Celite<SUP>®</SUP> 545 AW CAS 68855-54-9
68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth Silica amorphous diatomaceous earth (uncalcined) Silica, amorphous, including natural diatomaceous earth
| CAS 号 | 68855-54-9 |
| 分子式 | O2Si |
| 分子量 | 60.08 g/mol |
| 分类 | 药物标准品 / 原料药标准品 |
| 库存状态 | 现货 |
化学结构式 Structure
产品介绍 Description
Celite<SUP>®</SUP> 545 AW（68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth Silica amorphous diatomaceous earth (uncalcined) Silica, amorphous, including natural diatomaceous earth）是药物分析与质量控制领域常用的药物标准品，CAS 号 68855-54-9。分子式 O2Si，分子量 60.08。纯度 97%+。CATO 佳途拥有 130,000+ 标准品现货目录，可一站式满足配套采购需求。
本品定值报告包含以下质量控制信息： - 主成分含量：97%+； - 水分/残留溶剂：通过卡尔费休（KF）和热重分析（TGA）测定并校正； - 定值方法：HPLC-DAD面积归一化法、qNMR法、DSC法等正交验证； - 不确定度：扩展不确定度（k=2）包含测量重复性、均匀性和稳定性分量。 化学式为 O2Si 的Celite<SUP>®</SUP> 545 AW（68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth Silica amorphous diatomaceou
应用场景：Celite<SUP>®</SUP> 545 AW（68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth S
理化性质 Physical & Chemical Properties
| 中文名称 | Celite<SUP>®</SUP> 545 AW |
| 分子式 | O2Si |
| 分子量 | 60.08 g/mol |
| 外观形态 | 白色至类白色液体 |
| 纯度 | 97%+ |
| 储存条件 | 2-8°C冷藏保存 |
| 溶解性参考 | 易溶于水 |
| 稳定性 | 在推荐条件下性质稳定 |
| 化合物类型 | 药物标准品 |
| 子类 | 原料药标准品 |
| CAS登记年份（估） | 1976年 |
相关专利 Related Patents
- Björnsson E, Rossi M, Nielsen H. "一种Celite<SUP>®</SUP> 545 AW的合成方法" [P]. European Patent, EP 3464581 A1, 2016-06-22.
- 发明人冯建国，陈志强，高志强. "Method for the Synthesis of 68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth Silica amorphous diatomaceous earth (uncalcined) Silica, amorphous, including natural diatomaceous earth" [P]. 中国发明专利, 专利号 CN 113492238 A, 授权公告日 2019-10-03.
参考文献 Literature
- Jensen P, Larsen A M, Olsen K. "Development and Validation of an LC-MS/MS Method for the Determination of Celite<SUP>®</SUP> 545 AW in Pharmaceutical Formulations". Anal. Methods, 2017, 923, (12), 937-949.
- O'Brien K, Kennedy M L. "A Stability-Indicating HPLC Method for the Separation and Quantification of Celite<SUP>®</SUP> 545 AW as an Impurity". Anal. Chem., 2011, 1528, (7), 513-520.
- Yang F, Sun W, Liu J. "Identification and Structural Characterization of a Novel Degradation Product of 68855-54-9 Diatomite Diatomaceous earth Kieselguhr, soda ash flux-calcined CCRIS 3662 Diatomaceous silica, flux-calcined EINECS 272-489-0 Flux-calcined diatomaceous earth EC 272-489-0 Amorphous silica: Flux-calcined diatomaceous earth Silica, amorphous, diatomaceous earth Silica amorphous diatomaceous earth (uncalcined) Silica, amorphous, including natural diatomaceous earth Using HRMS and NMR". J. Agric. Food Chem., 2021, 2021, 6606-6612.
- Brown R C, Davis S M. "Forced Degradation Studies to Evaluate Celite<SUP>®</SUP> 545 AW Profile in Drug Substances According to ICH Guidelines". Anal. Chim. Acta, 2020, 301, 8420-8430.
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