Orlistat CAS 96829-58-2 API Tahlehelo ea Boima ba Lithethefatsi Purity 98.0~101.5%
Shanghai Ruifu Chemical Co., Ltd. ke moetsi ea ka sehloohong oa Orlistat (CAS: 96829-58-2) e nang le boleng bo phahameng, tlhahiso ea khoebo, lithethefatsi tsa tahlehelo ea boima ba 'mele.Ruifu Chemical e ka fana ka lits'ebeletso tsa lefats'e ka bophara, theko ea tlholisano, litšebeletso tse ntle haholo, tse nyane le tse ngata tse fumanehang.Reka Orlistat,Please contact: alvin@ruifuchem.com
Lebitso la Lik'hemik'hale | Orlistat |
Litlhaloso tse tšoanang | N-Formyl-L-Leucine (1S) -1-[[(2S,3S)-3-Hexyl-4-Oxo-2-Oxetanyl]Methyl] Dodecyl Ester;(S) -2-Formylamino-4-Methyl-Pentanoic Acid (S) -1-[[(2S,3S)-3-Hexyl-4-Oxo-2-Oxetanyl]Methyl]-Dodecyl Ester ;Tetrahydrolipstatin;Ro-18-0647 |
Nomoro ea CAS | 96829-58-2 |
Boemo ba Setoko | Ka Setokong, Sekhahla sa Tlhahiso Ho fihlela ho Lithane |
Foromo ea limolek'hule | C29H53NO5 |
Boima ba Molek'hule | 495.75 |
Melting Point | 43.0℃~48.0℃ |
Botenya | 0.976±0.06 g/cm3 |
E hloahloa | Mocheso o Mamela |
Solubility | E qhibiliha ka Chloroform |
Boemo ba ho Romela | Tlas'a Mocheso oa Ambient |
COA & MSDS | E fumaneha |
Brand | Ruifu Chemical |
Ntho | Litlhaloso |
Ponahalo | Phofo ea Crystalline e tšoeu kapa e batlang e le tšoeu |
Boitsebiso A | Ho kenngoa ha infrared |
Boitsebiso B | Nako ea ho boloka tlhōrō e kholo ea tharollo ea Sample e lumellana le ea tharollo ea Maemo, joalo ka ha e fumanoe ho Assay. |
Mokhoa oa Bohloeki / Analysis | 98.0 ~ 101.5% ea C29H53NO5, e baloang ka mokhoa oa anhydrous, o se nang solvent |
Phetoho e khethehileng | -48.0° ~ -51.0° |
Boikemisetso ba Metsi | ≤0.20% |
Masalla a ho Ignition | ≤0.10% |
Litšepe tse boima | ≤20ppm |
Motsoako o amanang le Orlistat A | ≤0.20% |
Orlistat Related Compound B | ≤0.05% |
Formylleucinea | ≤0.20% |
Motsoako o amanang le Orlistat C | ≤0.05% |
Orlistat Open Ring Epimer | ≤0.20% |
D-Leucine Orlistat | ≤0.20% |
Tšilafalo ea Motho ka Mong e sa Lemoheng | ≤0.10% |
Orlistat Related Compound D | ≤0.20% |
Orlistat Open Ring Amide | ≤0.10% |
Orlistat Related Compound E | ≤0.20% |
Litšila ka Kakaretso | ≤1.00% |
Tekanyetso ea Teko | Pharmacopoeia ea Sechaena;USP35 |
Tšebeliso | Active Pharmaceutical ingredient (API) |
Sephutheloana:Botlolo, Aluminium foil bag, 25kg/Cardboard Drum, kapa ho ea ka tlhokahalo ea moreki.
Boemo ba polokelo:Boloka setshelo se kwetswe ka thata mme o se boloke sebakeng se phodileng, se omeletseng (2~8℃) le se nang le moya o hlwekileng hole le dintho tse sa dumellaneng.Lula hole le leseli le matla le mocheso, mongobo.
