Betamethasone CAS 378-44-9 Maʻemaʻe 97.0%~103.0% API Factory Maʻemaʻe Kiʻekiʻe

Betamethasone
C22 H29FO5 392.46
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11,16)-.
9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione [378-44-9].
Aia ka Betamethasone ma lalo o 97.0 pakeneka a ʻaʻole i oi aku ma mua o 103.0 pakeneka o C22H29FO5, i helu ʻia ma ke kumu maloʻo.
Hoʻopili a mālama ʻia - mālama i loko o nā pahu paʻa.E mālama ma waena o 2 ℃ a me 30 ℃.
Nā kūlana hōʻike USP <11>-
USP Betamethasone RS
ʻike-
A: Infrared Absorption <197M>.
B: Ho'āʻo Hōʻike Kromatographic Layer Thin-Layer <201>-
Hoʻonā hoʻāʻo-E hoʻomākaukau i kahi hopena o Betamethasone i loko o ka waiʻona dehydrated i loaʻa ka 0.5 mg no ka mL.
Ke hoʻomohala nei i ka ʻōnaehana solvent: kahi hui o ka chloroform a me diethylamine (2: 1).
Ke Kaʻina Hana-E hoʻomau e like me ka kuhikuhi ʻana ma ka mokuna, koe wale nō ka ʻimi ʻana i nā kiko ma ke kāpī ʻana me ka waika sulfuric dilute (1 i ka 2) a me ka hoʻomehana ʻana ma kahi pā wela a i ʻole ma lalo o ke kukui a ʻike ʻia nā kiko.
ʻO ka hoʻololi kikoʻī <781S>: ma waena o +118 a me +126, helu ʻia ma ke kumu maloʻo.
Haʻina hoʻāʻo: 5 mg no ka mL, i ka methanol.
Pohō ma ka ho'omalo'o 731-Ho'omalo'o ma 105 no 3 mau hola: 'a'ole e emi ma mua o 1.0% o kona kaumaha.
ʻO ke koena ma ka ʻāʻī 281: ʻaʻole i ʻoi aku ma mua o 0.2%, hoʻohana ʻia kahi pahu platinum.
ʻO nā haumia maʻamau 466-
Haʻina hoʻāʻo: methanol.
Haʻina maʻamau: methanol.
Ka nui o ka noi: 10 µL.
Eluant: ka hui ʻana o toluene, acetone, methyl ethyl ketone, a me formic acid (55:20:20:5), i loko o kahi keʻena i hoʻohālikelike ʻole ʻia.
ʻIkeʻike: 5.
hoʻāʻo-
ʻĀpana Mobile-E hoʻomākaukau i kahi hui ʻana o ka wai a me ka acetonitrile (63:37).Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography 621).
ʻO ka hopena maʻamau i loko-E hoʻomākaukau i kahi hopena o propylparaben i loko o ka waiʻona i ʻike ʻia ma kahi o 0.25 mg no ka mL.
Hoʻomākaukau maʻamau-E hoʻopau i ka nui o ka USP Betamethasone RS i kaupaona pono ʻia i loko o ka waiʻona no ka loaʻa ʻana o kahi hopena i ʻike ʻia ma kahi o 0.2 mg no ka mL.E hoʻololi i 10.0 mL o kēia hāʻina i kahi hue kūpono, a hoʻohui i 10.0 mL o ka hopena maʻamau Kuloko, e loaʻa i kahi hoʻomākaukau maʻamau i ʻike ʻia ma kahi o 0.1 mg o ka betamethasone a ma kahi o 0.125 mg o propylparaben no ka mL.
Hoʻomākaukau hoʻāʻo-E hoʻohana ana ma kahi o 80 mg o Betamethasone, i kaupaona pono ʻia, e hoʻomākaukau e like me ke kuhikuhi ʻana no ka hoʻomākaukau maʻamau.
Pūnaehana Chromatographic (e nānā i ka Chromatography 621)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 240-nm a me kahi kolamu 4.6-mm × 25-cm i loaʻa i ka packing L1.ʻO ka nui o ke kahe e pili ana i 1.0 mL i kēlā me kēia minuke.Chromatograph the Standard preparation, 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 betamethasone a me 1.4 no propylparaben;ʻO ka hoʻonā, R, ma waena o ka betamethasone a me ka propylparaben ʻaʻole i emi iho ma mua o 3.0;a ʻo ka ʻokoʻa maʻamau pili no ka hoʻopiʻi hou ʻana ʻaʻole ia ma mua o 2.0%.
Kaʻina hana-Hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau ʻana i ka Assay i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a ana i nā pane no nā piko nui.E helu i ka nui, ma mg, o C22H29FO5 i loko o ka hapa o Betamethasone i lawe ʻia e ke kumu:
800C(RU / RS)
i loko o ka C ka manaʻo, i ka mg per mL, o USP Betamethasone RS i ka hoʻomākaukau maʻamau;a ʻo RU a me RS nā lakio kiʻekiʻe kiʻekiʻe o ka peak betamethasone a me ka piko maʻamau kūloko i loaʻa mai ka hoʻomākaukau Assay a me ka hoʻomākaukau maʻamau, kēlā me kēia.