Paclitaxel (Taxol) CAS 33069-62-4 Assay (HPLC) 97.0 ~ 102.0%
Shanghai Ruifu Chemical Co., Ltd jẹ olupilẹṣẹ ti Paclitaxel (Taxol) (CAS: 33069-62-4) pẹlu didara to gaju.Kemikali Ruifu le pese ifijiṣẹ agbaye, idiyele ifigagbaga, iṣẹ ti o dara julọ, kekere ati awọn iwọn olopobobo ti o wa.Ra Paclitaxel (Taxol),Please contact: alvin@ruifuchem.com
| Orukọ Kemikali | Paclitaxel |
| Awọn itumọ ọrọ sisọ | Taxol;Abraxane;Genaxol;Genetaxyl;OncoGel;Pacliex;(-) Paclitaxel |
| Iṣura Ipo | Ni Iṣura, Iṣowo Iṣowo |
| Nọmba CAS | 33069-62-4 |
| Fọọmu Molecular | C47H51NO14 |
| Òṣuwọn Molikula | 853,92 g / mol |
| Ojuami Iyo | 211 ℃ (oṣu kejila) |
| iwuwo | 0.200 |
| Omi Solubility | Ailopin ninu Omi |
| Solubility | Ni irọrun Soluble ni Chloroform, Acetone ati Awọn ojutu Organic miiran. |
| Iduroṣinṣin | Idurosinsin.Ibamu pẹlu Awọn Aṣoju Oxidizing Alagbara.Ijona. |
| COA & MSDS | Wa |
| Apeere | Wa |
| Ipilẹṣẹ | Shanghai, China |
| Brand | Ruifu Kemikali |
| Awọn nkan | Awọn pato | Esi |
| Ifarahan | Funfun Crystalline Powder, Odorless | Ibamu |
| Idanimọ (A) | IR: Concordant pẹlu RS | Ibamu |
| Idanimọ (B) | HPLC: RT Concordant pẹlu RS | Ibamu |
| Yiyi pato | -49,0 ° to -55,0 ° | -52.3° |
| Omi nipa Karl Fischer | ≤4.00% | 0.91% |
| Aloku lori Iginisonu | ≤0.20% | 0.02% |
| Awọn Irin Eru (Pb) | ≤20ppm | <20ppm |
| Awọn akojọpọ ibatan | ||
| Lapapọ | ≤2.00% | 0.11% |
| 10-Deacetylbaccatin III | ≤0.10% | Ko ṣe awari |
| Baccatin III | ≤0.20% | Ko ṣe awari |
| Photodegradant | ≤0.10% | Ko ṣe awari |
| 10-Deacetylpaclitaxel | ≤0.50% | 0.04% |
| 2-Debenzoylpaclitaxel-2-Pentenoate | ≤0.70% | Ko ṣe awari |
| 7-Epipaclitaxel | ≤0.40% | 0.014% |
| 10,13-Bissidechainpaclitaxel | ≤0.50% | 0.022% |
| 7-Acetylpaclitaxel | ≤0.60% | Ko ṣe awari |
| 13-Tes-baccatin III | ≤0.10% | 0.004% |
| 7-Tes-Paclitaxel | ≤0.30% | Ko ṣe awari |
| Awọn Egbin Olukuluku miiran | ≤0.10% | Ibamu |
| 0rganic Iyipada Aimọ | Ibamu | |
| Hexan | ≤290ppm | 31ppm |
| Aceton | ≤5000ppm | 1210ppm |
| Ayẹwo (HPLC) | 97.0 ~ 102.0% (iṣiro lori ipilẹ anhydrous, ipilẹ ti ko ni epo) | 99.88% |
| Makirobia Idiyewo | ||
| Lapapọ Aerobic makirobia kika | ≤100 cfu/g | <100 cfu/g |
| Staphylococcus Aureus | Àìsí | Àìsí |
| Salmonella | Àìsí | Àìsí |
| Escherichia Coli | Àìsí | Àìsí |
| Awọn endotoxins kokoro arun | ≤0.4EU/mg | <0.4EU/mg |
| Ipari | Ọja naa ti ni idanwo ati ni ibamu pẹlu USP43 Paclitaxel | |
Apo:Igo Fluorinated, apo apamọwọ Aluminiomu, 25kg / Paali Drum, tabi gẹgẹbi ibeere alabara.
Ipò Ìpamọ́:Jeki apo eiyan naa ni wiwọ ni pipade ati tọju ni itura, gbẹ (2 ~ 8℃) ati ile-itaja ti o ni afẹfẹ daradara kuro ninu awọn nkan ti ko ni ibamu.Dabobo lati ina ati ọrinrin.
