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Furthermore, at Eaglenot only can we develop, validate and execute stability-indicating assays for most sterile and nonsterile compounded preparations, but we also offer consulting services on all aspects of testing and regulatory compliance. Personnel are capable and qualified to perform their assigned duties. If you have questions about any of these matters, please contact us at There is assurance that processes are always carried out as intended or specified and are reproducible. Like other aspects of the medication-use process, extemporaneous compounding can be vulnerable to medication errors. The stability-indicating assay is then validated in the presence of the resulting degradation products, which provides assurance that any increases or decreases in the active ingredient represent actual changes in the concentration of the drug. Major revisions to the chapter include, but are not limited to, the following:

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References United States Pharmacopeial Convention.

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The child became less responsive and was taken to the local emergency department and then transferred to another hospital for further treatment. In a second case, a year-old male with a history of traumatic brain injury was administered a clo NID ine suspension which had been compounded at a community pharmacy. Rockville, MD: As a comparison, a stability-indicating assay is a potency testing method that is specifically developed and validated to differentiate between the active ingredient and the presence of other substances, such as impurities, degradation products and excipients. The proposed chapter is open to public comments until November 30,and is expected to become official on December 1,

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