Datasheet summary
AmberLite IRP69
PDF datasheet mirror for AmberLite IRP69 (DuPont). Verify with OEM before design.
Summary
Product identification
AMBERLITE™ IRP69 Ion Exchange Resin is a pharmaceutical grade, insoluble, strongly acidic, sodium form cation exchange resin supplied as a dry, fine powder. It is a Sodium Polystyrene Sulfonate USP.
Description
AMBERLITE™ IRP69 resin is suitable for use in pharmaceutical applications as both an active ingredient and a carrier for basic (cationic) drugs. It can also be used for sustained release applications with compatible coating technologies. The resin is manufactured in accordance with Good Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals.
Regulatory Status
A Drug Master File for AMBERLITE™ IRP69 is maintained with the United States Food and Drug Administration. Letters of authorization for FDA access are provided upon request, and similar support is offered for registrations in other countries.
Typical Properties
Physical Properties
- Copolymer: Styrene-divinylbenzene
- Type: Strong acid cation
- Functional Group: Sulfonic acid
- Physical Form: Fine powder
Chemical Properties
- Ionic Form as Shipped: Na⁺
- Heavy metals content: ≤ 10 ppm
- Potassium exchange capacity: 110–135 mg/g
- Water content: 10.0% maximum
- Ammonia salts: Negative to litmus paper
- Sodium content: 9.4%–11.5%
- Styrene content: 1 ppm maximum
Particle Size
- > 0.150 mm: 1.0% maximum
- > 0.075 mm: 10.0–25.0%
Applications
Applications for AMBERLITE™ IRP69 include:
- Taste Masking
- Drug Stabilization
- Sustained Release
- Active Ingredient (e.g., for lowering potassium levels in hyperkalemia treatment)
Drug Loading and Release
- Batch equilibration is the preferred method for loading drugs.
- The total cation exchange capacity is approximately ~5 meq/g.
- Actual drug loading will be influenced by factors such as inherent selectivity, drug concentration, competing cation concentration, solvent choice, and drug molecular size.
- Drug release rate and completeness in vivo are affected by diffusion rate through the resin, resin selectivity for the drug, and the nature and concentration of electrolytes.
- Hydrophobic drugs may elute at a lower rate due to hydrophobic interactions.
Drug Release Characteristics (Example)
| Time, minutes | % Drug released in 0.1N HCl |
|---|---|
| Phenylpropanolamine | |
| 15 | 82 |
| 30 | 88 |
| 60 | 92 |
| 90 | 95 |
Product Stewardship
DuPont emphasizes product stewardship, assessing safety, health, and environmental information for its products. Customers are encouraged to review their manufacturing processes and applications to ensure safe and intended use.
WARNING: Oxidizing agents such as nitric acid can attack organic ion exchange resins and may lead to violent exothermic reactions. Consult knowledgeable sources before using strong oxidizing agents.
Disclaimer: This extraction may miss figures, footnotes, or revisions. Contractual data must match the OEM PDF revision used on the project.
Official datasheet (PDF)
Curated from selected public technical reference material for discovery and preliminary comparison. This summary is not a substitute for a current certified manufacturer datasheet. Verify revisions and design limits before use.