Gbigbe:Firanṣẹ si agbaye nipasẹ afẹfẹ, nipasẹ FedEx / DHL Express.Pese ifijiṣẹ yarayara ati igbẹkẹle.
Paclitaxel
C47H51NO14 853.91
Benzenepropanoic acid, (benzoylamino)--hydroxy-, 6,12b-bis (acetyloxy) -12- (benzoyloxy) -2a,3,4,4a,5,6,9,10,11,12,12a,12b -dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4] benz [1,2-b] oxet-9-yl ester, [2aR-[2a,4,4a,6,9(R*,S*),11,12,12a,12b]]-.
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4,6, 9,11,12,12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4] -benz[1,2-b]oxet-5-ọkan 6, 12b-diacetate, 12-benzoate, 9-ester pẹlu (2R,3S) -N-benzoyl-3-phenylisoserine [33069-62-4].
Paclitaxel ni ko kere ju 97.0 ogorun ati pe ko ju 102.0 ogorun ti C47H51NO14, ṣe iṣiro lori ipilẹ anhydrous, ipilẹ ti ko ni epo.
[Iṣọra-Paclitaxel jẹ cytotoxic.O yẹ ki a ṣe itọju nla lati ṣe idiwọ awọn patikulu ifasimu ti Paclitaxel ati ṣiṣafihan awọ ara si rẹ.]
Iṣakojọpọ ati ibi ipamọ-Fipamọ sinu wiwọ, awọn apoti sooro ina, ati fipamọ ni iwọn otutu yara iṣakoso.
Ifiṣamisi-Ifilelẹ tọkasi iru ilana ti a lo lati ṣe agbejade ohun elo ati idanwo agbo-iṣọpọ ti o ni ibatan pẹlu eyiti ohun elo naa ni ibamu.
Awọn ajohunše Itọkasi USP <11>-
USP Endotoxin RS
USP Paclitaxel RS Tẹ lati Wo Eto
USP Paclitaxel Jẹmọ Agbo A RS
Cephalomannine.
USP Paclitaxel Jẹmọ Agbo B RS
10-Deacetyl-7-Epipaclitaxel.
USP Paclitaxel Aimọ Aimọ RS
Adalu ti Paclitaxel ati awọn agbo ogun ti o ni ibatan wọnyi: propyl analogue, cephalomannine, sec-butyl analog, n-butyl analog, analog benzyl, baccatin VI, analog pentyl, ati 7-epipaclitaxel.
Idanimọ-
A: Gbigba infurarẹẹdi <197K>.
B: Akoko idaduro ti tente oke pataki ni chromatogram ti igbaradi Assay ni ibamu si pe ninu chromatogram ti igbaradi Standard, bi a ti gba ni Assay.
Yiyi pato 781S: laarin 49.0 ati 55.0 ni 20, ṣe iṣiro lori ipilẹ anhydrous, ipilẹ-ọfẹ.
Ojutu idanwo: 10 miligiramu fun milimita, ni methanol.
Awọn idanwo iṣiro microbial <61> ati Awọn idanwo fun awọn microorganisms pàtó <62> - Apapọ iye makirobia aerobic ko kọja 100 cfu fun g.O pade awọn ibeere ti awọn idanwo fun isansa ti Staphylococcus aureus, Pseudomonas aeruginosa, Ẹya Salmonella, ati Escherichia coli.
Awọn endotoxins kokoro-arun 85-Ko ni diẹ sii ju 0.4 USP Endotoxin Unit fun miligiramu ti paclitaxel.
Omi, Ọna Ic <921>: ko ju 4.0%.
Aloku lori ina <281>: ko ju 0.2%.
Awọn irin ti o wuwo, Ọna II <231>: 0.002%.
Awọn nkan ti o jọmọ-
Idanwo 1 (fun ohun elo ti a samisi bi ipinya lati awọn orisun adayeba) Ti ohun elo ba ni ibamu pẹlu idanwo yii, aami aami tọkasi pe o ni ibamu pẹlu Idanwo Awọn agbo ogun ibatan USP.
Diluent-Mura bi a ti ṣe itọsọna ni Assay.
Solusan A-Mura filtered ati degassed acetonitrile.
Solusan B-Mura filtered ati degassed omi.
Alakoso Alagbeka-Lo awọn akojọpọ oniyipada ti Solusan A ati Solusan B gẹgẹbi a ti ṣe itọsọna fun eto Chromatographic.Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography 621).
