Inhibition Testing for the Harmonized USP <63> Mycoplasma Test

M-1450 Procedural Summary

The M-1450 Test is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique's Harmonized USP  assay.

USP and EP 2.6.7 both require the testing for inhibitory substances in the test article. This qualification study is recommended only once for any given final product unless changes within the test article matrix or manufacturing processes occur.

Shipping Instructions:

Please view our general sample submission instructions page for details on how to submit your sample(s) online.

Download Sample Submission Forms
GMP Service
Total Testing Time: 28 days
Sample Requirements: Minimum Test Volume = 45 mL

Specializing In

Real-Time PCR Testing

Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

PCR Testing Services Harmonized USP Testing