Food and Drug Regulations (C.R.C., c. 870)

• C.04.561. (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid 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 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 insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Rapid,

    • (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

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

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

  • (b) for the first finished lot of Insulin Zinc Suspension — Rapid prepared from each master lot of insulin or zinc-insulin crystals

    • (i) a report on the amount of each component used in the preparation,

    • (ii) a report of assay of its nitrogen content per 1,000 International Units of insulin,

    • (iii) a report of assay of its zinc content per 1,000 International Units of insulin,

    • (iv) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,

    • (v) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,

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

    • (vii) a report on the microscopic appearance of the suspended precipitate; and

  • (c) for the first filling of the first finished lot of Insulin Zinc Suspension — Rapid from each master lot of insulin or zinc-insulin crystals,

    • (i) a report on the determination of its pH,

    • (ii) a report on the microscopic examination of the precipitate, and

    • (iii) a report on its identification, as determined by an acceptable method.

    • (iv) [Repealed, SOR/95-203, s. 3]

C.04.562. The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Rapid shall be a date not later than two years after the date of filling of the immediate container.

C.04.563. The insulin preparation “Insulin Zinc Suspension — Medium” shall be a sterile suspension, in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of a mixture of crystals and amorphous material in an approximate ratio of seven parts of crystals to three parts of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,

• (a) weight by volume,

  • (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC₂H₃O₂.3H₂O),

  • (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

  • (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

• (b) as determined by an acceptable method, for each 1,000 International Units of insulin,

  • (i) not more than 7.0 milligrams of nitrogen of which not less than 63 per cent and not more than 73 per cent shall be in the crystalline component, and

  • (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.