Insulin Degludec API
Ultra-long acting insulin analogue with side chain modification for multi-hexamer formation. rDNA product classified in 2937.12.00.00 as polypeptide hormone structural analogue.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If multi-dose injection vials
Finished medicaments in Chapter 30 exclude bulk pure hormones.
If other recombinant polypeptide hormones
Insulin specificity at 2937.12 supersedes general hormone provisions.
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Import Tips & Compliance
• Provide peer-reviewed structural characterization of degludec modifications
• Special cold chain for ultra-long acting formulations; stability data required
• Bulk API form maintains Chapter 29 classification; avoid dosage declarations
Related Products under HTS 2937.12.00.00
Human Insulin (rDNA)
Recombinant human insulin produced via DNA technology, a polypeptide hormone used primarily for treating diabetes mellitus. Classified under HTS 2937.12.00.00 as a synthetic reproduction of insulin, the exact structural analogue of natural human insulin. Meets chapter 29 requirements for chemically defined organic compounds used as hormones.
Insulin Lispro (Humalog)
Rapid-acting insulin analogue created by recombinant DNA technology with amino acid modifications for faster absorption. Falls under HTS 2937.12.00.00 as a structural analogue of insulin used primarily as a hormone for glycemic control. Qualifies as a chain-modified polypeptide hormone per chapter notes.
Insulin Glargine (Lantus)
Long-acting basal insulin analogue produced by recombinant DNA, modified for prolonged release profile. HTS 2937.12.00.00 covers this as a derivative and structural analogue of insulin used primarily as a hormone. Chemically defined polypeptide meeting Chapter 29 hormone classification criteria.
Insulin Aspart (NovoRapid)
Fast-acting insulin analogue with aspartic acid substitution, rDNA origin, used for mealtime glycemic control. Classified in 2937.12.00.00 as insulin structural analogue per heading description for chain-modified polypeptides used as hormones.
Insulin Detemir (Levemir)
Soluble long-acting insulin analogue with fatty acid modification for albumin binding. HTS 2937.12.00.00 applies to this rDNA-produced derivative used primarily as a basal insulin hormone replacement.
Insulin Sodium Salt USP
Pharmaceutical grade sodium salt of bovine or porcine insulin meeting USP standards. Explicitly covered by HTS 2937.12.00.00 as 'insulin and its salts' for therapeutic hormone use.