Food and Drug Regulations
C.04.601 (1) A fabricator shall not sell Sulphated Insulin unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director 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(vii) [Repealed, SOR/95-203, s. 9]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
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