Orlistat CAS 96829-58-2 API Ịdị Ọcha Ọgwụ Na-efunahụ 98.0~101.5%

Nkọwa dị mkpirikpi:

Aha Chemical: Orlistat

Ọkụ: 96829-58-2

Ọdịdị: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ White Crystalline ntụ ntụ

Ịdị ọcha: 98.0 ~ 101.5% nke C29H53NO5

Orlistat bụ ụdị Lipase na-egbochi ọgwụ mbelata ibu

API Ogo dị elu, mmepụta azụmahịa

Kpọtụrụ: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Zitere anyị email

Nkọwa ngwaahịa

Ngwaahịa ndị emetụtara

Mkpado ngwaahịa

96829-58-2 - Nkọwa:

Shanghai Ruifu Chemical Co., Ltd. bụ onye na-emepụta Orlistat (CAS: 96829-58-2) nwere àgwà dị elu, mmepụta azụmahịa, ọgwụ na-ebelata ibu.Ruifu Chemical nwere ike ịnye nnyefe zuru ụwa ọnụ, ọnụahịa asọmpi, ọrụ magburu onwe ya, obere na nnukwu ọnụọgụ dị.Zụrụ Orlistat,Please contact: alvin@ruifuchem.com

96829-58-2 - Njirimara Chemical:

Aha Chemical	Orlistat
Ụdị okwu	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
Nọmba CAS	96829-58-2
Ọnọdụ Ahịa	N'ọkwa, Mpụta Ihe ruru Tọn
Usoro ihe omimi	C29H53NO5
Ibu molekụla	495.75
Ebe Na-agbaze	43.0 ℃ ~ 48.0 ℃
Njupụta	0,976±0.06 g/cm3
Mmetụta	Okpomọkụ nwere mmetụta
Solubility	Soluble na Chloroform
Ọnọdụ mbupu	N'okpuru ọnọdụ okpomọkụ
COA & MSDS	Dị
Ụdị	Ruifu Chemical

96829-58-2 - Nkọwapụta:

Ihe	Nkọwapụta
Ọdịdị	White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ọcha kristal ntụ ntụ
njirimara A	Infrared absorption
njirimara B	Oge njide nke nnukwu ọnụ ọgụgụ kachasị elu nke ngwọta Sample dabara na nke Standard Solution, dị ka enwetara na Assay.
Ụzọ ịdị ọcha / nyocha	98.0 ~ 101.5% nke C29H53NO5, gbakọọ na anhydrous, ihe mgbaze-free ndabere
Ntụgharị akọwapụtara	-48.0° ~ -51.0°
Mkpebi mmiri	≤0.20%
Ihe fọdụrụ na mgbanye	≤0.10%
Ọla dị arọ	≤20ppm
Ngwakọta metụtara Orlistat A	≤0.20%
Njikọ Orlistat metụtara B	≤0.05%
Formylleucinea	≤0.20%
Ngwakọta Orlistat metụtara C	≤0.05%
Orlistat Mepee mgbanaka Epimer	≤0.20%
D-Leucine Orlistat	≤0.20%
Ọdịghị ọcha n'otu n'otu na-amataghị	≤0.10%
Ngwakọta Orlistat metụtara D	≤0.20%
Orlistat mepere mgbanaka Amide	≤0.10%
Ngwakọta Orlistat metụtara E	≤0.20%
Mgbakọta adịghị ọcha	≤1.00%
Nlele ọkọlọtọ	Ndị China Pharmacopoeia;USP35
Ojiji	Ngwakọta ọgwụ na-arụ ọrụ (API)

Ngwungwu & Nchekwa:

ngwugwu:Kalama, Aluminom foil bag, 25kg / Cardboard Drum, ma ọ bụ dị ka ndị ahịa chọrọ.
Ọnọdụ Nchekwa:Debe akpa ahụ nke ọma ma chekwaa n'ebe dị jụụ, kpọrọ nkụ (2 ~ 8 ℃) yana ụlọ nkwakọba ihe nke ọma na-esi na ihe ndị na-adabaghị adaba.Zere ọkụ siri ike na okpomọkụ, mmiri mmiri.
Mbupu:Jiri ikuku na-ebuga ụwa niile site na FedEx / DHL Express.Nye nnyefe ngwa ngwa na ntụkwasị obi.

