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

C.04.568. The expiration date printed on the inner and outer labels of Insulin Zinc Suspension — Medium shall be a date not later than two years after the date of filling of the immediate container.

C.04.569. The insulin preparation “Insulin Zinc Suspension — Prolonged” 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 crystals with not more than a trace 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 90 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.

C.04.570. The insulin used in the preparation of Insulin Zinc Suspension — Prolonged 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.04.571. The clear supernatant liquid obtained from Insulin Zinc Suspension — Prolonged 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.04.572. No person shall sell Insulin Zinc Suspension — Prolonged 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.