Vitamini E-TPGS (Tocofersolan) CAS 9002-96-4 D-α-Tocopherol ≥25.0%

TANTHAUZO
Vitamini E Polyethylene Glycol Succinate ndi osakaniza opangidwa ndi esterification wa d-alpha tocopheryl asidi succinate ndi polyethylene glycol.Kusakaniza kwa ester kumakhala makamaka mono-esterified polyethylene glycol ndi pang'ono di-esterified polyethylene glycol.Lili ndi NLT 25.0% ya d-alpha tocopherol (C29H50O2).
CHIZINDIKIRO
• A. Gas Chromatographic Identification Test
Kusanthula: Chitani monga momwe mwawuzira poyesa Zomwe zili mu Alpha Tocopherol.
Njira zolandirira: Nthawi yosungitsa pachimake chachikulu cha Sample solution imagwirizana ndi njira ya Standard.
COMPOSITION
• Zomwe zili mu Alpha Tocopherol
Zosungunulira: 0,25 mL wa phenolphthalein TS mu 1 L mowa
Yankho lamkati lamkati: 12 mg/mL ya ethyl arachidate mu isooctane
Yankho lokhazikika: Chotsani 32.5 mg ya USP Alpha Tocopherol RS ku botolo loyenera.Onjezani 2 mL ya pyridine ndi 0.5 mL ya N,O-bis(trimethylsilyl)trifluoroacetamide ndi 1% trimethylchlorosilane, ndi kutentha botolo pa 100 kwa mphindi 10.Tsitsani botolo, onjezani 5.0 mL ya Internal standard solution yotsatiridwa ndi 20 mL ya isooctane, ndikugwedezani.
Yankho lachitsanzo: Chotsani kuchuluka kwa 0.100-0.160 g wa Vitamin E Polyethylene Glycol Succinate wosungunuka pa 60 ku chubu cha chikhalidwe (pafupifupi 20 cm m'litali ndi 2.5 cm m'mimba mwake) chokhala ndi kapu.Onjezerani 40-50 mg wa ascorbic acid ndi tchipisi tating'ono towiritsa, kenaka 20 ml ya zosungunulira.[Zindikirani-Reflux yankho mofatsa popanda kutulutsa zamkati.] Ikani chubu mu chotenthetsera chipika anapereka pa 100-150.Chitsanzocho chikasungunuka kwathunthu, onjezerani 0,25 g wa potaziyamu hydroxide, ndikupitirizabe reflux kwa mphindi 30.Chotsani chubu ku kutentha, ndipo zomwe zili mkati zidakali zotentha, onjezerani 1-2 mL ya hydrochloric acid dropwise mpaka mtundu wa pinki utatha.[Chenjezo—Kuchita mantha kwambiri.Lolani asidi kuti atsike mkati mwa chubu kuti asatayike.] Kuziziritsa chubu, ndiye kutsuka mbali za chubu ndi 20 mL madzi.Onjezani 5.0 mL ya Internal standard solution, kapu, ndi kugwedeza kuti muwonetsetse kusakaniza bwino.Lolani chubu kuima mpaka zigawo ziwiri zosiyana zitapangidwa.Tumizani 2.5-3.5 mL kumtunda wosanjikiza mu botolo loyenera, ndikuwonjezera 2.0 mL ya pyridine ndikutsatiridwa ndi 2.5 ml ya N,O-bis(trimethylsilyl) trifluoroacetamide ndi 1% trimethylchlorosilane.Kutenthetsa botolo pa 100 kwa mphindi 10.Kuzizira, ndiyeno onjezerani 12 ml ya isooctane.
Chromatographic system
(Onani Chromatography 621, System Suitability.)
Njira: GC
Chodziwira: Moto ionization
Mzere: 0.25-mm × 15-m fused-silika capillary;yokutidwa ndi filimu ya 0.25-µm ya gawo G27
Kutentha
jekeseni: 280
Chowunikira: 345
Mzere: Onani Table 1.
Table 1
Kutentha Koyamba(°) Kutentha Kwambiri (°/min) Kutentha Komaliza (°) Kusunga Nthawi Pakutentha Komaliza (min)
260 20 340 1
Gasi wonyamula: Helium
Kuthamanga: 1.5 mL / min
Kukula kwa jakisoni: 1 µL
Mtundu wa jakisoni: Chiŵerengero chogawanika, 200:1
Kuyenerera kwadongosolo
Chitsanzo: Njira yothetsera
Zofunikira zoyenera
Chotsalira: NMT 2.0 chapamwamba cha alpha tocopherol
Kupatuka kofananira: NMT 2.0% pa chiyerekezo cha malo a alpha tocopherol pachimake kupita kudera lapakati lokhazikika
Kusanthula
Zitsanzo: Standard solution ndi Sample Solution
Werengani kuchuluka kwa d-alpha tocopherol (C29H50O2) mu gawo la Vitamini E Polyethylene Glycol Succinate yomwe yatengedwa:
Zotsatira = (RU/RS) × (WS/WU) × 100
RU = chiŵerengero chamkati chamkati (malo apamwamba kwambiri a alpha tocopherol / malo apamwamba a muyezo wamkati) kuchokera ku Sample solution
RS = chiŵerengero chamkati chamkati (malo apamwamba kwambiri a alpha tocopherol/malo okwera kwambiri a muyezo wamkati) kuchokera ku Standard solution
WS= kulemera kwa USP Alpha Tocopherol RS yogwiritsidwa ntchito pokonzekera yankho la Standard (mg)
WU= kulemera kwa Vitamin E Polyethylene Glycol Succinate yotengedwa kukonzekera Sample solution (mg)
Njira zolandirira: NLT 25.0%
MAYESO AKE
• Kuzungulira Kwamawonekedwe, Kusintha Kwachindunji 781S
[Zindikirani-Mayesowa amazindikiritsa d-alpha tocopherol pambuyo pa saponification.]
