Content Uniformity Test
Dosage forms are the means by which an active pharmaceutical ingredient (API) is delivered to specific sites of action in the body. They are classified according to the physical forms and the routes of drug administration. Physical forms include solids, semi-solids, liquids, and gases, while drug delivery routes include oral, parenteral (injection), buccal, topical, inhalation, ophthalmic, otic, and rectal, etc They are available in various types such as pills, capsules, capsules, granules, powder, suspensions, emulsions, liniments, lotions, syrups, solutions, elixirs, liquids, drops, linctus, creams, pastes, gels, transdermal patch, chalks, col lodio, suppositories, pessaries and sprays, etc.
What is a content uniformity test?
Dosage forms of pharmaceuticals must be in the form of safe and therapeutically effective formulations that are administered in a consistent and predictable manner. Since dosage form is a method of introducing or delivering drugs into biological systems, they should be evaluated by pharmacopoeial listed quality control tests (USP/BP/IP) along with their standard limits . The evaluation test includes hardness test, weight variation, friability, content uniformity, dissolution and disintegration test. To meet quality standards (official or not), these tests must be carried out throughout the manufacturing process and validated once each batch is completed.
What is a content uniformity test?
The content uniformity test is a quality control test according to the official standards described in the pharmacopoeias (USP/BP/IP) which also mention their normative limits. Individual doses of finished pharmaceutical products are tested using the batch release content uniformity test method to confirm that the product meets quality criteria.
Content uniformity testing is intended to ensure that each dosage form contains the equivalent amount of pharmaceutical ingredient or drug substance. This method applies to tablets containing less than 10% w/w or 10 mg of the active pharmaceutical ingredient or drug substance. Use the method indicated in the product monograph to determine the drug content of each of 10 randomly selected coated tablets.
Content uniformity is different from the weight variation test. This test applies to pills in which less than 10 mg or less than 10% of the API is w/w. Does not apply to multivitamins and trace elements. The pooled sample of the test tablet is made only after the content of active ingredients, which is displayed within the allowed range of the specified content.
In accordance with the USP content uniformity procedure, 10 boards are drawn according to the method described in the individual monograph. Its API content is determined in each of the 10 tables and the average value is calculated. Samples occur if the mean value of more than one of the individual values is not out of range 85 to 115% and 75 to 125% of the mean value is not out of range. The test is repeated with another 20 tablets if two or three separate tablets represent 85-115% of the mean value and no limit exceeds the limit of 75-125%. The tablets pass the test if the total sample of 30 tablets is > 3 of the separate value 85-125% is out of range and 75-125% of the mean value is not out of range.
It has many benefits and is widely used in pharmaceutical industries where solid dosage forms such as pills and capsules are manufactured.
Why do we do a content uniformity test?
A content uniformity test is performed to ensure that the concentration of the drug (S) remains within particular acceptance limits.
How many tablets are used for content uniformity testing?
For content uniformity test, 10 tablets are randomly selected from a sample to assess and calculate the amount of active drug components present.
Factors Affecting Content Uniformity of Tablets:
Inconsistent drug distribution in granules or powder, variation in tablet weight, and segregation of powder or granulation throughout formulation processes are the major factors responsible for variable uniformity of tablet content. .
Enforcement of Content Uniformity:
The content uniformity and weight variation test is used for various dosage forms such as tablets, capsules, solids in unit containers and solutions in unit containers, etc. The content uniformity test of single dose preparation is based on testing the individual content of different single dose units to determine whether the individual content is within the limit established in the official with reference to the average content of the sample. .
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