Ho tsamaisa ka sekepe:Tsamaisa lefatšeng ka bophara ka sefofane, ka FedEx / DHL Express.Fana ka thomello e potlakileng le e tšepahalang.
Orlistat ke sethethefatsi se secha se tsebahalang lefatšeng ka bophara sa ho theola boima ba 'mele.Lebitso la eona la khoebo ke Sainike 'me e qalile ho rekisoa New Zealand ka 1998. Orlistat ke nako e telele le e sebetsang haholo e khethehileng ea gastrointestinal lipase inhibitor,' me ha e qhibilihe metsing, e qhibiliha ka chloroform, 'me e qhibiliha habonolo ka ethanol.Orlistat e ka sebelisoa tleliniking ho phekola botenya.Hangata, tekanyo ea 120mg e nkoa ka makhetlo a mararo ka letsatsi nakong ea hora e le 'ngoe ea lijo.Ho lahleheloa ke boima ba 'mele ho qala ho etsahala ka mor'a libeke tse peli tsa tšebeliso.E ka sebelisoa ka ho tsoelang pele bakeng sa likhoeli tse 6-12, 'me liphello tsa eona li tla khaotsa ho eketseha ka mor'a hore tekanyo ea letsatsi le letsatsi e fete 400mg.Setlhare sena se loketse ho sebelisoa hammoho le lijo tse nang le lik'halori tse tlaase ke batho ba batenya le ba batenya, hape li ka sebelisoa e le phekolo ea nako e telele bakeng sa bakuli ba tobaneng le maemo a kotsi a amanang le boima ba 'mele.Orlistat e na le phello ea nako e telele ea ho laola boima ba 'mele e fokotsang le ho boloka boima ba' mele le ho thibela ho khutlela morao.Ho sebelisa Orlistat ho ka fokotsa liketsahalo tsa likotsi le mafu a amanang le boima ba 'mele, ho kenyelletsa hypercholesterolemia, lefu la tsoekere la mofuta oa 2, ho se mamelle tsoekere, hyperinsulinemia le khatello ea mali,' me e ka fokotsa mafura a litho tsa 'mele.Orlistat e boetse e fetola maemo a lipid a mali: e ka fokotsa serum triglycerides (TG) le low density lipoprotein cholesterol (LDL-C), hape e ka eketsa karo-karolelano ea lipoprotein tse phahameng ho isa ho lipoprotein tse tlase ho bakuli ba batenya.
Orlistat
C29H53NO5 495.73
l-Leucine, N-formyl-, 1- [(3-hexyl-4-oxo-2-oxetanyl)methyl]dodecyl ester, [2S-[2(R*), 3]]-;
N-Formyl-l-leucine, ester e nang le (3S,4S) -3-hexyl-4-[(2S) -2-hydroxytridecyl] -2-oxetanone [96829-58-2].
TLHALOSO
Orlistat e na le NLT 98.0% le NMT 101.5% ea C29H53NO5, e baloang motheong oa anhydrous, o se nang solvent.
TS'ELISO TS'OANE
• A. Infrared Absorption <197M>
• B. Nako ea ho boloka tlhōrō e kholo ea tharollo ea Sample e lumellana le ea tharollo ea Maemo, joalo ka ha e fumanoe ho Assay.
TLHOKOMELO
• Tsamaiso
[Tlhokomeliso-Qoba tšebeliso ea lifolakha tsa polasetiki bakeng sa ho lokisa kapa ho boloka tharollo efe kapa efe tlhahlobisong ena.]
Mokhahlelo oa mobile: Acetonitrile, phosphoric acid, le metsi (860: 0.05: 140)
Tharollo e tloaelehileng: 0.5 mg / mL ea USP Orlistat RS karolong ea Mobile.Enta hang ka mor'a ho lokisa kapa boloka ka 5.
Tharollo ea mohlala: 0.5 mg / mL ea Orlistat karolong ea Mobile.Enta hang ka mor'a ho lokisa kapa boloka ka 5.
