This ICH guideline gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products. ICH Q1B C. Preamble. The intrinsic photostability characteristics should be evaluated to demonstrate that light exposure does not result in unacceptable. PDF | The photostability testing of pharmaceutical ingredients and products is governed by the ICH Q1B document. ICH Q5C is similar and.

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Skip to main content. Log In Sign Up. A critical assessment of the ICH guideline on photostability testing of new drug substances and products Q1B: The guideline describes a useful basic protocol for testing of new drug substances and associated drug products for manufacturing, storage, and distribution, but it does not cover the photostability of drugs under conditions of patient use.

The purpose of this commentary is to accomplish the following: The outline of the guideline is as been implemented in all three regions US and follows: Canada, EU, and Japan. B Light sources The guideline describes a useful basic protocol for C Procedure testing of new drug substances and associated drug II Drug substance products for manufacturing, storage, and distribu- A Presentation of samples tion, but it does not cover the photostability of B Analysis of samples C Judgment of results III Drug product Correspondence to: A Quinine chemical actinometry Additional guidance should be given to the V Glossary applicant for photostability forced degradation of VI Reference drug product samples.

It is left to the applicant to establish how the product will A sequential testing approach is recommended. The pharmaceutical industry now has con- exposure to the radiation source.

The purpose of this should then be further tested in primary and commentary is to accomplish the following: Products that are stable in the primary pack but unstable i highlight issues proposed for consideration in without it should be labeled in such a way that a the ICH revision process; transfer into a less protective pack, for example, by a ii offer a rationale for why these issues may pharmaceutical wholesaler or in a hospital pharmacy, compromise the design of a testing protocol is prevented.

A To avoid confusion, it should be clearly stated forced degradation study is testing under forcing that if no light degradation is observed in the fully conditions to characterize intrinsic stability charac- exposed sample, no further testing needs to be teristics of the drug substance or drug product, performed. This text change would more clearly to determine degradation products and reaction support the Decision Tree diagram. The ICH guideline gives two options for the selection Comments: Option 1 addresses exposure a.

Option 2 radiation sources lamps. This option and detailed than the guideline presents. The ICH allows for the use of two separate lamps; one for the guideline simply states that the lamp provide a UVA emission and one for the visible light. The term light source is used throughout the guideline.


Light refers, however, to the photopic response, i. For a lamp cover both the UV regions and the visible light. The Option 1 source would serve as a as to which should be used for studies with surrogate for the UVA component of the exposure. Option 1 light sources. It appears that the guide- line is suggesting that either one of the standards Further, the ICH guideline does not specify an D65 or ID65 is appropriate, yet the suggestion for irradiance level, only the overall illumination i.

Test conditions corresponding to below nm indicates that the ID65 emission the maximum output of the lamp will often be the standard is preferred. Clarity on length of exposure when using Option 1 conditions is needed. Procedure, the guidelines state: What could be made clear in the guideline is that both require- Figure 1. Illustration of sample presentation for solid ments need to be met at a minimumand that a oral dosage forms in their immediate packaging.

Important issues are alignment controls to evaluate the contribution of thermally of the samples relative to the irradiation source, induced change to the total observed change; thickness of sample layer, selection of protective these should be placed alongside the authentic material, uniform exposure of the samples, change in sample. Analysis of Samples Comments: Analysis of Samples, the j. Presentation of Samples, last sentence states: Quantitative photostability This would make the photostability testing in results must be evaluated together with long-term the containers more consistent with the direct stability results.

Drug Substance, the last paragraph, and in III. Clarity on interpretation of results is needed. Preamble, it is stated: Judgment of Results, photostable or photolabile. It is inferred that the dark control is to and drug product. The more critical area of concern enable differentiation between thermal degrada- is manufacturing for both the drug substance and tion and photodegradation. In-use photostability testing guidance e. Some guidance would be helpful to the industry, but perhaps this should come in a separate guidance.

In the case of section III. Anderson11 illu- calibrated radiometer or a validated actinometric strated the concepts intended by the ICH Expert system to monitor the exposure in the UV region.

Photostability test chambers in accordance with the ICH Q 1 B Guideline, Pharma-L

A Working group in a presentation inand this calibrated luxmeter is recommended to determine the illustration has been published by Thatcher et al. Further, these devices cannot be used to obtain an absolute measurement of irradiance or to compare irradiance between sources unless they are calibrated specifically for each source.

A detailed estimate of the SPD is obtained by use of ivh spectroradiometer. The total irradiance i. The chemical actinometer listed in the ICH guideline quinine hydrochloride has its limitations and it is not suitable for calibration of Option 1 radiation sources.


Photostability testing according to ICH Guideline Q1B

This limitation Ic has been some confusion as to whether needs to be made clear in the guideline. That is, Kester et al. Notwithstand- Option 1 light sources are not amenable to use with ing, many who use the guideline are not aware of quinine as an actinometer. For example, Baertschi16 the guidance. It is our hope that a revised photo- showed that with a xenon lamp that quinine is stability guidance document will provide clarity to sensitive to dissolved oxygen content and tem- the industry and eliminate potential errors and perature.

Brower The authors gratefully acknowledge helpful com- et al. Reed and Bernard A. Nonetheless, it is apparent Olsen during the preparation and review of this that many in the industry are not aware of these commentary.

ICH Q1B | Rycobel

The last line of this section states 1. The questions most fre- may be used. The International Conference on Harma- A discussion of experimental SW. A technical and conditions. Piechocki JT, Idh K, editors. Pharmaceutical practical interpretation of the ICH Guideline and its applica- photostability and stabilization technology, drugs and the tion to pharmaceutical stability: Pharm Technol US pharmaceutical sciences, Vol. A comment on photostability 4.

Photochemical degradation of testing according to the ICH guideline: Calibration of light components in drug formulations. Pharm Technol Eur 5: Quinine in pharmaceutical products: A review on the role of diluents, photochemistry: A proposed chemical actinometer to monitor excipients, and product components in promoting pharmaceu- UV-A exposure in photostability studies of pharmaceutical tical photochemistry.

Phar- drug substances and drug products. Piechocki JT, Thoma K, on photostability testing. Drugs and the pharmaceutical sciences, Vol. Commentary on the quinine actinometry York: On the choice of photolysis testing of new drug substances and products.

Drug Stability source for the photostability testing of pharmaceuticals.

Photoreactivity of biologically active icn. Eur J Pharm Sci 9: A technical and state and in various tablet formulations. Photoreactivity of practical interpretation of the ICH guideline and its application biologically active compounds. Pharm Technol US Gauglitz G, Hubig SM. Pie- in the solid state. A European perspective on photostability and stabilization technology, drugs and the pharmaceutical testing.

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