Test Services

Uniformity of Dosage Units

BACKGROUND
Definition: The degree of uniformity of drug substance between dosage units, where dosage units are defined as a dosage forms containing a single or part of a single dose. Uniformity may be demonstrated using two methods, content uniformity or weight variation. Weigh variation may be used in certain cases (see USP <905> Table 1), where as the content uniformity method may be used in all cases, and if the compound being tested fails weight variation.

OUR METHODOLOGY
DYNALABS conducts content uniformity and weight variation in accordance with the standards delineated in USP <905>.

The number of samples is established during the experimental design phase of the project. Samples are analyzed using appropriate potency testing methodology to determine uniformity.

Specifications for uniformity are expressed as Acceptance Values which are calculated according the instruction in USP <905> Calculation of Acceptance Value sections.

FORMS TYPICALLY TESTED

• All solid (eg. Capsules, Tablets, Pellets, Suppositories etc) and liquid (Injections, suspensions, gels, ointments, creams, etc.) dosage forms.