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Reported Trace Organic Acids Impurities in Pharmaceutical Excipients
| Impurity | Excipient | Reported levels (ppm) |
|---|---|---|
| Formic acid (13) (including formyl esters) | Polyethylene glycol | 10–1,000 s (MW-dependent) |
| Hydroxypropyl methylcellulose | 10–100 | |
| Povidone | 1000 s | |
| Polyvinyl alcohol | 30–40 | |
| Acetic acid (51,95) | Polyvinyl alcohol cellulose acetate butyrate | 100 s |
| Monochloro acetic acid | Sodium starch glycolate | 0–140 |
| Croscarmellose sodium | 22–53 |
