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药物

从药物成分的发现到药品配方分析、研发和问题解决策略,我们的系统将为您提供答案。

活性药物成分 (API)、赋形剂以及其他

雷尼绍的拉曼系统具有分析所有药用材料所需的性能和灵活性。

  • 识别和区分API多形体和赋形剂
  • 生成显示片剂、吸入剂和鼻喷剂配方的亚微米空间分辨率图像
  • 使用我们专用的高通量多形体筛选功能
  • 利用先进的控温技术,研究药品的热行为
  • 对整个药片和粉末混合物进行快速定量分析
  • 确定混合物的均匀性
  • 分析细胞和组织里的API和代谢物
  • 识别污染物

一条光谱即可揭示全部信息

节省时间。使用SynchroScan(同步连续扫描)可揭示所有关键的拉曼谱带:高光谱分辨率、覆盖整个光谱范围、只需一次数据采集。查看晶格振动模、OH谱带,以及它们之间的所有信息。识别出细微的样品差异,无论这种差异出现在光谱的哪个位置。

快速生成图像

使用StreamLine™可快速生成配方图像。它使用线聚焦照射,允许使用高激光功率,而不会损伤样品,从而减少实验时间。

使用RA802药物分析仪可以实现超过每秒1,500张光谱的成像速度。从将一个标准药片放在仪器上,直至生成完整的高分辨率拉曼图像,只需不到两分钟。

生成配方图像

使用雷尼绍的StreamLine可确保您的化学图像具有代表性。您可以改变分辨率以适应被测区域的尺寸;而且由于雷尼绍的WiRE软件能够处理大量数据文件,因此您可以对整个样品表面进行分析。无论您的药物配方是什么,雷尼绍拉曼仪器的强大功能都能为您提供所需的全部选项,例如Slalom(确保采集整个表面的数据)和HD高分辨率成像(获取清晰的图像)。

美国联邦法规第21章第11部分 (21 CFR Part 11)

雷尼绍WiRE软件符合美国联邦法规第21章第11部分的规定。

药片的拉曼成像

图库

产品选择

RA802药物分析仪

inVia™共焦显微拉曼光谱仪

雷尼绍RA802系统专为医药行业而设计。RA802是一款化学成像系统,针对常规分析所需的速度、自动化和准确性进行优化,可帮助用户获取可靠结果。在空间有限的繁忙实验室里,通常需要对许多样品进行快速分析,而RA802正是能够胜任这一工作的理想工具。

雷尼绍inVia是一款完全可配置的研究级拉曼光谱仪。全球科学家均信赖inVia及其高度灵活性。它可以升级、改造和定制,而不会影响性能。而且可配用附件、激光器、光纤探头,或与其他技术联用。不管您选择哪一种配置,您都将拥有高度灵活的拉曼系统。

随时为您服务

如需详细了解该应用领域或本网站未涵盖的应用,欢迎联系我们的应用团队。

联系我们的应用团队

资料下载:化学科学(药物)

  • 样本: 药物分析解决方案 样本: 药物分析解决方案

    雷尼绍在拉曼光谱设备领域占据世界领先地位,有超过25年为全球客户提供拉曼系统的经验。我们是一家跨国公司,拥有遍布全球的科学家和工程师网络,可随时为您提供产品、应用和技术方面的专业支持。 我们深谙药物分析领域存在的诸多挑战,并基于客户的需求设计灵活的解决方案。无论您是新手还是专家,是配方设计员还是质量分析员,我们的系统都能满足您的需求。

  • 产品说明:  RA802药物分析仪 产品说明: RA802药物分析仪

    RA802药物分析仪是一款紧凑型台式拉曼成像系统,它对配方分析进行了重新定义。RA802操作简单,能够揭示丰富的化学信息。 RA802是专为制药行业设计的,用于快速获取详细的化学物种分布信息。它采用雷尼绍独特的LiveTrack™实时聚焦追踪技术,能够以惊人的速度对凸凹不平、弯曲或粗糙的表面进行高效分析,无需任何样品制备。

  • Application note:  New methods for determining content uniformity of formulations Application note: New methods for determining content uniformity of formulations [en]

    Using the RA802 to monitor the uniformity of a drug product’s contents to ensure that the correct dose is delivered every time.

  • Application note:  Study the stability of pharmaceutical formulations with Raman microscopy Application note: Study the stability of pharmaceutical formulations with Raman microscopy [en]

    Many pharmaceutical materials are highly sensitive to changes in temperature and humidity which can affect their crystalline structure. Knowing the stability of these polymorphs and hydrates, in different conditions, is critical to ensure products are safe, efficient and can be patent protected.

