Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm metformin hydrochloride hmoov hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo metformin hydrochloride hmoov rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Metformin Hydrochloride Hmoovyog cov hmoov dawb crystalline hmoov uas yog nyob rau hauv chav kawm biguanide ntawm qhov ncauj cov tshuaj tiv thaiv hyperglycemic, dav siv hauv kev tswj hwm hom 2 mob ntshav qab zib mellitus. Nws nthuav tawm siab solubility hauv dej (50 mg / mL ntawm 20 degree), yog me ntsis soluble hauv ethanol, thiab yog xyaum insoluble hauv acetone thiab dichloromethane. Chemically, nws yog 1,1-dimethylbiguanide hydrochloride, nrog ib tug molecular mis ntawm C₄H₁₂ClN₅ thiab molecular hnyav ntawm 165.62. Nws lub luag haujlwm tseem ceeb ntawm kev ua haujlwm ntawm kev txhim kho insulin rhiab heev thiab txo qis hyperglycemia los ntawm ntau txoj hauv kev: nws inhibits hepatic gluconeogenesis thiab glycogenolysis, yog li txo qis cov piam thaj hauv endogenous, thiab txhim kho insulin-mediated qabzib thiab siv hauv cov ntaub so ntswg, tshwj xeeb tshaj yog cov leeg pob txha. Tsis zoo li cov tshuaj sulfonylurea, metformin tsis txhawb nqa cov tshuaj insulin ncaj qha los ntawm cov kab mob pancreatic, uas ua rau nws muaj kev pheej hmoo tsawg ntawm hypoglycemia raws li kev kho mob monotherapy. Ntxiv nrog rau nws cov kev txo qis hauv qabzib, metformin ua kom AMP-activated protein kinase (AMPK), qhov tseem ceeb ntawm cov cellular zog sensor, uas ua rau inhibits qhov kev qhia ntawm adipogenic enzymes, txhawb cov fatty acid oxidation, thiab ua kom muaj txiaj ntsig zoo ntawm lipid profile thiab kev tswj lub cev hnyav. Cov kev ua pleiotropic no ua rau metformin tsis yog tsuas yog lub hauv paus hauv kev tswj glycemic nkaus xwb tab sis kuj yog ib tus neeg sawv cev tseem ceeb hauv kev tswj hwm ntawm kev pheej hmoo metabolic cuam tshuam nrog hom 2 mob ntshav qab zib.
Peb cov khoom
Metformin Hydrochloride Hmoov
Metformin Hydrochloride ntsiav tshuaj
Cov ntaub ntawv ntxiv ntawm chemical compound:
| Khoom npe | Metformin Hydrochloride Hmoov | Metformin Hydrochloride ntsiav tshuaj |
| Yam khoom | Hmoov | Tablet |
| Khoom Purity | Ntau dua lossis sib npaug li 99% | Ntau dua lossis sib npaug li 99% |
| Khoom Specifications | 100g / 1kg / thiab lwm yam. | 250 mg / 500 mg |
| Daim ntawv khoom | Organic synthesis | Noj Orally |
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Metformin Hydrochloride COA
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| Certificate of Analysis | ||
| Compound npe | Metformin hydrochloride | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 1115-70-4 | |
| Ntau | 30g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202501090041 | |
| MFG | Peb 9, 2025 | |
| EXP | Peb 8, 2028 | |
| Qauv |
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| 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% | 0.39% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.28% |
| 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% | 99.90% |
| Ib leeg impurity | <0.8% | 0.47% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 80 |
| 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 | 500 ppm |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab 2-8 degree | |
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Daim ntawv ruaj khov ntawm Metformin Hydrochloride Powder: Kev tshuaj xyuas rau Polyforms thiab Hydrates
Metformin Hydrochloride HmoovRaws li cov tshuaj hypoglycemic siv ntau tshaj plaws thoob ntiaj teb, muaj kev cuam tshuam ncaj qha rau cov tshuaj zoo, bioavailability, thiab kev kho mob ua tau zoo vim qhov ruaj khov ntawm nws daim ntawv. Kev sib txawv ntawm cov ntaub ntawv, xws li polymorphs thiab hydrates, yuav ua rau muaj qhov sib txawv ntawm cov tshuaj solubility, dissolution tus nqi, thiab physicochemical zog, uas nyob rau hauv lem cuam tshuam rau formulation txheej txheem thiab cia tej yam kev mob.
