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

C.04.564. The insulin used in the preparation of Insulin Zinc Suspension — Medium shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.

C.04.565. The clear supernatant liquid obtained from Insulin Zinc Suspension — Medium shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.

C.04.566. No person shall sell Insulin Zinc Suspension-Medium unless

• (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

• (b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,

  • (i) 40 International Units of insulin,

  • (ii) 80 International Units of insulin, or

  • (iii) 100 International Units of insulin.

• C.04.567. (1) A fabricator shall not sell Insulin Zinc Suspension-Medium 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 insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension-Medium,

    • (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-Medium 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 in milligrams per cubic centimetre or per 1,000 International Units of insulin,

    • (iii) a report of assay of its zinc content in milligrams per cubic centimetre or 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 on the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,

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

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

    • (viii) 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 — Medium 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. 4]