Enalapril Maleate CAS 76095-16-4 Assay 98.0~102.0% API High Purity

Enalapril Maleate
C20H28N2O5·C4H4O4 492.52
l-Proline, 1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-l-alanyl]-, (S)-, (Z)-2-butenedioate (1:1).
1-[N-[(S)-1-Carboxy-3-phenylpropyl]-l-alanyl]-l-proline 1'-ethyl ester, maleate (1: 1) [76095-16-4].
Enalapril Maleate ine kwete pasi pe98.0 muzana uye kwete kupfuura 102.0 muzana yeC20H28N2O5 · C4H4O4, yakaverengerwa pane yakaomeswa.
Packaging uye kuchengetedza-Chengetedza mumidziyo yakavharwa zvakanaka, uye chengetedza pane inodzorwa tembiricha yekamuri.
USP Reference mwero <11>-
USP Enalapril Maleate RS Dzvanya kuti uone Chimiro
Identification-
A: Infrared Absorption <197M>.
B: Nguva yekuchengeta yepamusoro-soro muchromatogram yeAssay kugadzirira inoenderana neiyo mukromatogram yeStandard gadziriro, sezvakawanikwa muAssay.
Kutenderera chaiko <781S>: pakati -41.0 uye -43.5.
Mhinduro yekuedza: 10 mg pa mL, mu methanol.
Kurasikirwa pakuomeswa <731> -Dry it in vacuum pakumanikidzwa kusingapfuuri 5 mm ye mercury pa60 kwemaawa maviri: inorasikirwa kwete inopfuura 1.0% yehuremu hwayo.
Residue pakudzima <281>: kwete kupfuura 0.2%.
Heavy metals, Nzira II <231>: 0.001%.
Related compounds-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Solution A, Solution B, Mobile phase, Diluent, Enalapril diketopiperazine solution, System suitability solution, uye Chromatographic system— Enderera mberi sekurairwa muAssay.
Yakajairwa mhinduro-Dirusa huremu hwakayerwa nemazvo eUSP Enalapril Maleate RS muDiluent, uye wedzera huwandu, uye nhanho kana zvichidikanwa, neDiluent kuti uwane mhinduro ine huwandu hunozivikanwa hunosvika 3 µg pamL.
Test solution-Shandisa gadziriro yeAssay.
Maitiro-Baya jekiseni mavhoriyamu akaenzana (angangoita 50 µL) yeStandard solution uye Test solution muchromatograph, rekodha machromatogram, uye kuyera mhinduro dzenzvimbo yepamusoro.Verenga chikamu chekusachena kwega kwega muchikamu cheEnalapril Maleate chakatorwa neformula:
100(CS / CT)(ri / rS)
umo CS ndiyo yekuisa, mu mg per mL, yeUSP Enalapril Maleate RS muStandard solution;CT ndiyo inosungirirwa, mu mg per mL, yeEnalapril Maleate muMuedzo mhinduro;ri ndiyo nzvimbo yepamusoro yekusachena kwega kwega kunowanikwa kubva kuMubvunzo mhinduro;uye rS ndiyo nzvimbo yepamusoro yeenalapril inowanikwa kubva kuStandard solution: kwete kupfuura 1.0% yekusachena kupi zvako kune imwe nguva yekuchengetedza nguva inenge 1.10 inowanikwa;kwete kupfuura 0.3% yeimwe imwe tsvina yemunhu inowanikwa;uye kwete kupfuura 2% yetsvina yose inowanikwa.
Kuongorora-
pH 6.8 Phosphate buffer-Dissolve 2.8 g ye monobasic sodium phosphate mune inenge 900 mL yemvura mu1000-mL volumetric flask.Rongedza ne9 M sodium hydroxide solution kune pH ingangoita 6.8, dilue nemvura kusvika kuhuwandu, uye sanganisa.
pH 2.5 Phosphate buffer-Dissolve 2.8 g ye monobasic sodium phosphate mune inenge 900 mL yemvura mu1000-mL volumetric flask.Gadzirisa nephosphoric acid kune pH inosvika 2.5, dilue nemvura kusvika kuhuwandu, uye sanganisa.
Mhinduro A-Gadzirira musanganiswa wakasefa uye wakasvibiswa wepH 6.8 Phosphate buffer uye acetonitrile (19: 1).
