A distinct regulatory and customer profile from pharmaceuticals.
Dietary supplement manufacturers sit in a different regulatory position — lighter-touch registration, faster development cycles, and significant reputational exposure if elemental limits are exceeded.
Dietary supplement and nutraceutical manufacturers sit in a different regulatory and commercial position from pharmaceutical manufacturers proper — often lighter-touch registration pathways, faster product development cycles, and, because supplements are taken over long periods by label-conscious consumers, significant reputational exposure if elemental contaminant limits are exceeded, even where the regulatory consequence is less severe than a pharmaceutical recall.
USP <2232> — Elemental Contaminants in Dietary Supplements. This chapter sets the applicable limits and testing framework for this category, distinct from <232>/<233> which apply to pharmaceuticals. Like <233>, it mandates microwave digestion for samples that are not readily soluble, and it is in force now.
Raw botanical and nutraceutical ingredients, finished capsules and tablets, powders, gummies, liquid supplements, and protein/sports nutrition products.
Matched to the applicable USP chapter.
| Application | Product |
|---|---|
| Elemental impurity digestion (USP <2232>) | MARS 6, MARSXpress 2.0, BLADE |
| Residue on ignition / sulfated ash (USP <281>, <733>) | Phoenix BLACK — Sulfated Ashing |
| Protein content (protein/sports nutrition) | SPRINT |
| Moisture content | SMART 6 |
| Autosampler for ICP throughput | ASX-series |
South African dietary supplement and nutraceutical manufacturers.
- · Botanical and finished-dose supplement manufacturers
- · Sports nutrition and protein product manufacturers
- · Contract testing laboratories serving the sector
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