Compliance, Made Easy
The Spectrum Two™ Nutraceutical Analysis System 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, Spectrum Two offers the best user experience without any compromise in analytical performance. This analysis system includes:
- FT-IR Nutraceutical Compliance Resource Pack
- Spectrum Two Instrument with filter wheel
- Spectrum 10 ES™ Software
- Spectrum Validation Supplement
FT-IR Nutraceutical Compliance Resource Pack
The FT-IR Nutraceutical Compliance Resource Pack facilitates FT-IR spectroscopic analysis for Nutraceutical and Traditional Medicine professionals. The pack covers the requirements of seven key Pharmacopoeias (USP, BP, EP, IP, JP, CP and IntPhr). The quality assessment of most of natural products is supported by an included nutraceutical starter set of spectra.
The Nutraceutical Compliance Resource Pack:
- Facilitates rapid testing and release of samples in accordance with specific Pharmacopeia regulations, increasing lab productivity in FT-IR sampling methods and Pharmacopeia best practice.
- Provides quality assurance for nutraceutical ingredients.
- Provides training and skills development through tailored experiments.
Spectrum Two Instrument with Filter Wheel
The Spectrum Two spectrometer with KBr optics and a temperature-stabilized, high-performance DTGS (deuterated triglyine sulfate) detector delivers a spectral scan range of 8,300 – 350 cm-1 whilst offering 0.5 cm-1 resolution and 14,500:1 peak-peak signal-to-noise ratio for a 5 second scan in a sleek, compact design.
Key features that allow for consistent performance of this system include:
- Dynascan™ interferometer – Fixed mirror-pair interferometer design does not require dynamic alignment to compensate for errors.
- OpticsGuard™ technology – Unique humidity shield design protects Spectrum Two from environmental effects, allowing it to be used in more challenging conditions. Our long-life desiccant ensures maximum instrument uptime, regardless of where your analysis takes place.
- Atmospheric Vapor Compensation™ (AVC) – Features an advanced digital filtering algorithm designed to compensate for CO2 and H2O absorptions in real time removing the need for instrument purging.
- Automatic Performance Verification™ (APV) – Optional feature comprising an integrated, fully automatic filter wheel containing traceable reference materials and software allowing for abscissa, ordinate, noise, ASTM, and USP tests to be performed.
- Absolute Virtual Instrument™ (AVI) – Optional AVI standardization using gas phase methane spectra ensures instruments are accurately calibrated. Unique standardization allows data to be transferred precisely between instruments, side-by-side or in remote locations.
- Sigma-Delta Conversion: The use of Sigma-Delta converters in the digitization of the FT-IR interferogram improves the dynamic range, reduces spectral artifacts, and increases ordinate linearity to provide accurate, reproducible results.
Spectrum 10 ES™ Software
Included in this system is the 21 CFR Part 11 technically compliant Spectrum ES software suite, which 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.
Spectrum Software Validation Supplement
Spectrum 10 Software Validation Supplement contains a description of the algorithms used within Spectrum 10 and Spectrum 10 ES, as an overview of the testing methodology and a summary of the results. Synthetic data used in the testing of software functionality is also included in both secure and non-secure format.