Celecoxib CAS 169590-42-5 Assay 98.0~102.0%

Celecoxib
Chithunzi cha C17H14F3N3O2S 381.4
4- [5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide;
p-[5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide [169590-42-5]
TANTHAUZO
Celecoxib ili ndi NLT 98.0% ndi NMT 102.0% ya C17H14F3N3O2S, yowerengedwa pa maziko a anhydrous
CHIZINDIKIRO
• A. KUYAMBIRA KWA INFRARED <197>: [NOTE-Njira <197A>, <197K>, kapena <197M> pansi pa Infrared Absorption zingagwiritsidwe ntchito.]
[Dziwani-Ngati mawonekedwe omwe apezeka akuwonetsa kusiyana, sungunulani chinthu chomwe chiyenera kuyesedwa ndi Reference Standard padera mu mowa wa isopropyl, sungunuke mpaka kuuma, ndi kujambula mawonekedwe atsopano.]
• B. Nthawi yosungira pachimake chachikulu cha Sample solution ikufanana ndi ya Standard solution, monga momwe zapezedwa mu Assay.
ZOYESA
• NTCHITO
Buffer: 2.7 g/L wa monobasic potassium phosphate wosinthidwa ndi phosphoric acid mpaka pH ya 3.0 ± 0.2
Gawo lam'manja: Methanol, acetonitrile, ndi Buffer (3:1:6)
Diluent: Methanol ndi madzi (3: 1)
Njira yothetsera kuyenerera: 0.5 mg/mL ya USP
Celecoxib RS ndi 2.4 µg/mL iliyonse ya USP Celecoxib Related Compound A RS ndi USP Celecoxib Related Compound B RS mu Diluent
Njira yothetsera: 0.5 mg/mL ya USP Celecoxib RS mu Diluent
Yankho lachitsanzo: 0.5 mg/mL ya Celecoxib mu Diluent
Chromatographic system
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Njira: LC
Chowunikira: UV 215 nm
Mzere: 4.6-mm × 25-cm;5-µm kunyamula L11
Kutentha kwapakati: 60 °
Kuthamanga: 1.5 mL / min
Kukula kwa jekeseni: 25µL
Nthawi yothamanga: Pafupifupi nthawi 1.5 kuchuluka kwa celecoxib
Kuyenerera kwadongosolo
Zitsanzo: Njira yothetsera kuyenerera kwadongosolo ndi njira yokhazikika
Zofunikira zoyenera
Kusamvana: NLT 1.8 pakati pa celecoxib yokhudzana ndi gulu A ndi Celecoxib ndi NLT 1.8 pakati pa Celecoxib ndi Celecoxib yokhudzana ndi gulu B, Njira yothetsera vutoli
Kupatuka kofananira: NMT 0.73%, njira yokhazikika
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa C17H14F3N3O2S mu gawo la Celecoxib lomwe latengedwa:
Zotsatira = (rU/rS) × (CS/CU) × 100
rU = kuyankha kwapamwamba kuchokera ku Sample solution
rS = kuyankha kwakukulu kuchokera ku Standard solution
CS = kuchuluka kwa njira yokhazikika (mg/mL)
CU = ndende ya Sample solution (mg/mL)
Njira zolandirira: 98.0% ~ 102.0% pamaziko a anhydrous
ZOCHITSA
Zowonongeka Zachilengedwe
• ZINTHU ZOWERA: NMT 20 ppm
Diluent: Acetone ndi madzi (17:3)
Yankho lokhazikika: Dilute 1.0 mL ya Standard Lead Solution, yokonzedwa molingana ndi Heavy Metals <231>, Special Reagents, ndi Diluent mpaka 20 mL.
Yankho lachitsanzo: Sungunulani 0,50 g wa Celecoxib mu 20mL ya Diluent.
Njira yopanda kanthu: 20 ml ya Diluent
Kusanthula
Zitsanzo: Yankho lokhazikika, yankho lopanda kanthu, ndi yankho lachitsanzo
Pa njira iliyonse yothetsera, onjezerani 2 mL ya pH 3.5 Acetate Buffer yokonzedwa motsogoleredwa ndi Heavy Metals <231>, Njira I. Sakanizani, ndi kuwonjezera pa njira iliyonse 1.2 mL ya thioacetamide-glycerin base TS.Sakanizani nthawi yomweyo, ndikulola kuti muyime kwa 2 min.Dulani njirazo kudzera mu sefa ya 0.45-µm pore size.Yerekezerani mawanga pa zosefera zopezedwa kuchokera ku njira iliyonse.
Njira zolandirira: Mtundu wakuda wa malowo chifukwa cha yankho lachitsanzo siwokulirapo kuposa wamalo obwera chifukwa cha muyezo wa Standard.Kuyesako ndi kosavomerezeka ngati njira ya Standard ilibe mtundu wakuda wabulauni poyerekeza ndi yankho Lopanda kanthu.
ZOKHALA POYATSA <281>: NMT 0.2%, pogwiritsa ntchito chitsulo cha platinamu
Zowonongeka Zachilengedwe
• NTCHITO
Buffer, Mobile phase, Diluent, System suitability solution, Sample solution, ndi Chromatographic system: Pitirizani monga mwauzira mu Assay.
Yankho lokhazikika: 0.5 µg/mL ya USP Celecoxib RS mu Diluent
Kuyenerera kwadongosolo
Zitsanzo: Njira yothetsera kuyenerera kwadongosolo ndi njira yokhazikika
Zofunikira zoyenera
Kusamvana: NLT 1.8 pakati pa Celecoxib yokhudzana ndi gulu A ndi Celecoxib ndi NLT 1.8 pakati pa Celecoxib ndi Celecoxib yokhudzana ndi gulu B, Njira yothetsera vutoli
Chiŵerengero cha Signal-to-Noise: NLT 20, Standard solution
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa zodetsa zilizonse mu gawo la Celecoxib lomwe latengedwa:
Zotsatira = (rU/rS) × (CS/CU) × 100
rU = kuyankha pachimake pachidetso chilichonse muchitsanzo cha yankho
rS = kuyankha kwakukulu kwa celecoxib mu Standard solution
CS = kuchuluka kwa celecoxib mu Standard solution (mg/mL)
CU = kuchuluka kwa Celecoxib mu Sample solution (mg/mL)
Zovomerezeka zovomerezeka
Zodetsedwa paokha: Onani Table 1.
[Dziwani-Musanyalanyaze chiwopsezo chilichonse chodetsedwa chochepera 0.05%.]
Table 1

a 4--[5-(3-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide.
b 4--[3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide.
MAYESO AKE
• KUSINTHA KWA MADZI, Njira I <921>: NMT 0.5%, pogwiritsa ntchito chitsanzo cha 400-mg
ZOWONJEZERA ZOFUNIKA
• KUPAKA NDI KUSUNGA: Sungani m’zotengera zothina, zotetezedwa ku kuwala ndi chinyezi.Sungani kutentha
• MFUNDO ZA USP REFERENCE <11>
USP Celecoxib RS
p-[5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide
Chithunzi cha C17H14F3N3O2S 381.4
USP Celecoxib Related Compound A RS
4- [5-(3-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide.
Chithunzi cha C17H14F3N3O2S 381.4
USP Celecoxib Related Compound B RS
4- [3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide.
Chithunzi cha C17H14F3N3O2S 381.4