BRIEFING

 Kit for Preparation of Technetium Tc 99m Pentetate Injection. Based on the rationale proposed in the Stimuli article in PF 45(2) [Mar.–Apr. 2019] Monographs for Non-Radioactive Kits for the Preparation of Radiopharmaceuticals, the first kit monograph is proposed based on the submission received from an FDA-approved applicant:

1. Identification A is based on the UV spectral agreement of copper-pentetate complex in the Sample solution and Standard solution obtained from the Assay.

2. Identification B is based on the retention time agreement of copper-pentetate complex in the Sample solution and Standard solution obtained from the Assay.

3. Identification C is based on decolorization of the starch iodine complex in the test for Content of Stannous Chloride.

4. The Assay is based on a validated liquid chromatography (LC) procedure using the Symmetry C18 brand of column with L1 packing. The typical retention time of pentetic acid is about 4 min.

5. The Content of Stannous Chloride test is based on the iodimetric titration of stannous ions with iodine.

6. The Organic Impurities test is based on a validated LC procedure using the Synergi Max-RP brand of column with L87 packing. The typical retention time of pentetic acid is about 11 min.

 (SM4: G. Hsu)

 Correspondence Number—C253795