Levofloxacin Hydrochloride (CAS No.: 177325-13-}2) - Broad-Spectrum Fluoroquinolone Antibacterial rau Kab Mob Kab Mob
Raws li tus kws tshaj lij ntawm cov kws kho mob - qib tshuaj tua kab mob active cov khoom xyaw, peb muab siab - purity Levofloxacin Hydrochloride uas nruj me ntsis ua raws li lub ntiaj teb no pharmacopoeia cov qauv (USP, EP, BP, CP). Ib qho thib peb - tiam fluoroquinolone, nws yog tus nquag (S)-enantiomer ofloxacin- muab kev ua kom muaj zog, dav dua cov kab mob tua kab mob, thiab txo cov tshuaj toxicity piv rau racemic ofloxacin. Nws yog dav siv nyob rau hauvtib neeg tshuajkho cov kab mob loj heev ntawm cov kab mob ua pa, tso zis, tawv nqaij, thiab cov ntaub so ntswg, thiab xaivkev xyaum ua tsiajrau cov tsiaj sib raug zoo- ua rau nws yog tus neeg sawv cev tseem ceeb hauv kev tawm tsam tshuaj - cov kab mob tiv thaiv kab mob.
Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Levofloxacin Hydrochloride (Levofloxacin HCl) |
| CAS Nr. | 177325-13-2 |
| Synonyms | (S)-(-)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid; Levaquin® (lub npe hom rau tib neeg formulations) |
| Molecular Formula | C₁₈H₂₀FN₃O₄·HCl |
| Molecular Luj | 415.83 |
| Qhov tshwm sim | Dawb mus daj daj crystalline hmoov; Tsis muaj ntxhiab los yog nrog me ntsis cov yam ntxwv tsw |
| Specification | - Pharmaceutical Qib: Purity Ntau dua lossis sib npaug li 99.0% (HPLC); Assay (raws li levofloxacin) 98.0% -102.0%; Kev sib hloov kho qhov muag tshwj xeeb []²⁰D -103℃rau -111℃(hauv dej, c=0.5); Poob ntawm ziab Tsawg dua lossis sib npaug li 0.5%; Residue ntawm ignition Tsawg dua los yog sib npaug rau 0.1%; Cov hlau hnyav (Pb Tsawg dua lossis sib npaug ntawm 10ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug li 1ppm); Cov kuab tshuaj seem (methanol Tsawg dua lossis sib npaug rau 300ppm, acetone Tsawg dua lossis sib npaug li 500ppm) |
| Melting Point | 218-222℃(nrog decomposition) |
| Solubility | Dawb soluble hauv dej (Ntau dua lossis sib npaug ntawm 100 g / L ntawm 25 degree); Soluble hauv methanol, ethanol; me ntsis soluble hauv acetone; Insoluble hauv chloroform, ether |
| Kev cia khoom | Khaws rau hauv qhov txias (15-25 degree), qhuav, lub teeb -cov thawv tiv thaiv; Muab kaw kom tiv thaiv kom tsis txhob muaj dej noo thiab photodegradation (fluoroquinolone qauv yog lub teeb-sensitive); Lub neej txee: 36 lub hlis rau qib kws kho mob, 24 lub hlis rau qib kws kho tsiaj |
Core Functions & Mechanism of Action
Levofloxacin Hydrochloride CAS 177325-13-2 exerts abactericidal nyhuvlos ntawm kev xaiv inhibiting ob yam kab mob tseem ceeb enzymes:DNA gyrase (topoisomerase II)thiabtopoisomerase IV-ob qho tib si tseem ceeb rau cov kab mob DNA replication, transcription, kho, thiab chromosome segregation. Nws (S)-enantiomer qauv khi nruj dua rau cov enzymes ntau dua li (R)-enantiomer (pom nyob rau hauv racemic ofloxacin), uas ua rau:
Txhim kho potency: 2-8 npaug ntau dua li ofloxacin tawm tsam Gram- cov kab mob tsis zoo (xws li,Escherichia coli, Pseudomonas aeruginosa) thiab Gram{0}} cov kab mob zoo (xws li,Staphylococcus aureus, Streptococcus pneumoniae).
Dav spectrum: Active tiv thaiv ob qho aerobic Gram-tsis zoo thiab Gram- cov kab mob zoo, nrog rau cov kab mob atypical (xws li,Mycoplasma pneumoniae, Chlamydophila pneumoniaethiab mycobacteria (xws li,Mycobacterium tuberculosis).
Tom qab- cov nyhuv tshuaj tua kab mob (PAE): Tshem tawm cov kab mob regrowth rau 2-6 teev tom qab cov tshuaj txo qis hauv qhov tsawg kawg nkaus inhibitory concentration (MIC), tso cai rau ib zaug - noj txhua hnub.
