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

C.04.575. The insulin preparation “Globin Insulin with Zinc” shall be a sterile solution of insulin modified by the addition of globin prepared from beef blood, in the form of globin hydrochloride, and zinc, shall be a clear, yellowish, or almost colourless liquid free from insoluble matter and acceptably free from turbidity, shall have a pH of not less than 3.4 and not more than 3.8 and shall contain,

• (a) weight by volume, not less than 1.3 per cent and not more than 1.7 per cent glycerin, and either

  • (i) not less than 0.15 per cent and not more than 0.20 per cent cresol, or

  • (ii) not less than 0.20 per cent and not more than 0.26 per cent phenol, and

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

  • (i) not more than 15.0 milligrams of total nitrogen,

  • (ii) not less than 36.0 milligrams and not more than 40.0 milligrams of globin calculated as 6.0 times the nitrogen content of the globin, and

  • (iii) not less than 2.5 milligrams and not more than 3.5 milligrams of zinc.

C.04.576. The globin hydrochloride used in the preparation of Globin Insulin with Zinc shall contain not less than 16.0 per cent and not more than 17.5 per cent nitrogen calculated on a dry, ash-free and hydrochloric acid-free basis, and its ash content shall be not more than 0.3 per cent as determined by an acceptable method.

C.04.577. The insulin used in the preparation of Globin Insulin with Zinc shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40 or 80 International Units of insulin in each cubic centimetre of the Globin Insulin with Zinc.

• C.04.578. (1) The Canadian Reference Standard for Globin Insulin with Zinc 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 Globin Insulin with Zinc 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.04.579. No person shall sell Globin Insulin with Zinc 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, or

  • (ii) 80 International Units of insulin.