2023-04-30T22:46:51+03:00[Europe/Moscow] en true <p>stability testing </p>, <p>recommended storage conditions, shelf life, DP &amp; DS specifications </p>, <p>a</p>, <p>a</p>, <p>b</p>, <p>c</p>, <p>kinetics, MKT, global climate zones, standard testing </p>, <p>hydrolysis, oxidation, photolysis, racemization/epimerization </p>, <p>MKT</p>, <p>false</p>, <p>International Council on Harmonization (ICH)</p>, <p>Stability data</p>, <p>c</p>, <p>3 batches of drug substance, 3 batches of all different configurations, commercial batch size &amp; manufacturing procedure</p>, <p>USP 659</p>, <p>20-25 celsius</p>, <p>2-8</p>, <p>-25 &amp; -10</p>, <p>true </p> flashcards
Pharmaceutical Stability Testing

Pharmaceutical Stability Testing

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  • stability testing

    - provides evidence on how the quality of a drug substance (DS) or drug product (DP) varies with time under the influence of temperature, humidity, and light.

  • recommended storage conditions, shelf life, DP & DS specifications

    What does stability testing establish?

  • a

    Stability testing is a __________ quality test.

    a) primary

    b) secondary

    c) tertiary

  • a

    Which stability testing is designed to be predictive of the long-term storage conditions?

    a) accelerated stability studies

    b) long-term studies

    c) shelf life

  • b

    Which stability testing establishes the official shelf-life and storage conditions ?

    a) accelerated stability studies

    b) long-term studies

    c) shelf life

  • c

    Which stability testing establishes the time period which a DS or DP is expected to remain?

    a) accelerated stability studies

    b) long-term studies

    c) shelf life

  • kinetics, MKT, global climate zones, standard testing

    What are the 4 principles of stability testing?

  • hydrolysis, oxidation, photolysis, racemization/epimerization

    What are common degradation pathways for pharmaceuticals? (HOPER)

  • MKT

    -single derived temperature which, if maintained over a defined period, gives the same thermal challenge to a pharmaceutical product as would be experienced over a range of both higher and lower temperatures for an equivalent period of time

  • false

    MKT is the average temperature. T/F?

  • International Council on Harmonization (ICH)

    -is a collaborative alliance formed by leading global pharmaceutical regulatory agencies that creates global standard stability testing conditions.

  • Stability data

    -the required data for product approval.

  • c

    What is the minimum length of time required for formal stability data submission?

    a) 6 months

    b) 9 months

    c) 12 months

    d) 18 months

  • 3 batches of drug substance, 3 batches of all different configurations, commercial batch size & manufacturing procedure

    What kind of data is required for formal stability data submission? (4)

  • USP 659

    Official storage condition statements for the US are published in _______.

  • 20-25 celsius

    What is the range for controlled room temperature?

  • 2-8

    A refrigerator is a cold place in which temperature is maintained between __________ degrees celsius.

  • -25 & -10

    A freezer is a place where temperature is maintained between __________ degrees celsius.

  • true

    Manufacturers are required to place at least 1 lot of DS and 1 lot of DP of each strength, dosage form and packaging configuration into stability studies each year. T/F?