Yankho lachitsanzo: Chotsani 0,9 g wa Vitamin E Polyethylene Glycol Succinate, wosungunuka pa 60, ku chubu choyezera choyenera chokhala ndi kapu, ndikusungunula mu 10.0 ml ya mowa.Ikani chubu mu chotenthetsera chipika pa 100-105.[Zindikirani-Reflux yankho mofatsa popanda kutulutsa zamkati.] Chitsanzocho chikasungunuka kwathunthu, onjezerani 2-3 pellets ya sodium hydroxide, ndipo pitirizani reflux kwa mphindi 30 zowonjezera.Chotsani chubu pakutentha, ndipo zomwe zili mkati zikadali zotentha, chepetsani kugwiritsa ntchito phenolphthalein monga chizindikiro powonjezera pang'onopang'ono 10 ml ya madzi osakaniza ndi hydrochloric acid (1: 1) mpaka mtundu wa pinki utatha.[Chenjezo-Kutengera kwamphamvu.Lolani kuti asidi alowe mkati mwa chubu kuti asaponye.] Muziziziritsa chubu, kapu, ndi gwedezani mpaka zinthuzo zitasakanizika bwino.Onjezerani 25.0 mL wa heptane, kapu, ndikugwedezani kwa mphindi imodzi kuti mutsimikizire kusakaniza bwino.Lolani chubu kuima mpaka zigawo ziwiri zosiyana zitapangidwa.Tumizani chosanjikiza pamwamba pa chubu choyera, chowuma, kenaka onjezerani 10.0 mL yamadzi mu njira yobwezeretsedwa.Kapuni, gwedezani, ndi kulola kuti zigawo zilekanitse.Tumizani chosanjikiza chapamwamba ku chubu choyera, chowuma.Onjezerani 10.0 mL wa potassium ferricyanide solution, wokonzedwa ndi kusungunula 2 g wa potaziyamu ferricyanide mu 10.0 mL wa 0.2 M sodium hydroxide, ndikusintha kapu.Gwirani mwamphamvu kwa 45 s, ndikulola kuti zigawozo zisiyanitse kwa 30 min.Ngati chiwombankhanga chapamwamba cha heptane chikuwonekera bwino, pitirizani ndi kuyeza kwa kuzungulira kwapadera;Ngati sizikumveka bwino, yimitsani pa anhydrous sodium sulfate musanapitirize kuyezetsa.[Zindikirani-Gwiritsani ntchito zotsatira za mayeso a Zomwe zili mu Alpha Tocopherol kuti muwerenge mozungulira.]
Njira zovomerezeka: NLT +24.0
• Kusungunuka mu Madzi
Zitsanzo: 20 g wa wosungunuka Vitamini E Polyethylene Glycol Succinate
Kusanthula: Ikani Chitsanzo mu chidebe chagalasi pa magnetic stirrer.Kenaka yikani 80 ml ya madzi otentha pamene mukuyambitsa.Lolani kuziziritsa kutentha kwa chipinda ndikugwedeza nthawi zonse.
Njira zovomerezera: Yankho likuwonekera mkati mwa 3 h.
• Mtengo wa Acid
Chitsanzo: 1 g ya Vitamini E Polyethylene Glycol Succinate
Kusanthula: Sungunulani Chitsanzo mu 25 ml ya osakaniza mowa ndi efa (1: 1) kuti wakhala neutralized kuti phenolphthalein ndi 0.1 N sodium hydroxide.Onjezani 0,5 mL ya phenolphthalein TS, ndi titrate ndi 0.10 N sodium hydroxide mpaka yankho likhalebe lapinki mutagwedezeka kwa 30 s.
Njira zolandirira: NMT 0.027 mEq/g, yofanana ndi NMT 0.27 mL ya 0.10 N sodium hydroxide
ZOWONJEZERA ZOFUNIKA
• Kupaka ndi Kusunga: Sungani m’zotengera zothina, ndipo sungani motetezedwa ku kuwala.
• Kulemba: Kulembako kumasonyeza d-alpha tocopherol, yowonetsedwa mu mg/g.
• USP Reference Standards 11
USP Alpha Tocopherol RS