WEIGHT VAR

• Compendial standards define acceptable articles at the time of use
• Evaluation for visual appearance, labelling, odour, taste, texture, hardness and friability
• Moisture content limits are given in official compendia
• Standards and tests of identity demonstrate that the specimens contain the active ingredient(s) they purport to contain
• Standards and tests of homogeneity include a test for uniformity of weight
• Standards and tests for purity check for potentially harmful degradation compounds and contaminants indicating deviation from GMP
• Standards and assays for the active ingredient(s) provide quantitatively permitted range per tablet or capsule of average weight
• Uniformity of content involves individual analysis of a given number of dosage forms to assess possible variation
• Standards and tests of performance assure that the dosage form will release its active ingredient as intended
• Stability indicating tests consider deterioration in activity or strength of the drug product due to degradation of the active ingredient and physical instability
• Storage conditions are important for maintaining the quality of oral solid dosage forms
• Quality Control requirements for semi-solid dosage forms include evaluation for visual appearance, colour, odour, labelling, and homogeneity
• Tests for semi-solid dosage forms also include loss of water, consistency, softening range (for suppositories), viscosity, particle size distribution, and pH
• Assay of active ingredients and degradation products is essential for semi-solid dosage forms
• Identification test for active ingredient and possible contaminants is necessary for semi-solid dosage forms
• Stability of the active ingredient in the dosage form must be assessed for semi-solid dosage forms
• Release of the active ingredient from the dosage form is a critical test for semi-solid dosage forms
• Weight Variation Test involves the determination of individual weights of the samples tested and computation for the average weight
• NMT 2 tablets should differ by more than the % weight variation
• No tablet should differ by more than double the % weight variation
• Content Uniformity Test establishes that a product has a uniform amount of an active ingredient in a batch
• Factors responsible for variable content uniformity in tablets include tablet weight variation, uneven distribution of the drug, and segregation of the powder mixture or granulation during formulation processes