Stability Study in Pharma

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Stability Testing

This is a critical process in evaluating the quality and shelf life of pharmaceutical products.

Types of Stability Studies

Long-Term Stability Testing:

  • Conducted under normal conditions (e.g., 30°C ± 2°C, 65% RH ± 5% RH).
  • Designed to evaluate the product’s stability under recommended storage conditions.
  • Duration: Typically 12 months or more.

Accelerated Stability Testing:

  • Conducted at higher stress conditions (e.g., 40°C ± 2°C, 75% RH ± 5% RH).
  • Aims to accelerate the degradation process and predict the product’s stability over time.
  • Duration: Usually for 6 months.

Intermediate Stability Testing:

  • Conducted under conditions between long-term and accelerated testing (e.g., 30°C ± 2°C, 60% RH ± 5% RH).
  • Typically used for drugs that are in between both extremes of storage conditions.
  • Duration: Generally for 6 months.

Stability Study Conditions

Temperature and Humidity:

  • Long-term: 30°C ± 2°C and 65% RH ± 5% RH.
  • Accelerated: 40°C ± 2°C and 75% RH ± 5% RH.
  • Intermediate: 30°C ± 2°C and 60% RH ± 5% RH.

Container Closure Systems : Stability studies must also assess the effect of the container-closure system on the product. This ensures the integrity of the packaging throughout the product’s shelf life.

Parameters to be Tested

Physical Tests:

  • Appearance
  • Size and Shape
  • Uniformity of Dosage

Chemical Tests:

  • Assay of the API
  • Degradation Products
  • pH
  • Microbiological Testing
    ▪︎ Sterility Tests
    ▪︎ Other Tests:
  • Dissolution: For solid dosage forms
  • Water Content: For hygroscopic products.

Stability Study Design

  • Test Batches:This is done on multiple batches (usually at least 3 batches).
  • Storage Conditions : The product is stored under specific temperature and humidity conditions, as per the study type.
  • Time Intervals : Stability data should be recorded at predetermined intervals, typically at 0, 3, 6, 9, and 12 months.
  • Replicate Testing : Replicate samples should be tested at each time point to ensure the reliability of the results.

Shelf Life Determination

  • This is determined based on stability testing data. This is the period during which the drug product retains its full potency and quality as specified in the product’s labeling.
  • The expiry date is determined by the acceptable levels of API, degradation products, and any other critical parameters.


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Resource Person: Susmita

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