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

Regulations are current to 2019-06-20 and last amended on 2019-06-17. Previous Versions

PART CDrugs (continued)

DIVISION 4 (continued)

Protamine Zinc Insulin (continued)

  •  (1) A fabricator shall not sell Protamine Zinc Insulin unless he

    • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

    • (b) has furnished the Minister with such additional information as the Minister may require; and

    • (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

  • (2) A submission filed pursuant to subsection (1) shall include at least,

    • (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Protamine Zinc Insulin,

      • (i) protocols of assay of its potency in International Units per cubic centimetre in the case of insulin and in International Units per milligram in the case of zinc-insulin crystals,

      • (ii) a report on its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

      • (iii) reports of assay of its nitrogen content in milligrams, and its zinc content in milligrams per 1,000 International Units of insulin;

    • (b) for the components used in the preparation of the trial mixture of Protamine Zinc Insulin, a report on the quantity of

      • (i) insulin in grams or in International Units,

      • (ii) zinc in grams or in milligrams, per 1,000 International Units of insulin,

      • (iii) protamine in grams or in milligrams, per 1,000 International Units of insulin, and

      • (iv) the volume of the preparation in cubic centimetres or litres;

    • (c) for the trial mixture of Protamine Zinc Insulin,

      • (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

      • (ii) a report of assay of its zinc content in milligrams per cubic centimetre per 1,000 International Units of insulin,

      • (iii) protocols of its biological reaction showing retardation of the insulin effect, and

      • (iv) a report on the determination of its pH;

    • (d) for the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin, a report on the amount of each component in the preparation; and

    • (e) for the first filling of the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin,

      • (i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units,

      • (ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units, and

      • (iii) a report on the determination of its pH.

      • (iv) [Repealed, SOR/95-203, s. 8]

  • SOR/82-769, s. 4
  • SOR/95-203, s. 8
  • SOR/97-12, s. 61
  • SOR/2018-69, ss. 27, 31(E), 32(F)

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

  • SOR/82-769, s. 4

Sulphated Insulin

 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.

  • SOR/82-769, s. 4

 The neutralization ratio means the amount of anti-beef-insulin serum required to neutralize one unit of Sulphated Insulin divided by the amount required to neutralize one unit of beef insulin, and shall be determined by an acceptable method.

  • SOR/82-769, s. 4

 The neutralization ratio of Sulphated Insulin shall be not less than 4 to 1.

  • SOR/82-769, s. 4

 No person shall sell Sulphated Insulin 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 100 International Units of insulin as determined by an acceptable method.

  • SOR/82-769, s. 4
  •  (1) A fabricator shall not sell Sulphated Insulin unless he

    • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

    • (b) has furnished the Minister with such additional information as the Minister may require; and

    • (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

  • (2) A submission filed pursuant to subsection (1) shall include at least,

    • (a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin,

      • (i) protocols of assay of its potency in International Units per milligram,

      • (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and

      • (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and

    • (b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals,

      • (i) a report of the amount of each component,

      • (ii) a report of the protein content in milligrams per 1,000 International Units of insulin,

      • (iii) a report on the determination of the neutralization ratio,

      • (iv) a report on the determination of the number of sulphate groups per insulin molecule,

      • (v) protocols of assay of its potency expressed as International Units per cubic centimetre, and

      • (vi) a report on the determination of its pH.

      • (vii) [Repealed, SOR/95-203, s. 9]

  • SOR/82-769, s. 4
  • SOR/95-203, s. 9
  • SOR/97-12, s. 61
  • SOR/2018-69, ss. 27, 31(E), 32(F)

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

  • SOR/80-545, s. 4
  • SOR/82-769, s. 4
 
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