PRODUCT SPECIFICATIONS

DIRECTLY COMPRESSIBLE IBUPROFEN

APPEARANCE White to off-white granular powder IDENTIFICATION Ibuprofen: Matches reference standard WATER (H2O) 0.8% - 1.8% PARTICLE SIZE ANALYSIS SEIVE TEST US STANDARD (Cumulative % Retained) No. 20: 5% Max No. 60: 25% Min No. 100: 60% Min No. 200: 80% Min ASSAY (IBUPROFEN) (ANHYDROUS BASIS) 88.0 - 92.0% MICROBIOLOGICAL TOTAL VIABLE MICROBIAL COUNT <1000 microorganisms/gm YEAST AND MOLD <100 microorganisms/gm SALMONELLA Negative ESCHERICHIA COLI Negative STAPHYLOCOCCUS AUREAS Negative PSEUDOMONAS AERUGINOSA Negative

DCI-90 (Ibuprofen USP 90%)

ITEM CODE 3825

DCI-90 is a directly compressible form of Ibuprofen. It is not fully formulated meaning that additional excipients and lubricants must be added to this compressible Ibuprofen form before tableting. The high Ibuprofen content of the DCI-90 allows the formulator the flexibility to limit tablet size while including additional actives and/or the excipients in combination to meet specific tablet performance criteria. DCI-90 is manufacturered using Ibuprofen USP/Ph. Eur. (90%) pharmaceutical grade pregelatinized starch, and povidone (10%) also meeting USP and Ph. Eur. criterias. This composition is prepared through fluid bed granulation to yield a product that is similar in particle size and density to wet granulated directly compressible forms. Excellent flow properties and its compression characteristics make DCI-90 suitable for formulating to manufacture a wide range of Ibuprofen dosage forms. U.S., and European DMFs are maintained on DCI-90.

The information printed herein is derived from our own laboratories and other sources, and is believed to be accurate. However, it may be modified by later findings and should be used with this understanding. Nothing herein shall be construed as a recommendation to use any product in violation of any patent rights. The user shall have sole responsibility for determination of whether this product is suitable for any particular purpose. Prior to use, refer to the Material Safety Data Sheet for assistance in determining safe handling, storage, and use procedures.

Verified 1/2010