DuoLite AP143/1073

Summary

Product identification

• Product Name: DUOLITE™ AP143/1073 Resin
• Type: Pharmaceutical Grade Anion Exchange Resin Powder (Cholestyramine Resin USP)
• Manufacturer: DuPont
• Document: Product Data Sheet, Form No. 177-02365, Rev. 1, September 2019

Description

DUOLITE™ AP143/1073 resin is a strongly basic, anion exchange resin in the chloride form, supplied as a dry, fine powder. It is a styrene-divinylbenzene copolymer with quaternary amine functional groups. This resin is suitable for pharmaceutical applications, serving as either an active ingredient or a carrier for acidic (anionic) drug substances. It conforms to compendial specifications for Cholestyramine Resin USP and is manufactured under Good Manufacturing Practices (cGMP). A Drug Master File is maintained with the U.S. Food and Drug Administration.

Typical Properties

Physical Properties

• Copolymer: Styrene-divinylbenzene
• Type: Strong base anion
• Functional Group: Quaternary amine
• Physical Form: White to buff-colored, fine powder

Chemical Properties

• Ionic Form as Shipped: Cl⁻
• Loss on drying: 12.0% maximum (Contractual value)
• Identity (by IR spectrum): Identical to USP reference standard (Contractual value)
• Heavy metals: 0.002% maximum (Contractual value)
• pH of slurry: 4.1–6.0 (Contractual value)
• Residue on ignition: 0.1% maximum (Contractual value)
• Dialyzable quaternary amine: 0.05% (Contractual value)
• Chloride content: 13.0–17.0% (Contractual value)
• Sodium glycocholate exchange capacity: 1.8–2.2 g/g (Contractual value)
• Trimethylamine: 20 ppm maximum (Contractual value)
• Organic volatile impurities <467>: Meets requirements (Contractual value)

Particle Size

• < 150 microns: 95% minimum
• < 75 microns: 65% minimum
• < 45 microns: 45% maximum

Applications

• Taste Masking
• Drug Stabilization
• Controlled Release
• Active Ingredient

When used as a drug carrier, it binds medicinal agents onto a polymeric matrix to minimize taste and odor. It can impart controlled or sustained release properties to oral dosage forms. As an active ingredient, it binds bile acids, leading to a reduction in serum cholesterol levels.

Disclaimer

This extracted summary may not include all figures, footnotes, or revisions. Contractual data must be confirmed against the specific OEM PDF revision used on the project.

Official datasheet (PDF)

Lenntech datasheet mirror