ICH Guideline (人用药品注册技术规范国际协调会)药物光稳定性指导原

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2024年6月6日发(作者：)

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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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