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Questions and Answers
What is the purpose of sampling, testing, and monitoring the product after manufacture?
What is the purpose of sampling, testing, and monitoring the product after manufacture?
- To set the manufacturing process specifications
- To establish the pharmacopeial standards
- To determine the density of the granulation
- To ensure the tablet thickness falls within the acceptable range (correct)
What is the acceptable range for tablet thickness expressed in millimeters (mm)?
What is the acceptable range for tablet thickness expressed in millimeters (mm)?
- $ ext{±1.2 mm}$
- $ ext{±0.3 mm}$ (correct)
- $ ext{±0.9 mm}$
- $ ext{±0.6 mm}$
What are examples of pharmacopeial standards mentioned in the text?
What are examples of pharmacopeial standards mentioned in the text?
- European Pharmacopoeia (Ph. Eur.)
- British Pharmacopeia (BP)
- United States Pharmacopeia (USP) (correct)
- Japanese Pharmacopeia (JP)
What factors can influence the acceptable ranges for tablet thickness?
What factors can influence the acceptable ranges for tablet thickness?
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Why can tablet thickness vary with no change in weight?
Why can tablet thickness vary with no change in weight?
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Study Notes
Quality Control in Table Manufacturing
- Sampling, testing, and monitoring of the product after manufacture are crucial to ensure the quality of tablets, detecting any deviations from the expected standards, and implementing corrective actions.
Tablet Thickness
- The acceptable range for tablet thickness is typically expressed in millimeters (mm).
- Thickness variations can occur despite no change in weight, due to differences in density or compressibility of the tablet material.
Pharmacopeial Standards
- Examples of pharmacopeial standards mentioned in the text include standards for tablet thickness.
Factors Influencing Tablet Thickness
- Factors that can influence the acceptable ranges for tablet thickness include material properties, manufacturing processes, and storage conditions.
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Description
Test your knowledge on the sampling, testing, and monitoring processes involved in ensuring the quality of tablets. Learn about the acceptable range for tablet thickness and how deviations from standards are identified and addressed.
