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

C.04.589. The expiration date printed on the inner and outer labels of NPH Insulin shall be a date not later than two years after the date of filling of the immediate container.

C.04.590. The insulin preparation “Protamine Zinc Insulin” shall be a sterile white suspension in a buffered aqueous medium, containing insulin modified by the addition of protamine and zinc, shall have a pH of not less than 7.1 and not more than 7.4, and shall contain,

• (a) weight by volume,

  • (i) not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate,

  • (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin, and

  • (iii) either not less than 0.18 per cent and not more than 0.22 per cent cresol, or not less than 0.22 per cent and not more than 0.28 per cent phenol; and

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

  • (i) not more than 12.5 milligrams of total nitrogen,

  • (ii) not less than 10.0 milligrams and not more than 15.0 milligrams of protamine,

  • (iii) not less than 1.7 milligrams and not more than 2.5 milligrams of zinc.

C.04.591. The protamine used in the preparation of Protamine Zinc Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhunchus Suckley or Salmo Linne.

C.04.592. The insulin used in the preparation of Protamine Zinc Insulin 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.04.593. (1) The Canadian Reference Standard for Protamine Zinc Insulin shall be the standard adopted therefor by the Director from time to time.

• (2) Upon application of a person who holds an establishment licence, the Director shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.

• (3) The testing of the biological reaction of Protamine Zinc Insulin shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Director.

C.04.594. No person shall sell Protamine Zinc Insulin 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

  • (i) 40 International Units of insulin,

  • (ii) 80 International Units of insulin, or

  • (iii) 100 International Units of insulin.