Orlistat CAS 96829-58-2 API Tsabtace Tsabtace Nauyi 98.0 ~ 101.5%

Takaitaccen Bayani:

Sunan Chemical: Orlistat

Saukewa: 96829-58-2

Bayyanar: Fari ko Kusan Farin Lu'ulu'u Foda

Tsafta: 98.0 ~ 101.5% na C29H53NO5

Orlistat Nau'in Lipase Nau'in Maganin Rashin Nauyi ne

API High Quality, Kasuwancin Kasuwanci

Tuntuɓi: Dr. Alvin Huang

Wayar hannu/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

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Cikakken Bayani

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96829-58-2 - Bayani:

Shanghai Ruifu Chemical Co., Ltd. shine babban masana'anta na Orlistat (CAS: 96829-58-2) tare da inganci mai inganci, samar da kasuwanci, maganin asarar nauyi.Ruifu Chemical na iya samar da isar da saƙo na duniya, farashi mai gasa, kyakkyawan sabis, ƙanana da adadi mai yawa akwai.Sayi Orlistat,Please contact: alvin@ruifuchem.com

96829-58-2 - Abubuwan Sinadarai:

Sunan Sinadari	Orlistat
Makamantu	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;Saukewa: 18-0647
Lambar CAS	96829-58-2
Matsayin Hannun jari	A cikin Hannun jari, Ma'aunin samarwa Har zuwa Ton
Tsarin kwayoyin halitta	Saukewa: C29H53NO5
Nauyin Kwayoyin Halitta	495.75
Matsayin narkewa	43.0 ℃ ~ 48.0 ℃
Yawan yawa	0.976± 0.06 g/cm3
M	Zafi Sensitive
Solubility	Mai narkewa a cikin Chloroform
Yanayin jigilar kaya	Karkashin Zazzabi
COA & MSDS	Akwai
Alamar	Ruifu Chemical

96829-58-2 - Bayanan Bayani:

Abu	Ƙayyadaddun bayanai
Bayyanar	Fari ko Kusan Farin Crystalline Foda
Identification A	Infrared Absorption
Identity B	Lokacin riƙewa na babban kololuwar mafita na Samfurin ya dace da na daidaitaccen bayani, kamar yadda aka samu a cikin Assay.
Tsarkake / Hanyar Bincike	98.0 ~ 101.5% na C29H53NO5, lasafta a kan anhydrous, ƙarfi-free tushen
Takamaiman Juyawa	-48.0° ~ -51.0°
Ƙaddamar Ruwa	≤0.20%
Ragowa akan Ignition	≤0.10%
Karfe masu nauyi	≤20ppm
Abubuwan da ke da alaƙa da Orlistat A	≤0.20%
Abubuwan da suka danganci Orlistat B	≤0.05%
Formylleucinea	≤0.20%
Abubuwan da suka danganci Orlistat C	≤0.05%
Orlistat Buɗe Ring Epimer	≤0.20%
D-Leucine Orlistat	≤0.20%
Mutun da Ba a Gane Shi Ba	≤0.10%
Abubuwan da ke da alaƙa da Orlistat D	≤0.20%
Orlistat Buɗe Zoben Amide	≤0.10%
Abubuwan da ke da alaƙa da Orlistat E	≤0.20%
Jimlar ƙazanta	≤1.00%
Matsayin Gwaji	Pharmacopoeia na kasar Sin;USP35
Amfani	Sinadarin Magunguna Mai Aiki (API)

Kunshin & Ajiya:

Kunshin:Bottle, Aluminum tsare jakar, 25kg / Kwali Drum, ko bisa ga abokin ciniki ta bukata.
Yanayin Ajiya:Ajiye akwati sosai kuma a adana a wuri mai sanyi, bushe (2 ~ 8 ℃) da ma'ajin da ke da isasshen iska daga abubuwan da ba su dace ba.Nisantar haske mai ƙarfi da zafi, danshi.
Jirgin ruwa:Isar da shi zuwa duniya ta iska, ta FedEx / DHL Express.Bayar da isarwa cikin sauri kuma abin dogaro.