Cov khoom ntawm lub cev thiab tshuaj lom neeg thiab cov khoom siv hauv paus ntawm Metformin Hydrochloride
Basic Physical and Chemical Parameters
Cov mis mos molecular ntawm metformin hydrochloride yog C ₄ H ₁₂ ClN ₅, nrog rau qhov hnyav molecular ntawm 165.62 thiab CAS tus lej ntawm 1115-70-4. Nws daim ntawv yog dawb crystalline hmoov, melting point ntawm 223-226℃C, boiling point ntawm 224.1℃C (760 mmHg), thiab ib tug vapor siab ntawm 0.0929 mmHg ntawm 25℃C. Nyob rau hauv cov nqe lus ntawm solubility, lub compound yog yooj yim soluble nyob rau hauv dej (50 mg / mle nyob rau hauv soluble thiab soluble nyob rau hauv me ntsis soluble nyob rau hauv ib tug me ntsis soluble nyob rau hauv dej thiab soluble nyob rau hauv ib tug me ntsis soluble nyob rau hauv dej (50 mg / mL). Cov tshuaj dichloromethane. Tus qauv tshuaj pharmacopoeia qhia meej tias cov khoom siv qib tshuaj yuav tsum yog dawb lossis dawb crystalline hmoov nrog cov ntsiab lus tsis tsawg dua 99%, cov ntsiab lus noo noo tsawg dua 0.5%, thiab tsis muaj qhov pom tseeb impurities lossis tsw ntxhiab tsw.
Kev cuam tshuam ntawm daim ntawv khov kho ntawm kev ua yeeb yam
Cov khoom siv (crystal form, hydrate, amorphous) ncaj qha cuam tshuam rau solubility, dissolution tus nqi, bioavailability, thiab stability ntawm cov tshuaj. Piv txwv li, cov tshuaj uas muaj cov qauv siv lead ua sib txawv tuaj yeem muaj qhov sib txawv vim qhov sib txawv ntawm lub zog lattice, uas ua rau muaj kev cuam tshuam rau kev sib cais tus cwj pwm thiab kev kho mob. Kev tsim cov hydrates tuaj yeem hloov hygroscopicity, flowability, thiab compressibility ntawm cov tshuaj, tso siab dua xav tau ntawm cov txheej txheem formulation. Yog li, kev tshuaj xyuas thiab tswj cov polymorphic thiab hydrate xeev ntawm metformin hydrochloride yog ib kauj ruam tseem ceeb hauv kev ua kom cov tshuaj zoo sib xws.
Polycrystalline phenomenon thiab kev tshuaj ntsuam xyuas
Kev txhais thiab kev faib tawm ntawm polymorphs
Polycrystalline daim ntawv yog hais txog ntau cov qauv siv lead ua uas tsim los ntawm tib lub tebchaw hauv kev sib txawv molecular. Raws li qhov sib txawv ntawm cov rog intermolecular, polymorphs tuaj yeem muab faib ua cov complexes, eutectics, solvates (xws li hydrates), thiab lwm yam. Rau metformin hydrochloride, qhov tshwm sim polymorphic tuaj yeem ua rau muaj qhov sib txawv tseem ceeb hauv nws cov khoom siv physicochemical (xws li solubility, melting point) thiab lom (xws li cov tshuaj pharmacokinetic).
Kev tshawb nrhiav kev nce qib ntawm polymorphic cov ntaub ntawv ntawm metformin hydrochloride
Cov kev tshawb fawb uas twb muaj lawm tau tshaj tawm ntau cov ntaub ntawv siv lead ua ntawm metformin hydrochloride, ntawm cov X-ray hmoov diffraction qauv ntawm metformin dihydrochloride (ib daim ntawv siv lead ua tshiab) qhia cov yam ntxwv diffraction peaks ntawm 2 θ qhov tseem ceeb (xws li 12.2℃± 0.2℃, 13.1℃). Qhov kev tshawb pom ntawm daim ntawv siv lead ua no muab txoj hauv kev tshiab rau kev txhim kho tshuaj, xws li optimizing tshuaj solubility thiab dissolution tus nqi los ntawm crystal form regulation.
