Appendix C. Statements of Compliance
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United States Pharmacopeia (USP) Chapter <1120> - Raman Spectroscopy
Statement of Compliance
Summary
USP Chapter 1120 establishes guidance around Raman spectroscopy for implementation in a regulated,
pharmaceutical environment. USP <1120> establishes criteria for both qualitative and quantitative
implementation of Raman spectroscopy. Because Progeny instruments are intended for material
identification in pharmaceutical environments, only aspects that apply to qualitative analysis are
discussed. Additionally, USP <1120> was written for fixed, bench-top Raman systems and predates
portable Raman spectrometers. Only the requirements that pertain to portable Raman systems used for
material identification will be discussed. These requirements include laser safety, wavelength
calibration, external calibration, and performance qualification / verification. Progeny instruments are
compliant with this guidance.
Progeny instruments use a CLASS IIIb/Class3b laser.
Progeny instruments are factory calibrated for wavenumber accuracy according to ASTM E1840-
96 using benzonitrile and verified with cyclohexane, and napthalene.
Intensity axis calibration is not necessary since quantitative analytical methods are not intended
to be transferred between instruments.
Progeny instruments have a user-selected calibration module based on a certified benzonitrile
calibration standard.
Progeny instruments have a calibration validation routine based on a certified benzonitrile,
cyclohexane or naphthalene calibration standard that can be used to verify instruments’
calibration.
Progeny instruments have appropriate interfaces that allow a user to develop appropriate test
conditions and validate analytical methods.
European Pharmacopeia (Ph. Eur.) Chapter 2.2.48 - Raman Spectrometry
Statement of Compliance
Summary
Ph. Eur. Chapter 2.2.48 establishes guidance around Raman spectroscopy for implementation in a
regulated, pharmaceutical environment within the European Union and other areas that recognize Ph.
Eur. Chapter 2.2.48 establishes criteria for both qualitative and quantitative implementation of Raman
spectroscopy and summarizes instrument components and sample preparation for successful Raman
measurements. Because Progeny instruments are intended for material identification in pharmaceutical
environments, only aspects that apply to qualitative analysis are discussed. Progeny instruments are not
calibrated for Intensity axis and are not qualified for transfer of quantitative methods between
instruments. This guidance includes wavenumber shift tolerances for reference standards including:
cyclohexane, indene, and naphthalene. It is important to recognize these tolerances were developed for
high resolution bench instruments; European pharmaceutical regulatory agencies are aware these
tolerances don’t meet the needs of lower resolution hand-held Raman spectrometers. Progeny
instruments are compliant with this guidance.
Progeny instruments are factory calibrated using benzonitrile and verified with cyclohexane and
naphthalene.
Содержание Progeny
Страница 1: ...1006232_RevD 3 Progeny and Progeny LT Analyzer User Manual Rev D...
Страница 74: ...Advanced Options 67 1006232_RevD Figure 40 Sample Application...
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