Ojutu ìbójúmu eto-Tu awọn iwọn wiwọn deede ti USP Paclitaxel Compound Jẹmọ A RS ati USP Paclitaxel Jẹmọ Compound B RS ni methanol lati gba ojutu kan nini awọn ifọkansi ti o mọ ti bii 10 µg ti ọkọọkan fun milimita.Gbigbe 5.0 milimita ti ojutu yii si 50-mL volumetric flask, dilute pẹlu Diluent si iwọn didun, ati dapọ.
Standard ojutu-tu, pẹlu awọn iranlowo ti sonication, ohun parí wọn opoiye ti USP Paclitaxel RS ni Diluent, ati dilute quantitatively, ati stepwise ti o ba wulo, pẹlu Diluent lati gba a ojutu nini a mọ fojusi ti nipa 5 µg fun milimita.
Idanwo ojutu-Lo Assay igbaradi.
Eto Chromatographic (wo Chromatography <621>)) -Kromatograph olomi ti ni ipese pẹlu aṣawari 227-nm ati iwe 4.6-mm × 25-cm ti o ni iṣakojọpọ 5-µm L43.Iwọn sisan jẹ nipa 2.6 milimita fun iṣẹju kan.Awọn iwọn otutu iwe ti wa ni itọju ni 30. Awọn chromatograph ti wa ni siseto bi wọnyi.
Akoko (iṣẹju) Solusan A (%) Solusan B (%) Elution
0–35 35 65 isocratic
35–60 35®80 65®20 itesiwaju laini
60–70 80®35 20®65 itesiwaju laini
70–80 35 65 isocraticChromatograph ojutu ibamu Eto, ati ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: awọn akoko idaduro ibatan jẹ nipa 0.78 fun idapọ ti o ni ibatan paclitaxel A ati 0.86 fun idapọ ti o ni ibatan paclitaxel B (ni ibatan si akoko idaduro fun paclitaxel ti a gba lati ọdọ. ojutu idanwo);ati ipinnu, R, laarin awọn ohun elo ti o ni ibatan paclitaxel ati paclitaxel ti o ni ibatan B ko kere ju 1.0.Chromatograph the Standard ojutu, ati ki o ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: iyapa boṣewa ibatan fun awọn abẹrẹ ẹda ko ju 2.0%.
Ilana-Gbẹ iwọn didun kan (bii 15 µL) ti ojutu Idanwo sinu chromatograph, ṣe igbasilẹ chromatogram, ki o wọn awọn agbegbe fun awọn oke giga.Ṣe iṣiro ipin ogorun aimọ kọọkan ni apakan ti Paclitaxel ti o mu nipasẹ agbekalẹ:
100 (Jimọọ / rU)
ninu eyiti F jẹ ifosiwewe idahun ojulumo fun oke alaimọ kọọkan (wo Tabili 1 fun awọn iye);ri jẹ agbegbe ti o ga julọ fun aimọ kọọkan kọọkan;ati rU jẹ agbegbe ti o ga julọ fun paclitaxel.
Tabili 1
Akoko Idaduro ibatan Opin Idahun ibatan (F) Orukọ Opin (%)
0.24 1.29 Baccatin III 0.2
0.53 1.00 10-Deacetylpaclitaxel 0.5
0.57 1.00 7-Xylosylpaclitaxel 0.2
0.78 1.26 Cephalomannine (Apapọ ti o jọmọ Paclitaxel A) a11
0.78 1.26 2'',3''-Dihydrocephalomanninine a21
0.86 1.00 10-Deacetyl-7-epipaclitaxel (Paclitaxel ti o ni ibatan B) 0.5
1.10 1.00 Benzyl afọwọṣe3 b12
1.10 1.00 3 '',4''-Dehydropaclitaxel C b22
1.40 1.00 7-Epicephalomannin 0.3
1,85 1,00 7-Epipaclitaxel 0,5
1 Ipinnu le jẹ pipe fun awọn oke giga wọnyi, da lori awọn iye ibatan ti o wa;Apapọ a1 ati a2 ko ju 0.5%.
2 Ipinnu le jẹ pe fun awọn oke giga wọnyi, da lori awọn iye ibatan ti o wa;apapọ b1 ati b2 ko ju 0.5%.
3 Orukọ kẹmika ti o tẹle yii ni a yàn si agbo ti o jọmọ, afọwọṣe benzyl:Baccatin III 13-ester pẹlu (2R,3S) -2-hydroxy-3-phenyl-3- (2-phenylacetylamino) propanoic acid.
