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2024年6月6日发(作者:)
Atlas MTT LLC Internal
Atlas MTT BV & GmbH Internal
Atlas MTT Dom. Representatives
Atlas MTT Int. Representatives
Chicago Domestic
Chicago International
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Atlas Info approved and submitted
Distribution approved for
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ICH Guideline
25-Jan-06 No.: WC1007
Since the release of the ICH Guideline Atlas Info, WIP has made a correction to its formula for
the estimation of test durations at minimum and maximum SUNTEST irradiance levels (see
calculations on page 8). Please discard or delete any copies that you may have of the previous
version of this document. We would like to thank Chet Harris of Harris Weathering and Andreas
Riedl and Cees Van Teylingen for their attention to detail regarding this piece. If you have any
questions regarding the document please contact Al Zielnik at azielnik@ or contact
your local sales manager.
Thank you,
Marketing Services
Atlas Material Testing Technology LLC 4114 N. Ravenswood Ave. Chicago, Illinois 60613 USA
Phone/Fax +1-773-327-4520/5787 Website: Email: info@
SUNTEST CPS/CPS+ and
XLS/XLS+ Conformity to ICH
Conforming to the ICH Guideline for the Photostability Testing of New
Drug Substances and Drug Products (ICH Q1B) Using the Atlas
SUNTEST CPS/CPS+ and XLS/XLS+
This document summarizes the key requirements in the ICH Guidelines and offers recommendations for operating the
Atlas SUNTEST CPS/CPS+ and XLS/XLS+.
EXECUTIVE SUMMARY
“The International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings
together the regulatory authorities of Europe, Japan and the United States and experts
from the pharmaceutical industry in the three regions to discuss scientific and technical
aspects of product registration.” From the official website for ICH, .
The result of this effort was a guideline, the ICH Harmonized Tripartite Guideline on
Stability Testing of New Drug Substances and Products (ICH Q1A). Photostability
testing is further addressed in a separate official ICH document (ICH Q1B). This applies
to both forced degradation stress testing and confirmatory studies of the active drug
substance, drug product and excipients. ICH Q1B is applicable to small molecules; large
molecules (proteins, monoclonal antibodies, etc.) are addressed in the separate document,
Stability Testing of Biotechnological/Biological Products (ICH Q5C). Additionally the
Q1B protocol has been adopted as the VICH Tripartite Harmonized Guideline covering
the Photostability Testing of New Drug Substances and Products in the Veterinary Field.
Despite implementation of the ICH stability and photostability guidelines, issues remain
that are not specifically covered in the documents and left to the researcher’s discretion.
Additionally, several non-equivalent options are available, reflecting different practices
for handling drug products on different continents.
Atlas Material Testing Technology LLC 4114 N. Ravenswood Ave. Chicago, Illinois 60613 USA
Phone/Fax +1-773-327-4520/5787 Website: Email: info@
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