What is the ICH stability studies?

The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a re-test period applicable to all future batches of the …

What is the correct ICH guideline for stability study?

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 are the three types of stability studies?

Types of Drug stability studies: – Stability studies are mainly of following types:

  • Long term stability.
  • Intermediate stability.
  • Accelerated stability.
  • In-use stability.

How many types of stability studies are there?

In the pharmaceutical industry, Stability Testing is mainly of two types-Real-time stability testing and Accelerated stability testing. Accelerated Stability Testing is done to determine the shelf life of finished products.

What is ICH stability?

Guideline. Q1B Guideline. Q1CStability Testing for New Dosage Forms. The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted.

How does pH affect drug stability?

Factors affecting drug stability: pH: Acidic and alkaline pH influence the rate of decomposition of most drugs. Many drugs are stable between pH 4 and 8. Weekly acidic and basic drugs show good solubility when they are ionized and they also decompose faster when they are ionized.

What are the different types of drug stability?

The type of stability is generally divided into chemical, physical, microbiological, therapeutic, and toxicological.

What is Zone IVb stability conditions?

Zone IVb. Hot/higher humidity. These stability studies zones are created due to the difference in temperature and humidity in different parts of the world. These zones have different ICH stability conditions for pharmaceutical products.

What are the 4 subsets of ICH?

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.

  • Quality Guidelines.
  • Safety Guidelines.
  • Efficacy Guidelines.
  • Multidisciplinary Guidelines.