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Mokhoa: LC
Mosireletsi: UV 195
Kholomo: 3.9-mm × 15-cm;4-µm e paka L1
Sekhahla sa phallo: 1.0 mL/min
Boholo ba ente: 20 µL
Ho nepahala ha sistimi
Mohlala: Tharollo e tloaelehileng
Litlhoko tsa ho tšoaneleha
Tekanyetso e amanang le maemo: NMT 2.0%
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala peresente ea orlistat (C29H53NO5) karolong ea Orlistat e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × 100
rU = karabelo e phahameng ho tsoa ho Sample solution
rS = karabelo ea tlhōrō ho tsoa ho tharollo e tloaelehileng
CS = mahloriso a USP Orlistat RS ka har'a tharollo e tloaelehileng (mg/mL)
CU = mahloriso a Orlistat ho Sample solution (mg/mL)
Mekhoa ea ho amohela: 98.0% -101.5% motheong oa anhydrous, o se nang solvent
LITŠILA
Tšilafalo ea Inorganic
• Masalla a ho Ignition <281>: NMT 0.1%
• Metals e boima, Mokhoa oa II <231>: 20 ppm
Litšila tsa Organic
• Mokhoa oa 1: Moeli oa Orlistat Related Compound A
Tharollo e tloaelehileng: 0.1 mg/mL ea USP Orlistat Related Compound A RS ka acetone
Tharollo ea mohlala: 50 mg / mL ea Orlistat ka acetone
Sistimi ea chromatographic
(Sheba Chromatography <621>, Thin-Layer Chromatography.)
Mokhoa: TLC
Adsorbent: 0.25-mm lera la chromatographic silica gel motsoako
Bophahamo ba kopo: 10 µL
Ho hlahisa mokhoa oa ho qhibilihisa: Toluene le ethyl acetate (4:1)
Tharollo ea ho lemoha: Fetisetsa 2.5 g ea phosphomolybdic acid le 1 g ea cerric sulfate ka har'a botlolo ea volumetric ea 100-mL, qhibiliha 'me u hlapolle ka methanol ho ea bophahamong.
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Tlosa poleiti, 'me ue omise hantle ka moea.Fafatsa poleiti e omisitsoeng ka tharollo ea Detection, 'me u behe poleiti ka ontong ea 120 bakeng sa 30 min.
Mekhoa ea ho amohela: Sebaka leha e le sefe sa bobeli se tsoang ho Sample solution e lumellanang le motsoako o amanang le orlistat A ha o matla ho feta sebaka se lumellanang le tharollo ea Standard (0.2%).
• Mokhoa oa 2: Moeli oa Orlistat Related Compound B
Tharollo e tloaelehileng: 0.025 mg/mL ea USP Orlistat Related Compound B RS ka methylene chloride
Tharollo ea mohlala: 50 mg / mL ea Orlistat ka methylene chloride
Tharollo ea sampuli ea Spiked: 50 mg / mL ea Orlistat ka tharollo e tloaelehileng
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Mokhoa: GC
Mohloli: Ionization ea mollo
Kholomo: 0.32-mm x 30-m silika e kopantsoeng, e koahetsoeng ka karolo e emeng ea 0.25-µm G27
Mocheso oa kholomo: Sheba tafole ea lenaneo la mocheso ka tlase.
