Rabeprazole sulfone
(Synonyms: 雷贝拉唑杂质E) 目录号 : GC49627
A metabolite of rabeprazole
Cas No.:117976-47-3
Sample solution is provided at 25 µL, 10mM.
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Quality Control & SDS
- View current batch:
- Purity: >95.00%
- COA (Certificate Of Analysis)
- SDS (Safety Data Sheet)
- Datasheet
Rabeprazole sulfone is a metabolite of the proton pump inhibitor rabeprazole .1 It is formed from rabeprazole by the cytochrome P450 (CYP) isoform CYP3A. Rabeprazole sulfone has also been found as an impurity in bulk preparations of rabeprazole.2
1.VandenBranden, M., Ring, B.J., Binkley, S.N., et al.Interaction of human liver cytochromes P450 in vitro with LY307640, a gastric proton pump inhibitorPharmacogenetics6(1)81-91(1996) 2.Reddy, G.M., Bhaskar, B.V., Reddy, P.P., et al.Identification and characterization of potential impurities of rabeprazole sodiumJ. Pharm. Biomed. Anal.43(4)1262-1269(2007)
| Cas No. | 117976-47-3 | SDF | Download SDF |
| 别名 | 雷贝拉唑杂质E | ||
| Canonical SMILES | CC1=C(CS(C2=NC3=C(C=CC=C3)N2[H])(=O)=O)N=CC=C1OCCCOC | ||
| 分子式 | C18H21N3O4S | 分子量 | 375.4 |
| 溶解度 | Acetone: slightly,Methanol: slightly | 储存条件 | -20°C |
| General tips | 请根据产品在不同溶剂中的溶解度选择合适的溶剂配制储备液；一旦配成溶液，请分装保存，避免反复冻融造成的产品失效。 储备液的保存方式和期限：-80°C 储存时，请在 6 个月内使用，-20°C 储存时，请在 1 个月内使用。 为了提高溶解度，请将管子加热至37℃，然后在超声波浴中震荡一段时间。 |
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| Shipping Condition | 评估样品解决方案：配备蓝冰进行发货。所有其他可用尺寸：配备RT，或根据请求配备蓝冰。 | ||
| 制备储备液 | |||
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1 mg | 5 mg | 10 mg |
| 1 mM | 2.6638 mL | 13.3191 mL | 26.6383 mL |
| 5 mM | 0.5328 mL | 2.6638 mL | 5.3277 mL |
| 10 mM | 0.2664 mL | 1.3319 mL | 2.6638 mL |
| 第一步：请输入基本实验信息（考虑到实验过程中的损耗，建议多配一只动物的药量） | ||||||||||
| 给药剂量 | mg/kg |  |
动物平均体重 | g | |
每只动物给药体积 | ul | |
动物数量 | 只 |
| 第二步：请输入动物体内配方组成（配方适用于不溶于水的药物；不同批次药物配方比例不同，请联系GLPBIO为您提供正确的澄清溶液配方） | ||||||||||
| % DMSO % % Tween 80 % saline | ||||||||||
| 计算重置 | ||||||||||
计算结果:
工作液浓度： mg/ml；
DMSO母液配制方法： mg 药物溶于 μL DMSO溶液（母液浓度 mg/mL，
体内配方配制方法：取 μL DMSO母液，加入 μL PEG300，混匀澄清后加入μL Tween 80，混匀澄清后加入 μL saline，混匀澄清。
1. 首先保证母液是澄清的；
2.
一定要按照顺序依次将溶剂加入，进行下一步操作之前必须保证上一步操作得到的是澄清的溶液，可采用涡旋、超声或水浴加热等物理方法助溶。
3. 以上所有助溶剂都可在 GlpBio 网站选购。
Development and Validation of a UPLC Method by the QbD-Approach for the Estimation of Rabeprazole and Levosulpiride from Capsules
Sci Pharm 2014 Jan 16;82(2):307-26.PMID:24959404DOI:10.3797/scipharm.1310-17.
Statistical experimental design was used to optimize the chromatographic separations of two pharmaceutical compounds from their respective potential impurities. A fractional factorial design was utilized to study the effects of pH, organic solvent in mobile phases A&B, and flow rate on the resolution of Rabeprazole and Rabeprazole sulfone, which had closely eluting peaks. A desirability function applied to the optimized conditions predicted the peak resolution between 2.2 and 2.7 for the Rabeprazole & Rabeprazole sulfone impurity. The chromatographic method employed an Acquity UPLC, BEH C18 column (100 × 2.1 mm i.d., 1.7 μm particle size) with the mobile phase consisting of a phosphate buffer, pH 6.5, and acetonitrile in a gradient program. The flow rate and injection volumes were 0.45 mL/min & 5 μl, respectively, and detection was done at 254 nm. The chromatographic method was validated for linearity, accuracy, precision, specificity, and ruggedness according to ICH guidelines. The results clearly showed that the quality by design concept could be effectively applied to optimize a UPLC chromatographic method with fewer trials and error-free experimentation.
Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction
J Pharm Biomed Anal 2006 May 3;41(2):565-70.PMID:16442771DOI:10.1016/j.jpba.2005.12.016.
Here, we describe the development of a rapid, simple and sensitive high-performance liquid chromatography (HPLC) method for the simultaneous quantitative determination of rabeprazole enantiomers (1a,b) and their metabolites, rabeprazole-thioether (2) and Rabeprazole sulfone (3), in human plasma. Analytes and the internal standard (omeprazole-thioether) were separated using a mobile phase of 0.5 M NaClO4-acetonitrile (6:4, v/v) over a Chiral CD-Ph column. Analysis required only 100 microl of plasma and involved solid-phase extraction with an Oasis HLB cartridge, which gave high recovery (>91.8%) with good selectivity for all analytes. The lower limit of quantification was 5 ng/ml for analytes 1a, 1b and 3 and 10 ng/ml for 2. Linearity of this assay was determined to lie between 5 and 1000 ng/ml for 1a, 1b and 3 and 10 and 1000 ng/ml for 2 (r2>0.982 of the regression line). Inter- and intra-day coefficients of variation were less than 7.8% and accuracies were within 8.4% over the linear range for all analytes. Our results indicate that this method is applicable to the simultaneous monitoring of plasma levels of rabeprazole enantiomers and associated metabolites in human plasma.