Reduce the burden of compliance with the Spectrum Two™ Pharmaceutical System, and benefit from fast and easy analyses.
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Compliance, Made Easy
The Spectrum Two™ Pharmaceutical 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 Pharmacopeia Compliance Resource Pack
The FT-IR Pharmacopeia Compliance Resource Pack is designed to assist the user in understanding and achieving compliance to pharmacopeia regulatory requirements in FT-IR analysis, using PerkinElmer Spectrum 10 ES software and PerkinElmer FT-IR instruments. The pack covers the requirements of seven key Pharmacopoeias (USP, BP, EP, IP, JP, CP and IntPhr).
The documentation provided in the pack is structured to mirror the steps in the analysis process; namely:
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|
As experts in pharmaceutical compliance, PerkinElmer can help you navigate safely, through the regulations that govern nutraceutical and traditional medicine production., Our longstanding experience and knowledge of the highly regulated pharmaceutical, industry will help you undertake compliant sample testing, with complete confidence.
PerkinElmer works with you to assure absolute compliance of your IR testing, every time. Our in-depth knowledge of the pharmaceutical market has been distilled into a dedicated, Pharmacopoeia Compliance Resource Kit compatible.