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Making a batch

Weighing, and why percentages

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A supplement formula is a percentage composition that must convert exactly into a label claim per serving. Every weighing error propagates into that claim.

Percentages and a batch weight

Write the formula as percentages by weight with the batch size as a separate line, so quantities are derived rather than remembered. That survives scaling, packaging changes and a second person.

Then derive the label claim from the percentage and the serving size arithmetically. Typing numbers into artwork independently of the formula is how a panel comes to disagree with the blend.

The resolution the small components need

Your smallest component sets the requirement. A vitamin premix at half a percent of a 5 kg batch is 25 g, which is easy. The same premix in a 200 g development batch is one gram, and weighing that on a scale reading to a gram is guesswork on the ingredient your claim depends on.

Two scales: one to 0.01 g for small components, one larger for the bulk. One instrument rarely covers both ranges honestly.

Weigh, never measure

Everything by weight, including things it feels natural to scoop. Bulk densities across supplement ingredients vary enormously, so a level scoop of one material and of another are not comparable quantities of anything.

This is also the discipline that makes the finished product's scoop problem visible: if you would not trust a scoop to weigh an ingredient, you should think carefully about shipping one as a dose.

Recording as you go

Write the actual weighed amount beside the target at the time, and record the lot number of every component as you weigh it.

That is the link 21 CFR 111 expects and the link that turns a tub code into an answer about which supplier lot was involved. It takes seconds at the bench and cannot be reconstructed afterwards.

References

21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. In force for all manufacturers regardless of size since June 2010. ecfr.gov
Written from published regulation and peer-reviewed work, not from a laboratory of our own. Your own certificates of analysis, your blend uniformity results and your own written specifications override anything general said here. Nothing on this site is a substitute for the records 21 CFR 111 requires you to keep.