AmberLite IRP64

Summary

Product Identification

• Product Name: AMBERLITE™ IRP64 Ion Exchange Resin
• Type: Pharmaceutical Grade Cation Exchange Resin (Polacrilex Resin)
• Manufacturer: DuPont
• Document Revision: Rev. 2, September 2019

Description

AMBERLITE™ IRP64 resin is an insoluble, weakly acidic, hydrogen form, cation exchange resin supplied as a dry, fine powder. It is suitable for pharmaceutical applications, primarily as a carrier for basic (cationic) drugs and related substances, and for masking objectionable tastes.

• Commercial Examples: Stabilization of Vitamin B12, Sustained Release of Nicotine.
• A Drug Master File is maintained with the United States Food and Drug Administration.

Typical Properties

Physical Properties

• Copolymer: Crosslinked-acrylic
• Type: Weak acid cation
• Functional Group: Carboxylic acid
• Physical Form: White to off-white fine powder, free of foreign matter and any agglomeration

Chemical Properties

• IR Identification: Conforms to reference spectrum assay
• Ionic Form as Shipped: H⁺
• Exchange Capacity (as is): ≥ 10.0 meq/g, on dried basis
• Purity Testing:
  • Sodium: ≤ 0.20%
  • Heavy metals: ≤ 0.001%
  • Iron: ≤ 0.01%
  • Methacrylic acid: ≤ 300 ppm
  • Water extractable impurities: ≤ 2.0%
• Physico-chemical Testing:
  • Loss on drying: ≤ 5.0%

Particle Size

• < 0.150 mm: ≤ 1.0%
• < 0.075 mm: 15.0-30.0%

• 1.180 mm: ≤ 70.0%

  • For additional particle size information, refer to Form No. 177-01775.

Microbial Purity

• Total bacterial count: ≤ 100 cfu/g
• Total mold count: ≤ 100 cfu/g

Manufacturing and Identification

• Manufactured in accordance with Good Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals.
• Identification is confirmed by infrared spectroscopy (see Figure 1 in the original document).

Chemical Structure

Derived from a porous copolymer of methacrylic acid and divinylbenzene (see Figure 2 in the original document).

Applications

• Taste Masking
• Drug Stabilization
• Carrier for Cationic Drugs
• Controlled Release Formulations

AMBERLITE™ IRP64 binds medicinal agents onto an insoluble polymeric matrix, aiding in taste/odor masking and controlled release. Its affinity for the hydrogen ion allows for desorption in acidic environments, like the stomach.

Drug Loading

• Batch equilibration is the preferred method.
• Not suitable for conventional columnar operations due to fine particle size.
• Loading is typically carried out at pH 6 or higher.
• Loading efficiency is influenced by drug affinity, drug concentration, competing cations, and loading solution pH.
• Multiple equilibration stages may be required for maximum loading.
• Controlled laboratory experiments are necessary to determine precise loading and elution conditions.

Drug Release

• Rate and completeness of desorption are controlled by drug diffusion rate, drug selectivity for the resin, and electrolyte concentration (especially H⁺) in the desorption environment.
• More hydrophobic drugs and those with higher selectivity for the carboxylic acid functional structure tend to elute at a lower rate.

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