Levodopa (L-DOPA) CAS 59-92-7 99.0 ~ 100.5% USP BP EP Standard Anti-Parkinson ta Cutar Babban Tsabta

Juyawar gani [EP]
Narkar da adadin daidai da 0.200g na abin da aka bushe da 5g na hexamethylenetetramine R a cikin 10ml na 1mol/L hydrochloric acid da tsarma zuwa 25.oml tare da acid iri ɗaya.Bada bayani ya tsaya a karewa daga haske don 3h.Matsakaicin jujjuyawar gani shine -1.27° zuwa -1.34°
Bayyanar Magani
A narkar da 1.0g a cikin 1mol/L hydrochloric acid kuma a tsoma shi zuwa 25ml tare da solvnet iri ɗaya.Maganin bai fi tsananin launi fiye da bayani na BY6 ba.
Abubuwa masu alaƙa [EP]
Bincika ta chromatography na bakin ciki-Layer, ta amfani da cellulose don chromatography R azaman abin rufewa.
Maganin gwaji-Narke 0.1g na abu da za a bincika a cikin 5ml na anhydrous formic acid R kuma a tsarma zuwa 10ml tare da methanol R. Yi shiri nan da nan kafin amfani.
Maganin Magana (a) - Rarraba 0.5ml na maganin gwajin zuwa 100ml tare da methanol R.
Maganin Magana (b) -Narke 30mg na tyrosine R a cikin 1ml na anhydrous formic acid R kuma a tsarma zuwa 100ml tare da methanol R. Mix 1ml na wannan bayani tare da 1ml na maganin gwajin.
Aiwatar dabam zuwa farantin karfe a matsayin makada 20mm tsawo, 1oμl na gwajin bayani, 10μl na tunani bayani (a) da 20μl na tunani bayani (b).Busasshen iska a halin yanzu.Haɓaka kan hanyar od 15cm ta amfani da cakuɗen 50 na butanol R, juzu'i 25 na glacial acetic acid R da 25 na ruwa.Busasshen farantin a cikin iska mai dumi kuma a fesa tare da cakuda da aka shirya na daidai adadin adadin 10% m/v na ferric chloride R da 5% m/v bayani na postassium ferricyanide R. Yi nazarin chromatoframs nan da nan.Duk wani tabo a cikin chromatogram da aka samu tare da maganin gwajin, baya ga babban tabo, bai fi tabo a cikin chromatogram da aka samu tare da bayani ba (a) ya nuna.Gwajin ba ta da inganci sai dai idan chromatogram da aka samu tare da bayani na tunani (b) ya nuna, sama da babban tabo, wani tabo na musamman wanda ya fi tabo a cikin chromatogram da aka samu tare da bayani (a).
UV Spectrum [EP]
A narkar da 30.0mg a cikin 0.1mol/L hydrochloric acid kuma a tsoma shi zuwa 100.oml tare da acid iri ɗaya.Tsarma 10.0ml na wannan maganin zuwa 100.0ml tare da 0.1mol/L hydrochloric acid.An bincika tsakanin 230nm da 350nm, maganin yana nuna matsakaicin sha ɗaya a 280nm.Ƙayyadaddun shayarwa a wannan matsakaicin shine 137 zuwa 147, ƙididdiga tare da la'akari da busassun abu.
Asara akan bushewa
Ɗauki wannan samfurin, bushe zuwa madaidaicin nauyi a 105 ° C, asarar nauyi ba zai wuce 1.0% ba (Gaba ɗaya doka 0831).
Ragowa akan ƙonewa (Sulfated)
Ɗauki l.0g na Levodopa kuma duba shi bisa ga doka (Gaba ɗaya doka 0841).Ragowar hagu kada ta wuce 0.1%.
Karfe masu nauyi
Ragowar da aka bari a ƙarƙashin abin shan ragowar ƙonewa ba zai ƙunshi fiye da sassa 10 a kowace miliyan na ƙarfe mai nauyi ba lokacin da doka ta bincika (General Principles 0821, Law II).
Gwajin pH
0.10g a cikin 10ml na H2O girgiza na mintina 15.
Ƙaddamar da abun ciki
Ɗauki wannan samfurin game da 0.lg, daidaitaccen ma'auni, ƙara anhydrous formic acid 2ml don narkewa, ƙara glacial acetic acid 20ml, girgiza, ƙara crystal violet nuna alama 2 saukad, tare da perchloric acid titration bayani (0.1 mol / L) titration zuwa maganin shine mafita. kore, kuma an gyara sakamakon titration tare da gwaji mara kyau.Kowane 1 ml na maganin titration perchloric acid (0.1 mol/L) yayi daidai da 19.72mg na C9H11N04.

Hanyar Gwajin JP17

Levodopa, lokacin da aka bushe, ya ƙunshi ƙasa da 98.5% na Levodopa (C9H11NO4).
Bayanin Levodopa yana faruwa azaman fari ko ɗan fari mai launin toka, lu'ulu'u ko foda.Ba shi da wari.Yana narkewa da yardar kaina a cikin formic acid, dan kadan mai narkewa cikin ruwa, kuma a zahiri baya narkewa a cikin ethanol (95).Yana narke a cikin dilute hydrochloric acid.PH na cikakken bayani na Levodopa yana tsakanin 5.0 da 6.5.Narke batu: game da 275 ℃ (tare da bazuwa).
Ganewa
(1) Zuwa 5 ml na maganin Levodopa (1 a cikin 1000) ƙara 1mL na ninhydrin TS, da zafi don minti 3 a cikin wanka na ruwa: launin shuɗi yana tasowa.
(2) Zuwa 2 ml na maganin Levodopa (1 a cikin 5000) ƙara 10 ml na 4-aminoantipyrine TS, kuma girgiza: launin ja yana tasowa.
(3) Narkar da 3 MG na Levodopa a cikin 0.001 mol/L hydrochloric acid TS don yin 100 ml.Ƙayyade bakan shayarwar maganin kamar yadda aka umurce shi a ƙarƙashin Ultravioletvisible Spectrophotometry <2.24>, kuma kwatanta bakan tare da Bakan Magana: duka bakan suna nuna irin ƙarfin sha a tsawon madaidaicin raƙuman ruwa iri ɗaya.
Absorbance <2.24> E 1%1cm (280 nm): 136-146 (bayan bushewa, 30 MG, 0.001 mol/L hydrochloric acid TS, 1000 ml).
Juyawar gani <2.49> [a] 20D: -11.5° ~-13.0°(bayan bushewa, 2.5 g, 1 mol/L hydrochloric acid TS, 50 ml, 100 mm).
Tsafta
(1) Tsabtace da launi na bayani-Narke 1.0 g na Levodopa a cikin 20 ml na 1 mol / L hydrochloric acid TS: bayani ya bayyana kuma mara launi.
(2) Chloride <1.03>-Narke 0.5 g na Levodopa a cikin 6 mLof dilute nitric acid, kuma ƙara ruwa don yin 50 ml.Yi gwajin ta amfani da wannan maganin azaman maganin gwajin.Shirya maganin sarrafawa tare da 0.30 ml na 0.01 mol/L hydrochloricacid VS (ba fiye da 0.021%) ba.
(3) Sulfate <1.14>-Narke 0.40 g na Levodopa a cikin 1 mL na dilute hydrochloric acid da 30 ml na ruwa, kuma ƙara ruwa don yin 50 ml.Yi gwajin ta amfani da wannan maganin azaman maganin gwajin.Shirya maganin sarrafawa tare da 0.25 ml na 0.005 mol / L sulfuric acid VS (ba fiye da 0.030%) ba.
(4) Karfe masu nauyi <1.07> - Ci gaba da 1.0 g na Levodopa bisa ga Hanyar 2, kuma yi gwajin.Shirya maganin sarrafawa tare da 2.0 ml na Madaidaicin Maganin Gubar (bai wuce 20 ppm ba).
(5) Arsenic <1.11>-Narke 1.0 g na Levodopa a cikin 5 mLof dilute hydrochloric acid, kuma yi gwajin tare da wannan bayani a matsayin maganin gwajin (ba fiye da 2 ppm ba).
(6) Abubuwan da ke da alaƙa-Narke 0.10 g na Levodopa a cikin 10 ml na sodium disulfite TS, kuma amfani da wannan bayani azaman samfurin samfurin.Pipet 1 ml na maganin samfurin, ƙara sodium disulfite TS don yin daidai 25 ml.Pipet 1 ml na wannan bayani, ƙara sodium disulfite TS don yin daidai 20 ml, kuma amfani da wannan bayani azaman daidaitaccen bayani.Yi gwajin tare da waɗannan mafita kamar yadda aka umurce su a ƙarƙashin Thin-Layer Chro-matography<2.03>.Spot 5mL kowane samfurin mafita da daidaitaccen bayani akan farantin cellulose don bakin ciki-Layerchromatography.Ƙirƙirar farantin tare da cakuda 1-butanol, ruwa, acetic acid (100) da methanol (10: 5: 5: 1) zuwa nisa na kimanin 10 cm, kuma a bushe farantin.Sprayly wani bayani na ninhydrin a acetone (1 a 50) a kan farantin da kuma zafi a 90 ℃ na minti 10: da spots wanin babban tabo daga samfurin bayani ba su fi tsanani fiye da tabo daga misali bayani.
Asara akan bushewa <2.41> Bai wuce 0.30% (1 g, 105 ℃, 3 hours).
Ragowa akan ƙonewa <2.44> Bai wuce 0.1% ba (1 g).
Assay Yi nauyi daidai game da 0.3 g na Levodopa, wanda aka bushe a baya, narke a cikin 3 ml na formic acid, ƙara 80 ml na acetic acid (100), da titrate <2.50> tare da 0.1 mol / L perchloric acid VS har sai launi na maganin ya canza. daga purple ta blue-kore zuwa kore (mai nuna alama: 3 saukad da crystalviolet TS).Yi ƙayyadaddun ƙaƙƙarfan ƙaƙƙarfan ƙaƙƙarfan ƙaƙƙarfan ƙayyadaddun ƙayyadaddun ƙayyadaddun gyare-gyare.
Kowane ml na 0.1 mol/L perchloric acid VS 19.72 MG na C9H11NO4
Kwantena da Akwatunan ajiya - Kwantena masu tsauri.
Adana-Haske mai jurewa.