Fd And C Blue No 1 Aluminum Lake
FD&C Blue No. 1 Aluminum Lake: Reliable Bulk Supply for Pharma, Food & Cosmetics
From our Hebei factory, we deliver consistent, FDA-compliant batches. Proven in tablet coatings and confectionery. Get factory-direct pricing on your next order.
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Table of Contents
- • What Exactly is FD&C Blue No. 1 Aluminum Lake?
- • Production Insights from Our Factory
- • Key Applications Across Industries
- • Technical Specifications & Quality Data
- • Procurement Guide: Sourcing Smart
- • Logistics & Shipping Realities
- • Certifications & Compliance
- • What Buyers Say
- • FAQs for Importers
Li Wei
Export Director, Tang Zhi Technology (Hebei) Co., Ltd.
15+ years in pigment lakes & excipients export to USA/EU.
What Exactly is FD&C Blue No. 1 Aluminum Lake?
Procurement folks often ask this when scouting suppliers. FD&C Blue No. 1 Aluminum Lake starts with Brilliant Blue FCF, the water-soluble dye certified for food, drugs, and cosmetics in the US. We lake it onto aluminum hydroxide, making it insoluble. That shift matters in applications where bleeding colors ruin batches.
Picture a pharma tablet coating line. Soluble dyes migrate during compression or humidity swings. Lakes stay put. We've seen importers ditch soluble blues after recall scares. Our version hits 14-16% dye content, standard for FDA specs under 21 CFR 74.101. Particle size averages 5-10 microns, tunable if you need finer for sprays.
Production isn't glamorous. It kicks off with dye precipitation in controlled pH vats. Aluminum chloride drops in, binds the sulfonate groups. Filter, wash, dry under vacuum to lock purity above 99%. Miss a step, and heavy metals creep over limits. Our lab tests every lot for lead under 10ppm, arsenic nil.
Why lakes over dyes? Stability. Heat up to 200°C without fading. Lightfast in windowsill storage. For cosmetics, it suspends in oils without settling. Food guys love it for gum or hard candy—vibrant blue that doesn't leach in saliva.
We've shipped tons to US compounders. One repeat buyer in New Jersey runs it through gel caps for vitamins. Another in Texas coats pet treats. Demand spiked post-pandemic as clean-label pushes met blue preferences. But supply chains snag on raw dye quotas from China. We stockpile to buffer that.
Shade consistency trips up buyers. Our lake matches Pantone 286C-ish, measured by Hunter Lab. Delta E under 1.0 batch-to-batch. Importers test this religiously; we provide COAs with every drum.
Cost-wise, expect $25-35/kg FOB Tianjin for 500kg+. Scales down for samples. Compare to European lakes at 20% markup. Our edge? Direct factory, no middlemen. Hebei location cuts inland haul to port by half.
Regulations bind everything. FDA lists it GRAS for ingested use, max 300ppm in drugs. EU E133 lake equivalent, but aluminum caps at 8ppm soluble. We dual-certify for cross-border ease. Cosmetics? CIR safe up to 1% in eye area.
Handling quirks: It's dusty if not pelleted. Use anti-static bags. Shelf life 3 years sealed, but test moisture quarterly. We've had US customs hold shipments over labeling—always specify "Aluminum Lake" not just Blue 1.
This isn't entry-level stuff. Buyers need suppliers who grasp lot traceability. Our ERP tracks from dye melt to pallet. RFID tags if you want. Reduces audit time from days to hours.
Market's shifting. Clean beauty demands organic lakes, but FD&C rules synthetic. Still, pharma holds 60% volume. Food next, cosmetics trailing. Asia exports dominate 70%, but US duties favor verified Chinese sources.
One importer shared a story: Switched from Indian lake after microbiologies failed. Our plate count under 1000 CFU/g sealed the deal. Real-world wins like that build loyalty.
Depth here pays off. Skip generics; vet for batch data. We'll send spectra if asked.
Production Insights from Our Factory
Our 140,000 sqm site in Jinzhou, Hebei, runs three lake lines. Automated spray-dryers hit 500kg/hour. World-class from Germany—precision on particle morphology.
Workflow: Dye dissolve, alum add, age 4 hours at 60°C. Centrifuge spins out salts. Fluid bed dries to 2% moisture. Micronizer for size control. QC samples every 500kg.
Yield? 92% typical. Waste recycles to effluent plant. No shortcuts; FDA audits love that.
Capacity freed up from cellulose runs—HPMC shares reactors early. Diversifies us into excipients.
| Process Step | Equipment | Control Param |
|---|---|---|
| Precipitation | SS Reactor | pH 4.5-5.0 |
| Filtration | Belt Press | Cake 25% solids |
| Drying | Spray Tower | Inlet 180°C |
Scales from 25kg pilots to 20MT runs. OEM? We private-label drums.
Key Applications Across Industries
Pharma first. Tablet films—disperses in HPMC without agglomeration. 0.5-2% loading yields deep blue. Sustained release? Stable under enteric coats.
- Chewables: Masks bitterness in pediatrics.
- Capsules: Banding ink, no bleed.
- Liquid suspensions: Thickener compatible.
Food & bev. Candy shells—panned goods shine. Ice cream ripples hold through freezers. Bakery icings resist cracking.
Cosmetics. Lipsticks matte blue. Eye shadows pressed powders. Lotions for color claims.

One twist: Pet food. Blue kibble boosts appeal. Stable in extruders.
Industrial? Not core, but some mark extrusion plastics.
Technical Specifications & Quality Data
| Parameter | Specification | Test Method |
|---|---|---|
| Dye Content | 14.0 - 16.0% | Spectrophotometry |
| Particle Size D50 | 5-10 µm | Laser Diffraction |
| Loss on Drying | ≤5.0% | 105°C/3h |
| Lead (Pb) | ≤10 ppm | ICP-MS |
| Microbial Total Plate | ≤1000 CFU/g | USP 61 |
Tight controls. Bulk density 0.4-0.6 g/ml. Oil absorption 40-60g/100g.
Procurement Guide: Sourcing Smart
Risks abound. Fake lakes flood Alibaba—low dye content, migrates. Vet COA authenticity.
MOQ traps newbies. We start 25kg samples, 100kg production. Lead 7 days stock, 14 custom.
Pricing tiers: $32/kg 100kg, $28/kg 1MT. FOB/CIF quotes fast.
Compare suppliers:
| Factor | Tang Zhi | Generic China | EU Supplier |
|---|---|---|---|
| Cert Lead Time | 24h | 3-5 days | 1 week |
| MOQ | 25kg | 500kg | 100kg |
Tip: Request retention samples. Test parallel.
Logistics & Shipping Realities
Tianjin port, 2h drive. 20' container fits 4MT fiber drums (25kg ea). Palletized, shrinkwrapped.
US clearance: FDA prior notice mandatory. We pre-file. Duties 6.5% HTSUS 3204.17.
Incoterms: FOB safe for vets, CIF for hands-off. Air for urgency—$8/kg UPS.
Watch humidity in transit. Desiccant packs standard.
Certifications & Compliance
- ✓
FDA 21 CFR 74.101 - ✓
ISO 9001:2015 - ✓
REACH Compliant - ✓ Halal/Kosher on request
What Buyers Say
Mike R., Procurement Mgr, NJ Pharma Co.
"Switched to Tang Zhi after EU delays. Color matches spec, no lot variation. Saved 15% on freight too."
Sarah L., Ops Dir, TX Confectionery
"Samples arrived in 5 days. Runs clean in panners—no dust issues. Repeat order in."
John K., Formulations Lead, CA Cosmetics
"Good suspension in anhydrous bases. Microbials clean. COA detailed—easy FDA file."
Carlos M., Importer, FL Pet Food
"Bulk pricing beat quotes. Fast prior notice filing. Stable in high-fat feeds."
FAQs for Importers
Can you customize particle size?
Yes, from 2µm for sprays to 15µm for presses. Add 3 days lead.
Is it vegan?
Aluminum lake—synthetic, no animal products.
Free samples?
25g free with freight collect. Larger for testing.
OEM labeling?
Full service. Your logo on drums/COAs.
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