Cov ntawv thov tseem ceeb
1. Human Pharmaceutical Field
Levofloxacin Hydrochloride CAS 177325-13-2 tau pom zoo los khonruab nrab-rau- kab mob hnyav(tsis yog kis kab mob me me lossis kab mob kis xws li mob khaub thuas / mob khaub thuas) qhov twg yuav tsum tau kho qhov ncauj lossis parenteral:
1.1 Kab mob ua pa
Zej Zog -Tau mob ntsws (CAP): Kho CAP tshwm sim los ntawmS. pneumoniae(xws li penicillin- cov kab mob resistant),M. pneumoniae, los yogH. influenzae. Qhov ncauj / IV koob tshuaj: 500 mg ib hnub ib zaug rau 7-14 hnub, lossis 750 mg ib hnub ib zaug rau 5 hnub (luv-cov kev kho mob kom rov zoo dua).
Tsev Kho Mob -Tau mob ntsws (HAP): Siv tau los tiv thaiv HAP los ntawmP. aeruginosalos yog methicillin -sensitiveS. aureus(MSSA). IV koob tshuaj: 750 mg ib hnub ib zaug rau 7-14 hnub, kho rau lub raum ua haujlwm.
Kab mob kab mob sinusitis: Kho cov kab mob tsis teb rau thawj zaug - cov tshuaj tua kab mob (xws li amoxicillin). Qhov ncauj koob tshuaj: 500 mg ib hnub ib zaug rau 10-14 hnub, lossis 750 mg ib hnub ib zaug rau 5 hnub.
1.2 Urinary Tract Infections (UTIs)
Nyuaj UTIs & Pyelonephritis: Kho mob raum mob hnyav los yog urinary kab mob tshwm sim los ntawm ntau yam tshuaj -resistantE. colilos yogKlebsiella pneumoniae. Qhov ncauj / IV koob tshuaj: 750 mg ib hnub ib zaug rau 5 hnub, lossis 500 mg ib hnub ib zaug rau 10-14 hnub.
Uncomplicated UTIs: Qhov ncauj koob tshuaj: 250 mg ib hnub ib zaug rau 3 hnub (luv -cov kev kho mob kom txo qis kev pheej hmoo).
1.3 Daim tawv nqaij & cov ntaub so ntswg mos
Cellulitis, Abscesses, & Kab mob qhov txhab: Kho kab mob los ntawmS. aureus(MSSA) lubStreptococcus pyogenes muaj. Qhov ncauj / IV koob tshuaj: 750 mg ib hnub ib zaug rau 7-10 hnub, nrog rau kev phais mob yog tias xav tau.
1.4 Lwm yam kab mob
Tuberculosis (TB): Siv los ua tus thib ob -tus neeg sawv cev rau tshuaj- tiv thaiv kab mob TB (nrog rau lwm cov tshuaj tiv thaiv kab mob -TB). koob tshuaj: 500-750 mg ib hnub ib zaug rau 6-12 lub hlis.
Cov kab mob Atypical: KhoLegionella pneumophila(Legionnaires' kab mob) los yogChlamydia trachomatis(urethritis). IV / qhov ncauj koob: 500 mg ib hnub ib zaug rau 7-14 hnub.
2. Veterinary Field (Cov Tsiaj Txhaum Cai)
tau pom zoo raudev(tsis yog miv- muaj kev pheej hmoo siab ntawm cov kab mob retina) rau kev kho cov kab mob:
Kab mob ntawm Canine (Pyoderma): Ua los ntawmStaphylococcus pseudintermediaus. Qhov ncauj koob tshuaj: 5-10 mg / kg lub cev hnyav ib hnub ib zaug rau 7-14 hnub.
Kab Mob Canine Urinary Tract Infections: Ua los ntawmE. colilos yogKlebsiellaua spp. koob tshuaj hauv qhov ncauj: 5–10 mg/kg ib hnub ib zaug rau 7–10 hnub, nrog rau cov kab mob tso zis ua raws- nce.
Contraindications: Tsis txhob siv rau hauv miv, cev xeeb tub / tus dev noj qab haus huv, lossis dev nrog ua ntej - mob raum los yog qaug dab peg (txo qhov pib qaug dab peg).
Quality & Safety Assurance
Raws li kev siv dav dav fluoroquinolone nrog kev ua tau zoo thiab kev nyab xeeb, CAS 177325-13-2 tau txais kev tswj xyuas zoo:
1. Kev tsim khoom & Purity Control
Synthesis: Ua los ntawm chiral synthesis (kom cais cov nquag (S)-enantiomer) lossis kev daws teeb meem ntawm racemic ofloxacin, ua raws li hydrochlorination thiab recrystallization. Kev tswj nruj nruj ntawm enantiomeric purity kom ntseeg tau (S)-enantiomer Ntau dua lossis sib npaug li 99.5% (tsis ua haujlwm (R)-enantiomer Tsawg dua lossis sib npaug li 0.5%).
Ua raws li GMP: Ua nyob rau hauv Qib C/D cleanrooms (raws li ICH Q7 cov lus qhia) rau qib tshuaj, nrog cov txheej txheem automated kom tsis txhob hla - paug thiab xyuas kom cov khoom sib xws.
2. Cov Txheej Txheem Kev Ntsuas Zoo
| Cov khoom kuaj | Txoj kev | Kev lees txais |
|---|---|---|
| Purity & Assay | HPLC (C18 kem, 293 nm nrhiav pom) | Purity Ntau dua lossis sib npaug li 99.0%; Kev ntsuas 98.0% - 102.0% |
| Enantiomeric Purity yog qhov zoo | Chiral HPLC (polysaccharide{0}}raws li kem) | (S)-enantiomer Ntau dua lossis sib npaug li 99.5%; (R)-enantiomer Tsawg dua lossis sib npaug li 0.5% |
| Yam khoom muaj feem | HPLC (gradient elution) | Ib qho impurity Tsawg dua lossis sib npaug li 0.2%; Tag nrho impurities Tsawg dua lossis sib npaug li 0.5% |
| Hnyav Hlau | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb Tsawg dua lossis sib npaug rau 10ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug rau 1ppm |
| Residual Solvents | GC (headspace sampling, FID ntes) | Chav kawm 2 cov kuab tshuaj tsawg dua lossis sib npaug ntawm 500ppm; Cov kuab tshuaj Class 1 tsis kuaj |
| Sterility (Tshwj xeeb txhaj tshuaj) | Membrane filtration method | Tsis muaj kab mob / fungal loj hlob |
| Dissolution Rate (Tablets) | USP Apparatus II (paddle method, pH 6.8 tsis) | Ntau dua lossis sib npaug li 80% yaj hauv 30 feeb |
3. Kev ceeb toom kev nyab xeeb
Tib neeg siv:
Contraindications: hypersensitivity rau fluoroquinolones; keeb kwm ntawm tendon rupture; menyuam<18 years (risk of articular cartilage damage); pregnancy/lactation (Category C-potential fetal risk).
Cov teebmeem tsis zoo: Tej yam tshwm sim muaj xws li xeev siab, raws plab, thiab mob taub hau. Tsis tshua muaj tab sis muaj kev pheej hmoo loj: tendon rupture (tshwj xeeb tshaj yog nyob rau hauv cov neeg laus los yog corticosteroid cov neeg siv), QT ncua ncua sij hawm (tsis txhob nyob rau hauv cov neeg mob uas muaj kab mob plawv), thiab peripheral neuropathy (tshem tawm yog loog / tingling tshwm sim).
Resistance ceeb toom: Tsis txhob siv ntau dhau (piv txwv li, rau kev kis kab mob) los tiv thaiv kev tshwm sim ntawm levofloxacin - cov kab mob resistant (xws li,E. coli, K. pneumoniae).
Kev siv Veterinary:
Lub Sijhawm rho nyiaj: Cov dev (tsis yog- cov tsiaj noj): Tsis muaj lub sijhawm tshem tawm; zam kev siv hauv zaub mov- tsim cov tsiaj txhu (xws li nyuj, npua) los tiv thaiv kev pheej hmoo ntawm residue.
Kev koom tes & kev sib cuag
Peb muab Levofloxacin Hydrochloride hauv ntau qib thiab cov qauv tsim kom tau raws li cov kev xav tau sib txawv:
Pharmaceutical Qib: Raw hmoov rau cov ntsiav tshuaj ntawm qhov ncauj, tshuaj ntsiav, thiab txhaj tshuaj IV (1kg-100kg ib qho kev txiav txim).
Veterinary Qib: Hmoov rau qhov ncauj canine formulations (10kg-500kg ib qho kev txiav txim; txhua hli muaj peev xwm ntawm 1200kg).
Tus nqi - cov kev pabcuam ntxiv suav nrog:
Muab DMF (Drug Master File) thiab CEP (Certificate of Suitability) rau cov khoom siv tshuaj - qib los txhawb kev sau npe hauv EU, Asmeskas, thiab Asia.
Customized processing: Micronization (rau uniform dissolution hauv ntsiav tshuaj) los yog kua concentrates (rau IV formulations).
Kev taw qhia kev: Kev hloov tshuaj rau lub raum tsis zoo (tib neeg siv) thiab cov tswv yim tswj kev tiv thaiv.
Yog tias koj yog cov chaw tsim tshuaj, kws kho tsiaj, lossis tuam txhab tshuaj generic, thov hu rau peb kom paub meej kev koom tes:
Cov ntaub ntawv tiv tauj:
Email: sales@huarongpharma.com
Xov tooj/WhatsApp: +86 13751168070
Peb ua raws li cov hauv paus ntsiab lus ntawm "kev ua tau zoo, kev kho mob, thiab kev siv lub luag haujlwm" thiab tos ntsoov rau kev koom tes nrog kev noj qab haus huv thoob ntiaj teb thiab cov tuam txhab kev noj qab haus huv tsiaj!
Cim npe nrov: Levofloxacin Hydrochloride CAS 177325-13-2, Tuam Tshoj Levofloxacin Hydrochloride CAS 177325-13-2 manufacturers, lwm tus neeg
