400-600-8767

battle@labonce.com
ch en
  • Wechat
Constant Temperature and Humidity Chamber
Product categories
Latest product
ICHQ1B:STABILITY TESTING: PHOTOSTABILITY TESTING OF NEW PHARMACEUTICAL SUBSTANCES AND PRODUCTS

2018-08-21    Visits: 4163


STABILITY TESTING:

PHOTOSTABILITY TESTING OF NEW PHARMACEUTICAL SUBSTANCES AND PRODUCTS

1. GENERAL

The ICH Harmonized Tripartite Guideline covering the Stability Testing of New Pharmaceutical 

Substances and Products (hereafter referred to as the Parent Guideline) notes that

light testing should be an integral part of stress testing. This document is an annex

to the Parent Guideline and addresses the recommendations for photostability

testing.

A. Preamble

The intrinsic photostability characteristics of new pharmaceutical  substances and products

should be evaluated to demonstrate that, as appropriate, light exposure does not

result in unacceptable change. Normally, photostability testing is carried out on a

single batch of material selected as described under Selection of Batches in the Parent

Guideline. Under some circumstances these studies should be repeated if certain

variations and changes are made to the product (e.g., formulation, packaging).

Whether these studies should be repeated depends on the photostability

characteristics determined at the time of initial filing and the type of variation and/or

change made.

The guideline primarily addresses the generation of photostability information for

submission in Registration Applications for new molecular entities and associated

pharmaceutical products. The guideline does not cover the photostability of pharmaceutical after

administration (i.e. under conditions of use) and those applications not covered by the

Parent Guideline. Alternative approaches may be used if they are scientifically sound

and justification is provided.

A systematic approach to photostability testing is recommended covering, as

appropriate, studies such as:

i) Tests on the pharmaceutical substance;

ii) Tests on the exposed pharmaceutical product outside of the immediate pack;

and if necessary ;

iii) Tests on the pharmaceutical product in the immediate pack;

and if necessary ;

iv) Tests on the pharmaceutical product in the marketing pack.

The extent of drug product testing should be established by assessing whether or not

acceptable change has occurred at the end of the light exposure testing as described in

the Decision Flow Chart for Photostability Testing of Pharmaceutical Products. Acceptable

change is change within limits justified by the applicant.

The formal labeling requirements for photolabile pharmaceutical substances and drug products

are established by national/regional requirements.

1


Photostability Testing of New pharmaceutical Substances and Products

B. Light Sources

The light sources described below may be used for photostability testing. The

applicant should either maintain an appropriate control of temperature to minimize

the effect of localized temperature changes or include a dark control in the same

environment unless otherwise justified. For both options 1 and 2, a pharmaceutical

manufacturer/applicant may rely on the spectral distribution specification of the light

source manufacturer.

Option 1

Any light source that is designed to produce an output similar to the D65/ID65

emission standard such as an artificial daylight fluorescent lamp combining visible

and ultraviolet (UV) outputs, xenon, or metal halide lamp. D65 is the internationally

recognized standard for outdoor daylight as defined in ISO 10977 (1993). ID65 is the

equivalent indoor indirect daylight standard. For a light source emitting significant

radiation below 320 nm, an appropriate filter(s) may be fitted to eliminate such

radiation.

Option 2