Enalapril Maleate CAS 76095-16-4 Assay 98.0~102.0% API Maʻemaʻe Kiʻekiʻe

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].
Aia ka Enalapril Maleate ma lalo o 98.0 pakeneka a ʻaʻole i oi aku ma mua o 102.0 pakeneka o C20H28N2O5·C4H4O4, i helu ʻia ma ke kumu maloʻo.
Packaging a me ka waiho-Mālama i loko o ka maikai-paʻa ipu, a me ka mālama 'ia ma ka hoomaluia lumi wela.
Nā kūlana hōʻike USP <11>-
USP Enalapril Maleate RS Kaomi e nānā i ke ʻano
ʻike-
A: Infrared Absorption <197M>.
B: ʻO ka manawa paʻa o ka piko nui ma ka chromatogram o ka hoʻomākaukau Assay e pili ana i kēlā i loko o ka chromatogram o ka hoʻomākaukau maʻamau, e like me ka loaʻa ʻana ma ka Assay.
Ka hoʻololi kikoʻī <781S>: ma waena o -41.0 a me -43.5.
Hoʻoholo hoʻāʻo: 10 mg no ka mL, i ka methanol.
Nalo ma ka maloʻo <731>-Hoʻomaloʻo iā ia i loko o ka momi ma kahi kaomi ʻaʻole iʻoi aku ma mua o 5 mm o ka mercury ma 60 no 2 mau hola: ʻaʻole e nalowale ma mua o 1.0% o kona kaumaha.
Ke koena ma ka ʻā ʻana <281>: ʻaʻole ʻoi aku ma mua o 0.2%.
Nā metala kaumaha, Keʻano II <231>: 0.001%.
Huipuia pili-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Solution A, Solution B, Mobile phase, Diluent, Enalapril diketopiperazine solution, System suitability solution, and Chromatographic system— E holo e like me ke kuhikuhi ana ma ka Assay.
Hoʻonā maʻamau-E hoʻoheheʻe i ka nui o ka USP Enalapril Maleate RS i kaupaona pono ʻia i ka Diluent, a e hoʻoheheʻe me ka nui, a me ka stepwise inā pono, me ka Diluent e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 3 µg no mL.
Hoʻoholo hoʻāʻo-E hoʻohana i ka hoʻomākaukau Assay.
Ke Kaʻina Hana-E hoʻokaʻawale i nā puke like (ma kahi o 50 µL) o ka solution Standard a me ka solution Test i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a e ana i nā pane wahi kiʻekiʻe.E helu i ka pākēneka o kēlā me kēia haumia i ka ʻāpana o ka Enalapril Maleate i lawe ʻia e ke kumu:
100(CS / CT)(ri / rS)
i loko o ka CS ka hoʻopaʻa ʻana, i ka mg per mL, o USP Enalapril Maleate RS i ka hopena maʻamau;ʻO CT ka manaʻo, i ka mg per mL, o Enalapril Maleate i loko o ka hoʻonā Ho'āʻo;ʻO ri ka wahi kiʻekiʻe o kēlā me kēia haumia i loaʻa mai ka hoʻonā Ho'āʻo;a ʻo rS ka ʻāpana kiʻekiʻe o ka enalapril i loaʻa mai ka hopena maʻamau: ʻaʻole i ʻoi aku ma mua o 1.0% o nā haumia i loaʻa kahi manawa paʻa pili ma kahi o 1.10;ʻaʻole ʻoi aku ma mua o 0.3% o nā mea haumia ʻē aʻe i loaʻa;a ʻaʻole i ʻoi aku ma mua o 2% o ka nui o nā haumia i loaʻa.
hoʻāʻo-
pH 6.8 Phosphate buffer-Hoʻoheheʻe 2.8 g o ka sodium phosphate monobasic ma kahi o 900 mL o ka wai i loko o kahi pahu volumetric 1000-mL.E hoʻoponopono me kahi solution 9 M sodium hydroxide i kahi pH o 6.8, e hoʻoheheʻe me ka wai i ka nui, a hui.
pH 2.5 Phosphate buffer-Hoʻoheheʻe 2.8 g o ka sodium phosphate monobasic ma kahi o 900 mL o ka wai i loko o kahi pahu volumetric 1000-mL.E hoʻoponopono me ka phosphoric acid i kahi pH o 2.5, e hoʻoheheʻe me ka wai i ka nui, a hui.
