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  • records that the batch has been analysed using scientifically established test methods designed to assure that the product meets the established standards, specifications and characteristics,

  • adequate stability data to support the intended period of use of the excipient. These data can be obtained from historical data, actual studies on the specific excipient or from applicable “model product” studies that can reasonably be expected to simulate the performance of the specific excipient.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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