Open Access
Table 3
Contents of indapamide and impurities in sustained-release tablets (n=6) and the pharmacopoeia limits standards
| Item | Contents or limits of indapamide and impurities /% | |||||||
|---|---|---|---|---|---|---|---|---|
| Indapamide | Im3 | Im4 | Im5 | Im1 | ImA | ImB | Total† | |
| Content | 96.7 | 0.035‡ | 0.074‡ | 0.032‡ | ND | ND | 0.106 | 0.247 |
| Indapamide (BP) | 98.0-102.0 | ≤ 0.1* | ≤ 0.1* | ≤ 0.1* | — | 5 ppm | ≤ 0.3 | ≤ 0.5 |
| Indapamide Tablets (BP) | 95.0-105.0 | ≤ 0.1* | ≤ 0.1* | ≤ 0.1* | ≤ 0.2 | — | ≤ 0.5 | ≤ 0.3# |
| Indapamide Prolonged Release Tablets (BP) | 95.0-105.0 | ≤ 0.5* | ≤ 0.5* | ≤ 0.5* | ≤ 0.5 | — | ≤1.0 | ≤ 1.5 |
| Indapamide (USP) | 98.0-101.0 | ≤ 0.5* | ≤ 0.5* | ≤ 0.5* | — | — | — | ≤ 2.0 |
| Indapamide Tablets (USP) | 90.0-110.0 | — | — | — | — | — | — | — |
| Indapamide (ChP) | ≥98.5 | ≤ 0.5* | ≤ 0.5* | ≤ 0.5* | — | — | — | ≤ 1.0 |
| Indapamide Teblets (ChP) | 90.0-110.0 | — | — | — | — | — | — | ≤ 1.0 |
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