  • Application note:  Investigate pharmaceutical solid dose products using the inVia confocal Raman microscope Application note: Investigate pharmaceutical solid dose products using the inVia confocal Raman microscope [en]

    With so many components and properties, determining the composition, domain size and distribution of patent-expired commercially available formulations is highly desirable. This information creates opportunities to replicate an existing product without the need for lengthy development and prohibitive costs.

  • Application note:  Transmission Raman for monitoring pharmaceuticals Application note: Transmission Raman for monitoring pharmaceuticals [en]

    Whether at the research and development stage, or manufacturing, the inVia Raman microscope offers simple and fast transmission Raman analysis.

  • Application note:  Combined chemical and particle distribution analysis of pharmaceutical powders Application note: Combined chemical and particle distribution analysis of pharmaceutical powders [en]

    When formulating pharmaceuticals, it is important to understand the chemical composition and morphologies of the ingredients, as these can lead to changes in product performance. For example, active ingredient co-localisation and particle adhesion can affect the efficacy of formulation. This application note details how to use a Renishaw Raman system to conduct this type of analysis.

  • Application note:  Using Raman spectroscopy to tackle polymorphism, an industry problem Application note: Using Raman spectroscopy to tackle polymorphism, an industry problem [en]

    This note looks at incidences of polymorphism in drug development including advantages and challenges.

  • Application note:  Raman imaging for deformulating a transdermal patch Application note: Raman imaging for deformulating a transdermal patch [en]

    An application note detailing the RA802's ability to deformulate the make-up of a transdermal nicotine patch.

  • Application note:  Rapid polymorph identification with the RA802 Pharmaceutical Analyser Application note: Rapid polymorph identification with the RA802 Pharmaceutical Analyser [en]

    Characterising the polymorphism of active pharmaceutical ingredients when developing a commercially viable product.

  • Technical note:  Quantitative Raman spectroscopy Technical note: Quantitative Raman spectroscopy [en]

    This document focuses on concentration measurements but the principles detailed are also applicable to other quantitative measurements, such as stress/strain.

  • 白皮书: 鉴伪— 使用拉曼成像技术鉴别假冒伪劣药品 白皮书: 鉴伪— 使用拉曼成像技术鉴别假冒伪劣药品

    监管当局以及制药公司愈来愈关注如何鉴别假冒伪劣药品。拉曼光谱具有高度特异性,能够区分化学结构相似的材料。拉曼光谱的特异性使它更适用于识别假冒伪劣药品,因为假冒伪劣药品通常与参照品成分相似。

  • 白皮书: 药物逆向工程分析方法 白皮书: 药物逆向工程分析方法

    在本白皮书中,我们将介绍如何使用拉曼成像技术对现有药物制剂进行逆向工程分析。RA802能够成功鉴别原研药和仿制药,并加快药物逆向工程分析。RA802能够识别原研制剂的成分及其相对百分含量、颗粒尺寸和分布,方便仿制药制造商调整工艺,以制造出同等产品或者策略不同的产品。

  • Technical note:  Polymorph identification and qualification Technical note: Polymorph identification and qualification [en]

    This technology note illustrates the benefits of combining dedicated analysis software with a high-performance Raman instrument and how Renishaw supplies an effective, user-friendly solution to provide complementary information to the multitude of established HTS techniques commercially available.

  • Application note:  Detecting small amounts of multiple API polymorphic forms in powder blends Application note: Detecting small amounts of multiple API polymorphic forms in powder blends [en]

    The stability, bioavailability and processability of an active pharmaceutical ingredient (API) are key to a candidate molecule’s ability to be developed into a commercially viable product. Different drug polymorphs can vary markedly in properties such as their flowability, dissolution rate, solubility, and stability. Characterising the different polymorphic forms of a drug and selecting the optimum polymorph for drug product development have become important considerations in this process. Renishaw’s RA802 Pharmaceutical Analyser was used to detect small amounts of different polymorphic forms (form I and form II) of an active pharmaceutical ingredient (API) in a generic drug powder.

  • Product note:  Cluster analysis and data classification Product note: Cluster analysis and data classification [en]

    The ability to group highly similar spectral data is a key result for research areas including biology and medicine. It enables qualitative conclusions to be drawn objectively based on statistics, rather than subjectively based on an analyst’s experience.