How To Send A Compounded Preparation To Eagle Analytical Sample Size Required for Analysis PMS 280 Potency (only) Animal Treats...............................Minimum sample – 5 Capsules.....................................Minimum sample – 5 Creams/Lotions/Gels....................Minimum sample – 3 mL PMS 360 Liquids..................................... Minimum sample – 2 mL Lollipops................................... Minimum sample – 2 Pellets.......................................Minimum sample – 5 Powder Aliquots...........................Minimum sample – 1 gm PMS Black C Suppositories...............................Minimum sample – 5 Suspensions.................................Minimum sample – 5 mL Tablets.......................................Minimum sample – 5 Troches......................................Minimum sample – 5 Microbiological Bacterial Endotoxins......................Minimum sample – 2 mL (only) Sterility General Comment: Proper quality control procedures dictate the number of articles and amount of product necessary for a statistically valid sterility test procedure. In general, the more product furnished for analysis the higher the probability of detecting a nonsterile item. If possible, a sample size sufficiently large to represent the sample, packaged in the final delivery container, allows for the best chance in obtaining a valid sterility test. See USP <71> for recommended sample size for sterility tests. Combination Tests (See general comments above for sterility testing.) Separate samples are required for microbiological and potency tests. 1. See “Sample Size Required for Analysis” to the left. • Note – samples for sterility testing should be sent in the dispensing container. • Suspensions require a separate sample for microbiological and chemical tests. • Please send two (2) separate sample containers if requesting potency and microbiology analysis on the same sample. 2. Complete an Eagle “Sample Submission Form” for each sample. • You can download this form or submit your sample online at www.eagleanalytical.com/sample. Or call Eagle Analytical (800.745.8916) for a faxed form. • Include a formula worksheet for all preparations requiring a chemical test. Absence of a formula worksheet for your compound will delay getting your results. • Be sure to indicate any special handling requirements for your preparation. 3. Ship your preparation, suitably packaged, to Eagle Analytical. • We suggest that you use overnight shipping so that you can track your shipment. • For preparations that are temperature sensitive, send in a cool pack container. • Be sure to properly package to prevent leaking or breaking. Make sure all vials or syringes are capped securely. • Ship to: Eagle Analytical Services Attn: Sample Submission 9940 W. Sam Houston Pkwy S., Ste. 310 Houston, TX 77099 • Shipping for International Customers Follow the directions as above, with these additions: • Clearly mark on the shipping documents: “PHARMACEUTICAL SAMPLE FOR ANALYSIS ONLY – NOT FOR HUMAN USE.” • Give the shipment a value of $10.00. • Ship to Eagle at the address above. • Send tracking number to [email protected]. 4. A laboratory report will be faxed to you immediately upon completion of each test that you have indicated.You also can view your results online at www.eagleanalytical.com. Upon the completion of the Client Registration page you will be given a username and password. 5. At the conclusion of all of your tests, Eagle will issue a final Laboratory Report and invoice you for the tests. © 2014 Sample Submission Form PCCA Member/Customer #: Eagle Analytical Services • 9940 W. Sam Houston Pkwy S., Suite 310 • Houston, TX 77099 Phone: 1.800.745.8916 or 832.295.1276 • Fax: 713.570.2350 www.eagleanalytical.com _________________________ Eagle Analytical performs only non-cGMP testing. Send Invoice To: □ Same as Reporting Info □ Address Below Reporting Information Attn: Attn: Company: Company: Address: Address: Address: Address: City/ST/Zip: City/ST/Zip: Send Preliminary Results Via E-mail: □ Fax □ E-mail □ Web Are You Registered as a 503B Outsourcing Facility? □ Yes □ No SAMPLE INFORMATION (ENTER ALL SAMPLE INFORMATION AS LABELED ON CONTAINER) Compounded by: Actives to be Analyzed / Concentration of Each: 1) _________________________________________________________ Light Sensitive Frozen Refrigerated Room Temp □ □ □ □ □ □ □ ID □ pH Endotoxin □ □ □ Time Storage Rapid ® Scan RDI Lot # Sterility Test Concentration Eagle Quantity / Container of Use BUD Sample Name Potency Test(s) Requested $175 Fax: RUSH @ Additional Phone: □ Form of Sample (i.e., Cream, Liquid, Capsule, etc.) FOR ENDOTOXIN: List administration route and maximum patient dosage (i.e., IT, IV, IM, volume/hr) 2) _________________________________________________________ 3) _________________________________________________________ 4) _________________________________________________________ **Please Submit a Formula Worksheet or Ingredient List with Sample** **Please Send Two (2) Separate Sample Containers If Requesting Potency and Microbiology Analysis on the Same Sample** Indicate Testing Schedule for BUD / Additional Instructions / Comments: Online Results may be viewed at www.eagleanalytical.com. **Rush Available for Potency, Endotoxin, and BUD Day 0 at Additional $175/sample** For Internal Use Only Sample ID#___________________ Rec’d by / Date: __________________