Food and Drug Regulations

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.