Uru:

Ajụjụ:

96829-58-2 - Ngwa:

Orlistat bụ ụdị ọgwụ mbelata ibu dị ọhụrụ nke mba ụwa matara.Aha azụmahịa ya bụ Sainike na nke mbụ a na-ere na New Zealand na 1998. Orlistat bụ onye na-eme ihe na-eme ka eriri afọ lipase dị ogologo oge ma dị irè, ọ na-esikwaghị ike na mmiri, soluble na chloroform, na-adị mfe soluble na ethanol.Enwere ike iji Orlistat gwọọ oke ibu.Ọtụtụ mgbe, a na-ewere dose nke 120mg ugboro atọ n'ụbọchị n'ime otu awa nke nri.Mbelata ibu na-amalite ime mgbe izu abụọ gachara.Enwere ike iji ya na-aga n'ihu maka ọnwa 6-12, mmetụta ya ga-akwụsị ịba ụba mgbe usoro onunu ogwu kwa ụbọchị gafere 400mg.Ọgwụ a dabara adaba ka ejiri ya na nri nwere obere kalori site n'aka ndị buru oke ibu na ndị buru oke ibu, yana enwere ike iji ya dị ka ọgwụgwọ ogologo oge maka ndị ọrịa chere ihu ihe egwu metụtara ibu.Orlistat nwere mmetụta njikwa ibu dị ogologo oge nke na-ebelata ma na-echekwa ibu ma na-egbochi ịmaliteghachi.Iji Orlistat nwere ike belata ihe omume nke ihe ize ndụ metụtara ibu na ọrịa, gụnyere hypercholesterolemia, ụdị ọrịa shuga 2, nnabata glucose na-adịghị mma, hyperinsulinemia, na ọbara mgbali elu, yana ọ nwere ike ibelata ọdịnaya abụba n'ime akụkụ ahụ.Orlistat na-agbanwekwa ọkwa lipid ọbara: ọ nwere ike ibelata serum triglycerides (TG) na obere njupụta lipoprotein cholesterol (LDL-C), yana ọ nwere ike ịbawanye oke nke lipoproteins dị elu na lipoproteins dị ala na ndị ọrịa buru ibu.

96829-58-2 - ọkọlọtọ USP35:

