Finished Drug Product Testing

Potency Testing

This test measures the concentration of the active ingredient at a specific point in time. GMP potency testing uses laboratory methods developed and validated for client specific formulations.


Sterility USP <71>

Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.  Method suitability is performed to ensure contamination can be detected under the conditions of the test, providing confidence in the test result.



Endotoxin USP <85>

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.  Method validation is available to ensure the ideal test method is used consistently, and the most accurate results are reported.



Particulate Matter USP <788>/<789>

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.


Antimicrobial Effectiveness Testing USP <51>

Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>

This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations.  This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration. 


Content Assay

Qualitative or quantitative measurement of the presence, amount, or functional activity of a target entity (the analyte).

Impurity Assay

This test measures the presence of impurities and provides quantitative measurements.

Reconstitution time

A critical performance parameter, especially for lyophilized products.  The test provides an assessment of dissolution time for preparation of the final solution for patient administration.

Content Uniformity (Uniformity of Dosage Units)

This test measures the degree of uniformity in the amount of the drug substance among dosage units. It is based on assay of individual content of drug substance(s) in a number of dosage units to determine whether the individual content is within the specified limits.

Preservative content testing

This test demonstrates that the declared antimicrobial agent is present at the labeled concentration.

Container Content/ Fill Volume/ Weight Volume (Minimum Fill)

This test ensures that the amount of material filled into the product conforms to the labeled amount.