Ni afikun si ko kọja awọn opin fun awọn impurities ti o ni ibatan paclitaxel ni Table 1, kii ṣe diẹ sii ju 0.1% ti eyikeyi aimọ miiran kan ni a rii;ati pe ko ju 2.0% ti awọn idoti lapapọ ni a rii.
Idanwo 2 (fun ohun elo ti a samisi bi iṣelọpọ nipasẹ ilana semisynthetic) - Ti ohun elo ba ni ibamu pẹlu idanwo yii, aami aami tọkasi pe o pade Idanwo Awọn agbo ogun ibatan USP.
Diluent-Lo acetonitrile.
Solusan A-Lo a filtered ati degassed adalu omi ati acetonitrile (3: 2).
Solusan B-Lo filtered ati degassed acetonitrile.
Alakoso Alagbeka-Lo awọn akojọpọ oniyipada ti Solusan A ati Solusan B gẹgẹbi a ti ṣe itọsọna fun eto Chromatographic.Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography 621).
Ojutu ìbójúmu eto-Tu deede iwọn iwọn ti USP Paclitaxel RS ati USP Paclitaxel Jẹmọ Compound B RS ni Diluent, gbigbọn ati sonicating ti o ba wulo, lati gba ojutu kan nini mọ awọn ifọkansi ti nipa 0.96 mg ati 0.008 mg fun milimita, lẹsẹsẹ.
Idanwo ojutu-Gbigbe lọ si iwọn 10 miligiramu ti Paclitaxel, ni iwọn deede, si 10-mL volumetric flask, tu sinu ati dilute pẹlu Diluent si iwọn didun, gbigbọn ati sonicating ti o ba jẹ dandan, ati dapọ.
Eto Chromatographic (wo Chromatography 621)—Kromatograph olomi ti ni ipese pẹlu aṣawari 227-nm ati iwe 4.6-mm × 15-cm ti o ni iṣakojọpọ 3-µm L1.Iwọn sisan jẹ nipa 1.2 milimita fun iṣẹju kan.Awọn iwọn otutu ọwọn ti wa ni itọju ni 35. Awọn chromatograph ti wa ni siseto gẹgẹbi atẹle.
Akoko (iṣẹju) Solusan A (%) Solusan B (%) Elution
0-20 100 0 isocratic
20-60 100®10 0®90 itesiwaju laini
60-62 10®100 90®0 itọka laini
62-70 100 0 isocraticChromatograph ojutu ibamu System, ati igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: awọn akoko idaduro ibatan jẹ nipa 0.94 fun paclitaxel ti o ni ibatan B ati 1.0 fun paclitaxel;ipinnu, R, laarin paclitaxel ti o ni ibatan yellow B ati paclitaxel ko kere ju 1.2;ati iyapa boṣewa ojulumo fun awọn abẹrẹ ẹda ko ju 2.0%.
Ilana-Lọtọ lọ awọn iwọn didun dogba (nipa 15 µL) ti Diluent ati ojutu idanwo sinu chromatograph, ṣe igbasilẹ awọn chromatograms, ati wiwọn awọn agbegbe fun gbogbo awọn oke giga.Fojusi eyikeyi awọn oke nitori Diluent.Ṣe iṣiro ipin ogorun aimọ kọọkan ni apakan ti Paclitaxel ti o mu nipasẹ agbekalẹ:
100 (Jimọọ / s)
ninu eyiti F jẹ ifosiwewe idahun ojulumo fun aimọ kọọkan (wo Tabili 2 fun awọn iye);ri jẹ agbegbe ti o ga julọ fun aimọ kọọkan ti a gba lati inu ojutu Idanwo;ati rs ni apao awọn agbegbe ti gbogbo awọn oke ti o gba lati ojutu Idanwo.
Tabili 2
Akoko Idaduro ibatan Opin Idahun ibatan (F) Orukọ Opin (%)
