Easy, fast, and compliant materials testing of nutraceuticals is surprisingly simple with Spectrum Two™ and the Nutraceuticals QA/QC Resource Pack. A comprehensive suite of documents makes it easier to meet strict pharmacopeia requirements.
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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
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:
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:
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.
|21 CFR Part 11 Compatible||Yes|
|Operating Range||5 - 45 °C|
|Product Brand Name||Spectrum Two|
|Product Group||Application Pack|
|Wave Length Range||8,300 – 350 cm-1|