신약 개발부터 약물 제조, 개발, 문제 해결까지 Renishaw 시스템이 해답을 제시해 드릴 것입니다.
API, 부형제 및 기타
Renishaw의 라만 시스템은 모든 제약 물질을 분석하는 데 필요한 성능과 유연성 제공
- API 다형체와 부형제를 식별하여 차별화
- 마이크로미터 미만의 공간 분해능으로 정제, 흡입기 및 코 전용 스프레이에 사용되는 약물 제조 이미지 생성
- 높은 처리량을 자랑한 Renishaw의 전용 다형체 선별 기능 활용
- 첨단 온도 제어 기능을 사용하여 약물의 열적 반응 연구
- 정제 및 분말 혼합제의 신속한 정량 분석
- 혼합물의 균일성 판별
- 세포와 조직에서 API 및 대사 산물 분석
- 오염물 식별
21 CFR 11
Renishaw WiRE 소프트웨어는 21 CFR part 11을 준수하도록 지원합니다.
RA802 제약 분석기
inVia™ 칸포칼 라만 현미경
Renishaw의 RA802 시스템은 제약 산업용으로 특수 설계되었습니다. RA802는 안정적인 결과를 얻는 데 필요한 속도와 자동화 및 정밀도로 정기적인 분석을 하기에 적합하도록 최적화된 화학물질 이미징 시스템입니다. 여러 샘플의 빠른 분석이 필요하고 공간 절약이 중요한 바쁜 실험실에서 사용하기 적합합니다.
Renishaw의 inVia는 연구 등급 라만 현미경으로, 상황에 맞게 구성할 수 있는 기능이 강점입니다. 전 세계 과학자들이 inVia와 이 제품의 탁월한 유연성에 신뢰를 보내고 있습니다. 성능 저하 없이 업그레이드와 수정, 맞춤 설정이 가능합니다. 액세서리, 레이저, 광섬유 프로브를 추가하거나 다른 분석 기법과 조합해서 사용할 수 있습니다. 어떤 구성을 선택하든, 시장에서 가장 유연한 라만 시스템을 갖추게 됩니다.
언제든 도와드릴 것입니다
이 응용 분야 또는 이곳에서 언급하지 않은 응용 방법에 대한 자세한 정보가 필요하면 Renishaw 응용 팀에 문의하십시오.Renishaw 응용 팀 문의
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]
The RA802 Pharmaceutical Analyser is a compact benchtop Raman imaging system that redefines formulation analysis. It is easy to use, yet gives rich chemical information. Designed exclusively for the pharmaceutical industry, the RA802 rapidly obtains detailed information on the distribution of chemical species. With unique LiveTrack™ focus-tracking technology, it can efficiently analyse uneven, curved, or rough surfaces at incredible speeds and without any sample preparation.
Application note: New methods for determining content uniformity of formulations [en]
The uniformity of a drug product’s contents is a parameter that requires constant monitoring. It is important from a handling/processing standpoint, and it is of the utmost importance for patient safety 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. It also examines a trial between manufacturers, where Renishaw’s Raman instruments were used by a leading pharmaceutical company in an attempt to prove infringement by a generic competitor.
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]
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, sometimes referred to its ‘drugability’. Characterising the polymorphism of APIs has become an important consideration in this process.
White paper: Finding fakes – using Raman imaging to identify counterfeit medicines [en]
Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures. This specificity makes Raman 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.