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 na (3S,4S) -3-hexyl-4-[(2S) -2-hydroxytridecyl]-2-oxetanone [96829-58-2].
Nkọwa
Orlistat nwere NLT 98.0% na NMT 101.5% nke C29H53NO5, gbakọọ na anhydrous, enweghị mgbaze.
Nchọpụta
• A. Infrared absorption <197M>
• B. Oge njide nke isi ọnụ ọgụgụ kachasị elu nke ngwọta Sample dabara na nke Standard Solution, dị ka enwetara na Assay.
ASSAY
• Usoro
[Rịba ama- Zere iji ihe mkpuchi rọba maka nkwadebe ma ọ bụ ijide ihe ngwọta ọ bụla na nyocha a.]
Usoro mkpanaka: Acetonitrile, phosphoric acid, na mmiri (860: 0.05: 140)
Ngwọta ọkọlọtọ: 0.5 mg/mL nke USP Orlistat RS na usoro mkpanaka.Tinye ngwa ngwa mgbe nkwadebe ma ọ bụ chekwaa na 5.
Ihe ngwọta nlele: 0.5 mg/mL nke Orlistat na usoro mkpanaka.Tinye ngwa ngwa mgbe nkwadebe ma ọ bụ chekwaa na 5.
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Ihe nchọpụta: UV 195
Ogidi: 3.9-mm × 15-cm;4-µm mbukota L1
Ọnụego mmiri: 1.0 ml / min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Ngbanwe ọkọlọtọ emetụtara: NMT 2.0%
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent orlistat (C29H53NO5) na akụkụ Orlistat were:
Nsonaazụ = (rU/rS) × (CS/CU) × 100
rU = nzaghachi kacha elu sitere na ngwọta Sample
rS = nzaghachi kacha elu sitere na ngwọta Standard
CS = itinye uche nke USP Orlistat RS na ngwọta ọkọlọtọ (mg/mL)
CU = itinye uche nke Orlistat na ngwọta nlele (mg/mL)
Ụkpụrụ nnabata: 98.0% -101.5% na ihe mgbaze na-enweghị ihe mgbaze.
IHE adịghị ọcha
Ihe adịghị ọcha
• Ihe fọdụrụ na mgbanye <281>: NMT 0.1%
• Ọla dị arọ, Usoro II <231>: 20 ppm
Ihe adịghị ọcha
• Usoro 1: Oke nke ngwakọta Orlistat metụtara A
Ihe ngwọta ọkọlọtọ: 0.1 mg/mL nke USP Orlistat Njikọ Njikọ A RS na acetone
Ngwọta nlele: 50 mg / ml nke Orlistat na acetone
Sistemụ chromatographic
(Lee Chromatography <621>, Chromatography nke dị obere.)
Ụdị: TLC
Adsorbent: 0.25-mm oyi akwa nke chromatographic silica gel ngwakọta
Olu ngwa: 10µL
Sistemụ ihe mgbaze na-emepe emepe: Toluene na ethyl acetate (4: 1)
Ngwọta nchọpụta: Nyefee 2.5 g nke phosphomolybdic acid na 1 g ceric sulfate n'ime 100-mL volumetric flask, gbazee na itughari na methanol na olu.
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Wepu efere ahụ, ma kpochaa ya nke ọma.Fesa efere a mịrị amị na ngwọta nchọpụta, ma tinye efere na oven na 120 maka 30 min.
Nkwenye nnabata: Ebe ọ bụla nke abụọ sitere na ngwọta Sample kwekọrọ na orlistat metụtara compound A adịghị ike karịa ntụpọ kwekọrọ na Standard Solution (0.2%).
• Usoro 2: Oke nke ngwakọta Orlistat metụtara B
Ngwọta ọkọlọtọ: 0.025 mg/mL nke USP Orlistat Njikọ Njikọ B RS na methylene chloride
Ihe ngwọta nlele: 50 mg/mL nke Orlistat na methylene chloride
Ngwọta nlele spiked: 50 mg/mL nke Orlistat na ngwọta ọkọlọtọ
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: GC
Ihe nchọpụta: ionization ọkụ
Ogidi: 0.32-mm x 30-m silica fused, kpuchie ya na 0.25-µm G27 nkeji oge
Okpomọkụ kọlụm: Hụ tebụl mmemme okpomọkụ n'okpuru.
Okpomọkụ mbụ () Ọkụ ọkụ (/min) Okpomọkụ ikpeazụ () Jide oge na okpomọkụ ikpeazụ (min)
50 4 170 -
170 30 300 30
Okpomọkụ
Ntinye: 270
Onye nyocha: 280
Ihe na-ebu gas: Helium
Ọnụego mmiri: 30 ml / min
Oke nkewa: 10:1
Nha igba ogwu: 2µL
Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Ọkọlọtọ emetụtara: NMT 10.0%
Nyocha
Sample: Ngwọta nlele na ngwọta nlele spike
Gbakọọ pasent nke orlistat emetụtara ogige B na akụkụ Orlistat ewepụtara:
Nsonaazụ = [rU/(rSP rU)] × (CS/CT) × 100
