Table I.
Results of Medication API Assays
| Medication | Method | Results per sample | Mean ± Std | % Label |
|---|---|---|---|---|
| Aspirin (325 mg) | USP monograph: Aspirin tablets | A 314.1 | 313.7 ± 0.5 | 96.5 |
| B 313.0 | ||||
| C 314.0 | ||||
| D 313.5 | ||||
| E 314.1 | ||||
| Acetaminophen (325 mg) | USP monograph: Acetaminophen tablets | A 314.7 | 315.4 ± 3.2 | 97.0 |
| B 321.1 | ||||
| C 313.5 | ||||
| D 313.4 | ||||
| E 314.4 | ||||
| Ibuprofen (400 mg) | USP monograph: Ibuprofen tablets | A 403.0 | 399.6 ± 7.1 | 99.9 |
| B 403.0 | ||||
| C 387.0 | ||||
| D 404.0 | ||||
| E 399.6 | ||||
| Loratadine (10 mg) | USP monograph: Loratadine tablets | A 9.6 | 10.0 ± 0.3 | 99.9 |
| B 10.1 | ||||
| C 10.1 | ||||
| D 10.1 | ||||
| Loperamide (2.0 mg) | USP monograph: Loperamide hydrochloride tablets | A 1.9 | 2.0 ± 0.6 | 96.3 |
| B 1.9 | ||||
| C 2.0 | ||||
| D 2.0 | ||||
| Pseudoephedrine hydrochloride (120 mg) | USP monograph: Pseudoephedrine hydrochloride extended-release tablets | A 114.8 | 118.9 ± 3.3 | 99.0 |
| B 119.4 | ||||
| C 122.7 | ||||
| D 118.5 | ||||
| Melatonin (3 mg) | Dietary supplement: Melatonin tablets | A 2.6 | 2.7 ± 0.1 | 89.2 |
| B 2.7 | ||||
| C 2.7 | ||||
| D 2.7 | ||||
| E 2.7 | ||||
| Zolpidem (10 mg) | USP monograph: Zolpidem tablets | A 10.16 | 10.07 ± 0.09 | 100.6 |
| B 10.16 | ||||
| C 9.96 | ||||
| D 10.07 | ||||
| E 9.99 | ||||
| Modafinil (200 mg) | USP monograph: Modafinil tablets | A 197.8 | 201.2 ± 2.4 | 100.6 |
| B 203.2 | ||||
| C 202.2 | ||||
| D 201.4 |
USP criteria for all of these medications in 2012 was 90.0–110.0% of the amount stated on the product label. Results are given per individual sample and as mean ± standard deviation. Percentage of label claim (mean API amount/label claim) is given for each medication for reference