Enalapril Maleate CAS 76095-16-4 Assay 98.0~102.0% API Te Pure
Kaihanga Kaihanga Enalapril Maleate Intermediate Ki te Maamaa Nui
N-[(S)-1-Ethoxycarbonyl-3-phenylpropyl]-L-alanine;ECPPA CAS: 82717-96-2
Enalapril Maleate CAS: 76095-16-4
| Ingoa matū | Enalapril Maleate |
| Nga kupu taurite | MK-421;1-[N-[(S)-1-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl]-L-proline Maleate |
| Tau CAS | 76095-16-4 |
| Tūnga Taonga | Kei roto i nga taonga, ka eke ki te rau kirokaramu |
| Tātai rāpoi | C24H32N2O9 |
| Taumaha rāpoi | 492.52 |
| Waitohu | Ruifu Chemical |
| Tūemi | Whakatakotoranga |
| Te ahua | Ma ki te Paura Tioata-White |
| Tautuhi A | He rite te tuāwhiorangi IR ki tera o RS |
| Tautuhinga B | Ko te tihi nui i roto i te chromatogram ka whiwhi i te otinga whakamatautau i roto i te whakamatautau i runga i tera o te otinga tohutoro |
| Hurihuri Tauwhāiti | -41.0° ~ -43.5.0° |
| Ngaronga i te whakamaroke | ≤1.0% |
| Te toenga i runga i te mura | ≤0.20% |
| Nga Korewa Taamaha | ≤10ppm |
| Nga Taonga Paanga | |
| Enalaprilat | ≤0.30% |
| Moexipril Pūhui Pānga F | ≤0.30% |
| Enalapril Cyclohexyl Analog | ≤0.30% |
| Enalapril Pūhui Pānga D | ≤0.30% |
| Tetahi poke kore i tohua | ≤0.10% |
| Nga poke katoa | ≤2.00% |
| Wairewa toenga | |
| Ewaro | ≤5000ppm |
| Acetone | ≤5000ppm |
| Dichloromethane | ≤600ppm |
| n-Hexane | ≤290ppm |
| Te whakamatautau | 98.0%~102.0% (Kua tatauhia i runga i te whakamaroke) |
| Paerewa Whakamatau | USP Paerewa;EP Paerewa;Paerewa hinonga |
| Whakamahinga | Mahinga Rongoa Hohe (API) |
Mōkī:Pounamu, Peeke konumohe konumohe, 25kg / Cardboard Drum, kia rite ranei ki te hiahia a te kaihoko.
Tikanga Rokiroki:Kia kati tonu te ipu ka penapena ki roto i te whare putunga hauhautanga, maroke me te hau pai kia matara atu i nga matū hotokore.Tiaki i te marama me te makuku.Whakaorangia mai i nga matū waiora.
Tukunga:Tukuna ki te ao ma te rangi, ma te FedEx / DHL Express.Whakaratohia te tuku tere me te pono.
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].
Ko te Enalapril Maleate kaua e iti iho i te 98.0 ōrau me te kore e neke ake i te 102.0 ōrau o C20H28N2O5·C4H4O4, i tātaihia i runga i te tikanga maroke.
Packaging me te rokiroki-Whakaorangia i roto i te pai-katia ipu, me te rokiroki i te pāmahana rūma whakahaeretia.
Paerewa Tohutoro USP <11>-
USP Enalapril Maleate RS Pāwhiri ki te Tiro Hanganga
Tautuhinga-
A: Whakangao Infrared <197M>.
B: Ko te wa pupuri o te tihi nui i roto i te chromatogram o te whakaritenga Whakatau e rite ana ki tera i roto i te chromatogram o te whakaritenga Paerewa, i riro mai i te Assay.
Te hurihanga motuhake <781S>: i waenganui i te -41.0 me te -43.5.
Te otinga whakamatautau: 10 mg ia mL, i roto i te mewaro.
Ngaronga i runga i te whakamaroke <731>-Me whakamaroke ki roto i te korehau i te pehanga kaua e neke ake i te 5 mm o te mēkuri i te 60 mo te 2 haora: ka ngaro i te 1.0% o tona taumaha.