Polycrystalline tshuaj ntsuam technology
X-ray diffraction (XRD)
XRD yog "tus qauv kub" rau kev tshuaj ntsuam polymorphic. Los ntawm kev txheeb xyuas cov qauv diffraction ntawm cov muaju ntawm X-rays, cov cell tsis thiab cov qauv molecular tuaj yeem txiav txim siab. Piv txwv li, nyob rau hauv XRD qauv ntawm metformin hydrochloride, lub diffraction peaks ntawm 12.2℃thiab 13.1℃yog nws cov yam ntxwv identifiers, uas yuav siv tau sai sai qhov txawv qhov siv lead ua daim ntawv no los ntawm lwm yam ntaub ntawv.
Raman Spectroscopy
Raman spectroscopy muab cov ntaub ntawv tsim qauv los ntawm kev kuaj xyuas cov qauv kev co molecular, thiab muaj qhov zoo xws li tsis yog -kev puas tsuaj, siab rhiab heev, thiab tsis xav tau kev npaj ua qauv.
Kev tshawb fawb tau pom tias Raman spectrum ntawm metformin hydrochloride nthuav tawm cov kab nqaim spectral (4-10 cm ⁻¹) nyob rau hauv thaj tsam ntawm 70-1600 cm ⁻¹, sib xws rau cov tshuaj tiv thaiv kev co (xws li NH stretching vibration, CN dabtsi yog khoov kev co). Cov "ntiv tes" cov yam ntxwv no tuaj yeem siv los txheeb xyuas hom siv lead ua thiab lub xeev siv lead ua yam tsis muaj kev puas tsuaj rau cov qauv.
Fourier Transform Infrared Spectroscopy (FTIR)
FTIR txheeb xyuas cov tshuaj lom neeg thiab cov pab pawg ua haujlwm los ntawm kev kuaj xyuas cov yam ntxwv ntawm cov molecules ntawm lub teeb infrared. FTIR spectrum ntawm metformin hydrochloride qhia tau hais tias lub ncov muaj zog ntawm 3368.23 cm ⁻¹ sib raug rau N-H stretching vibration, thiab lub ncov ntawm 1621.05 cm ⁻¹ sib raug rau N-H bending vibration. Lub FTIR spectra ntawm cov ntaub ntawv siv lead ua sib txawv tuaj yeem pom qhov sib txawv me me vim qhov sib txawv ntawm cov rog intermolecular, thiab xav tau kev tshuaj xyuas dav dav ua ke nrog lwm cov tswv yim.
Thermal analysis techniques (DSC/TGA)
Sib txawv scanning calorimetry (DSC) thiab ntsuas ntsuas ntsuas ntsuas (TGA) tuaj yeem kuaj xyuas qhov kub thiab txias ntawm crystal transformation thiab thermal stability. Piv txwv li, DSC tuaj yeem ntsuas qhov sib txawv ntawm cov ntsiab lus melting, thaum TGA tuaj yeem txheeb xyuas cov kev hloov pauv ntawm cov dej noo, muab cov ntaub ntawv ntxiv rau kev tshuaj xyuas siv lead ua.
Tsim mechanism thiab tshuaj ntsuam lub tswv yim ntawm hydrates
Kev tsim cov txheej txheem ntawm metformin hydrochloride hydrate
Cov amino (- NH ₂) thiab imino (- NH -) pawg hauvMetformin Hydrochloride HmoovCov molecules tuaj yeem ua haujlwm raws li hydrogen daim ntawv cog lus pub dawb, tsim kom muaj kev ruaj khov hydrogen bond network nrog dej molecules. Hauv qhov chaw ntub dej, cov tshuaj molecules tuaj yeem ntes cov dej molecules los ntawm hydrogen bonding los tsim hydrates. Piv txwv li, kev cia khoom tsis raug tuaj yeem ua rau kev hloov pauv ntawm cov tshuaj anhydrous rau hauv hydrates, yog li cuam tshuam rau qhov zoo ntawm cov tshuaj.
Txhais thiab faib cov hydrates
Hydrate yog hais txog cov qauv siv lead ua los ntawm kev sib xyaw ntawm cov tshuaj molecules thiab dej molecules los ntawm hydrogen bonding lossis lwm yam quab yuam. Raws li qhov sib piv ntawm cov dej molecules rau cov tshuaj molecules, hydrates tuaj yeem muab faib ua monohydrate, dihydrate, thiab lwm yam. Kev tsim cov hydrates tuaj yeem hloov pauv lub zog ntawm cov tshuaj, xws li hygroscopicity, solubility, thiab stability.
Hydrate ntsuam xyuas technology
XRD tuaj yeem txheeb xyuas cov yam ntxwv ntawm qhov sib txawv ntawm cov hydrates, thaum Raman spectroscopy tuaj yeem lees paub lub xeev hydrate los ntawm kev txheeb xyuas cov qauv kev co ntawm cov dej molecules (xws li O-H stretching vibration). Piv txwv li, Raman spectrum ntawm hydrates tej zaum yuav nthuav dav peaks nyob rau hauv thaj tsam ntawm 3200-3600 cm ⁻¹, sib xws rau OH stretching vibrations.
Dynamic Dej Vapor Adsorption (DVS)
DVS txheeb xyuas qhov nqus dej noo thiab hydrate tsim kev nyiam ntawm cov qauv los ntawm kev saib xyuas lawv cov kev hloov pauv loj hauv cov av noo sib txawv. Piv txwv li, yog hais tias qhov loj ntawm cov qauv no nce nyob rau hauv ib tug tshwj xeeb humidity, nws yuav qhia tau hais tias tsim ntawm hydrates.
Nuclear Sib Nqus Resonance (NMR)
Cov khoom hauv lub xeev NMR tuaj yeem muab cov ntaub ntawv qib molecular kom paub meej cov qauv hydrate los ntawm kev tshuaj xyuas hydrogen bond networks thiab dej molecule txoj haujlwm. Piv txwv li, ¹ H NMR tuaj yeem kuaj xyuas hydrogen bonding kev sib cuam tshuam ntawm cov dej molecules thiab cov tshuaj molecules.
Kev ruaj ntseg ntawm Cov Khoom Muag Khoom thiab Pharmocopoeia Standards
Pharmacopoeia Requirements for Solid Form
Cov tshuaj pharmacopoeia kom meej meej tias cov tshuaj qib metformin hydrochloride yuav tsum yog cov hmoov dawb los yog dawb crystalline hmoov uas tsis muaj qhov pom tseeb impurities lossis tsw tsw ntxhiab. Qhov kev xav tau no txhais tau hais tias kev tswj hwm ntawm cov khoom siv lead ua sib xws, vim tias muaj cov impurities lossis cov qauv siv lead ua sib txawv tuaj yeem ua rau muaj qhov txawv txav. Tsis tas li ntawd, cov tshuaj pharmacopoeia nruj me ntsis txwv cov ntsiab lus (Ntau dua lossis sib npaug rau 99%) thiab noo noo (tsawg dua lossis sib npaug li 0.5%), tsis ncaj qha rau kev ruaj ntseg ntawm daim ntawv.
Nws yuav tsum tau muab cia rau hauv qhov chaw txias, qhuav kom tsis txhob muaj oxidants muaj zog. Qhov kub thiab txias ib puag ncig tuaj yeem ua rau muaj kev hloov pauv siv lead ua lossis hydrate tsim, xws li: Cov nyhuv kub: Cov kub kub tuaj yeem cuam tshuam cov kev sib txuas ntawm hydrogen, ua rau crystal transformation lossis amorphization.
Kev cuam tshuam ntawm cov av noo: Cov av noo ib puag ncig tuaj yeem txhawb nqa qhov nqus dej ntawm cov molecules, tsim hydrates, lossis ua rau kom ya raws thiab agglomeration.
Kev soj ntsuam kev ruaj ntseg
Kev ntsuas nrawm
Muab tso rau ntawm 40℃C / 75% RH rau 6 lub hlis, simulate ntev - lub sij hawm cia ib puag ncig, thiab saib xyuas cov kev hloov hauv cov ntaub ntawv siv lead ua thiab hydrate lub xeev los ntawm XRD, Raman spectroscopy, thiab ntsuas dej noo.
Forced degradation xeem
Inducing degradation nyob rau hauv huab mob xws li kub siab, high humidity, thiab lub teeb raug, thiab soj ntsuam cov kev sib raug zoo ntawm degradation khoom thiab khoom morphology. Piv txwv li, lub teeb pom kev tuaj yeem ua rau oxidative degradation thiab hloov cov qauv siv lead ua.
Long-term stability test
Muab tso rau ntawm 25℃C / 60% RH rau 24 lub hlis, tsis tu ncua xyuas cov qauv siv lead ua, cov ntsiab lus noo noo, thiab ntsuas qhov ruaj khov nyob rau hauv qhov chaw cia khoom.
Cim npe nrov: Metformin hydrochloride hmoov, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom