Division A.1
United Kingdom
Precise identification of the substance concerned by the application/request:
- A.1.1.
INN,
- A.1.2.
International Union of Pure and Applied Chemistry (IUPAC) name,
- A.1.3.
Chemical Abstract Service (CAS) number,
- A.1.4.
therapeutic, pharmacological and chemical classification,
- A.1.5.
synonyms and abbreviations,
- A.1.6.
structural formula,
- A.1.7.
molecular formula,
- A.1.8.
molecular weight,
- A.1.9.
degree of impurity,
- A.1.10.
qualitative and quantitative composition of impurities,
- A.1.11
.description of physical properties,
- A.1.11.1.
melting point,
- A.1.11.2.
boiling point,
- A.1.11.3.
vapour pressure,
- A.1.11.4.
solubility in water and organic solvents expressed in g/l, with indication of temperature,
- A.1.11.5.
density,
- A.1.11.6.
spectra of refraction, rotation, etc.,
- A.1.11.7.
pKa,
- A.1.11.8.
protein binding.
- A.1.11.1.
Notes on Annex
Textual amendments
- F1
Words in Annex para. 2 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 8(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
Footnotes
- f1
-
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
- f2
-
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).