Chloramphenicol CAS 56-75-7 Maʻemaʻe ≥99.0% (HPLC) Maʻemaʻe Kiʻekiʻe

Chloramphenicol
C11H12Cl2N2O5 323.13 [56-75-7].
Aia ka Chloramphenicol ma lalo o 97.0 pākēneka a ʻaʻole ʻoi aku ma mua o 103.0 pākēneka o C11H12Cl2N2O5.
Hoʻopili a mālama ʻia - mālama i loko o nā pahu paʻa.
Lepili-Ma kahi i manaʻo ʻia e hoʻohana i ka hoʻomākaukau ʻana i ka injectable a i ʻole nā ​​​​mea hoʻohana sterile ʻē aʻe, ua ʻōlelo ka lepili he sterile a pono e hoʻokō ʻia i ka hana hou ʻana i ka wā o ka hoʻomākaukau ʻana i nā ʻano ʻano injectable a i ʻole nā ​​​​mea ʻē aʻe sterile.
Nā kūlana hōʻike USP <11>-
USP Chloramphenicol RS Kaomi e nānā i ke kūkulu
USP Endotoxin RS
ʻike-
A: Infrared Absorption <197K>.
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.
Māhele heheʻe <741>: ma waena o 149 a me 153.
Ka hoʻololi kikoʻī <781S>: ma waena o +17.0 a me +20.0.
ʻO ka hopena hoʻāʻo: 50 mg, ʻaʻole maloʻo, no ka mL, i loko o ka waiʻona maloʻo.
Crystallinity <695>: kūpono i nā koi.
Bacterial endotoxins 85-Ma kahi o Chloramphenicol i manaʻo ʻia e hoʻohana i ka hoʻomākaukau ʻana i nā ʻano hana injectable, ʻaʻole i ʻoi aku ma mua o 0.2 USP Endotoxin Unit no ka mg o ka chloramphenicol.
Sterility 71- Ma kahi e ʻōlelo ai ka lepili he sterile ʻo Chloramphenicol, hoʻokō ʻo ia i nā koi ke hoʻāʻo ʻia e like me ke kuhikuhi ʻana no ka Membrane Filtration ma lalo o ka hoʻāʻo ʻana no ka maʻemaʻe o ka huahana e nānā ʻia, koe wale nō ka hoʻohana ʻana i 1 g o ka specimen paʻa.
pH <791>: ma waena o 4.5 a me 7.5, i loko o ka wai hoʻokuʻu ʻia he 25 mg no ka mL.
Chromatographic maʻemaʻe-E hoʻoheheʻe i ka nui o Chloramphenicol i kaupaona pololei ʻia i ka methanol e loaʻa ai kahi hopena hoʻāʻo i loaʻa he 10 mg no ka mL.E hoʻomākaukau i ka hopena o USP Chloramphenicol RS i loko o ka methanol me 10 mg no ka mL (Hoʻonā maʻamau A).E hoʻoheheʻe i nā ʻāpana o ka solution maʻamau A me ka methanol no ka loaʻa ʻana o ka solution maʻamau B me 100 µg no ka mL a me ka solution maʻamau C i loaʻa iā 50 µg no mL.E hoʻopili i nā ʻāpana 20-µL kaawale o ka hoʻonā hoʻāʻo a me nā hāmeʻa maʻamau B a me C i kahi pā chromatographic ʻāpana lahilahi kūpono (e nānā i ka Chromatography 621), i uhi ʻia me kahi papa 0.25-mm o ka hui ʻana o ka chromatographic silica gel.E hoʻomohala i ka chromatogram i loko o kahi ʻōnaehana hoʻoheheʻe i hui pū ʻia me ka chloroform, methanol, a me ka ʻakika acetic glacial (79:14:7) a hiki i ka neʻe ʻana o ka ʻūhā mua ma kahi o ʻekolu hapahā o ka lōʻihi o ka pā.Wehe i ka pā mai ke keʻena, maloʻo i ka ea, a nānā ma lalo o ke kukui UV pōkole-lōʻihi: ʻaʻole ʻoi aku ka nui o nā wahi ʻē aʻe ma waho o ka wahi nui i loaʻa mai ka hopena hoʻāʻo i ka nui a i ʻole ka ikaika. ), a ʻo ka huina o nā haumia i hōʻike ʻia e nā kiko āpau ʻē aʻe ma waho o ke kiko nui, ma muli o ka hoʻohālikelike ʻana i ka ikaika o ia mau kiko me ka ikaika o nā kiko nui i loaʻa mai nā ʻano maʻamau B a me C, ʻaʻole i ʻoi aku ma mua o 2% .
hoʻāʻo-
ʻĀpana paʻa-E hoʻomākaukau i kahi hui kānana kūpono o ka wai, methanol, a me ka ʻakika acetic glacial (55:45:0.1).Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography 621).
Hoʻomākaukau maʻamau- E hoʻoheheʻe i ka nui o ka USP Chloramphenicol RS i kaupaona pono ʻia ma ka pae Mobile, a hoʻoheheʻe ʻia me ka nui, a me ka stepwise inā pono, me ka pae Mobile e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 80 µg no mL.E kānana i kahi ʻāpana o kēia hoʻonā ma o kahi kānana porosity 0.5-µm a ʻoi aku ka maikaʻi, a hoʻohana i ka kānana maʻemaʻe e like me ka hoʻomākaukau maʻamau.
Hoʻomākaukau hoʻāʻo- E hoʻololi ma kahi o 200 mg o Chloramphenicol, i kaupaona pono ʻia, i loko o kahi pahu volumetric 100-mL, e hoʻohui i ka pae Mobile i ka leo, a hui.E hoʻololi i 4.0 mL o ka hopena i loko o kahi pahu volumetric 100-mL, e hoʻoheheʻe me ka pae Mobile i ka leo, a hui.E kānana i kahi ʻāpana o kēia hoʻonā ma o kahi kānana porosity 0.5-µm a ʻoi aku ka maikaʻi, a hoʻohana i ka kānana maʻemaʻe e like me ka hoʻomākaukau ʻana i ka Assay.
Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 280-nm a me kahi kolamu 4.6-mm × 10-cm i loaʻa iā 5-µm packing L1.ʻO ka nui o ke kahe e pili ana i 1 mL i kēlā me kēia minuke.ʻO Chromatograph i ka hoʻomākaukau maʻamau, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana ma lalo o ke Kaʻina: ʻo ke kolamu kūpono i hoʻoholo ʻia mai ka analyte peak ʻaʻole i emi iho ma mua o 1800 theoretical plates, ʻaʻole i ʻoi aku ke kumu huelo ma mua o 2.0, a ʻaʻole ʻo ka ʻokoʻa maʻamau pili no nā injections replicate. ʻoi aku ma mua o 1.0%.
Kaʻina hana-[note-E hoʻohana i nā kiʻekiʻe kiʻekiʻe kahi i hōʻike ʻia ai nā pane kiʻekiʻe.] Hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau Assay i loko o ka chromatograph, hoʻopaʻa i nā chromatograms, a ana i nā pane no nā piko nui.E helu i ka nui, ma mg, o C11H12Cl2N2O5 ma ka mahele o Chloramphenicol i laweia e ke kumu:
2.5C(rU / rS)
i loko o ka C ka hoʻopaʻa ʻana, ma µg per mL, o USP Chloramphenicol 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, kēlā me kēia.