Mhinduro B-Gadzirira musanganiswa wakasefa uye wakasvibiswa weacetonitrile uye pH 6.8 Phosphate buffer (33:17).
Nharembozha chikamu-Shandisa akasiyana musanganiswa weSolution A uye Solution B sekurairwa kweChromatographic system.Ita zvigadziriso kana zvichidikanwa (ona System Suitability pasi peChromatography 621).
Diluent-Gadzirira musanganiswa wepH 2.5 Phosphate buffer uye acetonitrile (95: 5).
Enalapril diketopiperazine solution-Nyatsoisa inosvika 20 mg yeUSP Enalapril Maleate RS mubeaker 100-mL kuita murwi pazasi pebeaker.Isa beaker mundiro inopisa pane imwe-hafu yepamusoro yetembiricha yetembiricha inopisa.Pisa kwemaminetsi mashanu kusvika gumi kusvika gobvu ranyunguduka.Bvisa beaker kubva mundiro inopisa, uye bvumira kuti itonhore.[Cherechedza-Dzivisa kupisa kwepamusoro kudzivirira kushatisa kunokonzerwa nekupisa, izvo zvingapa kuti kuve neruvara rwebrown.] Kune zvakanyoroveswa zvakasara mubeaker wedzera 50 mL yeacetonitrile, uye sonicate kwemaminitsi mashomanana kuti inyunguduke.Mushonga wacho unowanzo kuve, mumL yega yega, pakati pe0.2 mg ne0.4 mg yeenalapril diketopiperazine.
Kugadzirira kwakajairwa-Bvisa huremu hwakayerwa nemazvo eUSP Enalapril Maleate RS muDiluent, uye dilute zvine huwandu, uye nhanho kana zvichidikanwa, neDiluent kuti uwane mhinduro ine huwandu hunozivikanwa hunosvika 0.3 mg per mL.
Kukodzera kweSystem mhinduro-Wedzera 1 mL yeEnalapril diketopiperazine mhinduro kune 50-mL chikamu cheiyo Standard gadziriro, uye sanganisa.
Kugadzirira kweAssay- Shandura inenge 30 mg yeEnalapril Maleate, yakanyatsoyerwa, kune 100-mL volumetric flask, nyunguduka uye nyura neDiluent kusvika kuhuwandu, uye sanganisa.
Chromatographic system (ona Chromatography <621>) -Iyo chromatograph yemvura inogadzirwa ne 215-nm detector uye 4.1-mm × 15-cm column ine packing L21.Chiyero chekuyerera chinenge 1.5 mL paminiti.Iko kupisa kwembiru inochengetwa pa 70. Chromatograph inorongwa sezvinotevera.
Nguva(maminitsi) Solution A(%) Solution B(%) Elution
0 95 5 kuenzana
0-20 95→40 5→60 linear gradient
20-25 40 60 isocratic
25-26 40→95 60→5 linear gradient
26-30 95 5 isocratic
Chromatograph iyo Sistimu yakakodzera mhinduro, uye rekodha mhinduro dzepamusoro sekurairwa kwaProcedure: nguva dzekuchengeta dzinenge 1.0 yeenalapril uye 2.1 yeenalapril diketopiperazine;uye chisarudzo, R, pakati peenalapril neenalapril diketopiperazine haisi pasi pe3.5.Chromatograph iyo Yakajairwa gadziriro, uye rekodha mhinduro dzepamusoro sekurairwa kweMaitiro: chiyero chakajairwa kutsauswa kwemajekiseni anodzokorora hakusi kudarika 1.0%.
Maitiro- Baira mavhoriyamu akaenzana (angangoita 50 µL) eChimiro chegadziriro uye gadziriro yeAssay muchromatograph, rekodha machromatogram, uye kuyera mhinduro dzepamusoro-soro.Verenga huwandu, mu mg, hweC20H28N2O5·C4H4O4 muchikamu cheEnalapril Maleate chakatorwa neformula:
100C(rU / rS)
umo C ndiyo inosungirirwa, mu mg per mL, yeUSP Enalapril Maleate RS muKugadzirira Kwemaitiro;uye rU nerS ndiwo mhinduro dzepamusoro dzakawanikwa kubva mukugadzirira kweAssay uye gadziriro yeStandard, zvichiteerana.