- 識別和區分 API 多形體和賦形劑
- 分析細胞組織中的 API 和代謝物
21 CFR 11
Renishaw 的 WiRE 軟體符合 21 CFR 第 11 部分的規範。
Renishaw RA802 系統是專為製藥產業所設計。RA802 為化學成像系統，提供您所需的速度、自動化和精度，協助您取得可靠結果，是例行分析的最佳選擇。這款系統適用於繁忙的實驗室，因為其中需要迅速分析多個樣品，而且空間十分有限。
Renishaw inVia 是可完全配置的研究級拉曼顯微鏡。全球各地科學家都信任 inVia 無可比擬的靈活性。inVia 可升級、修改及客製化，不會損害效能。您可在其中新增各種配件、雷射、光纖測頭，或結合其他分析技術。不論您選擇的配置為何，都將享有市面上最靈活的拉曼系統。
Brochure: Solutions for pharmaceutical analysis [en]
Renishaw is a world leader in Raman spectroscopy instrumentation, with over 25 years’ experience supplying Raman systems to customers worldwide. We are a global company, with a worldwide network of scientists and engineers who are on-hand to provide you with expert product, applications and technical support. We understand the many challenges within pharmaceutical analysis and our flexible solutions have been designed with your needs in mind. Whether novice or expert, formulator or quality analyst, we have a system to meet your requirements.
Product note: RA802 Pharmaceutical Analyser [en]
Designed exclusively for the pharmaceutical industry, the RA802 rapidly obtains detailed information on the distribution of chemical species.
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 [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 [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 [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 [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 [en]
This note looks at incidences of polymorphism in drug development including advantages and challenges.
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 [en]
Characterising the polymorphism of active pharmaceutical ingredients when developing a commercially viable product.
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.
White paper: Finding fakes – using Raman imaging to identify counterfeit medicines [en]
Raman spectroscopy is highly specific and well-suited to identifying counterfeits which often use similar components to the reference product.
White paper: Methods for deformulating drugs [en]
In this white paper we look at reverse engineering existing drug products using Raman imaging. We show that the Renishaw RA802 Pharmaceutical Analyser can be used to successfully characterise innovator and generic products and facilitate deformulation activities, and can characterise the components, concentrations, particle sizes and distributions of the innovator formulation, allowing generic followers to adjust their processes in order to create equivalent products, or products which are strategically different.