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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

Canadian Standard Drugs

  • Conjugated Estrogens
  • Conjugated Estrogens for Injection
  • Conjugated Estrogens Tablets
  • Digitoxin
  • Digitoxin Tablets
  • Digoxin
  • Digoxin Elixir
  • Digoxin Injection
  • Digoxin Tablets
  • Esterified Estrogens
  • Esterified Estrogens Tablets
  • Gelatin
  • Thyroid
  • SOR/80-544, s. 11.

General

C.06.001. In this Division,

  • (a) solubility and specific gravity shall be determined at 25°C;

  • (b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and

  • (c) determination of physical and chemical constants shall be carried out by acceptable methods.

Conjugated Estrogens

C.06.002. [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that

  • (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

  • (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

  • SOR/82-429, s. 5.

Conjugated Estrogens for Injection

C.06.003. [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that

  • (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

  • (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

  • SOR/82-429, s. 6.