Table 2.
HPLC-determined strength of out-of-date batches of albuterol and montelukast products relative to manufacturer-disclosed dose per unit.
| Product | Exp. Date | Manufacturer | Lot# | Dosage Form | Dose (mg/unit) | Strength (% of Dose) |
|---|---|---|---|---|---|---|
|
(A) Albuterol | ||||||
| Generic | March 2001 | Bausch & Lomb | 166071 | Solution | 5 | 88.4 ± 0.1 |
| Generic | August 2001 | Bausch & Lomb | 215981 | Solution | 5 | 92.0 ± 0.1 |
| Generic | June 2003 | Bausch & Lomb | 435071 | Solution | 5 | 92.9 ± 0.1 |
| Generic | June 2007 | Bausch & Lomb | 915631 | Solution | 5 | 85.3 ± 0.0 |
| Generic | May 2009 | Nephron | A6211C | Solution | 0.83 | 101.0 ± 0.0 |
| Generic | December 2013 | Watson | 1T06 | Solution | 0.83 | 97.6 ± 0.0 |
| Generic | October 2015 | Ritedose | 3P94 | Solution | 0.83 | 105.6 ± 0.0 |
| Generic | April 2016 | Mylan | 4D09 | Solution | 0.83 | 97.4 ± 0.0 |
| Generic | January 2019 | Nephron | 721211 | Solution | 0.83 | 97.6 ± 0.1 |
| Generic | March 2019 | Ritedose | 7CB5 | Solution | 0.83 | 101.7 ± 0.0 |
| Generic∗ | June 2021 | Nephron | 921481 | Solution | 0.83 | 96.7 ± 0.1 |
| Ventolin® | June 2009 | GSK | 8ZP8118 | Inhaler | 0.09 | 102.5 ± 0.0 |
| Proventil® | February 2012 | Schering-Plough | 100443 | Inhaler | 0.09 | 77.8 ± 0.1 |
| Proventil® | December 2012 | Schering-Plough | 110293 | Inhaler | 0.09 | 72.9 ± 0.0 |
| Proventil® | May 2015 | Schering-Plough | 130401 | Inhaler | 0.09 | 82.7 ± 0.0 |
| Ventolin® | December 2017 | GSK | 7L8E | Inhaler | 0.09 | 97.5 ± 0.0 |
| Ventolin®∗ |
January 2021 |
GSK |
8W9R |
Inhaler |
0.09 |
87.2 ± 0.1 |
|
(B) Montelukast | ||||||
| Singulair® | January 2003 | Merck | L5267 | Tablet | 10 | 97.2 ± 0.6 |
| Singulair® | April 2003 | Merck | M3448 | Tablet | 5 | 96.0 ± 0.2 |
| Singulair® | June 2003 | Merck | M3453 | Tablet | 10 | 95.6 ± 0.5 |
| Singulair® | August 2009 | Merck | F8279 | Granule | 4 | 94.3 ± 0.7 |
| Generic∗ | September 2019 | Torrent | BU65D024 | Tablet | 10 | 93.1 ± 1.0 |
∗
In-date at time of analysis.