Thempereichara ea Pele () Mocheso oa Mocheso (/min) Mocheso oa ho Qetela () Ho Tšoara Nako ka Mocheso oa ho Qetela (mets)
50 4 170 -
170 30 300 30
Mocheso
Ente: 270
Mosireletsi: 280
Khase e tsamaisang thepa: Helium
Sekhahla sa phallo: 30 mL / min
Arohane karo-karolelano: 10:1
Boholo ba ente: 2 µL
Ho nepahala ha sistimi
Mohlala: Tharollo e tloaelehileng
Litlhoko tsa ho tšoaneleha
Tekanyetso e amanang le maemo: NMT 10.0%
Tlhahlobo
Mehlala: Mehlala ea tharollo le tharollo ea sampole ea Spiked
Bala liperesente tsa motsoako o amanang le orlistat B karolong ea Orlistat e nkiloeng:
Sephetho = [rU/(rSP rU)] × (CS/CT) × 100
rU = karabelo ea tlhōrō ea motsoako oa orlistat o amanang le B ho tsoa ho Sample solution
rSP = karabelo ea tlhoro ea motsoako o amanang le orlistat B ho tsoa ho tharollo ea sampole ea Spiked
CS = mahloriso a USP Orlistat Related Compound B RS ka tharollo e tloaelehileng (mg/mL)
CT = mahloriso a Orlistat ka har'a tharollo ea sampole ea Spiked (mg/mL)
Mekhoa ea ho amohela: NMT 0.05% ea motsoako oa orlistat o amanang le B o fumanoa.
• Mokhoa oa 3
[Tlhokomeliso-Qoba tšebeliso ea lifolakha tsa polasetiki bakeng sa ho lokisa kapa ho boloka tharollo efe kapa efe tlhahlobisong ena.]
Mohato oa Mobile, Tharollo e Tloaelehileng, le Mohlala oa tharollo: Lokisetsa joalokaha ho laetsoe ho Assay.
Tharollo ea ho tšoaneleha ha Sisteme: 10 µg/mL ea USP Orlistat RS, 0.1 µg/mL ea USP Orlistat Related Compound C RS, le 0.25 µg/mL ea USP Orlistat Related Compound D RS in Mobile phase
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Tsoela pele joalo ka ha ho laetsoe ho Assay, ntle le ho chromatograph tharollo ea ho lekana ha Sisteme.
Ho nepahala ha sistimi
Mohlala: Tharollo ea ho lekana ha sistimi
Litlhoko tsa ho tšoaneleha
Karo-karolelano ea pontšo-ho-lerata: NLT 3 bakeng sa motsoako o amanang le orlistat C le litlhōrō tse amanang le orlistat D
Phapang e amanang le maemo: NMT 10.0% bakeng sa tlhoro ea orlistat
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liperesente tsa ho se hloeke ka 'ngoe karolong ea Orlistat e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × (1/F) × 100
rU = karabelo ea tlhoro bakeng sa ho se hloeke ha motho ka mong ho tsoa ho Sample solution
rS = karabelo ea tlhōrō ea USP Orlistat RS ho tloha ho Standard solution
CS = mahloriso a USP Orlistat RS ka har'a tharollo e tloaelehileng (mg/mL)
CU = mahloriso a Orlistat ho Sample solution (mg/mL)
F = ntlha e amanang le karabo joalo ka ha e fanoe ho Lethathamo la 1 la Tšilafalo
Mokhoa oa ho amohela: Sheba Lethathamo la 1 la Tšilafalo.
Lethathamo la 1 la Tšilafalo
Bolela Maemo a Mang a Tšebeliso ea Nako ea Karabelo e Amanang ea Karabelo Lintlha tsa Kamohelo, NMT (%).
Formylleucinea 0.10 4.0 0.2
Motsoako o amanang le Orlistat C 0.13 33 0.05
Orlistat e bulehileng lesale epimerb 0.44 1.0 0.2
Motsoako o amanang le Orlistat D * 0.90 - E baloa ho
Mokhoa oa 4
Orlistat bula ring amidec * 0.90 - E baloa ka
Mokhoa oa 4
Orlistat 1.00 - -
d-Leucine orlistatd 1.18 1.0 0.2
Ho se hloeke ha motho ka mong ho sa tsejoeng - 1.0 0.1
* Coelutes tsamaisong ena ea LC, e ikemiselitseng ho sebelisa Ts'ebetso ea 4.
