100GC® Mycoplasma Standards

100GC® Mycoplasma Standards are non-infectious, purified mycoplasma nucleic acid reference materials with a defined target amount of ≤100 genome copies (GC). They are designed for use in NAT-based mycoplasma testing and support the verification of the limit of detection (LoD) of molecular mycoplasma assays.
They 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, 100GC® Mycoplasma Standards can be used as external positive control (EPC) and extraction inhibition control (EIC), supporting reliable mycoplasma NAT assay validation, LoD verification, and routine quality control.