The document discusses technical materials, technical concentrates, and specifications for various types of solid formulations including dustable powders, granules, wettable powders, water soluble powders, and more. It provides definitions and examples of technical materials and concentrates. It then lists typical specifications that are evaluated for each type of solid formulation, including appearance, moisture content, pH, active ingredient percentage, wettability, dispersion stability, degree of dissolution, and stability under various conditions. The specifications aim to ensure the formulations maintain quality and perform their intended functions.

1. UNDERSTANDING THE PHYSICO-
CHEMICAL PROPERTIES AND
REQUIREMENTS TECHNICAL
MATERIALS AND SOLID
FORMULATIONS
Anand Balkrishna Pandya
Quality Assurance Unit
Krish Biotech Research Private Limited
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2. What is a Technical Material?
• A technical material is an active
ingredient isolated) from the starting
materials, solvents, etc., used to produce
it.
• A Technical material is traded between
manufacturers and formulators.
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3. What is Technical Concentrate ?
• A technical concentrate 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.
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4. What is Technical Concentrate ?
• In some cases it is necessary or advantageous to
manufacture formulations from a technical
concentrate .
• 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
Technical material .
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5. • Technical grade active ingredient is used in this
Manual as a generic term, referring to both
Technical Material and Technical Concentrate .
• The 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 i.e. Technical
Material and Technical Concentrate .
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6. Specifications of Technical Materials ?
• Appearance / Description
• Percentage of A.I.Content & Relevant impurities
• Moisture Content
• pH
• Acidity / Alkalinity
• Insoluble matter
• Viscosity
• Specific Gravity / Density
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7. SOLID FORMULATIONS FOR
DIRECT USE :
• Dustable Powders (DP) (A free-flowing powder
suitable for dusting)
• Powders for Dry Seed Treatment (DS) (powder for
application in the dry state directly to the seed)
• Granules (GR) (A free-flowing solid formulation of a
defined granule size range ready for use)
• Tablets for Direct Application (DT) (Formulation in
the form of tablets to be applied individually and
directly in the field, and/or bodies of water, without
preparation of a spraying solution or dispersion)
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8. SOLID FORMULATIONS FOR DISPERSION
• Wettable Powders (WP) (A powder formulation to be applied as a
suspension after dispersion in water.)
• Water Dispersible Powders for Slurry Seed Treatment (WS) (A
powder to be dispersed at high concentration in water before
application as a slurry to the seed)
• Water Dispersible Granules (WG) (formulation consisting of granules
to be applied after disintegration and dispersion in water .)
• Water Dispersible Tablets (WT) (Formulation in the form of tablets
to be used individually, to form a dispersion of the active ingredient
after disintegration in water. )
• Emulsifiable Granules (EG) (A granular formulation, which may
contain water-insoluble formulants, to be applied as an oil-in-water
emulsion of the active ingredient(s) after disintegration in water. )
• Emulsifiable Powders (EP)(A powder formulation, which may
contain water-insoluble formulants, to be applied as an oil-in-water
emulsion of the active ingredient(s) after dispersion in water. ) 8

9. SOLID FORMULATIONS FOR DISSOLUTION
• Water Soluble Powders (SP) (A powder formulation to be
applied as a true solution of the active ingredient after
dissolution in water, but which may contain insoluble inert
ingredients.)
• Water Soluble Powders for Seed Treatment (SS) (same as SP)
• Water Soluble Granules (SG) (A formulation consisting of
granules to be applied as a true solution of the active
ingredient after dissolution in water, but which may contain
insoluble inert ingredients.)
• Water Soluble Tablets (ST) (Formulation in form of tablets to
be used individually, to form a solution of the active
ingredient after disintegration in water. The formulation may
contain water-insoluble formulants.)
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10. Specifications Requirements
Of Solid Formulation
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11. Dustable Powders (DP)
• Name
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Dry Sieve Test
• Accelerated Storage Stability at 54 ± 2 ° C
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12. Powders for Dry Seed Treatment (DS)
• Description
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Dry sieve test
• Adhesion to seeds
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13. Granules (GR)
• Description
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Pour and tap density
• Nominal size range
• Dustiness
• Attrition resistance
• Rate of release of
active ingredient
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14. Tablets for Direct Application (DT)
• Description & Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• Tablet integrity
• Tablet hardness
• Degree of attrition
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15. Wettable Powders (WP)
• Description
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Wet sieve test
• Suspensibility
• Persistent foam
• Wettability
• Stability at elevated
temperature
• Material packaged in a
sealed water soluble
bag
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16. Water Dispersible Powders for Slurry
Seed Treatment (WS)
• Description
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Wet sieve test
• Persistent foam
• Wettability
• Adhesion to seeds
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17. Water Dispersible Granules (WG)
• Description
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Wet sieve test
• Wettability
• Degree of dispersion
• Suspensibility
• Dustiness
• Flowability
• Attrition resistance
• Storage stability at
elevated temperature
• Persistent Foam
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18. Water Dispersible Tablets (WT)
• Description & Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• Tablet integrity
• Tablet hardness
• Degree of attrition
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19. Emulsifiable Granules (EG)
• Identity tests & Active
ingredient
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Wet sieve test
• Wettability
• Dispersion stability
• Wet sieve test
• Dustiness
• Attrition resistance
• Persistent foam
• Flowability
• Stability at elevated
temperature
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20. Emulsifiable Powders (EP)
• Identity tests &
Active ingredient
• Identity tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Wettability
• Dispersion stability
• Wet sieve test
• Persistent foam
• Stability at elevated
temperature
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21. Water Soluble Powders (SP)
• Description & Identity
tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• Wettability
• Degree of dissolution
and solution stability
• Persistent foam
• Dissolution of the bag
• Degree of dissolution
and solution stability
• persistent foam
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22. Water Soluble Powders for Seed
Treatment (SS)
• Description & Identity
tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• Degree of dissolution
and solution stability
• Persistent foam
• Adhesion to seeds
• Stability at elevated
temperatures .
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23. Water Soluble Granules (SG)
• Identity tests & Active
ingredient
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• % Active Ingredient
• Dustiness
• Attrition resistance
• stability at elevated
temperatures
• Dissolution of the bag
• Degree of dissolution
and solution stability
• Persistent foam
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24. Water Soluble Tablets (ST)
• Description & Identity
tests
• Appearance
• Moisture Content
• pH
• Acidity
• Alkalinity
• Degree of dissolution
and solution stability
• Persistent foam
• Adhesion to seeds
• Stability at elevated
temperatures .
• Disintegration time
• Degree of dissolution
and solution stability
• Wet sieve test
• Tablet integrity
• Degree of attrition
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