Receiving a certificate of analysis is not the same as having verified quality. A figure only means something once you know by what method, and at what point in time, it was measured. We draw on the GMP-compliant manufacturing of our affiliated business and look at materials from the receiving side.
1. Figures move with the method
Content depends on the analytical method. Lining up specification figures and concluding “this one is higher” risks treating the same material as two, and two materials as one. We check four things.
- The method — the Japanese Standards for Food Additives, the Pharmacopoeia, or in-house. If in-house, the basis for its validity
- When it is guaranteed — measured at manufacture, or guaranteed at end of shelf life. For cell counts, anthocyanins and carotenoids, which decline in storage, this changes the meaning entirely
- The unit — mg and μg appear side by side. 0.6 mg and 600 μg are the same amount, written differently
- Lot-to-lot variation — natural materials move by lot. We look at the observed distribution, not only the specified minimum
2. Verified by lot
Quality is confirmed per lot. COAs are provided per lot, and the handling of an out-of-specification result is agreed in advance. On continuing supply, we check whether the difference from the previous lot sits inside the acceptable range.
3. Weighing control — problems you can design out
Japan’s Ministry of Health publishes import violation records, now 1,682 cases. We take this public data in periodically and track the pattern of violations relevant to the items we handle.
What the record shows is that most violations concern control, not the quality of the material. For high-intensity sweeteners, exceedances of the use standard have been published with “inadequate weighing control” as the stated cause. Where a material is dosed at grams per kilogram, adopting a premix reduces weighing error by an order of magnitude — a problem solved by the choice of material, not by vigilance on the line.
4. What storage changes
| Material group | Sensitive to | What we confirm |
|---|---|---|
| Lactic acid bacteria, bifidobacteria | Temperature, humidity | When the cell count is guaranteed; storage range |
| Anthocyanin extracts | Heat, light, pH | Light-barrier packaging, temperature, shelf life |
| Carotenoids (lutein etc.) | Light, oxygen | Packaging format, handling after opening |
| Hygroscopic powders | Humidity | Handling after opening, sub-division size |
5. Fit to the dosage form
- Particle size — flow and fill behaviour for tableting; resistance to segregation for powder filling
- Oil- or water-soluble — oil-soluble carotenoids suit softgels or emulsified preparations
- Hygroscopicity — affects tablet hardness and storage stability
- Heat resistance — spore-forming bacteria tolerate heat, but the formulation assumes that; changes to heat conditions need checking
Documents we provide
- Specification — per item
- COA — per lot
- Analytical method behind the specified figures
- Storage conditions and shelf life
- Samples — small quantities for trial
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