rU = nzaghachi kacha elu nke orlistat metụtara ogige B sitere na ngwọta Sample
rSP = nzaghachi kacha elu nke orlistat metụtara ogige B sitere na ngwọta nlele Spiked
CS = ntinye uche nke USP Orlistat Njikọ Njikọ B RS na ngwọta ọkọlọtọ (mg/mL)
CT = ntinye nke Orlistat na ngwọta spiked (mg/mL)
Usoro nnabata: NMT 0.05% nke orlistat metụtara ogige B ka achọtara.
• Usoro nke 3
[Rịba ama- Zere iji ihe mkpuchi rọba maka nkwadebe ma ọ bụ ijide ihe ngwọta ọ bụla na nyocha a.]
Usoro mkpanaaka, Ọkọlọtọ ngwọta, na ngwọta nlele: Kwadebe dị ka a gwara ya na Assay.
Ngwọta kwesịrị ekwesị nke sistemu: 10 µg/mL nke USP Orlistat RS, 0.1 µg/mL nke USP Orlistat metụtara Compound C RS, na 0.25 µg/mL nke USP Orlistat metụtara Compound D RS na usoro mkpanaka.
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Gaa n'ihu dị ka enyere ya na Assay, belụsọ iji chromatograph nke dabara adaba sistemụ.
Sistemu kwesịrị ekwesị
Ọmụma: Ngwọta dabara adaba sistemụ
Kwesịrị ekwesị chọrọ
Mgbama-na- mkpọtụ ruru: NLT 3 maka orlistat metụtara ogige C na orlistat metụtara compound D ọnụ ọnụ.
Ọkọlọtọ emetụtara: NMT 10.0% maka oke orlistat
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent nke adịghị ọcha ọ bụla na akụkụ Orlistat ewepụtara:
Nsonaazụ = (rU/rS) × (CS/CU) × (1/F) × 100
rU = nzaghachi kacha elu maka adịghị ọcha onye ọ bụla site na ngwọta Sample
rS = nzaghachi kacha elu nke USP Orlistat RS sitere na ngwọta ọkọlọtọ
CS = itinye uche nke USP Orlistat RS na ngwọta ọkọlọtọ (mg/mL)
CU = itinye uche nke Orlistat na ngwọta nlele (mg/mL)
F = ihe nzaghachi nke ikwu dị ka e nyere na Tebụl adịghị ọcha 1
Usoro nnabata: Lee Tebụl adịghị ọcha 1.
Tebụl adịghị ọcha 1
Aha Oge Njide Ndị ikwu Nkwekọrịta Nkwekọrịta Nkwekọrịta, NMT (%)
Formylleucinea 0.10 4.0 0.2
Ngwakọta metụtara Orlistat C 0.13 33 0.05
Orlistat meghere mgbanaka epimerb 0.44 1.0 0.2
Ngwakọta metụtara Orlistat D* 0.90 - gbakọrọ na
Usoro 4
Orlistat meghere mgbanaka amidec * 0.90 - gbakọọ na
Usoro 4
Orlistat 1.00 - -
d-Leucine orlistatd 1.18 1.0 0.2
Ihe adịghị ọcha nke onye ọ bụla na-amaghị - 1.0 0.1
* Coelutes na sistemụ LC a, kpebisiri ike site na iji Usoro 4.
N-Formyl-l-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 ma ọ bụ enantiomer.
• Usoro 4: Oke nke Orlistat metụtakwara Compound D
Usoro mkpanaka: methanol na mmiri (83:17)
Ngwọta kwesịrị ekwesị nke sistemu: 4 mg/mL nke USP Orlistat RS na 2.4 µg/mL nke USP Orlistat metụtara Compound D RS na acetonitrile, n'otu n'otu.
Ngwọta ọkọlọtọ: 5.0 mg/mL nke USP Orlistat RS na acetonitrile
Ngwọta nlele: 5.0 mg/mL nke Orlistat na acetonitrile
Sistemụ chromatographic
(Lee Chromatography 621, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Ihe nchọpụta: 205 nm
Ogidi: 4.0-mm × 25-cm;5-µm nkwakọ ngwaahịa L7
Ọnụego mmiri: 0.6 ml/min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị
Ọmụma: Ngwọta dabara adaba sistemụ
Kwesịrị ekwesị chọrọ
Oke mgbaama na mkpọtụ: NLT 3 maka oke orlistat metụtara ogige D
Ọkọlọtọ emetụtara: NMT 10.0% maka oke orlistat
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent nke adịghị ọcha ọ bụla na akụkụ Orlistat ewepụtara:
Nsonaazụ = (rU/rS) × (CS/CU) × (1/F) × 100
rU = nzaghachi kacha elu maka adịghị ọcha onye ọ bụla site na ngwọta Sample
rS = nzaghachi kacha elu maka USP Orlistat RS site na ngwọta ọkọlọtọ
CS = itinye uche nke USP Orlistat RS na ngwọta ọkọlọtọ (µg/mL)
CU = itinye uche nke Orlistat na ngwọta nlele (µg/mL)
F = ihe nzaghachi nke ikwu dị ka enwetara na Tebụl adịghị ọcha 2
Usoro nnabata: Lee Tebụl adịghị ọcha 2.
