cov kua qaub me ntsis rau qhov nruab nrab (pH 5.5-7.0).

Sab nraum qhov no, acid-catalyzed los yog hauv paus-catalyzed hydrolysis ntawm peptide daim ntawv cog lus nrawm nrawm heev. Nyob rau hauv lub xeev cov khoom, tus thawj degradation tsav tsheb yog ya raws -mediated hydrolysis, nyob rau hauv adsorbed dej molecules pab txhawb nucleophilic nres ntawm amide carbonyl carbon. Tus nqi ntawm cov tshuaj tiv thaiv no ua raws li Arrhenius kinetics, nrog degradation tshaj tawm kwv yees li ob npaug rau txhua 10℃nce hauv qhov kub thiab txias.

Cov dipeptide kuj tseem nkag siab rau cov kab hlau ions, tshwj xeeb tshaj yog tooj liab (Cu²⁺) thiab hlau (Fe³⁺), uas tuaj yeem ua rau oxidative degradation los ntawm Fenton- hom tshuaj tiv thaiv tsim hydroxyl radicals. Cov hlau no -catalyzed oxidation txoj kev yog tshwj xeeb tshaj yog muaj feem xyuam thaum lub sij hawm tsim khoom, qhov twg kev sib cuag nrog stainless hlau khoom nto yuav tsum tau ua tib zoo tswj.

Raw Material Stability Control

Bloomtechz siv cov txheej txheem raw khoom ruaj khov rau L-carnosine API ua ntej kev tsim cov ntsiav tshuaj. Cov hmoov crystalline yog khaws cia rau hauv ob npaug - cov hnab polyethylene hauv cov thawv ntawv aluminium laminated, muab kev tiv thaiv zoo tiv thaiv kev ya raws huab cua (WVTR<0.5 g/m²/day) and oxygen permeation. Storage conditions are maintained at 15–25°C with relative humidity controlled below 40% RH in dedicated climate-controlled warehouses.

Txhua API ntau yuav raug kuaj xyuas raws sijhawm raws li ICH Q1A(R2) cov lus qhia, nrog rau kev lees paub ntawm tus kheej los ntawm FT-IR spectroscopy thiab purity verification los ntawm HPLC.Qhov kev lees paub rau cov khoom muaj feem xyuam (cov lej ntawm tag nrho cov khoom degradation) tau teeb tsa tsawg dua lossis sib npaug li 1.0% los ntawm thaj chaw normalization,

 

 

zoo hauv qab ntawm ICH Q3A(R2) kev txheeb xyuas qhov pib ntawm 0.10% rau ib tus neeg tsis paub qhov tsis huv. Kev poob ntawm kev ziab yog tswj kom tsawg dua lossis sib npaug li 0.5%, kom ntseeg tau tias qhov seem ntawm cov dej noo tsawg kawg nkaus uas tuaj yeem pib hydrolytic degradation thaum ua haujlwm tom ntej.

Bloomtechz Carnosine Tablets siv ntau yam -cov khoom stabilization txoj hauv kev ua kom zoo dua los ntawm kev tshawb fawb txog kev sib raug zoo ntawm cov txheej txheem ua tau raws li ICH Q1A(R2) Annex cov lus qhia.

Excipient Selection Rationale: Microcrystalline cellulose (MCC) yog thawj diluent, xaiv rau nws qis hygroscopicity (equilibrium noo noo cov ntsiab lus<3% at 50% RH) and neutral pH profile. Croscarmellose sodium functions as the superdisintegrant, chosen over starch-based alternatives due to its superior chemical inertness and lack of reducing sugar content that could participate in Maillard reactions with the histidine residue. Colloidal silicon dioxide (Aerosil®) is incorporated at 0.5–1.0% w/w as a glidant and moisture scavenger, adsorbing trace water molecules that may be introduced during processing.Magnesium stearate, the lubricant, is sourced in pharmaceutical grade with controlled heavy metal content (Pb ≤5ppm, Fe ≤20ppm) to minimize metal-catalyzed oxidation risk.

pH Microenvironment Control: Cov qauv tsim los tswj cov ntsiav tshuaj microenvironment pH ntawm 6.0–6.5, thaj tsam ntawm qhov siab tshaj plaws carnosine stability. Qhov no yog ua tiav los ntawm kev ua tib zoo xaiv cov khoom ntxiv nrog rau cov pH profiles thiab, yog tias tsim nyog, suav nrog cov neeg ua haujlwm tsawg kawg nkaus. Cov ntsiav tshuaj kawg pH raug txheeb xyuas los ntawm txoj kev slurry (10% w/v hauv dej huv) ua ib feem ntawm - txheej txheem tswj kom zoo.

Tswj dej noo: Tag nrho cov kev tsim khoom lag luam uas cuam tshuam cov khoom lag luam yog ua nyob rau hauv cov chav huv huv uas muaj cov dej lwg taw tes - tswj cov tshuab cua tswj kom tsawg dua lossis sib npaug li 10℃dew point (kwv yees<35% RH at 20°C).Granulation processes, if employed, utilize minimal aqueous binder solutions with immediate drying to target moisture content below 2.0% w/w.Final blend moisture is verified by Karl Fischer titration before compression.

Lub kaw lus ntim ua haujlwm tseem ceeb tiv thaiv ib puag ncig degradation yam thoob plaws hauv cov khoom txee lub neej. Bloomtechz muaj peb qhov kev ntim khoom siv tau zoo, txhua tus xaiv raws li cov ntaub ntawv kev ua haujlwm tsis zoo thiab lub hom phiaj kev lag luam.

Tag nrho cov txheej txheem ntim tau raug muab tshem tawm thiab kev soj ntsuam cov leachables ntawm USP<1663>thiab<1664>cov txheej txheem los xyuas kom meej tias tsis muaj kev cuam tshuam ntawm cov khoom ntim thiab cov txheej txheem carnosine uas tuaj yeem cuam tshuam cov khoom zoo lossis kev nyab xeeb.

[1]Hipkiss, AR (2009). "Carnosine thiab nws lub luag haujlwm ua tau hauv kev noj haus thiab kev noj qab haus huv."Kev nce qib hauv Kev Tshawb Fawb Khoom Noj thiab Khoom Noj, 57, 87–154.

[2]Derave, W., Ozdemir, MS, Harris, RC, et al. (2007). " -Alanine supplementation augments nqaij carnosine cov ntsiab lus thiab txhim kho siab - siv zog ua tau zoo nyob rau hauv cov neeg tseem ceeb sprinters."Phau ntawv Journal of Applied Physiology, 103(5), 1689–1695. 

[3]Boldyrev, AA, Aldini, G., & Derave, W. (2013). "Physiology thiab pathophysiology ntawm carnosine."Kev tshuaj xyuas lub cev, 93(4), 1803–1845. 

[4]Scheuller, M., & Derave, W. (2020). "Qhov ncauj carnosine supplementation: Bioavailability, metabolism, thiab ua haujlwm tau zoo."Amino Acids, 52(6-7), 897–912. 

[5]Gariballa, S., & Sinclair, AJ (2000). "Carnosine: Muaj peev xwm siv tshuaj kho mob hauv hnub nyoog- kab mob ntsig txog."Phau ntawv Journal of Nutrition, Health & Aging, 4(4), 231–235. 

Cim npe nrov: carnosine ntsiav tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom