It depends on a few factors. The testing requirements depend on your compounding category (Category 2 or 3, as sterility testing is not required for Category 1 CSPs) and assigned BUD. See USP <797>, Section 12.2 Sterility Testing.

If the presence or absence of microbial growth cannot be readily determined by Day 14 (i.e. the test is inconclusive), incubation must occur for an additional 4 days. This most often occurs when performing sterility tests on sterile pellets and suspensions.

A method suitability test is required in order to verify that the sterility testing method works for your formulation. Method suitability testing involves inoculating your sample with 6 challenge microorganisms in order to ensure that they can be detected by the test and that no components of the compounded preparation inhibit microbial recovery.

Related Resources:

• Stability Indicating Method Development & Validation
• Method Verification Services
• Other Validation Services 

Other:

• Stability Study Questionnaire 
• Laboratory Testing Services, Turnaround Times, & Pricing

The amount required for method suitability is dependent on your batch size and is calculated using values taken from Tables 2 and 3 of USP <71>. A formulation you can follow to calculate the required amount of product for testing is Table 2 x Table 3 x 6 (# of challenge microorganisms). Product sent for method suitability testing can be sent in bulk containers; it does not need to be packaged in unit-dose containers.

When submitting for USP <85> Bacterial Endotoxin testing, you will be asked to provide to us the maximum dose (mL/hr), the average weight of patient (kg), and the route of administration.  This information is required so that the endotoxin limit (EU/mL) for the sample can be calculated.

In order to justify an extended BUD for a compounded preparation, a science-based stability testing program should be designed with data collected and analyzed over the course of the desired BUD for the preparation. Potency must be analyzed using a stability-indicating assay, which is a potency testing method that is developed and validated in order to separate active ingredients, excipients, and degradant products to allow accurate quantitation of the potency of the active ingredient(s). Depending on the nature of the product being evaluated, additional microbiological, chemical, and/or physical tests may be required to justify the extended BUD.

For more information about our stability study program and how to get started, please contact a member of our Client Care team at 1-800-745-8916 or at info@eagleanalytical.com

Committed to quality, our scientific experts can help you define challenges, risks, and opportunities. Eagle can discover and implement cost-effective science-based solutions. Some of the services offered can include facility design reviews, Gap Analysis Audits, Standard Operating Procedures Development and Implementation, assistance with 483 responses, and more! For more information, please contact a member of our Client Care team at 1-800-745-8916 or at info@eagleanalytical.com.

Yes! Eagle receives samples on Saturdays from 7 a.m. – 2 p.m. Central Time Zone.

Please contact a member of our Client Care team at 1-800-745-8916 or at info@eagleanalytical.com.

RUSH service cuts the standard turnaround in half for two times the standard price, whereas a Super RUSH service can provide a turnaround within the same business day, when applicable. For more information, please contact a member of our Client Care team at 1-800-745-8916 or at info@eagleanalytical.com.

Your sample has been analyzed and preliminary results are currently under investigation. If your results are Out-Of-Specification (OOS), this may take additional days to be resolved.

Testing has been completed and a qualified personnel is doing a final review and approval of the data packet.

Laboratory reports for a completed test can be downloaded from EagleTrax. Once logged into EagleTrax, go to the “Find Submissions” icon. In the “Submission Status” dropdown, select “Complete”. From the generated submission list, select the EagleTrax number for your sample. Select the third tab from the left, “Tests,” and then click the green “Print Test Report” button. Following these steps will allow you to obtain a PDF file for your laboratory report.