element. They apply to single-dose aerosol products and they apply to multiple-dose products. It's a two-tiered test as it's presented in the guidance, and at tier 1, it says that there's not more than 1 of 10 containers outside of 80 to a 120 percent of label claim and 0 outside of 75 to 125 percent of label claim. That's what we call the zero tolerance criterion, and it's an attempt to use the sample but to provide some assurance that there will not in the batch be samples with very high variability.
The parametric element in that test is the last line indicating that the mean of the 10 samples at the first tier shall not be outside of 85 to a 115 percent of label claim.
In addition to that dose content uniformity test, there's an additional test for multi-dose products and that additional test is called the Dose Content Uniformity Through Container Life for Multi-Dose Products, and for metered-dose inhalers, that test says that the dose content uniformity is measured at the beginning, middle and end life stages.
Now, for multiple-dose products, like, let's say, albuterol MDI, where the standard product is labeled