Table 3.

Qualitative and quantitative analysis according to the suggested classification of Neves [25], and Weber and colleagues [26] into original, substandard or counterfeit and subclassifications with some adaptions for analysis

Classification	Description and subclassification
Original	• Formulation detected fully matches the one declared on the label/ accurately labeled (qualitative) • Levels of active pharmaceutical ingredients (AI) detected are between the defined range of the declared formulation defined by the individual studya (quantitative)
Substandard	• Formulation detected fully matches the one declared/ accurately labeled (qualitative) • Levels of AI detected are not between the acceptable range defined for original productsa (quantitative) • Subclassification (quantitative): - Over-concentrated: AI detected above defined range - Under-concentrated: AI detected below defined range
Counterfeitb	• Formulation detected does not match the label/ not accurately labeled (qualitative) • Subclassification (qualitative): - Inert: no AI present - Substituted: different AI than labeled present - Adulterated: not all or more AI than the labeled AI present

AI Active ingredient

^a Adapted from Neves and colleagues’ specific range of 80–130% of the declared formulation

^b Adapted from Neves and colleagues: for our study there is no focus on authentic packaging, unregistered or non-existent manufacturer, lot numbers and expiry dates, or classes with no specification