Food and Drug Regulations

C.04.553 The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain

• (a) weight by volume,

  • (i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and

  • (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; 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 for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals,

  • (ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and

  • (iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash.