Food and Drug Regulations

C.04.601 (1) A fabricator shall not sell Sulphated Insulin unless he

• (a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

• (b) has furnished the Director with such additional information as the Director may require; and

• (c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

• (a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin,

  • (i) protocols of assay of its potency in International Units per milligram,

  • (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and

  • (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and

• (b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals,

  • (i) a report of the amount of each component,

  • (ii) a report of the protein content in milligrams per 1,000 International Units of insulin,

  • (iii) a report on the determination of the neutralization ratio,

  • (iv) a report on the determination of the number of sulphate groups per insulin molecule,

  • (v) protocols of assay of its potency expressed as International Units per cubic centimetre, and

  • (vi) a report on the determination of its pH.

  • (vii) [Repealed, SOR/95-203, s. 9]