bwxt medical ltd. - Medication Listings

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Indium In 111 Oxyquinoline INDIUM IN 111 OXYQUINOLINE
BWXT MEDICAL LTD. FDA Rx Only

Indium In 111 oxyquinoline (oxine) is a diagnostic radiopharmaceutical intended for radiolabeling autologous leukocytes. It is supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5. Each mL of the solution contains 37 MBq, 1 mCi of indium In 111 [no carrier added, >1.85 GBq/µg indium (>50 mCi/µg indium)] at calibration time, 50 µg oxyquinoline, 100 µg polysorbate 80, and 6 mg of HEPES (N-2-hydroxyethyl-piperazine-N’-2-ethane sulfonic acid) buffer in 0.75% sodium chloride solution. The drug is intended for single use only and contains no bacteriostatic agent. The radionuclidic impurity limit for indium 114m is not greater than 37 kBq, 1 µCi of indium 114m per 37 MBq, 1 mCi of indium In 111 at the time of calibration. The radionuclidic composition at expiration time is not less than 99.75% of indium In 111 and not more than 0.25% of indium In 114m/114. Chemical name: Indium In 111 Oxyquinoline. The precise structure of the indium In 111 oxyquinoline complex is unknown at this time. The empirical formula is (C 9 H 6 NO) 3 In 111.

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