0.11 1.24 10-Deacetylbaccatin III 0.1
0.20 1.29 Baccatin III 0.2
0.42 1.39 Photodegradant2 0.1
0,47 1.00 10-Deacetylpaclitaxel 0,5
0.80 1.00 2-Debenzoylpaclitaxel-2-pentenoate 0.7
0.921 1.00 Oxetane oruka ṣiṣi, acetyl ati benzoyl migrated2 x1
0.921 1.00 10-Acetoacetylpaclitaxel x2
0.941 1.00 10-Deacetyl-7-epipaclitaxel (Paclitaxel ti o ni ibatan B) x3
1.37 1.00 7-Epipaclitaxel 0.4
1.45 1.00 10,13-Bissidechainpaclitaxel2 0.5
1.54 1.00 7-Acetylpaclitaxel 0.6
1,80 1,75 13-Tes-baccatin III 0,1
2.14 1.00 7-Tes-paclitaxel 0.3
1 Ipinnu le jẹ pipe fun awọn oke giga wọnyi, da lori awọn iye ibatan ti o wa;apao x1, x2, ati x3 ko ju 0.4%.
2 Awọn orukọ kemikali wọnyi ni a yàn si awọn agbo-ara ti o jọmọ Photodegradant;Oxetane oruka ṣii, acetyl ati benzoyl losi;ati 10,13-Bissidechainpaclitaxel:
Photodegradant
(1R,2R,4S,5S,7R,10S,11R,12S,13S,15S,16S)-2,10-diacetyloxy-5,13-dihydroxy-4,16,17,17-tetramethyl-8-oxa- 3-oxo-12-phenylcarbonyloxypentacyclo[11.3.1.01,11.04,11.07,10] heptadec-15-yl
(2R,3S)-2-hydroxy-3-phenyl-3- (phenylcarbonylamino) propanoate
Oxetane oruka ti ṣii, acetyl ati benzoyl losi
(1S,2S,3R,4S,5S,7S,8S,10R,13S)-5,10-diacetyloxy-1,2,4,7-tetrahydroxy-8,12,15,15-tetramethyl-9-oxo- 4- (phenylcarbonyloxymethyl) tricyclo[9.3.1.03,8] pentadec-11-en-13-yl
(2R,3S)-2-hydroxy-3-phenyl-3- (phenylcarbonylamino) propanoate
10,13-Bissidechainpaclitaxel
Baccatin III 13-ester pẹlu (2R,3S) -2-hydroxy-3-phenyl-3- (phenylcarbonylamino) propanoic acid, 10-ester pẹlu (2S,3S) -2-hydroxy-3-phenyl-3- (phenylcarbonylamino). )propanoic acid
Ni afikun si ko kọja awọn opin fun awọn impurities ti o ni ibatan paclitaxel ni Table 2, kii ṣe diẹ sii ju 0.1% ti eyikeyi aimọ miiran kan ni a rii;ati pe ko ju 2.0% ti awọn idoti lapapọ ni a rii.
idanwo 3 (fun awọn ohun elo ti a samisi gẹgẹbi iṣelọpọ nipasẹ ilana ilana bakteria sẹẹli) - Ti ohun elo naa ba ni ibamu pẹlu idanwo yii, aami aami tọkasi pe o ni ibamu pẹlu Idanwo Awọn agbo ogun ibatan USP.
Solusan A-Mura a filtered ati degassed adalu omi ati acetonitrile (3: 2).
Solusan B-Mura filtered ati degassed acetonitrile.
Alakoso Alagbeka-Lo awọn akojọpọ oniyipada ti Solusan A ati Solusan B gẹgẹbi a ti ṣe itọsọna fun eto Chromatographic.Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography 621).
Ojutu ìbójúmu eto-Tu USP Paclitaxel Aimọ Adalu RS ni acetonitrile, sonicating ti o ba wulo, lati gba a ojutu nini a mọ fojusi ti nipa 1 miligiramu fun milimita.
Standard ojutu-tu ohun parí wọn opoiye ti USP Paclitaxel RS ni acetonitrile, sonicating ti o ba wulo, lati gba a ojutu nini a mọ fojusi ti nipa 1 miligiramu fun milimita.
Ojutu idanwo-Gbigbe lọ si nkan bii miligiramu 10 ti Paclitaxel, ni iwọn deede, si ọpọn iwọn didun 10-mL.Tu sinu ati dilute pẹlu acetonitrile si iwọn didun, sonicating ti o ba jẹ dandan, ati dapọ.
Eto Chromatographic (wo Chromatography 621)—Kromatograph olomi ti ni ipese pẹlu aṣawari 227-nm ati iwe 4.6-mm × 15-cm ti o ni iṣakojọpọ 3-µm L1.Iwọn sisan jẹ nipa 1.2 milimita fun iṣẹju kan.Awọn chromatograph ti wa ni siseto bi atẹle.
