xiii. Ionic strength for parenteral dosage forms;

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

transdermal dosage forms;

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

transdermal dosage forms;

xvi. Osmolarity for parenteral dosage forms;

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

and special handling requirements for solid and inhaled dosage forms;

76 Industrial Pharmacy II

xviii. Moisture content range for parenteral, semisolid or topical, liquid and transdermal

dosage forms;

xix. Microbiological considerations including sterility, bacterial endotoxins and

bioburden levels where the excipient supports microbiological growth

xx. As per national, regional or international pharmacopoeial requirements, as

applicable for general and specific monographs;

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

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

design criteria (for transdermal dosage forms);

xxiii. 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

Excipients

Excipients have a potential impact on each aspect of the final product. Any relevant

information, which is of the importance for product manufacturing and is related to

excipients should be given to RU by SU. This information may include:

i. Manufacturer and associated supply chain;

ii. Description of functionality, with justification for the inclusion of any antioxidant,

preservative or any excipient;

iii. Definitive form (particularly for solid and inhaled dosage forms);

iv. Solubility profile (particularly for inhaled and transdermal dosage forms);

v. Partition coefficient, including the method of determination (for transdermal

dosage forms);

vi. Intrinsic dissolution rate, including the method of determination (for transdermal

dosage forms);