Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations.

An extensive set of analytical testing and acceptance criteria are applicable to drug substances including universal and specific test criteria established by ICH Q6 guidelines and methods described in the specific monograph for the raw API. All drug substances should undergo a specific, stability-indicating assay to determine their strength and content.

All drug products must be GMP compliant before release for commercial use. We provide the tools you need to release safe and effective medicines, giving you peace of mind when it comes to audits.

Spectrum 3

The PerkinElmer Spectrum 3 range of near, mid, and far infared fourier transform (FT-IR) spectrometers provide the ultimate sampling flexibility and spectroscopic performance you need. The highly configurable platform provides dependable, consistent and trouble-free operation through years of service. Spectrum 3 is loaded with a range of advanced innovations designed to provide you with exceptional performance and flexibility from the configuration you choose.

  • 21 CFR Part 11 Compatible
  • Exceptional signal-to-noise ratio and photometric performance
  • High reproducibility of spectral data without spectral interferences
  • Best-in-class sensitivity, even when using room temperature detectors
  • Characterize fast reactions with scan speed up to 100 scans/sec

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Lambda 365

The LAMBDA 365 delivers state-of-the-art UV Vis performance that meets the needs of pharmaceuticals, analytical 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.

  • Variable spectral bandwidth capability from 0.5 nm to 20 nm to meet your application needs
  • Accommodates a wide range of accessories to meet your sampling requirements
  • Ideal solution when high stability and low stray light are critical
  • Large sample compartment accommodates more than 10 sampling accessory combinations

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Spectrum Two FT-IR

The Spectrum Two FT-IR spectrometer delivers everything required to perform FT-IR analyses within regulated environments with complete confidence in the results. From rapid raw material identification to sensitive analysis of formulated products, the Spectrum Two system offers the best user experience without any compromise in analytical performance. With fully integrated, robust universal sampling for trouble-free measurements and portability options, this system is ideal for use in both laboratory and remote testing environments.

  • Dynascan Interferometer: Fixed mirror-pair interferometer design does not require dynamic alignment to compensate for errors
  • OpticsGuard Technology: A unique humidity shield design protects Spectrum Two from environmental effects
  • Atmospheric Vapor Compensation (AVC): Its advanced digital filtering algorithm feature is designed to compensate for CO2 and H2O absorptions in real time
  • Absolute Virtual Instrument (AVI): Standardization using gas phase spectra ensures your instruments are accurately calibrated

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Spectrum Two N FT-NIR

The Spectrum Two N is a high-performance, robust, and transportable FT-NIR system platform enabling simple, reliable NIR analyses. It’s the perfect system for labs that need to combine high-end performance with the ease-of-use features of a portable instrument, allowing users with different levels of expertise – from novice to seasoned professionals – to be proficient in no time.

Spectrum Two N FT-NIR spectrometers feature:

  • Standard, high-performance, room-temperature LiTaO3 (lithium tantalate) NIR detector
  • Optional, high-sensitivity, temperature-stabilized InGaAs detector for use in quantitative, low-light applications
  • Standard Atmospheric Vapor Compensation (AVC), Absolute Virtual Instrument (AVI), and Automatic Performance Verification (APV) for accurate and reproducible results anywhere
  • Optional Spectrum Two N Portability Pack enabling wireless connectivity, battery powered operation, and convenient transport with the dedicated Spectrum Two N carrying case

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Flexar FX-20 UHPLC

Ultra-high performance means the highest resolution, highest sensitivity and fastest analysis for your stability-indicating assays. Flexar FX-20 is the ultimate in UHPLC with maximum throughput and minimum stress for you. Getting more sample information in less time lets you be more productive – Just what you want.

  • Dual-reciprocating piston 18,000 psi pump provides as much as 10 times, if not more, improvement in productivity
  • UV/Vis and PDA detectors offer fast, sensitive performance for a wide range of applications
  • Integrated piston wash function keeps pump pistons clean, even with buffers
  • Synchronized injection with piston position for ultimate retention time precision
  • View pump pressure profiles real-time with Chromera CDS
  • Pulse dampener-less design allows for increased productivity with less recovery time between runs
  • Dual binary solvent selection adds more solvent choices to support your applications

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Flexar HPLC

The need for high performance and reliability are a given for QC labs performing assays to determine the strength and content of drug substances. Our proven, rugged, and reliable Flexar HPLC system is the perfect choice when you need fast cycle times, reproducibility, and low carryover. With its elegant streamlined interface, our Flexar LC is easy to use and simplifies your day-to-day processes so you can focus on your applications.

  • Integrated LC tube management for streamlined chromatography
  • UV/Vis and PDA detectors offer fast, sensitive performance for a wide range of applications
  • Hidden plug-and-play drainage automatically interconnects with components added to system
  • Convenient solvent manager with integrated degasser and software communication link
  • Built on rugged and reliable LC technology for maximum uptime and low cost of ownership

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Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.

We invest heavily in testing and validating our complete portfolio of solutions to ensure that you receive accurate, repeatable results – on-time, every time – throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.

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Keep your scientists focused on science and away from activities keeping them from discovering the next breakthrough. Whether you need trained scientists, assistance analyzing the results from an FDA finding to determine corrective actions and roll them out, or trained IT resources to upgrade you to the latest version of software across your entire enterprise, OneSource has the trained, certified experts that will support your lab operations.

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UV WinLab Enhanced Security (ES software)

Unleash the power of your LAMBDA UV/Vis spectrophotometer with UV WinLab software designed for operational simplicity and the power to address the most challenging analyses. Our Enhanced Security (ES) UV WinLab software is designed for busy pharmaceutical, manufacturing, industrial, food, or academic laboratories in regulated environments that require compliance with US FDA 21 CFR Part 11 regulations.

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Spectrum 10 ES™ Software

The 21 CFR Part 11 technically compliant Spectrum ES software suite is designed for regulated industries that demand secure IR quality testing. The Spectrum 10 ES suite encompasses the comprehensive features of Spectrum 10 and encompasses user access control, audit trailing, data security, and data integrity to ensure secure analyses. The software package includes instrument control, basic and advanced data manipulation routines, a spectral calculator, COMPARE spectral comparison, PLS/PCR/Beer’s Law predictions, Report Builder, Report Viewer, and Administration Utility.

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