10CFU® Mycoplasma Standards

10CFU® Mycoplasma Standards are non-infectious, inactivated mycoplasma reference materials with a defined target amount of ≤10 CFU. They are specifically designed for the determination and verification of the limit of detection (LoD) of NAT-based mycoplasma tests.
Manufactured in accordance with EP 2.6.7 (12.2), 10CFU® Mycoplasma Standards exhibit a specified GC:CFU ratio of <10 and support pharmacopoeia-compliant method validation (described as "test for inhibitory substances" and "method suitability test") according to EP 2.6.7, USP <77>, and JP 18 G3.
In addition, 10CFU® Mycoplasma Standards can be used as an external positive control (EPC) and extraction inhibition control (EIC), supporting reliable mycoplasma NAT assay validation, LoD verification, and routine quality control.