The Total Organic Carbon (TOC) limit for Water for Injection (WFI) is ≤ 500 ppb (≤ 0.5 mg/L).
This limit is crucial for ensuring the purity and safety of WFI, which is used extensively in pharmaceutical manufacturing. TOC refers to the amount of carbon found in organic compounds within a water sample. High TOC levels can indicate the presence of undesirable contaminants that could compromise product quality or patient safety.
Many pharmaceutical facilities implement online TOC monitoring systems to continuously assess water quality and promptly detect any deviations from the specified limits. This allows for quick intervention and prevents potentially contaminated water from being used in production.
Here's a breakdown of why this limit is important:
- Purity: TOC is an indicator of organic impurities that could affect product stability and efficacy.
- Compliance: Regulatory bodies like the FDA and EMA have stringent guidelines regarding water quality, including TOC limits.
- Patient Safety: High TOC levels can potentially introduce harmful substances into injectable drugs, posing a risk to patients.
In summary, maintaining TOC levels below the specified limit is a critical aspect of producing safe and effective pharmaceuticals.
