SPECIFICATION GUIDELINES FOR TECHNICAL MATERIALS AND TECHNICAL CONCENTRATES (except microbial TKs 1 )

Introduction

A technical material (TC) is an active ingredient isolated (as far as is practicable) from the starting materials, solvents, etc., used to produce it. The isolation process may be simple, for example filtration and drying of a precipitate, or relatively complex. A TC may be prepared from a TK but it may also be diluted, with or without conversion to a salt or other derivative, to prepare a TK. A TC is formulated before use as a pesticide and a salt or other derivative may be formed during the formulation process. A TC is traded between manufacturers and formulators.

A technical concentrate (TK) may be an active ingredient which has not been isolated from the materials, solvents, etc., used to produce it, or it may be a minimally diluted TC intended for use in preparing formulations. In some cases it is necessary or advantageous to manufacture formulations from a technical concentrate (TK), rather than from a TC. For example, the active ingredient may be unstable in a pure form or an isolation process may introduce unnecessary cost and complexity, especially if the only impurity removed is water. A salt or other derivative may be formed during the formulation process or in the preparation of the TK.

Where a TC/TK is intended for application by the end user, it should comply with the formulation specifications appropriate to its physical state.

If necessary, TC and TK materials can usually be reworked by manufacturers, to ensure compliance with specifications prior to formulation, and therefore storage stability clauses are not included in these specifications.

TC and TK specifications may also appear to be very simple because very few physical properties are likely to affect the stability and performance of the active ingredient in this form. The simplicity of the TC/TK specifications may appear to contrast with the volume of data evaluated in support them but it should be remembered that TC/TK specifications form the starting point for all formulation specifications.

―Technical grade active ingredient‖ is used in this Manual as a generic term, referring to both TC and TK.

1 For information on specifications for microbial pesticides, see section 9.

5.1 TECHNICAL MATERIALS (TC)

Note for preparation of draft specifications. Do not omit clauses or insert additional clauses, nor insert limits that are more lax than those than given in the guidelines, without referring to section 4. From the ―Notes‖ provided at the end of this guideline, incorporate only those which are applicable to the particular specification.

... [ISO common name] TECHNICAL MATERIAL [CIPAC number]/TC (month & year of publication)

5.1.1 Description

The material shall consist of …… [ISO common name] together with related manufacturing impurities, in the form of ... (see Section 4.2), and shall be ... [physical description] free from visible extraneous matter and added modifying agents, except stabilizers if required.

5.1.2 Active ingredient

5.1.2.1 Identity tests (Note 1)

The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test.

5.1.2.2 ... [ISO common name] content (Note 1)

The …… [ISO common name] content shall be declared (not less than ... g/kg) and, when determined, the average measured content shall not be lower than the declared minimum content.

5.1.2.3 Any other relevant clause (Note 1), if required Such as isomer ratio.

5.1.3 Relevant impurities

5.1.3.1 By-products of manufacture or storage (Note 2), if required Maximum: ... g/kg.

5.1.3.2 Water (MT 30.5) (Notes 3 & 4), if required Maximum: ... g/kg.

5.1.3.3 Insolubles (Notes 3 & 4), if required, Maximum: ... g/kg.

5.1 Technical materials (TC), continued

5.1.4 Physical properties

5.1.4.1 Acidity and/or Alkalinity (MT 191) (Note 3), if required Maximum acidity: ... g/kg calculated as H₂SO₄.

Maximum alkalinity: ... g/kg calculated as NaOH.

5.1.4.2 Any other clause (Notes 3 & 4), if required

Such as a sieve test, kinematic viscosity range, specific gravity, etc.

________________________

Note 1 Method(s) of analysis must be CIPAC, AOAC or equivalent. If the methods have not yet been published then full details, with appropriate method validation data, must be submitted to FAO/WHO by the proposer.

Note 2 This clause should include only relevant impurities and the title should be changed to reflect the name of the relevant impurity. Method(s) of analysis must be peer validated.

Note 3 Clauses to be included only if appropriate to the material.

Note 4 The method to be used shall be stated. If several methods are available, a referee method shall be selected.

5.2 TECHNICAL CONCENTRATES (TK)

Note for preparation of draft specifications. Do not omit clauses or insert additional clauses, nor insert limits that are more lax than those than given in the guidelines, without referring to section 4. From the ―Notes‖ provided at the end of this guideline, incorporate only those which are applicable to the particular specification.

... [ISO common name] TECHNICAL CONCENTRATE [CIPAC number]/TK (month & year of publication)

5.2.1 Description

The material shall consist of …… [ISO common name] together with related manufacturing impurities, in the form of ... (see Section 4.2), and shall be …… [physical description] free from visible extraneous matter and added modifying agents except for the diluent and stabilizer, if required.

5.2.2 Active ingredient

5.2.2.1 Identity tests (Note 1)

The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test.

5.2.2.2 ... [ISO common name] content (Note 1)

The …… [ISO common name] content shall be declared (g/kg or, for liquids only, g/l at 20 ± 2°C,) and, when determined, the average measured content shall not differ from that declared by more than the appropriate tolerance, given in the table of tolerances, Section 4.3.2.

5.2.2.3 Any other clause (Note 1), if required Such as isomer ratio.

5.2.3 Relevant impurities

5.2.3.1 By-products of manufacture or storage (Note 2), if required Maximum: ...% of the …… [ISO common name] content found under 5.2.2.2.

5.2.3.2 Water (MT 30.5) (Note 3), if required Maximum: ... g/kg.

5.2.3.3 Insolubles (Notes 3 & 4), if required Maximum: ... g/kg.

5.2 Technical concentrates (TK), continued

5.2.4 Physical properties

5.2.4.1 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3) (Notes 3 & 4), if required

Maximum acidity: ... g/kg calculated as H₂SO₄. Maximum alkalinity: ... g/kg calculated as NaOH.

pH range: ... to ...

5.2.4.2 Any other clause (Note 4)

Such as a sieve test, kinematic viscosity range, specific gravity, etc.

________________________

Note 1 Method(s) of analysis must be CIPAC, AOAC or equivalent. If the methods have not yet been published then full details, with appropriate method validation data, must be submitted to FAO/WHO by the proposer.

Note 2 This clause should include only relevant impurities and the title should be changed to reflect the name of the relevant impurity. Method(s) of analysis must be peer validated.

Note 3 Clauses to be included only if appropriate to the material.

Note 4 The method to be used shall be stated. If several methods are available, a referee method shall be selected.