Akoko (iṣẹju) Solusan A (%) Solusan B (%) Elution
0-28 100 0 isocratic
28-33 100®98 0®2 itọka laini
33–58 98®10 2®90 itesiwaju laini
58-60 10 90 isocratic
60-63 10®100 90®0 itesiwaju laini
63-70 100 0 isocraticChromatograph ojutu ibamu System, ati igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: ipinnu, R, laarin paclitaxel ati afọwọṣe benzyl ko kere ju 1.8.Chromatograph the Standard ojutu, ati ki o ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: iyapa boṣewa ibatan fun awọn abẹrẹ ẹda ko ju 2.0%.[akọsilẹ-Fun idi ti idanimọ ti o ga julọ, awọn akoko idaduro isunmọ isunmọ ni a fun ni Table 3. Awọn akoko idaduro ojulumo jẹ iwọn si Paclitaxel.]
Tabili 3
Orúkọ Opin Akoko Idaduro ibatan (%)
Propyl afọwọṣe1 0.54 0.2
Cephalomannine (Paclitaxel ti o ni ibatan agbo A) 0.76 0.5
sec-Butyl afọwọṣe2 0.81 0.2
n-Butyl afọwọṣe3 0,89 0.1
Benzyl afọwọṣe 1.10 0.4
Baccatin VI 1.23 0.2
Pentyl afọwọṣe4 1.31 0.2
7-Epipaclitaxel 1.51 0.4
1 Orukọ kẹmika ti o tẹle yii ni a yàn si agbo ti o jọmọ Propyl analog:Baccatin III 13-ester pẹlu (2R,3S) -3-butanoylamino-2-hydroxy-3-phenylpropanoic acid.
2 Orukọ kẹmika ti o tẹle yii ni a yàn si agbo-ara ti o jọmọ sec-Butyl analog:Baccatin III 13-ester pẹlu (2R,3S) -2-hydroxy-3- (2-methylbutanoylamino) -3-phenylpropanoic acid.
3 Orukọ kẹmika ti o tẹle yii ni a yàn si apapọ n-Butyl afọwọṣe:Baccatin III 13-ester pẹlu (2S,3S) -2-hydroxy-3- (pentanoylamino) -3-phenylpropanoic acid.
4 Orukọ kẹmika ti o tẹle yii ni a yàn si apapọ Pentyl afọwọṣe:Baccatin III 13-ester pẹlu (2R,3S)-3-(hexanoylamino) -2-hydroxy-3-phenylpropanoic acid.
Ilana-Gbẹ iwọn didun kan (bii 12 µL) ti ojutu Idanwo sinu chromatograph, ṣe igbasilẹ chromatogram, ki o wọn awọn agbegbe fun gbogbo awọn oke giga.Ṣe iṣiro ipin ogorun aimọ kọọkan ni apakan ti Paclitaxel ti o mu nipasẹ agbekalẹ:
100(ri/rU)
ninu eyiti ri ni esi ti olukuluku aimọ;ati rU ni apao awọn agbegbe ti gbogbo awọn oke ti o gba lati ojutu Idanwo.Ni afikun si ko kọja awọn opin fun awọn impurities ti o ni ibatan paclitaxel ni Table 3, kii ṣe diẹ sii ju 0.1% ti eyikeyi aimọ ẹyọkan miiran ni a rii;ati pe ko ju 2.0% ti awọn idoti lapapọ ni a rii.
Ayẹwo-
Diluent-Mura adalu kẹmika ati acetic acid (200: 1).
Mobile alakoso-Mura a filtered ati degassed adalu omi ati acetonitrile (11:9).Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography 621).
Standard igbaradi-tu, lilo sonication ti o ba wulo, ohun parí wọn opoiye ti USP Paclitaxel RS ni diluent, ki o si dilute pipo, ati stepwise ti o ba wulo, pẹlu diluent lati gba a ojutu nini a mọ fojusi ti nipa 1 miligiramu fun milimita.
Igbaradi Assay-Gbigbe lọ si nkan bii miligiramu 10 ti Paclitaxel, ni iwọn deede, si ọpọn iwọn didun 10-mL kan.Tu ni Diluent, lilo sonication ti o ba jẹ dandan, dilute pẹlu Diluent si iwọn didun, ati dapọ.
Eto Chromatographic (wo Chromatography <621>)) -Kromatograph olomi ti ni ipese pẹlu aṣawari 227-nm ati iwe 4.6-mm × 25-cm ti o ni iṣakojọpọ 5-µm L43.Iwọn sisan jẹ nipa 1.5 milimita fun iṣẹju kan.Chromatograph awọn Standard igbaradi, ati ki o gbasilẹ awọn idahun tente bi a ti ṣe itọsọna fun Ilana: ifosiwewe iru wa laarin 0.7 ati 1.3;ati iyapa boṣewa ibatan fun awọn abẹrẹ ẹda ko ju 1.5%.
