Section 73.1550 lists talc among colour additives exempt from certification for use in drugs. Talc is defined as a finely powdered, native, hydrous magnesium silicate that sometimes contains a small proportion of aluminium silicate. It must meet the talc specifications of the United States Pharmacopeia XX (1980) and two metal specifications.
Key numbers
| Paragraph | Analyte | Specification | How it is measured |
|---|---|---|---|
| 73.1550(b) | Lead (as Pb) | not more than 20 parts per million | in the solution obtained by boiling 10 g of talc for 15 minutes in 50 mL of 0.5 N hydrochloric acid |
| 73.1550(b) | Arsenic (as As) | not more than 3 parts per million | same extract |
Talc may be used in amounts consistent with good manufacturing practice to colour drugs generally (paragraph c). Batches are exempt from certification (paragraph e).
Scope and basis
The limits apply to talc as a colour additive in drugs. They are raw-material specifications, not limits for a finished baby powder or for talc used in cosmetics. The test is an extraction in dilute hydrochloric acid, so the limits bound extractable lead and arsenic, expressed per mass of talc, not total content after full digestion. The regulatory limits register carries these two values with an annotation that they are measured on the acid extract, are extractable rather than total content, and must never be compared directly with total-content results.
Evidence fitness
The section is the primary text for the US federal colour-additive specification for talc. Where papers in this collection cite an FDA arsenic limit of 3 ppm or an FDA lead limit of 20 ppm, this is the only FDA instrument in the collection that prints those numbers, and it applies to a different product and a different measurement.
Related evidence
- Baby Talcum Powder
- Dusting/talc powders (adult)
- US FDA 21 CFR Part 73 - color-additive metal specifications
- Lead
- Arsenic, Total
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