SPINOSAD TABLETS FOR DIRECT APPLICATION
WHO specification 636/DT (March 2008. )
This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturer whose name is listed in the evaluation reports (636/2005, 636/2007). It should be applicable to relevant products of this manufacturer, and those of any other formulators who use only TC from the evaluated source. The specification is not an endorsement of those products, nor a guarantee that they comply with the specification. The specification may not be appropriate for the products of other manufacturers who use TC from other sources.
The evaluation reports (636/2005, 636/2007), as PART TWO, form an integral part of this publication.
1 Description (Note 1)
The material shall consist of two homogeneous layers of technical spinosad complying with the requirements of WHO specification 636/TC (February 2007) together with carriers and any other necessary formulants. It shall be in the form of tablets for direct application. The formulation shall be of dry, unbroken tablets, free from visible extraneous matter.
2 Active ingredient
2.1 Identity tests (636/DT/M/2, CIPAC Handbook, Notes 2 and 3)
The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test.
2.2 Spinosad content (636/DT/M/3, CIPAC Handbook, Notes 2 and 3)
The spinosad (spinosyn A + spinosyn D) content shall be declared (74.8 g/kg) and, when determined, the average measured content shall not differ from that declared by more than ±10%.
2.3 Tablet dose uniformity (636/DT/M/3, CIPAC Handbook, Notes 2 and 3) The spinosad (spinosyn A + spinosyn D) content, measured separately in 20 tablets shall have a relative standard deviation (RSD) of not more than 10%.
3 Physical properties
3.1 Tablet integrity (Notes 2, 4 and 5)
No broken tablets observed on inspection.
3.2 Attrition resistance (MT178.2, CIPAC Handbook H, p.304, 1998) (Notes 2 and 5) Minimum: 98% attrition resistance.
. 4 Storage stability
4.1 Stability at elevated temperature (MT 46.3, CIPAC Handbook J, p.128, 2000) After storage at 54 ± 2°C for 14 days without pressure (Note 6), the determined average active ingredient content must not be lower than 95% relative to the determined average content found before storage (Note 7) and the formulation shall continue to comply with the clauses for:
– tablet integrity (3.1),
– attrition resistance (3.2).
Note 1 The tablets are round, 12 mm in diameter, approximately 6 mm in height, weighing approximately 1.34 g. The tablets consist of two layers, one contains an effervescent system with its water-soluble acid component present in excess, a combination intended to aid gentle dispersion in water after application and to provide a relatively quick initial release of the active ingredient into the water. The other layer provides a slower release of spinosad to maintain an appropriate concentration over an extended period of time. The tablets are not intended for dispersion in water prior to application.
Note 2 For determination of identity (2.1) and spinosad content (2.2), a sufficient quantity of entire tablets may be milled and thoroughly mixed to provide an homogeneous powder, prior to weighing portions for analysis. Alternatively, the spinosad content may be calculated as the average g/kg obtained from the analyses of 20 separate tablets (2.3) and identity may be confirmed using one or more individual tablets. Tablets to be analyzed individually must also be crushed or milled to a fine powder, prior to extraction.
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