Ilana-Lọtọ ara awọn ipele dogba (bii 10 µL) ti igbaradi Standard ati igbaradi Assay sinu chromatograph, ṣe igbasilẹ awọn chromatograms, ati wiwọn awọn agbegbe fun awọn oke giga.Ṣe iṣiro opoiye, ni mg, ti C47H51NO14 ni apakan ti Paclitaxel ti o mu nipasẹ agbekalẹ:
10C(rU/rS)
ninu eyiti C jẹ ifọkansi, ni mg fun mL, ti USP Paclitaxel RS ni igbaradi Standard;ati rU ati rS jẹ awọn idahun ti o ga julọ fun paclitaxel ti a gba lati igbaradi Assay ati igbaradi Standard, lẹsẹsẹ.
Bawo ni lati Ra?Jọwọ kan siDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
15 Ọdun Iriri?A ni diẹ sii ju ọdun 15 ti iriri ni iṣelọpọ ati okeere ti ọpọlọpọ awọn agbedemeji elegbogi didara tabi awọn kemikali to dara.
Awọn ọja akọkọ?Ta si ọja ile, North America, Europe, India, Korea, Japanese, Australia, ati be be lo.
Awọn anfani?Didara to gaju, idiyele ifarada, awọn iṣẹ alamọdaju ati atilẹyin imọ-ẹrọ, ifijiṣẹ yarayara.
DidaraIdaniloju?Eto iṣakoso didara to muna.Awọn ohun elo ọjọgbọn fun itupalẹ pẹlu NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, bbl
Awọn apẹẹrẹ?Pupọ awọn ọja pese awọn apẹẹrẹ ọfẹ fun igbelewọn didara, idiyele gbigbe yẹ ki o san nipasẹ awọn alabara.
Ayẹwo ile-iṣẹ?Ayẹwo ile-iṣẹ kaabo.Jọwọ ṣe ipinnu lati pade ni ilosiwaju.
MOQ?Ko si MOQ.Ibere kekere jẹ itẹwọgba.
Akoko Ifijiṣẹ? Ti o ba wa laarin ọja iṣura, iṣeduro ifijiṣẹ ọjọ mẹta.
Gbigbe?Nipa Express (FedEx, DHL), nipasẹ Air, nipasẹ Okun.
Awọn iwe aṣẹ?Lẹhin iṣẹ tita: COA, MOA, ROS, MSDS, ati bẹbẹ lọ ni a le pese.
Aṣa Synthesis?Le pese awọn iṣẹ iṣelọpọ aṣa lati baamu awọn iwulo iwadii rẹ dara julọ.
Awọn ofin sisan?Iwe risiti Proforma yoo firanṣẹ ni akọkọ lẹhin ijẹrisi aṣẹ, ti ifi alaye banki wa sinu.Isanwo nipasẹ T/T (Telex Gbigbe), PayPal, Western Union, ati bẹbẹ lọ.
Awọn aami ewu Xn - ipalara
Awọn koodu Ewu R37/38 - Irritating si eto atẹgun ati awọ ara.
R41 - Ewu ti pataki ibaje si oju
R42/43 - Le fa ifamọ nipasẹ ifasimu ati olubasọrọ ara.
R62 - Owun to le ewu ti bajẹ irọyin
R68 - Owun to le ewu ti irreversible ipa
R40 - Ẹri to lopin ti ipa carcinogenic
R48 - Ewu ti pataki ibaje si ilera nipa pẹ ifihan
R20/21/22 - Ipalara nipasẹ ifasimu, ni olubasọrọ pẹlu awọ ara ati ti o ba gbe.
R68/20/21/22 -
Apejuwe Aabo S22 - Maṣe simi eruku.
S26 - Ni ọran ti olubasọrọ pẹlu awọn oju, fi omi ṣan lẹsẹkẹsẹ pẹlu ọpọlọpọ omi ki o wa imọran iṣoogun.
S36/37/39 - Wọ aṣọ aabo to dara, awọn ibọwọ ati aabo oju / oju.
S45 - Ni ọran ti ijamba tabi ti o ba ni ailara, wa imọran iṣoogun lẹsẹkẹsẹ (fi aami han nigbakugba ti o ṣee ṣe.)
