Analysis of [11C]Choline and [13N]Ammonia using a single HPIC method

Huailei Jiang; Ping Fang; Mark S Jacobson; Manoj K Jain; Hancheng Cai

doi:10.1016/j.apradiso.2020.109560

Analysis of [¹¹C]Choline and [¹³N]Ammonia using a single HPIC method

Appl Radiat Isot. 2021 Feb:168:109560. doi: 10.1016/j.apradiso.2020.109560. Epub 2020 Dec 10.

Authors

Huailei Jiang¹, Ping Fang², Mark S Jacobson², Manoj K Jain¹, Hancheng Cai³

Affiliations

¹ PET Radiochemistry Facility, Department of Radiology, Mayo Clinic, Jacksonville, FL, USA.
² PET Radiochemistry Facility, Department of Radiology, Mayo Clinic, Rochester, MN, USA.
³ PET Radiochemistry Facility, Department of Radiology, Mayo Clinic, Jacksonville, FL, USA. Electronic address: [email protected].

PMID: 33321370
DOI: 10.1016/j.apradiso.2020.109560

Abstract

A single HPIC method was developed and validated for the analysis of both [¹¹C]Choline and [¹³N]Ammonia with the same setup. The HPIC system suitability tests were performed and [¹¹C]Choline and [¹³N]Ammonia were used to verify their performance on this HPIC method. The HPIC setup and method provides qualitative and quantitative analysis information of [¹¹C]Choline and [¹³N]Ammonia. The data suggested this HPIC method is validated for determining radiochemical/chemical purity and radiochemical identity of [¹¹C]Choline and [¹³N]Ammonia products in CGMP compliant manufacturing process.

Keywords: HPIC; Method validation; PET; Quality control; [(11)C]Choline; [(13)N]Ammonia.