Spectrum Two Pharmaceutical System

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:

• Pharmacopeia Compliance Resource Pack
• Spectrum Two Instrument with filter wheel
• Spectrum 10 ES^™ Software
• Spectrum Validation Supplement

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:

• FT-IR Instrument Performance Verification
• FT-IR Sampling Methods and Pharmacopeia best practice
• FT-IR Pharmacopeia Identification Tests
• 21 CFR Part 11 Technical Compliance

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.