Introduction
The product is a water emulsion of the granules can be, it is the active ingredient dissolved or diluted in an organic solvent, and then adsorbed on a suitable carrier is made (Note A). Used, diluted with water, the product will collapse or dissolved to form a common oil in water (O / W) emulsion. This product may contain one or several active ingredients. These (species) before the active ingredient dissolved or diluted in a suitable organic solvent, and then adsorbed on the water-soluble polymer shell or other types of soluble or insoluble carrier. Upon request, the preparation can also add other additives.
In accordance with the disintegration of the product is diluted or emulsified condition, respectively similar to its water dispersible granules and the cream of the disposal methods.
[ISO common name] emulsifiable granule CIPAC No. / EG
1 Overview
This product should be consistent with FAO specifications by the [ISO common name]
Original drug dissolved in organic solvents and additives added into a suitable granular formulations; appearance should be dry, uniform, free-flowing particles can be no visible extraneous matter and hard lumps; diluted with water to form emulsion.
2 active ingredients
2.1 Identification Test (Note l3)
The active ingredient shall comply with an identity test; when the authentication test when in doubt, or at least should be consistent with other screening tests.
2.2. [ISO common name] content (Note B)
[Iso common name] content shall be marked (g / kg), when the detection, the average content measured shall not exceed the given section of this manual 4,3.2 permitted fluctuation range.
3 related impurities
3,1. Production and storage of by-products (Note B and C) For control, maximum: 2.2 measured [ISO common name] content%
3.2 Water (MT 30) For more control, maximum: g / kg
4 Physical properties
PH or pH range of 4.1
If necessary,
Maximum acidity: g / kg (H2SO4)
Maximum alkalinity: g / kg (in NaOH)
pH range: (MT 75) (Note 1)
4,2 Wettability (MT 53.3) (Note D) This product should be in the rain, the complete wetting.
4.3 The dispersion stability (MT 18o)
4.4 Wet sieve test (MT 185) (Note 2) Maximum: 75 m test sieve to stay in volume% on
4.5 Dust (MT 171) This product should be essentially almost no dust or no dust (Note E)
4.6 Persistent foaming (MT 47.2) Maximum: 1 rain after mL
5 Storage stability
5.1 High temperature stability (MT 46.3)
Sample at 54 ℃ ± 2 ℃ after storage at 14 d, measured by the average active ingredient content should not be less than the average measured before storage% (Note 3); If necessary, the sample should also meet the following Terms:
- - Production and storage of by-products
- - PH or pH range
- - Dispersion stability
- - Wet sieve test
- - Dust Note 1: The drift in the pH value of the uncertain circumstances, if 10rain in (not stirred), the deviation is less than 0.1 pH, still think that reading is determined and effective.
Note 2: The test can plug nozzles and filters the detection of coarse particles.
Note 3: before and after the storage stability of sample storage after the test should be measured simultaneously to reduce the analytical error.
Note A: Because of different manufacturing process, the granules may have different shapes and size ranges. For the specific preparation, for concrete proposals on the particle shape description (such as: irregular shape, spherical, cylindrical), and that size range.
Note B: Content analysis of the active ingredient must be CIPAC or AOAC Method method; correlation analysis method of impurities must be equally effective. If the method has not been published, authors should verify all information and data submitted valid
FAO.
Note C: This provision includes only the relevant impurities.
Note D: on the method used should be stated, is the mixing or not mixing (MT 53.3.1 or MT 53.3.2).
Note E: for some unique product specifications, which only provides one of the requirements.
Note F: Unless other temperatures and (or) time to make provisions (other storage conditions, see manual section 4.6.2).
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