What is the USP limit for tablet content uniformity?
CAPSULES, TRANSDERMAL SYSTEMS, INHALATIONS PACKAGED IN PREMETERED DOSAGE UNITS, AND MOLDED TABLETS — Unless otherwise specified in the individual monograph, the requirements for dosage uniformity are met if the amount of the active ingredient in not less than 9 of the 10 dosage units as determined from the Weight …
What is the criteria for content uniformity?
Criteria The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to L1% and no individual content of the dosage unit is less than (1－ L2 × 0.01)M nor more than (1 ＋ L2 × 0.01)M in Calculation of Acceptance Value under Content Uniformity or under Mass Variation.
What is uniformity content?
Content uniformity refers to a pharmaceutical analysis technique used to ensure that each dosage form includes the equivalent amount of active pharmaceutical ingredient or drug substance while assay refers to an investigative procedure for qualitatively assessing or quantitatively measuring the presence, amount, or …
What is uniformity content test?
Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.
How do you calculate label claims?
- Adjusted Ingredient Amount (adjusted for moisture loss and overage) = [ingredient label claim x ((100 – moisture loss) / 100)] x [(100 – overage ) /100]
- Scale Factor = (ingredient label claim / adjusted ingredient amount)
- Amount Per Serving = (scale factor x ingredient label claim)
Why is content uniformity important?
Content uniformity is an important quality measure of the final solid dosage product, notes Ian Robertson, spectroscopy applications specialist at PerkinElmer. It ensures that a consistent dose of the API is maintained between batches so that the patient receives the correct dose.
What is the difference between weight variation and content uniformity?
Content Uniformity is the default test and may be applied in all cases. The test for Weight Variation is applicable for dosage forms specified as W1, W2, W3, and W4. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%.
How Content Uniformity test is done?
Uniformity of Content is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.