Certified FD&C Red 40 for Pharmaceuticals
Pharmaceutical-grade FD&C Red 40 (CAS 25956-17-6) meeting USP/NF standards with heavy metal limits <10ppm, used in tablets and syrups. Specifically classified under 3204.12.50.10 due to CAS identification within synthetic organic acid dyes. Purity certificate required for drug master files.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If imported pre-mixed in pharmaceutical finished dosage form
Coloring matter incorporated into final medicinal products classifies under Chapter 30 as medicaments rather than separate dyes.
If classified as premetallized acid dye variant
Premetallized acid dyes have separate statistical suffix 3204.12.20 from basic acid dyes like FD&C Red 40.
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Import Tips & Compliance
• Provide Certificate of Analysis showing USP compliance and batch-specific heavy metals/arsenic testing
• Register with FDA Color Certification program; mislabeling purity leads to detention
Related Products under HTS 3204.12.50.10
FD&C Red 40 Powder
Pure FD&C Red 40 (Allura Red AC, CAS 25956-17-6) synthetic organic coloring matter in powdered form, certified for food, drug, and cosmetic use. Classified under HTS 3204.12.50.10 as a specific acid dye listed by CAS number in the synthetic organic coloring matter category. Used primarily to impart red color to beverages, candies, and pharmaceuticals.
FD&C Red 40 Lake Pigment
FD&C Red 40 precipitated onto alumina substrate to form an insoluble lake pigment (CAS base 25956-17-6), used in coatings and chewing gum. While based on the specified synthetic coloring matter, classified under 3204.12.50.10 due to specific CAS identification in acid dyes category. Not considered a preparation dispersed in nonaqueous media per chapter notes.
FD&C Red 40 10% Solution
Aqueous solution containing 10% FD&C Red 40 (CAS 25956-17-6) for use in beverage manufacturing and oral pharmaceuticals. Falls under HTS 3204.12.50.10 as a preparation based on the specified synthetic organic acid dye per chapter note 3. The water content does not change classification from the base coloring matter.
FD&C Red 40 Granular Form
Granulated FD&C Red 40 (CAS 25956-17-6) with maltodextrin carrier for improved dust control in food processing. Remains classified under HTS 3204.12.50.10 as the specific synthetic coloring matter preparation not exceeding dispersion thresholds in chapter notes. Carrier content typically under 20%.
FD&C Red 40 High Purity Batch
Ultra-high purity FD&C Red 40 (>88% dye content, CAS 25956-17-6) for parenteral drug applications and high-end cosmetics. Classified precisely under HTS 3204.12.50.10 matching the official description. Batch testing includes microbial limits and HPLC purity profiles.