N-Formyl-leucine.
b (2S,3R,5S) -5-[(S)-2-Formylamino-4-methyl-pentanoyloxy] -2-hexyl-3-hydroxy-hexadecanoic acid.
c N-Formyl-l-leucine (S) -1-[(2S,3S)-2-hydroxy-3--[1-phenyl-R-ethylcarbomoyl]nonyl] -dodecyl ester.
d N-Formyl-d-leucine (S) -1-[[(2S,3S) -3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester kapa enantiomer.
• Mokhoa oa 4: Moeli oa Orlistat Related Compound D
Mokhahlelo oa mobile: Methanol le metsi (83:17)
Tharollo ea ho tšoaneleha ha tsamaiso: 4 mg/mL ea USP Orlistat RS le 2.4 µg/mL ea USP Orlistat Related Compound D RS ka acetonitrile, ka ho latellana.
Tharollo e tloaelehileng: 5.0 mg / mL ea USP Orlistat RS ka acetonitrile
Tharollo ea mohlala: 5.0 mg / mL ea Orlistat ka acetonitrile
Sistimi ea chromatographic
(Sheba Chromatography 621, Ho Hlokahala Sistimi.)
Mokhoa: LC
Mosireletsi: 205 nm
Kholomo: 4.0-mm × 25-cm;5-µm e paka L7
Sekhahla sa phallo: 0.6 mL / min
Boholo ba ente: 20 µL
Ho nepahala ha sistimi
Mohlala: Tharollo ea ho lekana ha sistimi
Litlhoko tsa ho tšoaneleha
Karo-karolelano ea pontšo ea lerata: NLT 3 bakeng sa motsoako o amanang le orlistat D tlhōrō
Phapang e amanang le maemo: NMT 10.0% bakeng sa tlhoro ea orlistat
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liperesente tsa ho se hloeke ka 'ngoe karolong ea Orlistat e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × (1/F) × 100
rU = karabelo ea tlhoro bakeng sa ho se hloeke ha motho ka mong ho tsoa ho Sample solution
rS = karabelo ea tlhōrō ea USP Orlistat RS ho tsoa ho Standard solution
CS = mahloriso a USP Orlistat RS ka har'a tharollo e tloaelehileng (µg/mL)
CU = mahloriso a Orlistat ho Sample solution (µg/mL)
F = lebaka la karabelo le lekanyelitsoeng joalo ka ha le fumanoe ho Lethathamo la 2 la Tšilafalo
Mokhoa oa ho amohela: Sheba Lethathamo la 2 la Tšilafalo.
Lethathamo la 2 la Tšilafalo
Bolela Maemo a Mang a Tšebeliso ea Nako ea Karabelo e Amanang ea Karabelo Lintlha tsa Kamohelo, NMT (%).
Motsoako o amanang le Orlistat D 0.94 1.0 0.2
Orlistat 1.00 - -
Orlistat bula lesale amidea 1.25 4.3 0.1
e N-Formyl-l-leucine (S) -1-[(2S,3S)-2-hydroxy-3--[1-phenyl-R-ethylcarbomoyl]nonyl] -dodecyl ester.
• Mokhoa oa 5: Moeli oa Orlistat Related Compound E
Buffer: tharollo ea 0.4 N borate, e lokiselitsoeng ho pH ea 10.2
Moemeli oa ho tsoa: tharollo ea o-Phthaldehyde (OPA).[Tlhokomeliso-Haeba e sa khone ho fumana khoebong, Derivitizing agent e ka lokisoa e le 1% e 'ngoe le e 'ngoe ea 3-mercaptopropionic acid le o-phthaldialdehyde ka tharollo ea 0.4 M borate buffer.]
Tharollo A: Fetisetsa 4.1 g ea sodium acetate trihydrate le 40 mg ea ethylenediaminetetraacetic acid (EDTA) ho 1-L ea volumetric flask.Qhibiliha ka har'a 950 mL ea metsi, 'me u ikamahanye le 0.1 N sodium hydroxide ho pH ea 7.2.Hlakola ka metsi ho ea holimo, eketsa 2.5 mL ea tetrahydrofuran, 'me u kopanye.Sefe, le degas.
