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AMBERLITE

Pharmaceutical Grade Cation Exchange Resin  Polacrilin Potassium NF
Description
AMBERLITE  resin is a weakly acidic potassi um form cation exchange resin supplied as a dry powder. It is widely used as a tablet disintegrant in oral dosage form ulations of drug products. AMBERLITE IRP88 resin is the potassium salt of a crosslinked polymer derived from me thacrylic acid. Its swelling properties upon hydration provide its utility as a tablet disintegrant. AMBERLITE sin has been proposed for use in taste masking applications, specifically for B-lactam antibiotics

Typical Physical Properties
AMBERLITE IRP88 resin complies with the compendial specifications for Polacrilin Potassium NF when tested in
conformance to the compendial test methods presented in current USP/NF.
These compendial properties are shown below. A Drug Master File for this product is
maintained with the United States Food and Drug Administration Letters of authorization
granting access to the file by  FDA in support of NDA and ANDA  submittals will be provided
upon request. Similar help can also be offered in support of the registration of formulations containing AMBERLITE
IRP88 in many other countries worldwide. AMBERLITE IR P88 resin is manufactured in accordance with Good
Manufacturing Practices (cGMP) for bulk pharmaceutical chemicals. .

Certificates
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