Amfani:

FAQ:

96829-58-2 - Aikace-aikace:

Orlistat sabon nau'in maganin asarar nauyi ne da aka sani na duniya.Sunan kasuwancin sa Sainike kuma ya fara siyarwa a New Zealand a cikin 1998. Orlistat wani dogon lokaci ne kuma yana da matukar tasiri takamaiman mai hana lipase na ciki, kuma ba shi da narkewa a cikin ruwa, mai narkewa a cikin chloroform, kuma cikin sauƙi mai narkewa a cikin ethanol.Ana iya amfani da Orlistat a asibiti don magance kiba.Yawancin lokaci, ana shan kashi na 120mg sau uku a rana a cikin sa'a daya na abinci.Rage nauyi ya fara faruwa bayan makonni biyu na amfani.Ana iya amfani dashi akai-akai don watanni 6-12, kuma tasirin sa zai daina karuwa bayan adadin yau da kullun ya wuce 400mg.Wannan magani ya dace a yi amfani da shi tare da abinci mai ƙarancin kalori ta hanyar masu kiba da masu kiba, kuma ana iya amfani da shi azaman magani na dogon lokaci ga marasa lafiya waɗanda suka fuskanci abubuwan haɗari masu alaƙa da nauyi.Orlistat yana da tasirin sarrafa nauyi na dogon lokaci wanda ke ragewa da kiyaye nauyi kuma yana hana sake dawowa.Yin amfani da Orlistat na iya rage abubuwan da suka faru na abubuwan haɗari masu alaƙa da nauyi da cututtuka, gami da hypercholesterolemia, nau'in ciwon sukari na 2, rashin haƙuri na glucose, hyperinsulinemia, da hauhawar jini, kuma yana iya rage kitse a cikin gabobin.Orlistat kuma yana daidaita matakan lipid na jini: yana iya rage serum triglycerides (TG) da ƙananan ƙarancin lipoprotein cholesterol (LDL-C), kuma yana iya ƙara yawan adadin lipoproteins masu yawa zuwa ƙananan ƙarancin lipoproteins a cikin marasa lafiya masu kiba.

96829-58-2 - USP35 Standard:

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 tare da (3S,4S) -3-hexyl-4-[(2S) -2-hydroxytridecyl]-2-oxetanone [96829-58-2].
BAYANI
Orlistat ya ƙunshi NLT 98.0% da NMT 101.5% na C29H53NO5, an ƙididdige su akan tushen rashin ƙarfi, rashin ƙarfi.
GANO
• A. Ciwon Infrared <197M>
• B. Lokacin riƙewa na babban kololuwar samfurin samfurin ya dace da na daidaitaccen bayani, kamar yadda aka samu a cikin Assay.
ASSAY
• Tsari
[Lura-Kauce wa yin amfani da filayen filastik don shirya ko ɗaukar kowane bayani a cikin wannan bincike.]
Lokacin wayar hannu: Acetonitrile, phosphoric acid, da ruwa (860: 0.05: 140)
Daidaitaccen bayani: 0.5 mg/mL na USP Orlistat RS a cikin lokacin Wayar hannu.Allurar nan da nan bayan shiri ko adana a 5.
Maganin samfurin: 0.5 mg/mL na Orlistat a cikin lokacin Wayar hannu.Allurar nan da nan bayan shiri ko adana a 5.
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: LC
Saukewa: UV195
Tushen: 3.9-mm × 15-cm;4-µm shiryarwa L1
Yawan gudu: 1.0 ml/min
Girman allura: 20µL
Dacewar tsarin
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Matsakaicin madaidaicin dangi: NMT 2.0%
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin orlistat (C29H53NO5) a cikin ɓangaren Orlistat da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × 100
rU = kololuwar amsa daga Maganin Samfurin
rS = kololuwar amsa daga daidaitaccen bayani
CS = maida hankali na USP Orlistat RS a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na Orlistat a cikin Samfurin bayani (mg/mL)
Sharuɗɗan karɓa: 98.0% -101.5% akan tushen rashin ƙarfi, rashin ƙarfi
RASHIN ZUCIYA
Najasa Na Inorganic
• Ragowa akan ƙonewa <281>: NMT 0.1%
• Karfe masu nauyi, Hanyar II <231>: 20 ppm
Najasa Na Halitta
• Hanya na 1: Iyakar Abun da ke da alaƙa da Orlistat A
Daidaitaccen bayani: 0.1 mg/mL na USP Orlistat Related Compound A RS a cikin acetone
Maganin samfurin: 50 MG / ml na Orlistat a cikin acetone
Tsarin chromatographic
(Duba Chromatography <621>, Chromatography na bakin-Layer.)
Yanayin: TLC
Adsorbent: 0.25-mm Layer na chromatographic silica gel cakuda
Girman aikace-aikacen: 10 µL
Haɓaka tsarin ƙarfi: Toluene da ethyl acetate (4: 1)
Maganin ganowa: Canja wurin 2.5 g na phosphomolybdic acid da 1 g na ceric sulfate a cikin 100-mL volumetric flask, narkar da a cikin kuma tsarma da methanol zuwa girma.
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Cire farantin, kuma a bushe shi sosai.Fesa busassun farantin tare da maganin ganowa, kuma sanya farantin a cikin tanda a 120 na minti 30.
Sharuɗɗan karɓa: Duk wani tabo na biyu daga samfurin samfurin da ya dace da mahaɗin da ke da alaƙa da orlistat A bai fi ƙarfin daidai ba daga daidaitaccen bayani (0.2%).
• Hanya na 2: Iyakar Abun da ke da alaƙa da Orlistat B
Daidaitaccen Magani: 0.025 mg/mL na USP Orlistat Mai Haɗin Haɗin B RS a cikin methylene chloride
Maganin samfurin: 50 mg/mL na Orlistat a cikin methylene chloride
Maganin samfurin spiked: 50 mg/mL na Orlistat a daidaitaccen bayani
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: GC
Mai ganowa: ionization na harshen wuta
Rukunin: 0.32-mm x 30-m silica mai haɗaka, an lulluɓe shi da 0.25-µm G27 a tsaye lokaci
Zafin ginshiƙi: Duba teburin shirin zafin jiki a ƙasa.
Zazzabi na farko () Matsayin Zazzabi (/min) Zazzabi na ƙarshe () Riƙe Lokaci a Zazzabi na Ƙarshe (min)
50 4 170 -
170 30 300 30
Zazzabi
Saukewa: 270
Mai ganowa: 280
Gas mai ɗaukar nauyi: Helium
Yawan kwarara: 30ml/min
Raba rabo: 10:1
Girman allura: 2 µL
Dacewar tsarin
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Matsakaicin madaidaicin dangi: NMT 10.0%
Bincike
Samfurori: Samfurin Magani da Maganin samfurin Spiked
Ƙirƙiri adadin abubuwan da ke da alaƙa da orlistat B a cikin ɓangaren Orlistat da aka ɗauka:
Sakamako = [rU/(rSP rU)] × (CS/CT) × 100
rU = kololuwar martani na fili mai alaƙa da orlistat B daga Maganin Samfurin
rSP = kololuwar martani na fili mai alaƙa da orlistat B daga maganin samfurin Spiked
CS = maida hankali na USP Orlistat Related Compound B RS a cikin daidaitaccen bayani (mg/mL)
CT = maida hankali na Orlistat a cikin maganin samfurin Spiked (mg/mL)
Sharuɗɗan karɓa: NMT 0.05% na fili mai alaƙa da orlistat B ana samun su.
• Hanya ta 3
[Lura-Kauce wa yin amfani da filayen filastik don shirya ko ɗaukar kowane bayani a cikin wannan bincike.]
Lokacin Wayar hannu, Daidaitaccen Magani, da Samfurin Magani: Shirya kamar yadda aka umurce a cikin Assay.
Maganin dacewa da tsarin: 10 µg/mL na USP Orlistat RS, 0.1 µg/mL na USP Orlistat Related Compound C RS, da 0.25 μg/mL na USP Orlistat Compound D RS a cikin Wayar hannu lokaci
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Ci gaba kamar yadda aka umarce shi a cikin Assay, sai don chromatograph da tsarin dacewa da tsarin.
Dacewar tsarin
Misali: Maganin dacewa da tsarin
Abubuwan da suka dace
Rarraba siginar-zuwa-amo: NLT 3 don mahaɗin da ke da alaƙa da orlistat C da kololuwa masu alaƙa da fili D.
Matsakaicin madaidaicin dangi: NMT 10.0% don kololuwar orlistat
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Ƙirƙiri adadin kowane ƙazanta a cikin ɓangaren Orlistat da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × (1/F) × 100
rU = kololuwar amsa ga kowane ƙazanta ɗaya daga Maganin Samfurin
rS = kololuwar amsa na USP Orlistat RS daga daidaitaccen bayani
CS = maida hankali na USP Orlistat RS a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na Orlistat a cikin Samfurin bayani (mg/mL)
F = Matsayin martani na dangi kamar yadda aka bayar a Teburin Najasa 1
Sharuɗɗan karɓa: Duba Teburin Najasa 1.
Tebur Najasa 1
Sunan Lokaci Tsayawa Na Dangi Ma'anar Karɓar Ma'anar Amsa, NMT (%)
Formylleucinea 0.10 4.0 0.2
Abubuwan da ke da alaƙa Orlistat C 0.13 33 0.05
Orlistat bude zobe epimerb 0.44 1.0 0.2
Abubuwan da ke da alaƙa da Orlistat D* 0.90 - An ƙididdige shi a ciki
Tsari 4
Orlistat bude zobe amidec* 0.90 - An ƙididdige shi a ciki
Tsari 4
Orlistat 1.00 - -
d-Leucine orlistatd 1.18 1.0 0.2
Najasa wanda ba a tantance shi ba - 1.0 0.1
* Coelutes a cikin wannan tsarin LC, an ƙaddara ta amfani da tsari 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 ko enantiomer.
• Tsari na 4: Iyaka na Abubuwan da ke da alaƙa da Orlistat D
Lokacin wayar hannu: methanol da ruwa (83:17)
Maganin dacewa da tsarin: 4 mg/mL na USP Orlistat RS da 2.4 μg/mL na USP Orlistat Related Compound D RS a cikin acetonitrile, bi da bi.
Daidaitaccen bayani: 5.0 mg/mL na USP Orlistat RS a cikin acetonitrile
Maganin samfurin: 5.0 mg/mL na Orlistat a cikin acetonitrile
Tsarin chromatographic
(Duba Chromatography 621, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: 205 nm
Tushen: 4.0-mm × 25-cm;5-µm shiryarwa L7
Yawan gudu: 0.6 ml/min
Girman allura: 20µL
Dacewar tsarin
Misali: Maganin dacewa da tsarin
Abubuwan da suka dace
Matsakaicin siginar-zuwa-amo: NLT 3 don kololuwar mahaɗan orlistat D
Matsakaicin madaidaicin dangi: NMT 10.0% don kololuwar orlistat
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Ƙirƙiri adadin kowane ƙazanta a cikin ɓangaren Orlistat da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × (1/F) × 100
rU = kololuwar amsa ga kowane ƙazanta ɗaya daga Maganin Samfurin
rS = kololuwar amsa ga USP Orlistat RS daga daidaitaccen bayani
CS = maida hankali na USP Orlistat RS a cikin daidaitaccen bayani (µg/mL)
CU = taro na Orlistat a cikin Samfurin bayani (µg/ml)
F = Matsayin martani na dangi kamar yadda aka samu a Teburin Najasa 2