UN ID 1544
WGK Germany 3
RTECS DA8340700
FLUKA BRAND F CODES 10-21
HS koodu 2932999021
Ewu Kilasi 6.1(b)
Iṣakojọpọ Ẹgbẹ III
Majele LD50 intraperitoneal ninu Asin: 128mg/kg
Paclitaxel (Taxol) (CAS: 33069-62-4), ọja adayeba ti o ya sọtọ lati epo igi ti Pacific yew, jẹ doko ni atọju akàn ọjẹ-ara metastatic refractory.Ko dabi awọn aṣoju antineoplastic miiran, paclitaxel yoo han lati ni ọpọlọpọ awọn ilana iṣe ti iṣe, pẹlu iṣe antimicrotubule nipasẹ igbega ti tubulin polymerization ati imuduro ti awọn microtubules, nitorinaa, dẹkun mitosis ati igbega iku sẹẹli.Ipese ti paclitaxel ni opin nipasẹ opoye adayeba kekere rẹ ati lọwọlọwọ o ti jẹ iṣelọpọ nipasẹ ọna ologbele-synthetic lati deacetylbaccatin Ⅲ ti o ya sọtọ si awọn abere igi yew.Ipari aipẹ ti awọn akojọpọ lapapọ meji ti taxol ṣẹgun idiju igbekalẹ ti akopọ akọle ati pe o le wulo ni gbigba awọn afọwọṣe ti o ni ibatan pẹkipẹki, diẹ ninu eyiti a ti rii lati ni iṣẹ antitumor.Paclitaxel ni awọn lilo ti o pọju ni itọju ti akàn igbaya metastatic, akàn ẹdọfóró, akàn ori ati ọrun, ati melanoma buburu.
Awọn eroja majele ti o wa ninu awọn ẹka ati awọn leaves ti Taxus chinensis ni a yapa ni 1856 ati pe a fun ni orukọ "taxine," eyiti a mọ gẹgẹbi iru paati alkaloid funfun kan.Lọwọlọwọ, laarin gbogbo awọn oogun antitumor, tita paclitaxel di akọkọ ni agbaye bi oogun akàn ti a mọ daradara pẹlu iṣẹ ṣiṣe gbooro-spekitiriumu.Ni Oṣu Kẹwa ti ọdun 1995, China di orilẹ-ede keji pẹlu iṣelọpọ ti paclitaxel ati abẹrẹ rẹ ni agbaye.Aṣeyọri naa ni a gba labẹ awọn igbiyanju ailopin ti awọn oniwadi ni Institute of Materia Medica, Ile-ẹkọ giga Kannada ti Awọn sáyẹnsì Iṣoogun.
Paclitaxel (CAS: 33069-62-4) jẹ ẹya antineoplastic ti o lo lati toju awọn alaisan ti o ni ẹdọfóró, ovarian, oyan akàn, ori ati ọrun akàn, ati advanc ed fọọmu ti Kaposi's sarcoma.Paclitaxel jẹ inhibitor mitotic ti a lo ninu kimoterapi akàn.O tun lo ninu iwadi ti eto ati iṣẹ ti microtubles sinu tubulin.
Paclitaxel ni ipa ti o dara lori akàn ovarian refractory ati akàn igbaya pẹlu resistance oogun gẹgẹbi akàn ọjẹ ati Pilatnomu, ati ireti ti o dara fun itọju akàn pirositeti, akàn ori ati ọrun, akàn esophageal, tumo sẹẹli germ, akàn endometrial, lymphoma, akàn àpòòtọ, akàn ẹ̀jẹ̀ apá òkè, sẹ́ẹ̀lì kékeré àti akàn ẹ̀dọ̀fọ́ tí kìí ṣe kékeré.
Paclitaxel (Taxol) (CAS: 33069-62-4) jẹ eka pupọ kan, ohun elo Organic ti o ya sọtọ lati epo igi ti igi yew Pacific.O sopọ mọ awọn dimers tubulin ati awọn filaments microtubulin, igbega apejọ ti awọn filamenti ati idilọwọ depolymerization wọn.Ilọsoke yii ni iduroṣinṣin ti microfilaments awọn abajade ni idalọwọduro ti mitosis ati cytotoxicity ati idilọwọ awọn iṣẹ microtubular deede miiran, gẹgẹbi gbigbe axonal ninu awọn okun nafu ara.Ilana pataki ti resistance ti a ti ṣe idanimọ fun paclitaxel ni gbigbe jade kuro ninu awọn sẹẹli tumo, eyiti o yori si idinku ikojọpọ oogun intracellular.Fọọmu atako yii jẹ ilaja nipasẹ olutaja oogun pupọ P-glycoprotein.
Le jẹ ifarabalẹ si ifihan gigun si ọrinrin.
