Residual Process Impurities (NTPs, cap analogs, buffer components)
Context in Practice: Example Specifications
From Specification: Typical mRNA (Drug Substance) Specifications
- Rationale: Ensures removal of unreacted nucleotides/reagents.
- Acceptance Criteria: • Residual NTPs: <X mg/mg RNA• Cap analog: <Y%• Limits established during process validation (Product-specific; justified by process capability and toxicology assessment)
- Orthogonal Method(s): UV-Vis Spectrophotometry