Sharuɗɗan karɓa: Dubi Shafukan Najasa 2.
Tebur Najasa 2
Sunan Lokaci Tsayawa Na Dangi Ma'anar Karɓar Ma'anar Amsa, NMT (%)
Abubuwan da ke da alaƙa da Orlistat D 0.94 1.0 0.2
Orlistat 1.00 - -
Orlistat bude zobe amidea 1.25 4.3 0.1
wani N-Formyl-l-leucine (S) -1-[(2S,3S) -2-hydroxy-3-[1-phenyl-R-ethylcarbomoyl] nonyl] -dodecyl ester.
• Tsari na 5: Iyaka na Abubuwan da ke da alaƙa da Orlistat E
Buffer: 0.4 N borate bayani, daidaitacce zuwa pH na 10.2
Wakilin Ƙarfafawa: o-Phthaldehyde (OPA) maganin.[Lura-Idan ba za a iya samun kasuwanci ba, ana iya shirya wakilin Derivitizing azaman 1% kowane 3-mercaptopropionic acid da o-phthaldialdehyde a cikin maganin buffer na 0.4M.]
Magani A: Canja wurin 4.1 g na sodium acetate trihydrate da 40 MG na ethylenediaminetetraacetic acid (EDTA) a cikin 1-L flask volumetric.Narke a cikin 950 ml na ruwa, kuma daidaita tare da 0.1 N sodium hydroxide zuwa pH na 7.2.Tsarma da ruwa zuwa girma, ƙara 2.5 ml na tetrahydrofuran, da kuma Mix.Tace, kuma dagas.
Magani B: Canja wurin 2.7 g na sodium acetate trihydrate da 40 MG na EDTA a cikin flask na 1-L.Narke a cikin 200 ml na ruwa, kuma daidaita tare da 0.1 N sodium hydroxide zuwa pH na 7.2.Ƙara 800 ml na acetonitrile, tace, da degas.
Matakin wayar hannu: Duba teburin gradient da ke ƙasa.
Lokaci (min) Magani A (%) Magani B (%)
096.7 3.3
20 60 40
240 100
380 100
38 96.7 3.3
45 96.7 3.3
Madaidaicin bayani: Canja wurin adadi mai ƙima na kusan 0.2 MG na USP Orlistat Related compound E RS cikin 20-mL vial-sarari.Ƙara 10 ml na 4 N sodium hydroxide, kuma rufe vial.Yi zafi da kwanon rufi zuwa 100 don 1 h, sa'an nan kuma ba da damar yin sanyi zuwa zafin jiki.Canja wurin 2 ml na maganin da aka samu a cikin gilashin 50-mL mai girma, kuma a tsoma shi da ruwa zuwa girma.Zuwa 0.5 ml na wannan maganin ƙara 2.0 ml na Buffer da 0.5 ml na wakilin Derivatizing.
Maganin samfurin: Ci gaba kamar yadda aka umarta don daidaitaccen bayani, amma a maimakon haka yi amfani da 25 MG na Orlistat don maye gurbin 0.2 MG na USP Orlistat Related Compound E RS.
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: Fluorescence 340 nm (haɗawa);450 nm (fitarwa)
ginshiƙai
Tsaro: 2.1-mm × 2-cm;50-µm shiryarwa L1
Nazari: 2.1-mm × 20-cm;shirya L1
Yawan gudana: 0.5 ml/min
Girman allura: 20µL
Dacewar tsarin
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Matsakaicin ma'auni na dangi: NMT 6.0% don kololuwar fili E mai alaƙa da orlistat
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin wannan ƙazanta a cikin ɓangaren Orlistat da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × 100
rU = amsa kololuwa don mahaɗin da ke da alaƙa da orlistat E a cikin Samfurin bayani
rS = kololuwar amsa don USP Orlistat Related Compound E RS a cikin Madaidaicin bayani
CS = maida hankali na USP Orlistat Related Compound E RS a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na Orlistat a cikin Samfurin bayani (mg/mL)
Sharuɗɗan karɓa
Rashin ƙazanta ɗaya: NMT 0.2% na abubuwan da ke da alaƙa da orlistat ana samun su.
Jimlar ƙazanta: NMT 1.0% na jimlar ƙazanta ana samun su, ana ƙara sakamakon Tsarin 1, 2, 3, 4, da 5.
MAKAMMAN JARRABAWA
• Juyawar gani, Jujjuya ta musamman <781>
Maganin samfurin: 30 MG / ml a cikin barasa mai bushe
Sharuɗɗan karɓa: Tsakanin -48.0 da -51.0, a 20
• Ƙaddamar da Ruwa, Hanyar Ic <921>: NMT 0.2%
KARIN BUKATA
• Marufi da Ajiya: Ajiye a cikin kwantena da aka rufe da kyau tsakanin 2 da 8 ℃.
• Matsayin Magana na USP <11>
USP Orlistat RS
Abubuwan da ke da alaƙa da USP Orlistat A RS
Abubuwan da ke da alaƙa da USP Orlistat B RS
Abubuwan da ke da alaƙa da USP Orlistat C RS
Abubuwan da ke da alaƙa da USP Orlistat D RS
Abubuwan da ke da alaƙa da USP Orlistat E RS
USP35