Food and Drug Regulations

C.04.597 The insulin preparation “Sulphated Insulin” shall be a clear or slightly turbid, colourless or almost colourless, sterile, isotonic preparation of zinc-insulin crystals chemically modified by treatment with sulphuric acid, shall have a pH of not less than 6.0 and not more than 7.0, and shall contain,

• (a) weight by volume,

  • (i) not less than 0.6 per cent and not more than 1.0 per cent sodium chloride, and

  • (ii) not less than 0.2 per cent and not more than 0.3 per cent phenol; and

• (b) as determined by an acceptable method,

  • (i) not more than 200 milligrams protein for each 1,000 International Units of insulin, and

  • (ii) not less than 5.5 and not more than 6.5 sulphate groups per insulin molecule.