Levofloxacin Lactate (CAS No.: 294662-}18-3) - Soluble Fluoroquinolone Antibacterial for Parenteral & Oral Therapy
Raws li tus kws tshaj lij kev lag luam tshuaj - qib tshuaj tua kab mob cov khoom xyaw, peb muab siab - purity Levofloxacin Lactate uas nruj me ntsis ua raws li cov qauv tshuaj tshuaj thoob ntiaj teb (USP, EP, BP, CP). Ib daim ntawv ntsev lactate ntawm levofloxacin (tus nquag S-enantiomer ofloxacin), nws muajtxhim kho dej solubilitypiv rau levofloxacin hydrochloride- ua rau nws zoo tagnrho rau cov tshuaj parenteral formulations (IV txhaj) thiab cov kua hauv qhov ncauj npaj. Nws yog dav siv nyob rau hauvtib neeg tshuajrau kev kho cov kab mob loj heev thiab hauv kev xaivkev xyaum ua tsiajrau cov tsiaj sib raug zoo, ua ib tus neeg sawv cev tseem ceeb tiv thaiv tshuaj - cov kab mob tiv taus.
Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Levofloxacin Lactate |
| CAS Nr. | 294662-18-3 |
| 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; Levofloxacin (lactic acid ntsev) |
| Molecular Formula | C₁₈H₂₀FN₃O₄·C₃H₆O₃ |
| Molecular Luj | 475.49 |
| Qhov tshwm sim | Dawb rau tawm -dawb crystalline hmoov; Tsis muaj ntxhiab lossis nrog me ntsis lactic acid-zoo li tsw |
| Specification | - Pharmaceutical Qib: Purity Ntau dua lossis sib npaug li 99.0% (HPLC); Assay (raws li levofloxacin) 97.0% -103.0%; Kev sib hloov kho qhov muag tshwj xeeb []²⁰D -98℃rau -106℃(hauv dej, c=1); Poob ntawm ziab Tsawg dua lossis sib npaug li 1.0%; 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 | 185-190℃(nrog decomposition) |
| Solubility | Soluble hauv dej (Ntau dua lossis sib npaug ntawm 200 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); Tsis txhob sib cuag nrog cov oxidizing muaj zog; 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 Lactate cas294662-18-3 exerts abactericidal nyhuvzoo ib yam rau nws niam txiv compound (levofloxacin)- daim ntawv ntsev lactate tsuas yog txhim kho cov solubility yam tsis muaj kev hloov pauv tshuaj. Nws xaiv inhibits ob yam kab mob tseem ceeb enzymes:
DNA gyrase (topoisomerase II): Qhov tseem ceeb rau cov kab mob DNA supercoiling thiab replication.
Topoisomerase IV: Qhov tseem ceeb rau kev sib cais chromosome thaum lub sij hawm cov kab mob ntawm tes faib.
Los ntawm thaiv cov enzymes no, Levofloxacin Lactate cuam tshuam cov kab mob DNA synthesis, ua rau cell tuag. Nws cov txiaj ntsig tseem ceeb suav nrog:
Txhim kho potency: 2–8 npaug ntau dua li racemic ofloxacin tawm tsam Gram-tsis zoo (xws li,Escherichia coli, Pseudomonas aeruginosa) thiab Gram -positive (eg,Staphylococcus aureus, Streptococcus pneumoniae) cov kab mob.
Dav spectrum: Active tiv thaiv kab mob aerobic, atypical microbes (xws li,Mycoplasma pneumoniae, Chlamydophila pneumoniaethiab mycobacteria (piv txwv li,Mycobacterium tuberculosis).
Tom qab- cov nyhuv tshuaj tua kab mob (PAE): Tshem tawm cov kab mob regrowth rau 2-6 teev tom qab- noj, ua kom ib zaug- noj txhua hnub.
Cov ntawv thov tseem ceeb
1. Human Pharmaceutical Field
Levofloxacin Lactate 294662-18-3 feem ntau yog siv raunruab nrab-rau- kab mob hnyavqhov twg yuav xa tshuaj sai sai (ntawm IV) lossis kev txhaj tshuaj rau qhov ncauj (rau cov menyuam yaus/cov neeg laus) yuav tsum tau. Nws tsis yog qhia txog kev kis kab mob (xws li mob khaub thuas/flu).
1.1 Parenteral Therapy (IV Txhaj)
Tsev Kho Mob -Tau mob ntsws (HAP): Kho HAP tshwm sim los ntawmPseudomonas aeruginosalos yog methicillin -sensitiveS. aureus(MSSA). IV koob tshuaj: 500-750 mg (raws li levofloxacin) ib hnub ib zaug rau 7-14 hnub, kho rau lub raum ua haujlwm.
Septicemia & Bacteremia: Siv rau cov kab mob hauv cov hlab ntsha uas tshwm sim los ntawm cov tshuaj -Resistant Gram- cov kab mob tsis zoo (xws li,Klebsiella pneumoniae). IV koob tshuaj: 750 mg ib hnub ib zaug rau 10-14 hnub, nrog rau kev hloov mus rau qhov ncauj kho ib zaug ruaj khov.
Complexed Urinary Tract Infections (cUTIs): Rau cov neeg mob tsis tuaj yeem noj cov tshuaj hauv qhov ncauj (xws li, tom qab- phais). IV koob tshuaj: 750 mg ib hnub ib zaug rau 5 hnub, lossis 500 mg ib hnub ib zaug rau 10-14 hnub.
1.2 Oral Liquid Formulations
Pediatric Infections: Siv raws li kev txwv qhov ncauj rau cov menyuam yaus siab dua lossis sib npaug li 6 lub hlis nrog kev kis mob hnyav (xws li, zej zog- kis mob ntsws). koob tshuaj: 8-10 mg / kg (raws li levofloxacin) ib hnub ib zaug rau 7-10 hnub, max 750 mg / hnub.
Cov neeg laus lossis cov neeg mob Dysphagic: Cov kua dej hauv qhov ncauj lossis tee rau cov neeg mob uas muaj teeb meem nqos tau (xws li, cov neeg muaj mob stroke) xav tau kev kho mob rau cov tawv nqaij / cov nqaij mos. koob tshuaj: 500-750 mg ib hnub ib zaug rau 7-10 hnub.
2. Veterinary Field (Cov Tsiaj Txhaum Cai)
tau pom zoo raudev(tsis yog miv-txoj kev pheej hmoo ntawm retinal toxicity) rau kev kho cov kab mob kab mob, nrog rau kev tsom mus rau cov tshuaj txhaj rau cov mob hnyav:
Canine Pyoderma (Cov kab mob ntawm daim tawv nqaij): Ua los ntawmStaphylococcus pseudintermediaus. IV / qhov ncauj koob tshuaj: 5-10 mg / kg (raws li levofloxacin) ib hnub ib zaug rau 7-14 hnub.
Canine Respiratory Infections: Rau kennel hnoos (ua los ntawmBordetella bronchiseptica+ kab mob co-kab mob). IV koob tshuaj: 7.5 mg / kg ib hnub ib zaug rau 5-7 hnub, ua raws li kev saib xyuas qhov ncauj.
Contraindications: Tsis txhob siv rau hauv miv, tus dev cev xeeb tub / tu dev, lossis dev uas muaj lub raum tsis zoo, qaug dab peg, lossis kab mob ntawm lub qhov muag.
Quality & Safety Assurance
Raws li cov tshuaj fluoroquinolone soluble rau kev kho mob tseem ceeb, cas294662-18-3 tau txais kev tswj xyuas nruj kom ntseeg tau tias muaj txiaj ntsig, solubility, thiab kev nyab xeeb:
1. Kev tsim khoom & Purity Control
Synthesis: Ua los ntawm reacting levofloxacin dawb puag nrog lactic acid nyob rau hauv aqueous tov, ua raws li crystallization. Cov txheej txheem yog optimized los xyuas kom meej:
Kev solubility siab: Lactate ntsev ua tiav ntau dua lossis sib npaug li 200 g / L solubility hauv dej (vs. ~ 100 g / L rau hydrochloride), tseem ceeb rau IV formulations.
