Liquid Chromatography-Mass Spectrometry (LC-MS) Systems
Common Platforms & Models
Associated Analytical Procedures
Context in Practice: Example Specifications
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute 5′ Capping Efficiency with the following details:
- Purpose / Rationale: Ensures translational efficiency and immune safety (reduces innate immune activation via RIG-I/MDA5). Confirms correct cap structure (Cap 0 vs. Cap 1).
- Typical Acceptance Criteria: Total capped species: ≥90–95% (product-specific)• Cap structure profile: Consistent with qualified reference standard - For enzymatic capping (e.g., CleanCap): ≥90% Cap 1 - For co-transcriptional capping: Cap 0/Cap 1 ratio per reference• Uncapped RNA: ≤5–10% (justified limit)