Weight variation and content uniformity are used for the same purpose but in different ways. They both are the official quality control tests for the dosage forms, one of two methods can be used to demonstrate uniformity of dosage units.
The dosage forms are pharmaceutical products meant to be delivering the active pharmaceutical ingredients (API) at the particular site within the body to treat the diseases. The dosage forms have different types such as solid, liquid, and gaseous based on the physical form, and based on the route of drug administration they are topical, oral, parenteral (injection), inhalation, sublingual and buccal, etc.
Quality of pharmaceutical products such as tablet, capsules, caplets, powders, granules, liquid, solution, syrup, suspension, emulsion, colloid, drop, liniment, lotion, elixir, linctus, gel, cream, and paste, etc. is very important because pharmaceuticals must be marketed as safe and therapeutically active formulations with consistent and predictable performance.
Hence they need to be evaluated by quality control tests mentioned in pharmacopeias (USP/BP/IP) such as appearance, organoleptic properties, weight variation, hardness, friability, content uniformity, disintegration, and dissolution test. In order for the product to meet quality standards (official or unofficial), these tests must be performed throughout production and verified after each batch is produced.
Difference between weight variation and content uniformity:
The major difference between weight variation and content uniformity is that the weight variation testing is to ensure that the weight of the active ingredient per weight of dosage unit is uniform, whereas the content uniformity testing is performed to ensure that each dosage form contains the same amount of the active pharmaceutical ingredient (API) or drug.
Weight variation test:
- The purpose of the uniformity of weight test is to ensure that each batch is uniform around the label claim in the product, which indicates the uniformity of the drug throughout all formulation batches.
- It is performed by weighing and determining the individual weights of 20 tablets randomly selected from a tablets/capsules batch and calculates the average weight.
- The sample passes the test, If not more than two tablets are outside the % limit and no tablet differs by more than two times the percentage restriction.
Content uniformity test:
- The purpose of the content uniformity test is to ensure the content consistency of the drug within a narrow range.
- Several tablets/capsules are chosen at random, and the individual content of the active ingredient in each dosage is determined using a suitable analytical method is applied to the assay.
- The sample passes the test, if not more than one individual ingredient is outside the range of 85 to 115% of the average content and no one is out of the range of 75 to 125% of the average content.
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