Biphasic Isophane Insulin Bulk Mixture
Bulk biphasic mixture of human insulin isophane suspension and soluble insulin for prolonged action, with protamine and buffers. Meets HTS 3003.31.00.00 as multi-constituent bulk therapeutic with insulin.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If containing antibiotics mixed with insulin
Mixed medicaments with antibiotics use 3003.91, not hormone-specific.
If separated isophane vs soluble components
Unmixed forms revert to base hormone heading 2937.
If pre-filled pen cartridges for retail
Retail-measured hormone medicaments classify in 3004.20.
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Import Tips & Compliance
• Validate pH stability documentation for biphasic suspensions during transit
• Declare as non-retail bulk with production contracts to support classification
• Beware of chapter exclusions for veterinary uses potentially shifting codes
Related Products under HTS 3003.31.00.00
Bulk Insulin Glargine Solution
A pharmaceutical preparation containing recombinant human insulin glargine mixed with stabilizers and preservatives for therapeutic use in diabetes management. Classified under HTS 3003.31.00.00 as it contains insulin (a hormone of heading 2937) and is a mixed multi-constituent medicament not in measured doses or retail packaging.
Insulin Lispro Premix Bulk Formulation
Bulk mixed suspension of insulin lispro protamine and regular insulin lispro for glycemic control, containing buffers and preservatives. Falls under HTS 3003.31.00.00 due to insulin hormone content and multi-constituent therapeutic mixture not suited for retail.
Recombinant Human Insulin Bulk Powder
Lyophilized powder formulation of recombinant human insulin mixed with mannitol and buffers for reconstitution in manufacturing. HTS 3003.31.00.00 applies as a mixed therapeutic containing insulin, bulk form excluding retail packing.
Insulin Aspart Injectable Bulk Solution
Sterile aqueous solution of insulin aspart with zinc and phenolic preservatives for diabetes therapy, supplied in bulk for further processing. Classified in 3003.31.00.00 for mixed insulin-containing medicaments not in retail forms.
Insulin Detemir Long-Acting Bulk Prep
Bulk formulation of insulin detemir fatty acid acylated analog mixed with phosphate buffers for basal insulin therapy. HTS 3003.31.00.00 for insulin-containing mixed bulk medicaments.
Regular Human Insulin Bulk for IV Use
Bulk regular human insulin solution with sodium chloride for intravenous hyperglycemic treatment, mixed for hospital compounding. Under 3003.31.00.00 as therapeutic mixed insulin not retail-packed.