Frequently Asked Questions on Uniformity of Dosage Units
Q: What is the purpose of the weight variation test in pharmaceuticals?
The weight variation test is an in-process check to ensure that the finished pharmaceutical product remains within the acceptable weight range.
Q: How is the weight variation test conducted?
The test involves weighing 20 tablets individually and calculating the average weight. The test is met if no more than two tablets deviate beyond the specified percentage set by the pharmacopoeia.
Q: What is content uniformity in pharmaceuticals?
Content uniformity ensures that each dosage form contains the correct amount of the active pharmaceutical ingredient (API).
Q: How should samples be collected for content uniformity testing?
Samples should be collected from at least 30 locations across the batch, including the beginning and the end of the manufacturing process.
Q: According to USP <905>, how is dosage unit uniformity assessed?
Dosage unit uniformity is assessed through either Content Uniformity or Weight Variation testing.
Q: When is the Content Uniformity test applicable?
Content Uniformity applies to capsules, uncoated, or film-coated tablets containing less than 25 mg of API or less than 25% of the total dosage weight.
Q: When is the Weight Variation test applicable?
The Weight Variation test is used when the API content is 25 mg or more, or constitutes 25% or more of the total dosage weight.
Q: What method did ISPE develop to enhance industry acceptance of dosage uniformity testing?
ISPE developed a method mirroring USP <905>, ensuring statistical reliability with 50% confidence, 95% probability, and practical usability similar to current USP <905> applications.
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