Pane A-E hoʻomākaukau i ka hui ʻana o ka pH 6.8 Phosphate buffer a me ka acetonitrile (19:1).
Pane B-E hoʻomākaukau i ka hui ʻana o ka acetonitrile a me ka pH 6.8 Phosphate buffer (33:17).
ʻĀpana paʻalima-E hoʻohana i nā hui like ʻole o ka Solution A a me ka Solution B e like me ke kuhikuhi ʻana no ka ʻōnaehana Chromatographic.Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography 621).
Diluent-Hoʻomākaukau i kahi hui o ka pH 2.5 Phosphate buffer a me acetonitrile (95: 5).
Enalapril diketopiperazine solution-E kau me ka akahele ma kahi o 20 mg o ka USP Enalapril Maleate RS i loko o ka bea 100-mL e hana i puu ma ka lalo o ka beaker.E kau i ka beaker ma kahi pā wela ma kahi o ka hapalua o ka hoʻonohonoho wela wela loa.E wela ma kahi o 5 a 10 mau minuke a hoʻoheheʻe ʻia ka paʻa.Wehe koke i ka beaker mai ka pā wela, a e hoʻomaloʻo.[note-E pale i ka wela nui e pale ai i ka hoʻohaʻahaʻa ʻana i ka wela, kahi e hoʻāla ai i kahi waihoʻoluʻu ʻeleʻele.] I ke koena maloʻo i loko o ka beaker e hoʻohui i 50 mL o ka acetonitrile, a sonicate no kekahi mau minuke e hoʻoheheʻe.Aia i loko o kēlā me kēia mL ka hopena ma waena o 0.2 mg a me 0.4 mg o enalapril diketopiperazine.
Hoʻomākaukau maʻamau-E hoʻoheheʻe i ka nui i kaupaona pono ʻia o USP Enalapril Maleate RS i ka Diluent, a dilute quantitatively, a me ka stepwise inā pono, me ka Diluent e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 0.3 mg no ka mL.
Pūnaehana kūpono hoʻonā-Hoʻohui 1 mL o Enalapril diketopiperazine hoʻonā i ka 50-mL hapa o ka Standard hoomakaukau, a hui.
Hoʻomākaukau hoʻomākaukau- E hoʻololi i kahi 30 mg o Enalapril Maleate, i kaupaona pono ʻia, i loko o kahi pahu volumetric 100-mL, hoʻoheheʻe i loko a hoʻoheheʻe me ka Diluent i ka nui, a hui pū.
Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 215-nm a me kahi kolamu 4.1-mm × 15-cm i loaʻa i ka packing L21.ʻO ka nui o ke kahe ʻana he 1.5 mL i kēlā me kēia minuke.Mālama ʻia ka mahana o ke kolamu ma 70. Hoʻonohonoho ʻia ka chromatograph penei.
Manawa(mau minuke) Hoʻonā A(%) Hoʻonā B(%) Elution
0 95 5 kaulike
0-20 95→40 5→60 kaha kaha laina
20-25 40 60 hoʻokalakupua
25-26 40→95 60→5 kaha kaha laina
26-30 95 5 hoʻokalakupua
Chromatograph the System suitability solution, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻo nā manawa paʻa pili ma kahi o 1.0 no ka enalapril a me 2.1 no ka enalapril diketopiperazine;a ʻo ka hoʻonā, R, ma waena o enalapril a me enalapril diketopiperazine ʻaʻole i emi iho ma mua o 3.5.Chromatograph i ka hoʻomākaukau maʻamau, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻaʻole ʻoi aku ka ʻokoʻa maʻamau pili no ka hoʻopili hou ʻana ma mua o 1.0%.
Kaʻina hana- E hoʻokaʻawale i nā puke like (ma kahi o 50 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau ʻana i ka Assay i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a e ana i nā pane no nā piko nui.E helu i ka nui, ma mg, o C20H28N2O5·C4H4O4 i loko o ka hapa o Enalapril Maleate i lawe ʻia e ke kumu:
100C(rU / rS)
i loko o ka C ka manaʻo, i ka mg per mL, o USP Enalapril Maleate RS i ka hoʻomākaukau maʻamau;a ʻo rU a me rS nā pane kiʻekiʻe i loaʻa mai ka hoʻomākaukau Assay a me ka hoʻomākaukau maʻamau.