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

C.04.581. The expiration date printed on the inner and outer labels of every package of Globin Insulin with Zinc shall be a date not later than two years after the date of filling of the immediate container.

C.04.582. The insulin preparation “NPH Insulin” or “Isophane Insulin” shall be a sterile preparation of rod-shaped crystals containing insulin, protamine and zinc, suspended in a buffered aqueous medium, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain

• (a) weight by volume, not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate, and either

  • (i) not less than 1.4 per cent and not more than 1.8 per cent glycerin and not less than 0.15 per cent and not more than 0.17 per cent metacresol and not less than 0.06 and not more than 0.07 per cent phenol, or

  • (ii) not less than 0.40 per cent and not more than 0.45 per cent sodium chloride and not less than 0.7 per cent and not more than 0.9 per cent glycerin and not less than 0.18 per cent and not more than 0.22 per cent metacresol; and

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

  • (i) not more than 8.5 milligrams of nitrogen,

  • (ii) not less than 3.0 milligrams and not more than 6.0 milligrams of protamine except that the ratio of the protamine to the insulin shall be not less than the isophane ratio and shall not exceed the isophane ratio by more than 10 per cent,

  • (iii) not less than 0.16 milligram and not more than 0.40 milligram of zinc, and

  • (iv) no protease activity significant for the stability of NPH insulin.

C.04.583. The protamine used in preparing NPH Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhynchus Suckley, or Salmo Linne.

C.04.584. The “isophane ratio” means the minimum number of milligrams of protamine required to precipitate 100 International Units of insulin and shall be determined by an acceptable method.

C.04.585. The insulin used in the preparation of NPH 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.04.586. The clear supernatant liquid obtained from NPH insulin shall contain not more than 0.4 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, not more than 0.6 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 80 units per cubic centimetre and not more than 0.7 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 100 units per cubic centimetre, as determined by an acceptable method.