Case Study: Resolving Unexpected Vitamin B12 Results in Supplement Testing
Client Challenge
A supplement manufacturer added methylcobalamin (Vitamin B12) to a product, expecting to meet label claims. However, testing revealed only ~50% of the claimed amount, triggering an out-of-spec (OOS) result. The client consulted with their contract manufacturer, who confirmed the correct dosage—including overages—had been added during production.
Eurofins Investigation & Approach
Eurofins Supplement Testing conducted a detailed review of the chromatographic data and discovered that the methylcobalamin had degraded into hydroxycobalamin, a different form of B12. This degradation explained the discrepancy between the expected and measured values.
To address this, the team of experts at Eurofins recommended switching to a total B12 method that accounts for all active forms. Using this approach, the product tested within specification, confirming the presence of B12 despite the degradation.
Outcome & Solution
With the new method in place, the client understood that:
- Increasing overages of methylcobalamin could help maintain label claims despite degradation.
- Labeling adjustments may be necessary to reflect the actual forms present or to use a broader term like “cobalamin.”
Key Takeaways
- Labeling Accuracy: Ensure product labels reflect the actual forms of nutrients present.
- Method Selection Matters: Total B12 methods may pass, but form-specific methods can reveal degradation.
- Methylcobalamin Stability: It’s more bioavailable but less stable than other forms.
- Legacy Methods May Fall Short: Traditional micro or HPLC methods may not detect degradation.
- Regulatory Insight: Selective methods provide clearer data for FDA compliance.
Conclusion
This case highlights the importance of method selection, material stability, and collaborative investigation when facing unexpected test results. By partnering with Eurofins Supplement Testing, the client not only resolved an out-of-spec issue but gained deeper insight into the behavior of methylcobalamin and how it impacts product performance and labeling.
Advanced analytical tools like ICP-MS and form-specific testing methods empower manufacturers to make informed decisions about raw materials, packaging, and formulation strategies—ensuring regulatory compliance, consumer safety, and brand integrity. As the industry evolves, so must the testing strategies that support it.
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