
TRS100 Quantitative Pharmaceutical Analysis System
A TRS100 system can reduce content uniformity, assay, and ID tests to minutes per batch, saving significant cost and speeding up your quality control workflow. Sample preparation and consumables are not needed, meaning skilled analytical resources are not required. Content uniformity testing methods using transmission Raman have been approved by regulators using ICH and regulatory authority-acceptable protocols.
- Raman Pharmaceutical Analysis Systems
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Product Details
- Assay hundreds of tablets or capsules in minutes
- Works with intact capsules and coated tablets of most thicknesses
- No sample preparation, wet chemistry, or skilled testing resources needed
- Quantifies APIs and excipients in a single measurement
- Limit of quantification as low as 0.1% w/w
- Quantifies polymorphs in intact tablets
- Lean calibration models—easy to build and maintain
- Methods approved by regulators
- A range of sample trays and accessories for tablets, capsules, liquids, and powders are available
- Built-in technical controls ensure the security of your data, control access, and facilitate compliance as defined by US FDA 21 CFR Part 11 and EU Annex 11 regulations
Videos
- Key Literature
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Quantitative Determination of Salt-Form Impurities of Warfarin at the Lowest Commercial Dose Strength using Transmission Raman Spectroscopy
An analysis and quantification of Warfarin sodium salts in intact tablets at low doses.
- Application Notes
- English
- 20 May 2019
- 1.66 MB
Agilent TRS100 – Quantitative Pharmaceutical Analysis System
The Agilent TRS100 is ideal for fast assay of tablets, capsules, and other pharmaceutical dosage forms.
- Brochures
- English
- 30 Mar 2020
- 5.60 MB
Quantification of Tablets Containing Multiple APIs Using Transmission Raman
The quantification of three active pharmaceutical ingredients and 2 excipients using a 9 second transmission Raman spectroscopy measurement
- Application Notes
- English
- 22 Jan 2018
- 788.16 KB
- Application Notes
- Flyers
- Site Preparation Checklists
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TRS100 Rapid Assay System Pre-Installation Guide
Pre-Installation Guide for TRS100
- Site Preparation Checklists
- English
- 24 Oct 2018
- 665.90 KB
Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
The webinar highlights the approach that led to the implementation of transmission Raman spectroscopy for content uniformity testing at a pharmaceutical company. The webinar also discusses the reasons for using transmission Raman spectroscopy for content uniformity and how it works in conjunction with established liquid chromatography (LC) methods.
Solid State Analysis in Pharmaceutical Formulation Development: Advantages and Limitations of Transmission Raman and LDIR Chemical Imaging techniques
Transmission Raman Spectroscopy (TRS) is licensed in the pharmaceutical industry for the identification and determination of bulk assay and uniformity of content of finished products. The first part of this webcast will cover the basic principles of Raman spectroscopy, discussing the advantages and limitations over conventional testing methods, the process and steps required to select suitable products for Raman testing, and the development and validation requirements of Raman methods and models. This presentation will also review regulatory submissions of Raman methods and the lifecycle maintenance of licensed Raman models. The second part of this webcast will describe how LDIR technology can enable rapid, high-quality surface imaging of large tablet surfaces, for applications including polymorph screening in the formulation.
Content Uniformity by Transmission Raman - Regulatory Approval
TRS takes seconds per sample, it is robust to sample variation, needs no preparation, solvents or consumables and saves significant cost and resource per batch. An important factor for adoption of the technique is the regulatory approval of TRS CU methods and, as submissions are made with regulators, it is important to take the correct strategy.
- Publications
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- Analytical method development using transmission Raman spectroscopy for pharmaceutical assays and compliance with regulatory guidelines—Part II: Practical Implementation Considerations, B. Igne et al., J. Pharm. Innov., 14 2019 Learn More
- Quantitation of trace amorphous solifenacin succinate in pharmaceutical formulations by transmission Raman spectroscopy, M. Otsuka et al., International Journal of Pharmaceutics, 565 (2019) Learn More
- Manufacturing amorphous solid dispersions with a tailored amount of crystallized API for biopharmaceutical testing, F. Theil, H. van Lishaut et al., Abbvie Deutschland GmbH & Co., Molecular Pharmaceutics, 15 (2018) Learn More
- Quantifying low levels (<0.5% w/w) of warfarin sodium salts in oral solid dose forms using Transmission Raman spectroscopy, J. Griffen, A. Owen and P. Matousek, Journal of Pharmaceutical and Biomedical Analysis, 155 (2018) Learn More
- Rapid quantitation of atorvastatin in process pharmaceutical powder sample using Raman spectroscopy, Y. Lim, M. J. Kang et al., Chong Kun Dang Pharm. and Dankook University, Spectrochim. Acta Part A: Mol. and Biomol. Spectr., 200 Learn More
- Analytical method development using transmission Raman spectroscopy for pharmaceutical assays and compliance with regulatory guidelines—Part I: TRS and method development, D. Andrews et al., J. Pharm. Innov., 13 (2018) Learn More
- View all SORS and TRS publications Learn More
Transmission Raman Spectroscopy (TRS)
Transmission Raman Spectroscopy (TRS) is an ideal method for quantitative analysis of mixtures such as tablets capsules, powders, liquids and suspensions.
Learn MoreJerry Jin
PAT Scientist at Allergan
The analysis of 10 pharmaceutical tablets for their content uniformity takes only several minutes, as compared to one day turnaround time when using a traditional HPLC method. Method development using TRS100 for material identification and quantitative assay is generally easier than other vibrational spectroscopic techniques such as near infrared (NIR). One intrinsic advantage of TRS is its excellent specificity. Considering the unique strength of Agilent’s TRS100 in pharmaceutical analysis, I expect to see its deployment in more QC labs for product identification and assay, as well as its deployment on factory floors for real-time release testing.
View MoreContent Uniformity, Assay and Identification
Streamline your quality control process with transmission Raman spectroscopy from Agilent
Content uniformity testing, required for batch release, is a critical task in the tightly regulated pharmaceutical industry. It ensures that drug products contain a safe dosage of the active pharmaceutical ingredient (API).
Traditionally, liquid chromatography (LC) has been the standard analytical technique for the analysis of dose strength in finished drug products due to its specificity, sensitivity, and ability to obtain a measurement from the entire tablet, after an extraction procedure.
In recent years, transmission Raman spectroscopy (TRS) has emerged as a cost-effective alternative for content-uniformity testing and polymorph analysis. The process is non-destructive and dramatically reduces testing time from hours or days to minutes.
TRS, unlike near-infrared spectroscopy (NIRS), is not an absorption technique. This means TRS can measure through most sizes of coated or uncoated tablets as well as colored gel capsules. Ideal for process monitoring and real-time batch release testing, TRS produces a feature-rich spectrum that can be used to separately quantify API, polymorph, and excipient components in one fast scan.
With the Agilent TRS100 system, your pharmaceutical quality control lab can:
• Save time and money by avoiding sample preparation
• Analyze polymorph content in intact dosage forms.
• Quickly switch between testing different tablets or capsules.
• Reduce the use of solvents and consumables during high-volume testing.
Agilent, renowned for reliability and accuracy, provides a variety of technologies for content uniformity testing, giving you the specificity, sensitivity, and confidence, you need, dramatically streamlining testing and batch release to get pharmaceutical products from testing to release quickly.
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Polymorph Analysis
Many chemical compounds exist in multiple crystalline forms known as polymorphs. Polymorphs can differ broadly in chemical and physical properties, and in pharmaceutical products these differences can affect stability, solubility and dissolution rate, potentially impacting drug efficacy and safety. Drug manufacturing processes and conditions must be tightly controlled so that only the intended crystalline forms are produced and then screened for polymorphism. Agilent’s technologies for polymorph analysis provide fast quantification of intact samples including capsules, tablets, powders, gels and suspensions, getting you to the answers you need quickly and confidently.
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