Amberlite IRP64

Summary

Product identification

AMBERLITE™ IRP64 Pharmaceutical Grade Cation Exchange Resin (Polacrilex Resin)

This is an insoluble, weakly acidic, hydrogen form, cation exchange resin supplied as a dry, fine powder.

Description

AMBERLITE IRP64 resin is suitable for use in pharmaceutical applications, primarily as a carrier for certain basic (cationic) drugs and related substances. It is also used to mask objectionable tastes associated with certain basic drugs. Examples of its use include:

• Stabilization of Vitamin B12
• Sustained Release of Nicotine

A Drug Master File for this product is maintained with the United States Food and Drug Administration. The resin is manufactured in accordance with Good Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals.

Chemical Structure

AMBERLITE IRP64 resin is derived from a porous copolymer of methacrylic acid and divinylbenzene.

Applications

Applications for AMBERLITE IRP64 resin include:

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

Typical Properties

These properties are typical but do not constitute specifications.

• Ionic form: Hydrogen
• Appearance: White to off white fine powder free of foreign matter and any agglomeration
• IR Identification: Conforms to reference spectrum assay
• Exchange capacity (as is): Not less than 10.0 meq/g, on dried basis

Purify testing

• Sodium: Not more than 0.20 %
• Heavy metals: Not more than 0.001 %
• Iron: Not more than 0.01 %
• Methacrylic acid: Not more than 300 ppm
• Water extractable impurities: Not more than 2.0 %

Physico-chemical testing

• Loss on drying: Not more than 5.0 %

Particle size

• > 0.150 mm: Not more than 1.0 %
• > 0.075 mm: 15.0 to 30.0 %
• > 0.050 mm: Not more than 70.0 %

Microbial purity

• Total bacterial count: Not more than 100 cfu/g
• Total mold count: Not more than 100 cfu/g

Drug Loading

Batch equilibration is the preferred practice for loading drugs or other sorbates. Due to its fine particle size, AMBERLITE IRP64 resin is not suited for conventional columnar operations. Adsorption is usually carried out at pH 6 or higher. The amount of drug loaded is influenced by:

• The inherent affinity or selectivity between the resin and the drug.
• The concentration of the drug in the loading solution.
• The concentration and selectivity of competing cations.
• The pH of the loading solution.

The rate of loading is affected by the activity of the drug, its molecular dimensions, and the extent of polymer phase swelling. Multiple loading stages may be required to achieve maximum loading.

Drug Release

The rate and completeness of drug desorption are controlled by:

• The diffusion rate of the drug through the polymer phase.
• The selectivity of the drug for the resin.
• The concentration of electrolytes, particularly hydrogen ion, in the desorption environment.

Hydrophobic drugs or those with high selectivity for the carboxylic acid functional structure will generally elute at a lower rate. Other resin-sorbate interactions, such as coordination with transition metals, can also affect loading capacities and rates.

Safe Handling Information

Material Safety Data Sheets (MSDS) are available for all Rohm and Haas products.

Acidic and basic regenerant solutions are corrosive. Nitric acid and other strong oxidizing agents can cause explosive reactions when mixed with ion exchange resins. Proper equipment design is necessary if oxidizing agents are used. Consult knowledgeable sources before using strong oxidizing agents with ion exchange resins.

Ion exchange resins contain by-products from the manufacturing process. The user must determine the extent to which these by-products need to be removed for their specific application and establish techniques to ensure the appropriate level of purity. The user must ensure compliance with all safety standards and regulatory requirements. Rohm and Haas does not recommend its resins as supplied as suitable or appropriately pure for any particular use unless specifically stated otherwise. Consult a Rohm and Haas technical representative for further information.

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Disclaimer: This 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