What is photostability test?
For substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing. The purpose of forced degradation testing studies is to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation.
How many batches should be considered for photostability testing as per ICH?
The standard conditions for photostability testing are described in ICH Q1B. Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.
What is ICH testing?
ICH Stability Studies: Storage and Testing Services. Gathering pharmaceutical stability testing data on drug products or drug substances to determine an overall stability profile is a necessary step in the drug approval process.
How do you measure photostability?
To determine photostability, an experiment is performed that measures fluorescence intensity over time.
What is photostability?
The photostability of a drug substance may be defined as the response of the drug or drug product to the exposure to solar, UV, and visible light in the solid, semisolid, or liquid state that leads to a physical or chemical change.
What is ICH full form?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
What is photostability chamber?
Photostability chambers are utilized for light exposure testing of drug products in the pharmaceutical industry according to ICH Q1B FDA Photostability Testing of New Drug Substances and Products. Our photostability test chambers are designed to meet option 2 of this guideline.
What is photo stability?
Why photostability study is important?
Photostability can impact shelf life, handling, and packaging of the product. This testing is an important part of the drug development process. The photostability studies are usually performed in a sequential manner, with the drug/supplement substance being tested first.
What is purpose of ICH?
ICH aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high-quality medicines in the most resource-efficient manner.
What is PH in speed post?
P. H. Colony P.O. is a Sub Post Office. So far as the public is concerned, there is basically no difference in the character of the service rendered by Sub-Post Offices and Head-Post Offices except in regard to a few Post Office Savings Bank (SB) transactions.
How does a stability chamber work?
The working of a stability chamber is based on a simple principle which is that by maintaining a stable temperature, stable value of relative humidity will also be maintained. Relative humidity is the ratio of how much water the air has and how much it could potentially hold.
What is the ICH Q1b guideline?
The ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.
Should photostability testing be part of stress testing?
The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug 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.
What is the photostability guideline for new molecules?
The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. It does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guideline.
Why is photostability testing important for pharmaceuticals?
All companies developing or manufacturing pharmaceutical drugs, require a robust photostability testing process to ensure product quality and regulatory compliance. Inadequate testing can result in costly delays and lost revenue.