Uniformity of dosage units, dissolution, uniformity in containers and container content.
| Tests |
|
|---|---|
| Method | Tested to the USP chapter, monograph or customer specification you choose. |
| Results | Reported against your monograph or specification, with pass/fail where limits apply. |
| Price | Quoted per project |
These tests look at finished products: how consistent the dose is, how the active ingredient is released and how much product a container holds. The procedure follows the chapter, monograph or method you name.
Assesses how consistent the amount of drug substance is between individual dosage units, by the approach USP <905> sets for the dosage form. The chapter is harmonized with the European and Japanese Pharmacopoeias.
Measures how much of the active ingredient is released from a dosage form into a dissolution medium over time, using the apparatus and conditions the monograph or product method names. Samples of the medium are taken at the stated times and the dissolved active ingredient is measured; the result is the percentage of the labeled amount dissolved, compared with the acceptance criteria. Tell us the monograph or method.
Checks that the product is uniform within its containers. Portions are taken as the product monograph or specification directs, for example from different parts of a container or from several containers, and the named content or property is measured in each; the spread of results is compared with the acceptance criteria. Tell us which document applies.
Checks the amount of product in a container against its labeled content. The contents of each container tested are measured by weight or volume, as your monograph or specification directs, and compared with the labeled amount and the acceptance criteria. Tell us the product type and the document you work to.
Send the material or product sealed and labeled, with its storage conditions.
Tell us the monograph or specification, the tests you need and the number of samples. We work to the current official USP-NF unless you name another applicable edition, and confirm the sample amount at quote.
Questions about a sample or a method, call 360-967-7010 or email [email protected].
