Alumina Depyrogenates F 18 Fludeoxyglucose Injection during Purification Processes

References

1. 1.↵
   1. Kowalsky R. J.

   1. Petry N. A

   . Licensing and Regulatory Control. In Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine, 3rd ed.; Kowalsky R. J. , Ed.; American Pharmacists Association: Washington, DC, 2011; pp 373–410.
2. 2.↵
   1. Yu S

   . Review of 18F-FDG synthesis and quality control. Biomedical Imaging and Intervention Journal 2006, 2 (4), 57.

   OpenUrl
3. 3.↵
   1. Hung J. C

   . Comparison of various requirements of the quality assurance procedures for (18)F-FDG injection. J. Nucl. Med. 2002, 43 (11), 1495–1506.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   PDA Technical Report 3. Validation of dry heat processes used for depyrogenation and sterilization. PDA, Inc.: Bethesda, MD, 2011 (pending publication).
5. 5.↵
   1. Coletti-Previero M. A.,
   2. Previero A

   . Alumina-phosphate complexes for immobilization of biomolecules. Anal. Biochem. 1989, 180 (1), 1–10.

   OpenUrlPubMed
6. 6.↵
   1. Shi Y.,
   2. HogenEsch H.,
   3. Regnier F. E.,
   4. Hem S. L

   . Detoxification of endotoxin by aluminum hydroxide adjuvant. Vaccine 2001, 19 (13–14), 1747–1752.

   OpenUrlPubMed
7. 7.↵
   1. Petsch D.,
   2. Anspach F. B

   . Endotoxin removal from protein solutions. J. Biotechnol. 2000, 76 (2–3), 97–119.

   OpenUrlCrossRefPubMedWeb of Science
8. 8.↵
   1. O'Brien T. P.,
   2. Conway R.,
   3. Chen H. L.,
   4. Buckland K

   . Evaluation of endotoxin retention by adsorptive-based filtration media. PDA J. Pharm. Sci. Technol. 2007, 61 (2), 75–87.

   OpenUrlAbstract/FREE Full Text
9. 9.↵
   U.S. Food and Drug Administration. Positron emission tomography (PET) drugs. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory/Guidances/UCM070306.pdf. Accessed June 6, 2011.
10. 10.↵
    1. Prince R.

    1. Cooper J. F

    . Bacterial Endotoxins Test. In Microbiology in Pharmaceutical Manufacturing, 2nd ed.; Prince R. , Ed.; DHI: Bethesda, MD, 2008; Vol. 2, pp 245–274.

    OpenUrl
11. 11.↵
    1. Zigler S. S

    . Applied PET Chemistry Studies for U.S. FDA approval of F 18 FDG. Proceedings of 6th Workshop on Targetry and Target Chemistry, August 17–19, 1995, pp 322–327.
12. 12.↵
    1. Braithwaite C.,
    2. Cooper J. F

    . Gamma Irradiation and Endotoxin Reduction of Medical Devices. Poster presented at Parenteral Drug Association Annual Meeting, December 2001.
13. 13.↵
    1. Neuza T. O

    . A portable test system for determination of bacterial endotoxins in 18F-FDG, 99mTc, and lyophilized reagents for 99mTc. J. Nucl. Med. Technol. 2011, 39, 121–124.

    OpenUrlAbstract/FREE Full Text
14. 14.↵
    1. Ensor L. A.,
    2. Hussong D

    . Microbiology/Sterility Assurance Information for PET Application—NDAs & ANDAs. Presented at FDA Public Meeting: Submitting an Application for PET Drugs Currently in Clinical Use. Silver Spring, MD, March 2, 2011.