This assay is performed as described in the United States Pharmacopeia National Formulary USP30/NF25. One-half of test article is placed in Fluid Thioglycolate Medium (FTM) and incubated at 32.5 C + 2.5 C. The other half of the test article is placed in Soybean Casein Digest Medium (SCDM) and incubated at 22.5 C + 2.5 C. Both media vials are incubated for 14 days and examined visually for turbidity on days 3, 7 and 14, the last day of the test period. At the same time, one uninoculated container of each medium is designated as a negative control and examined on days 3, 7 and 14.
A final reports that details the procedures performed is issued and reviewed by the quality assurance unit.
The sponsor will NOT be required to review and approve a protocol prior to study initiation. Please fill out the sample submission form below in either Word or PDF format and send along with the samples.
