AmberLite IRP88

Summary

Product Identification

• Product Name: AMBERLITE™ IRP88 Ion Exchange Resin
• Description: Pharmaceutical Grade Cation Exchange Resin (Polacrilin Potassium NF)
• Type: Weak acid cation
• Functional Group: Carboxylic acid
• Copolymer: Crosslinked acrylic
• Physical Form: Fine powder
• Ionic Form as Shipped: K⁺
• CAS Number: 39394-76-5 (for the potassium salt)

Chemical and Physical Properties

• Loss on drying: 10.0 % maximum
• Iron: 100 ppm maximum
• Sodium: 0.20% maximum
• Heavy metals: 0.002% maximum
• Potassium: 20.6%–25.1%
• Residual Methacrylic acid: 200 ppm max.
• Organic volatile impurities <467>: Meets standard specifications
• Particle Size:

  • 0.150 mm: 1.0% maximum

  • 0.075–0.150 mm: 30.0%

Applications

• Tablet Disintegrant: Used in oral dosage formulations. It swells upon hydration, enhancing tablet disintegration rates, even for tablets subjected to high compression forces. Typically used at 1–2% (weight) of the formulation.
• Taste Masking: Proposed for taste masking, specifically for β-lactam antibiotics.
• Water Adsorption: Adsorbs water rapidly due to its hydrophilic nature, causing significant swelling.
• Non-adhesive: Unlike some cellulosic disintegrants, AMBERLITE™ IRP88 is non-adhesive and effective in overcoming particle bonding in compressed tablets.

Manufacturing and Compliance

• Manufactured in accordance with Good Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals.
• Complies with compendial specifications for Polacrilin Potassium NF when tested according to current USP/NF methods.
• A Drug Master File (DMF) is maintained with the United States Food and Drug Administration.

Disclaimer

Extraction may miss figures, footnotes, or revisions; contractual data must match the OEM PDF revision used on the project.

Official datasheet (PDF)

Lenntech datasheet mirror