Enantiomeric purity: (S)-enantiomer Ntau dua lossis sib npaug li 99.5% (tsis ua haujlwm (R)-enantiomer Tsawg dua lossis sib npaug li 0.5%), ua kom muaj zog.
Ua raws li GMP: Tsim nyob rau hauv Qib C cleanrooms (raws li ICH Q7 cov lus qhia) rau txhaj tshuaj - qib raw cov ntaub ntawv, nrog kev tswj nruj ntawm endotoxin qib (tsawg dua los yog sib npaug rau 0.25 EU/mL rau IV siv).
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 ntsuam xyuas 97.0% -103.0% (raws li levofloxacin) |
| Enantiomeric Purity yog qhov zoo | Chiral HPLC (polysaccharide 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 |
| Endotoxin (Kev txhaj tshuaj qib) | LAL (limulus Amebocyte Lysate) Test | Tsawg dua lossis sib npaug li 0.25 EU / ml |
| Solubility Test | Gravimetric txoj kev (25 degree, dej) | Ntau tshaj los yog sib npaug rau 200 g / L, ntshiab tov (tsis muaj turbidity) |
3. Kev ceeb toom kev nyab xeeb
Tib neeg siv:
Contraindications: hypersensitivity rau fluoroquinolones; keeb kwm ntawm tendon rupture; menyuam<6 months; pregnancy/lactation (Category C).
Cov teebmeem tsis zoo: Feem ntau: xeev siab, raws plab, mob taub hau. Tsis tshua muaj tab sis hnyav: tendon rupture (cov neeg laus / cov neeg siv corticosteroid), QT ntev (cov neeg mob plawv), peripheral neuropathy.
Resistance ceeb toom: Tsis txhob siv ntau dhau (piv txwv li, rau cov kab mob me me) txhawm rau tiv thaiv cov kab mob resistant (xws li,E. coli, Acinetobacter baumannii).
Kev siv Veterinary:
Lub Sijhawm rho nyiaj: Cov dev (tsis yog- cov tsiaj noj): Tsis muaj lub sijhawm tshem tawm; txwv tsis pub nyob rau hauv cov zaub mov- tsim cov tsiaj (xws li, nyuj, npua) kom tsis txhob muaj qhov seem seem.
Kev koom tes & kev sib cuag
Peb muab Levofloxacin Lactate nyob rau hauv cov qib uas haum rau parenteral thiab qhov ncauj daim ntawv thov:
Pharmaceutical Qib (Injectable): Cov hmoov zoo rau IV formulations (1kg-100kg ib qho kev txiav txim, amber iav vials nrog nitrogen tiv thaiv).
Pharmaceutical Qib (Qhov ncauj): Granules rau qhov ncauj tshem tawm (10kg-500kg ib qho kev txiav txim; txhua hli muaj peev xwm ntawm 1500kg).
Veterinary Qib: Powder for canine injectables/oral liquids (5kg–200kg per order).
Tus nqi - cov kev pabcuam ntxiv suav nrog:
Muab DMF (Drug Master File) thiab CEP (Certificate of Suitability) rau cov kws tshuaj -qib cov khoom los txhawb EU/US/Asia rau npe.
Customized solubility optimization (piv txwv li, rau siab -cov ntsiab lus IV) thiab impurity profileing.
Kev taw qhia txuj ci: Kev hloov kho lub raum koob tshuaj (tib neeg siv) thiab kev ntsuam xyuas kev ruaj ntseg ntawm kws kho tsiaj.
Yog tias koj yog cov chaw tsim tshuaj, lub tuam txhab tshuaj generic, lossis kev lag luam tshuaj veterinary, thov hu rau peb kom paub meej kev koom tes:
Cov ntaub ntawv tiv tauj:
Email: sales@huarongpharma.com
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Cim npe nrov: Levofloxacin Lactate 294662-18-3, Tuam Tshoj Levofloxacin Lactate 294662-18-3 manufacturers, lwm tus neeg