Te toenga i runga i te mura <281>: kaua e neke ake i te 0.2%.
Nga konganuku taumaha, Tikanga II <231>: 0.001%.
Pūhui pā-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Solution A, Solution B, Waahanga pūkoro, Diluent, Enalapril diketopiperazine solution, Pūnaha pai te otinga, me te Chromatographic system— Haere tonu i roto i te Whakatau.
Wairewa Paerewa-Warekahia te rahinga tika o te USP Enalapril Maleate RS i roto i te Diluent, me te waimeha ine, me te hikoi mena e tika ana, me te Diluent kia whiwhi ai i tetahi otinga e mohiotia ana he 3 µg ia mL.
Whakamātautau otinga-Whakamahia te whakaritenga Assay.
Tikanga-Tukuhia wehe nga pukapuka rite (mo te 50 µL) o te otinga Paerewa me te otinga Whakamatau ki roto i te chromatograph, tuhia nga chromatograms, me te ine i nga whakautu o te waahi teitei.Tātaihia te ōrau o ia poke i te wahanga o te Enalapril Maleate i tangohia e te tauira:
100(CS / CT)(ri / rS)
i roto i te CS te kukū, i roto i te mg ia mL, o USP Enalapril Maleate RS i roto i te otinga Paerewa;Ko te CT te kukū, i roto i te mg ia mL, o Enalapril Maleate i roto i te otinga Whakamatau;Ko ri te waahi teitei o ia poke i puta mai i te otinga Whakamatau;a ko rS te waahi teitei o te enalapril i riro mai i te otinga Paerewa: kaua e neke ake i te 1.0% o nga poke e mau ana ki te 1.10 pea te waa pupuri;kaua e neke ake i te 0.3% o etahi atu pokenga takitahi ka kitea;a kaua e neke ake i te 2% o nga poke katoa ka kitea.
whakamātautau-
pH 6.8 Phosphate buffer-Warekahia te 2.8 g konutai konutai phosphate ki roto i te 900 mL wai i roto i te ipu 1000-mL.Whakaritea me te wairewa konutai 9 M ki te pH o te 6.8 pea, waimeha ki te wai ki te rōrahi, ka uru.
pH 2.5 Puawai Phosphate-Whakarewa 2.8 g konutai konutai phosphate ki roto i te 900 mL wai i roto i te ipu 1000-mL.Whakaritea ki te waikawa ūkuikui ki te pH o te 2.5, waimeha ki te wai ki te rōrahi, ka uru.
Otinga A-Whakaritea he ranunga kua tātarihia, kua whakahekehia te pH 6.8 Phosphate buffer me te acetonitrile (19:1).
Otinga B-Whakaritea he ranunga kua tātarihia, kua whakahekehia te acetonitrile me te pH 6.8 Phosphate buffer (33:17).
Waahanga pūkoro-Whakamahia nga ranunga rereke o te Rongoa A me te Otinga B e kiia ana mo te punaha Chromatographic.Whakaritea nga whakarereketanga mehemea e tika ana (tirohia te Tikanga Pūnaha i raro i te Chromatography 621).
Diluent-Whakaritea he ranunga o te pH 2.5 Phosphate buffer me te acetonitrile (95:5).
Te wairewa Enalapril diketopiperazine-Kia ata whakanohohia te 20 mg o te USP Enalapril Maleate RS ki roto i te ipurau 100-mL kia hanga he puranga ki raro o te ipurau.Whakanohoia te ipurau ki runga i te pereti wera i te haurua pea o te teitei o te pāmahana pereti wera.Whakawerahia mo te 5 ki te 10 meneti kia rewa te totoka.Tangohia tonutia te ipurau mai i te pereti wera, ka tuku kia whakamatao.[Tuhipoka-Kaua e wera kia kore ai e paheke te wera, ka puta he tae parauri.] Ki te toenga kua whakamataohia i roto i te ipurau me tapirihia te 50 mL acetonitrile, ka sonicate mo etahi meneti kia memeha.Ko te otinga kei roto i ia mL, i waenga i te 0.2 mg me te 0.4 mg o te enalapril diketopiperazine.
Whakariterite Paerewa-Whakarewa i te rahinga tika o te USP Enalapril Maleate RS i roto i te Diluent, me te waimeha ine ine, me te hikoi mena e tika ana, me te Diluent kia whiwhi ai i tetahi otinga e mohiotia ana mo te 0.3 mg ia mL.
Te otinga pai o te punaha-Taapirihia te 1 mL o te otinga Enalapril diketopiperazine ki tetahi waahanga 50-mL o te whakaritenga Paerewa, ka uru.
Te whakarite whakamatautau- Whakawhitihia te 30 mg o te Enalapril Maleate, kua tika te pauna, ki te 100-mL ipu pukapuka, memeha ki roto ka waimeha ki te Diluent ki te rōrahi, ka uru.
Pūnaha Chromatographic (tirohia te Chromatography <621>)-Ko te chromatograph wai he mea rite ki te 215-nm kaitahuri me te 4.1-mm × 15-cm tīwae kei roto te whakakakahu L21.Ko te tere rere he 1.5 mL ia meneti.Ka mau tonu te mahana o te pou ki te 70. Ko te chromatograph te whakatakotoranga penei.
Wā(mēneti) Rongoā A(%) Rongoā B(%) Elution
0 95 5 taurite
0-20 95→40 5→60 rōnaki rārangi
20-25 40 60 tito
25-26 40→95 60→5 rōnaki rārangi
26-30 95 5 whakapouri
Chromatograph te otinga pai o te Pūnaha, me te tuhi i nga whakautu teitei e kiia ana mo te Tikanga: ko nga wa pupuri e pa ana ki te 1.0 mo te enalapril me te 2.1 mo te enalapril diketopiperazine;me te whakatau, R, i waenga i te enalapril me te enalapril diketopiperazine kaua e iti iho i te 3.5.Chromatograph te Whakariterite Paerewa, ka tuhi i nga whakautu teitei i runga i te tohutohu mo te Tikanga: ko te inenga paerewa mo nga werohanga tukurua kaua e neke ake i te 1.0%.
Tikanga- Tuhia motuhaketia nga pukapuka rite (mo te 50 µL) o te whakaritenga Paerewa me te whakaritenga Whakatau ki te chromatograph, tuhia nga chromatograms, me te ine i nga whakautu mo nga tihi nui.Tātaihia te rahinga, i te mg, o C20H28N2O5·C4H4O4 i te wahanga o te Enalapril Maleate i tangohia e te tauira:
100C(rU / rS)
i roto i te C ko te kukū, i roto i te mg ia mL, o USP Enalapril Maleate RS i roto i te whakaritenga Paerewa;me rU me rS nga whakautu teitei i puta mai i te whakaritenga Whakatau me te whakaritenga Paerewa.
Waehere Whakararuraru R36/37/38 - Ka whakaparahako ki nga kanohi, te punaha manawa me te kiri.
R62 - Ka tupono pea ka paheke te hua
R63 - Ka tupono pea he kino ki te tamaiti kare i whanau
Whakaahuatanga Haumaru S22 - Kaua e pupuhi puehu.
S24/25 - Kaua e pa ki te kiri me nga kanohi.
S36/37 - Mau kakahu whakamarumaru me nga karapu tika.
S26 - Mena ka pa ki nga kanohi, horoi tonu ki te nui o te wai me te rapu tohutohu hauora.
UN ID 3077
WGK Tiamana 2
RTECS TW3666000
Waehere HS 2933990099
Paitini LD50 waha i te kiore: 2973mg/kg
Ko te Enalapril Maleate (CAS: 76095-16-4) he angiotensin converting enzyme inhibitor (ACE), e whakamahia ana ki te rongoa i te toto toto tiketike, te mate pukupuku mate huka, me te ngoikore o te ngakau.He kaha te waha.He kaihoko Antihypertensive.Ko te Enalapril maleate (Vasotec), te metabolite kaha o te enalapril, ka whakataetae ki te angiotensin I mo te here ki te angiotensin-converting enzyme, ka aukati i te hurihanga o te angiotensin I ki te angiotensin II.
