Food and Drug Regulations
C.04.580 (1) A fabricator shall not sell Globin Insulin with Zinc 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 insulin or zinc-insulin crystals employed in the manufacture of Globin Insulin with Zinc,
(i) protocols of assay of its potency expressed 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 of 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 master lot of globin hydrochloride used in the preparation of Globin Insulin with Zinc, reports of assay of
(i) its nitrogen content in per cent calculated on a dry, ash-free and hydrochloric acid free basis,
(ii) its chloride content in per cent calculated as hydrochloride, and
(iii) its ash content in percentage;
(c) for the components used in the preparation of the trial mixture of Globin Insulin with Zinc, 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) globin hydrochloride in grams or in milligrams, per 1,000 International Units of insulin, and
(iv) the volume of the preparation in cubic centimetres or litres;
(d) for the trial mixture of Globin Insulin with Zinc,
(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 or per 1,000 International Units of insulin,
(iii) protocols of the biological reaction showing the retardation of the insulin effect, and
(iv) a report on the determination of its pH;
(e) for the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc, a report on the amount of each component in the preparation; and
(f) for the first filling of the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc,
(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 or per 1,000 International Units of insulin, and
(iii) a report on the determination of its pH.
(iv) [Repealed, SOR/95-203, s. 6]
- SOR/82-769, s. 4
- SOR/95-203, s. 6
- SOR/97-12, s. 61
- Date modified: