What is photostability testing?

ACTIVE SUBSTANCE 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.

What is the guideline ICH Q1A R2?

ICH Q1A(R2) Stability Testing of new drugs and products (Revised guideline) Content: This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new active substances.

What is FDA stability testing?

Testing procedures must include a stability indicating test which will distinguish the active ingredient from any degradation products and be able to make a reliable estimate of the quantity of any degradate. The stability indicating test does not have to be the assay method used to determine product strength.

Which ICH guideline for stability?

Q1A – Q1F Stability This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II.

How do you measure photostability?

To determine photostability, an experiment is performed that measures fluorescence intensity over time.

What is bracketing and Matrixing in stability testing?

According to the ICH Q1A(R2) Glossary , bracketing is defined as “the design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design.” Matrixing is “the design of a stability schedule such that a selected …

How many types are in stability testing?

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. As per the result, the expiry date of a particular product is fixed.

What are the types of stability testing?

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.

How do you perform a stability test?

7 Steps for Stability Testing

  1. Step 1: Batch Production.
  2. Step 2: Product Container Filling.
  3. Step 3: Initial Test (Time Point Zero).
  4. Step 4: Product Storage.
  5. Step 5: Product Evaluation.
  6. Step 6: Determine Stability.
  7. Step 7: Conclusion Report.

What is meant by 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.

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