Dear ETPN members, dear colleagues from the European Nanomedicine community, we would like to share with you of an opportunity to participate in a scientific initiative from the FDA / ASTM International Committee E56 on Nanotechnology, calling for your prompt action. The Committee is currently organizing three Interlaboratory Studies (ILS) to assess the precision and bias of test methods regarding liposomal lipid quantitation. They are actively recruiting laboratories proficient in performing one or more of the following tests:
- E3324-22: Lipid Quantitation in Liposomal Formulations Using Ultra-High-Performance Liquid Chromatography (UHPLC) with Triple Quadrupole Mass Spectrometry (TQMS)
- E3323-22: Lipid Quantitation in Liposomal Formulations High-Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
- E3297-21: Lipid Quantitation in Liposomal Formulations Using High-Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)
Eligibility & conditions
- Membership in ASTM International is not required for participation.
- Participants can be outside US; Standards and liposome samples will be provided.
- Precision and bias will be developed for these published test methods from the ILS.
- Participating laboratories will be listed in the resulting ASTM Research Report.
- Participants will receive a complimentary copy of the finished Research Report, which will include coded data that cannot be identified to specific labs.
This will be a partial blind study in which the project lead will know the exact composition of the test specimen. Sufficient quantities of all required calibration standard material and test specimens will be supplied to the participating laboratories free of charge by ASTM. Support does not include financial support for new or alternate equipment, columns, or solvents.Published test methods, and additional instructions regarding sample handling, storage and other details will also be provided. Conference calls will be set up before starting the study with all participating laboratories to discuss the study, logistics, and answer any questions. The study will be conducted within a specified time frame, during summer of 2023, to report data. Lipids to be analyzed: (1,2- distearoyl-sn-glycero-3- phosphoethanolamine-N-[methoxy (polyethylene glycol)-2000] (DSPE- PEG 2000), and hydrogenated (soy) L-α-phosphatidylcholine (HSPC)). Each lab will be provided with three individual lipid standards in powder form for calibration purposes and one liposomal formulation as the test sample. Results will be reported in triplicates, individual values, their mean and standards deviation to determine intra-laboratory repeatability. The participating laboratories will have six weeks to report the data from when they receive the samples.
The participating labs are requested to follow and strictly adhere to the methods described in the standard to assess its reproducibility. In brief, calibration standards will be prepared using the three lipids provided in powder form. The participating labs are required to optimize instrument condition as discussed in the standard methods and analyze the sample to obtain lipid (cholesterol, DSPE-PEG2000, and HSPC) concentration and component ratio.
Please provide ILS@astm.org your following laboratory information and methods you are able to test:
- Lab Name
- Contact Name
- Telephone number:
- Shipping Address:
- Instruments to be used for the study
- Test Method(s)
If you have any questions, or would like more information on the study, please contact the Technical Contact for this study:
- TC Name(s): Sanghamitra Majumdar (LC-MS) and Goutam Palui (LC-ELSD or LC-CAD)
- E-mail address: Sanghamitra.firstname.lastname@example.org; Goutam.Palui@fda.hhs.gov
For general ILS questions, please contact ILS@astm.org.
About ASTM Committee E56 on Nanotechnology
Staff Manager: Frank McConnellASTM Committee E56 on Nanotechnology was formed in 2005. E56 meets twice each year, in May and November, with about 25 members attending three days of technical meetings (every 3rd to 4th meeting of E56 is held outside of the United States). This Committee addresses issues related to standards and guidance materials for nanotechnology & nanomaterials, as well as the coordination of existing ASTM standardization related to nanotechnology needs. This coordination includes the apportioning of specific requests for nanotechnology standards through ASTM’s existing committee base, as well as the maintenance of appropriate global liaison relationships with activities (internal and external) related to this subject area. The Committee, with a membership of approximately 180, currently has its standards published in the Annual Book of ASTM Standards, Volume 14.02. E56 has 6 technical subcommittees that maintain jurisdiction over these standards. More information about the ASTM Committee E56 on Nanotechnology here.