Tebụl adịghị ọcha 2
Aha Oge Njide Ndị ikwu Nkwekọrịta Nkwekọrịta Nkwekọrịta, NMT (%)
Ngwakọta metụtara Orlistat D 0.94 1.0 0.2
Orlistat 1.00 - -
Orlistat mepere emepe amidea 1.25 4.3 0.1
N-Formyl-l-leucine (S) -1- [(2S,3S) -2-hydroxy-3-[1-phenyl-R-ethylcarbomoyl] nonyl] -dodecyl ester.
• Usoro 5: Oke nke Orlistat metụtakwara ogige E
Ihe nchekwa: 0.4 N ngwọta borate, gbanwee ka ọ bụrụ pH nke 10.2
Ihe na-emepụta ihe: o-Phthaldehyde (OPA) ngwọta.[Rịba ama-Ọ bụrụ na enweghị ike ịnweta azụmaahịa, onye ọrụ Derivitizing nwere ike ịkwado dị ka 1% nke ọ bụla n'ime 3-mercaptopropionic acid na o-phthaldialdehyde na 0.4M borate buffer solution.]
Ngwọta A: Nyefee 4.1 g nke sodium acetate trihydrate na 40 mg nke ethylenediaminetetraacetic acid (EDTA) n'ime flask volumetric 1-L.Gbarie n'ime mmiri 950 ml, ma dozie ya na 0.1 N sodium hydroxide na pH nke 7.2.Tinye mmiri na oke olu, tinye 2.5 ml nke tetrahydrofuran, ma gwakọta ya.Iyo, na degas.
Ngwọta B: Nyefee 2.7 g nke sodium acetate trihydrate na 40 mg nke EDTA n'ime flask volumetric 1-L.Gbarie n'ime mmiri 200 ml, ma dozie ya na 0.1 N sodium hydroxide na pH nke 7.2.Tinye 800 ml nke acetonitrile, nzacha, na degas.
Usoro mkpanaka: Lee tebụl gradient n'okpuru.
Oge (nkeji) Ngwọta A (%) Ngwọta B (%)
0 96.7 3.3
20 60 40
24 0100
38 0100
38 96.7 3.3
45 96.7 3.3
Ngwọta ọkọlọtọ: Nyefee ọnụọgụ nke ihe dị ka 0.2 mg nke USP Orlistat Njikọ Njikọ E RS n'ime vial-isi oghere 20-mL.Tinye 10 ml nke 4 N sodium hydroxide, ma mechie vial.Kpoo vial ahụ ruo 100 maka awa 1, wee kwe ka ọ dị jụụ n'ime ụlọ.Nyefee 2 ml nke ihe ngwọta a ga-esi na ya pụta n'ime 50-mL volumetric flask, ma jiri mmiri na-atụgharị na olu.Na 0.5 ml nke ngwọta a tinye 2.0 ml nke ihe nchekwa na 0.5 ml nke ihe na-emepụta ihe.
Ngwọta nlele: Gaa n'ihu dị ka akwadoro maka ngwọta ọkọlọtọ, mana kama jiri 25 mg nke Orlistat dochie 0.2 mg nke USP Orlistat Related Compound E RS.
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Nchọpụta: Fluorescence 340 nm (ihe mkpali);450 nm (mkpọpu)
Ogidi
Nchekwa: 2.1-mm × 2-cm;50-µm mbukota L1
Nyocha: 2.1-mm × 20-cm;mbukota L1
Ọnụego mmiri: 0.5 ml / min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị
Ihe atụ: Ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Ọkọlọtọ emetụtara: NMT 6.0% maka ogige E kacha elu metụtara orlistat
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent nke adịghị ọcha a na akụkụ Orlistat ewepụtara:
Nsonaazụ = (rU/rS) × (CS/CU) × 100
rU = nzaghachi kacha elu maka orlistat metụtara compound E na ngwọta Sample
rS = nzaghachi kacha elu maka USP Orlistat Njikọ Njikọ E RS na ngwọta ọkọlọtọ
CS = ntinye uche nke USP Orlistat Njikọ Njikọ E RS na ngwọta ọkọlọtọ (mg/mL)
CU = itinye uche nke Orlistat na ngwọta nlele (mg/mL)
Usoro nnabata
Adịghị ọcha nke onye ọ bụla: NMT 0.2% nke orlistat metụtara ogige a hụrụ.
Mkpokọta adịghị ọcha: NMT 1.0% nke mkpokọta adịghị ọcha ka a na-ahụ, a na-agbakwunye nsonaazụ maka Usoro 1, 2, 3, 4, na 5.
Nnwale akọwapụtara
• Ntụgharị anya, ntụgharị akọwapụtara <781>
Ihe ngwọta nlele: 30 mg / ml na mmanya na-egbu egbu
Usoro nnabata: N'etiti -48.0 na -51.0, na 20
• Mkpebi mmiri, Usoro ic <921>: NMT 0.2%
NKWUO GBASARA YA
• Nkwakọ ngwaahịa na Nchekwa: Chekwaa n'ime akpa mechiri emechi nke ọma n'etiti 2 na 8 ℃.
• Ụkpụrụ ntụaka USP <11>
USP Orlistat RS
Ngwakọta jikọrọ USP Orlistat A RS
Ngwakọta jikọtara USP Orlistat B RS
Ngwakọta jikọrọ USP Orlistat C RS
Ngwakọta jikọrọ USP Orlistat D RS
Ngwakọta jikọtara USP Orlistat E RS
USP35