Evidence-Based Complementary and Alternative Medicine

Review Article

Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

Table 2

Common testing parameters of external dosage forms of herbal products.
ParameterCreamsaEmulsionsGelsaLinimentsLotionsaOintmentsaSolutionsaSuspensionsaExternal fluidSuppositoriesbInjectionsPlasterscTransdermal patchesInhalersSpraysdAerosols
PhysicalDescription1⋁⋁ ⋁⋁⋁⋁  ⋁⋁⋁⋁ ⋁⋁
Purity      ⋁    ⋁    
Transparency/clarity⋁   ⋁⋁    ⋁     
Homogeneity⋁   ⋁⋁          
Particulate matter      ⋁         
Microscopic evaluation             ⋁⋁ 
Foreign mechanical inclusions             ⋁  
Weight variation2⋁   ⋁⋁⋁  ⋁   ⋁⋁ 
Uniformity of dose unit3⋁     ⋁  ⋁  ⋁⋁  
Particle-size distribution⋁   ⋁⋁⋁⋁        
Aerodynamic particle-size distribution             ⋁⋁ 
Water content4         ⋁   ⋁⋁ 
Softening temperature         ⋁ ⋁    
Viscosity⋁ ⋁ ⋁⋁  ⋁       
Adhesive forces5           ⋁⋁   
Pump delivery             ⋁⋁ 
ChemicalAssay/content     ⋁   ⋁ ⋁  ⋁⋁
Identification ⋁ ⋁⋁⋁⋁  ⋁⋁⋁⋁ ⋁⋁
Dissolution      ⋁  ⋁ ⋁    
Disintegration      ⋁  ⋁ ⋁    
pH⋁ ⋁ ⋁⋁   ⋁⋁     
Extractable volume⋁    ⋁⋁⋁        
Ethanol content   ⋁⋁      ⋁    
Extractables/leachables from devices6             ⋁  
BiologicalAllergenicity/primary irritation test         ⋁ ⋁    
Sterility⋁    ⋁⋁⋁  ⋁ ⋁   
Pyrogenicity7          ⋁     
Microbiological limits8⋁⋁⋁⋁⋁⋁⋁⋁ ⋁ ⋁⋁⋁⋁⋁
Release rate in vitro            ⋁   
1Includes organoleptic characteristics such as color, odor, form, shape, size, and texture; rancidification, odor, color, phase separation, and coating for ointments; and precipitate and phase separation for sprays. 2Includes weight loss or average weight. 3Includes uniformity of mass or uniformity of weight 4or moisture content. 5Includes adhesive strength, adhesive property, peel force, peel strength, or tensile strength. 6Includes substances extracted and discharged from plastic and elastomeric components of the container, closure, and pump. 7Includes the content of endotoxins. 8Includes microbial content or microbial purity. aIncludes dosage form for ophthalmic or otic use. bIncludes intravaginal suppositories (or pessaries). cIncludes cataplasma or medicinal membrane. dIncludes dosage form for nasal use.