vii. Particle size and distribution, including the method of determination (for solid,

inhaled and transdermal dosage forms);

viii. Bulk physical properties, including data on bulk and tap density, surface area

and porosity as appropriate (for solid and inhaled dosage forms);

ix. Compaction properties (for solid dosage forms);

x. Melting point range (for semisolid or topical dosage forms);

xi. pH range (for parenteral, semisolid or topical, liquid and transdermal dosage

forms);

xii. Ionic strength (for parenteral dosage forms);

xiii. Specific density or gravity (for parenteral, semisolid or topical, liquid and

transdermal dosage forms);

xiv. Viscosity and/or viscoelasticity (for parenteral, semisolid or topical, liquid and

transdermal dosage forms);

xv. Osmolarity (for parenteral dosage forms);

xvi. Water content and determination of hygroscopicity, including water activity data

and special handling requirements (for solid and inhaled dosage forms);

xvii. Moisture content range (for parenteral, semisolid or topical, liquid and

transdermal dosage forms);

xviii. Microbiological considerations (including sterility, bacterial endotoxins and

bioburden levels where the excipient supports microbiological growth) as per

national, regional or international pharmacopoeial requirements, as applicable

(for general and specific monographs);

WHO Guidelines for Transfer of Technology 77

xix. Specifications and justification for release and end-of-life limits;

xx. Information on adhesives supporting compliance with peel, sheer and adhesion

design criteria (for transdermal dosage forms);

xxi. Special considerations with implications for storage and/or handling, including

but not limited to safety and environmental factors (e.g. as specified in material

safety data sheets (MSDS)) and sensitivity to heat, light or moisture; and

xxii. Regulatory considerations, e.g. documentation to support compliance with

transmissible animal spongiform encephalopathy certification requirements

(where applicable)