100GC® Mycoplasma Standards

100GC® Mycoplasma Standards are non-infectious, purified nucleic acid reference materials with a defined target amount of ≤100 genome copies (GC). They are specifically designed for the validation, verification, and routine performance monitoring of NAT-based mycoplasma detection methods in regulated and research environments. The standards support matrix-specific validation, determination of the limit of detection (LoD), method suitability testing, and use as external positive controls (EPC) in PCR-based mycoplasma assays. They are compatible with PCR, qPCR, RT-qPCR, and digital PCR workflows and support compliance with EP 2.6.7 (12.2), USP <77>, and JP 18 G3 requirements. The lyophilized, ready-to-use format simplifies handling and improves stability during storage and transport. As non-infectious standards, 100GC® Mycoplasma Standards provide a safe and practical solution for regulated pharmaceutical quality control, ATMP testing, and routine laboratory applications.