[F1ANNEX I U.K. CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS

TITLE I U.K. REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS U.K.

PART 3: U.K. SAFETY AND RESIDUES TESTS

A. Safety tests U.K.

CHAPTER I: U.K. PERFORMANCE OF TESTS

1. Precise identification of the product and of its active substance(s) U.K.

• international non-proprietary name (INN),

• International Union of Pure and Applied Chemistry Name (IUPAC),

• Chemical Abstract Service (CAS) number,

• therapeutic, pharmacological and chemical classification,

• synonyms and abbreviations,

• structural formula,

• molecular formula,

• molecular weight,

• degree of impurity,

• qualitative and quantitative composition of impurities,

• description of physical properties,

• melting point,

• boiling point,

• vapour pressure,

• solubility in water and organic solvents expressed in g/l, with indication of temperature,

• density,

• spectra of refraction, rotation, etc,

• formulation of the product.]