The LAMBDA™ 365 delivers state-of-the-art UV Vis performance that meets the needs of pharmaceuticals, analytic chemists, geneticists, and manufacturing QA/QC analysts everywhere. With 21 CFR part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
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With 21 CFR part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
The system delivers a variable spectral bandwidth capability from 0.5 nm to 20 nm, to meet your application needs. It can accommodate a wide range of accessories, including multicell changers (both water and Peltier temperature-controlled), solid sample accessories for transmission and reflectance, optical fiber probes for remote measurements, an integrating sphere for color and diffuse measurements, and a range of cuvette holders to meet your sampling requirements.
When high stability and low stray light are critical, the LAMBDA 365 double-beam technology is the ideal solution. The large sample compartment can easily accommodate more than 10 sampling accessory combinations. Easy-to-install accessories minimize setup time and effort, and multicell changers are autoaligned by the instrument software to optimize the sample position for the best results in a wide range of routine applications.
|21 CFR Part 11 Compatible||Yes|
|Interface||Tungsten-halogen and Deuterium|
|Maximum Temperature||35 °C|
|Minimum Temperature||15 °C|
|Model Name||LAMBDA 365|
|Operating Range||190 - 1100 nm|
|Product Brand Name||LAMBDA|
Combination drugs containing Paracetamol and Aspirin are widely used analgesics with anti-inflammatory properties for treatment of migraines. UV/Vis spectrometry is a fast and commonly used technique in quality control laboratories for routine analysis of purity and quantity of components within various stages of a product’s manufacture in many industries. This application describes the efficient use of the LAMBDA 365™ UV/Vis spectrometer in determining the quantity and percent assay of Paracetamol according to U.S. Pharmacopeia’s (USP) methods, and component concentration in pharmaceutical formulations, while achieving 21 CFR Part 11 compliance.
Quality and consistency of medicines is critical to ensuring their identity, strength, and purity is at a safe level for human consumption.
That's why we rely on strict guidelines – to guarantee medications that make it to the shelves are exactly what they claim to be. This guide helps provide a simple breakdown of USP Chapters and what they contain, so that you can be confident your products are in compliance.
Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. It makes an impact at almost every step of the journey, from early product development to late-stage quality control - so it's no surprise that it is a key concern for regulatory bodies. To ensure quality and compliance in your lab, the dissolution testing solution you depend on must provide the most accurate and reproducible results available.
Revision to General Chapter USP 857, which emphasized on performance specifications for UV-Vis Spectrometers (e.g. Lambda 365), on December 1st 2019 USP officially announced the amended chapter with new regulations on testing parameters. There are some major modifications made related to calibration parameters which will supersede the earlier method protocols that were practiced in the regulated environment of QA/QC lab. This PerkinElmer note gives a quick look at the parameter changes and additions to the test limits and wavelengths to be tested.