Tharollo B: Fetisetsa 2.7 g ea sodium acetate trihydrate le 40 mg ea EDTA ka har'a botlolo ea 1-L ea volumetric.Qhibiliha ka har'a 200 ml ea metsi, 'me u ikamahanye le 0.1 N sodium hydroxide ho pH ea 7.2.Kenya 800 ml ea acetonitrile, sefa, le degas.
Mohato oa Mobile: Sheba tafole ea gradient e ka tlase.
Nako (metsotso) Tharollo A (%) Tharollo B (%)
0 96.7 3.3
20 60 40
24 0 100
38 0 100
38 96.7 3.3
45 96.7 3.3
Tharollo e tloaelehileng: Fetisetsa tekanyo e lekantsoeng ea hoo e ka bang 0.2 mg ea USP Orlistat E amanang le motsoako oa E RS ka har'a vial ea 20-mL ea sebaka sa hlooho.Kenya 10 mL ea 4 N sodium hydroxide, 'me u koale vial.Chesa vial ho 100 bakeng sa 1 h, ebe u lumella ho pholile mocheso oa kamore.Fetisetsa 2 mL ea tharollo e hlahisoang ka botlolo ea volumetric ea 50-mL, 'me u hlapolle ka metsi ho ea bophahamong.Ho 0.5 mL ea tharollo ena eketsa 2.0 mL ea Buffer le 0.5 mL ea Derivatizing agent.
Tharollo ea mohlala: Tsoela pele ka mokhoa o laetsoeng bakeng sa tharollo e tloaelehileng, empa ho e-na le hoo sebelisa 25 mg ea Orlistat ho nkela sebaka sa 0.2 mg sa USP Orlistat Related Compound E RS.
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Mokhoa: LC
Mofuputsi: Fluorescence 340 nm (ho tsosoa);450 nm (khase)
Likholomo
Molebeli: 2.1-mm × 2-cm;50-µm e paka L1
Tlhahlobo: 2.1-mm × 20-cm;ho paka L1
Sekhahla sa phallo: 0.5 mL / min
Boholo ba ente: 20 µL
Ho nepahala ha sistimi
Mohlala: Tharollo e tloaelehileng
Litlhoko tsa ho tšoaneleha
Phapang e amanang le maemo: NMT 6.0% bakeng sa motsoako o amanang le orlistat E tlhoro
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liperesente tsa litšila tsena karolong ea Orlistat e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × 100
rU = karabelo ea tlhōrō bakeng sa motsoako o amanang le orlistat E ka tharollo ea Mohlala
rS = karabelo e phahameng ea USP Orlistat Related Compound E RS ka tharollo e tloaelehileng
CS = mahloriso a USP Orlistat Related Compound E RS ka tharollo e tloaelehileng (mg/mL)
CU = mahloriso a Orlistat ho Sample solution (mg/mL)
Mekhoa ea ho amohela
Ho se hloeke ha motho ka mong: NMT 0.2% ea motsoako oa E o amanang le orlistat e fumanoa.
Kakaretso ea litšila: NMT 1.0% ea kakaretso ea litšila e fumanoa, liphetho tsa Mekhoa ea 1, 2, 3, 4, le 5 li eketsoa.
LITEKO TSEKO
• Optical Rotation, Specific Rotation <781>
Tharollo ea mohlala: 30 mg/mL ka joala bo se nang metsi
Mekhoa ea ho amohela: Pakeng tsa -48.0 le -51.0, ho 20
• Boikemisetso ba Metsi, Mokhoa Ic <921>: NMT 0.2%
KEKELETSO LIHLOKO
• Ho paka le ho Boloka: Boloka ka lijaneng tse koetsoeng hantle pakeng tsa 2 le 8℃.
• USP Reference Standards <11>
USP Orlistat RS
USP Orlistat Related Compound A RS
USP Orlistat Related Compound B RS
USP Orlistat Related Compound C RS
USP Orlistat Related Compound D RS
USP Orlistat Related Compound E RS
USP35