Table 4 The relative retention time (RRT) and relative response factor (RRF) of three batches of related substances of albumin-bound paclitaxel at different temperatures
From: Study on the thermal stability of nab-paclitaxel during hyperthermic intraperitoneal chemotherapy
Batch number: B042001249 | |||||||
Impurities and degradation products, limits | RRT | RRF | 25 °C | 37 °C | 41 °C | 42 °C | 43 °C |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.21 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
Baccatin III (0.1%) | 0.22–0.24 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.24–0.26 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
C3-C11 bridge paclitaxel isomers (0.1%) | 0.41 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetylpaclitaxel (0.1%) | 0.79–0.80 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
Taxane (0.1%) | 0.83–0.84 | 1.00 | 0.018 | 0.017 | 0.021 | 0.018 | 0.018 |
Cephalomannine (0.4%) | 0.89 | 1.33 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetyl-7-epipaclitaxel (0.1%) | 1.14 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epicephalomannine (0.1%) | 1.26–1.28 | 1.31 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epitaxol (1.0%) | 1.41–1.45 | 1.00 | 0.244 | 0.249 | 0.249 | 0.253 | 0.255 |
Paclitaxel C (0.1%) | 1.89–2.08 | 1.80 | Not detected | Not detected | Not detected | Not detected | Not detected |
N-methyl-paclitaxel C (0.1%) | RT = 57-60 min | 1.68 | Not detected | Not detected | Not detected | Not detected | Not detected |
Other single impurities (0.1%) | – | 1.00 | 0.021 | 0.017 | 0.020 | 0.016 | 0.018 |
Total impurities (1.5%) | – | – | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
Batch number: B0420012450 | |||||||
Impurities and degradation products, limits | RRT | RRF | 25 °C | 37 °C | 41 °C | 42 °C | 43 °C |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.21 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
Baccatin III (0.1%) | 0.22–0.24 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.24–0.26 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
C3-C11 bridge paclitaxel isomers (0.1%) | 0.41 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetylpaclitaxel (0.1%) | 0.79–0.80 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
Taxane (0.1%) | 0.83–0.84 | 1.00 | 0.017 | 0.011 | 0.012 | 0.014 | 0.014 |
Cephalomannine (0.4%) | 0.89 | 1.33 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetyl-7-epipaclitaxel (0.1%) | 1.14 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epicephalomannine (0.1%) | 1.26–1.28 | 1.31 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epitaxol (1.0%) | 1.41–1.45 | 1.00 | 0.251 | 0.267 | 0.266 | 0.258 | 0.288 |
Paclitaxel C (0.1%) | 1.89–2.08 | 1.80 | Not detected | Not detected | Not detected | Not detected | Not detected |
N-methyl-paclitaxel C (0.1%) | RT = 57-60 min | 1.68 | Not detected | Not detected | Not detected | Not detected | Not detected |
Other single impurities (0.1%) | – | 1.00 | 0.022 | 0.017 | 0.019 | 0.019 | 0.021 |
Total impurities (1.5%) | – | – | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
Batch number: B042001251 | |||||||
Impurities and degradation products, limits | RRT | RRF | 25 °C | 37 °C | 41 °C | 42 °C | 43 °C |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.21 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
Baccatin III (0.1%) | 0.22–0.24 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
(2R,3S)-N-benzoyl-3-phenylisoserine methyl ester (0.1%) | 0.24–0.26 | 0.90 | Not detected | Not detected | Not detected | Not detected | Not detected |
C3-C11 bridge paclitaxel isomers (0.1%) | 0.41 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetylpaclitaxel (0.1%) | 0.79–0.80 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
Taxane (0.1%) | 0.83–0.84 | 1.00 | 0.016 | 0.017 | 0.015 | 0.017 | 0.013 |
Cephalomannine (0.4%) | 0.89 | 1.33 | Not detected | Not detected | Not detected | Not detected | Not detected |
10-Deacetyl-7-epipaclitaxel (0.1%) | 1.14 | 1.00 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epicephalomannine (0.1%) | 1.26–1.28 | 1.31 | Not detected | Not detected | Not detected | Not detected | Not detected |
7-Epitaxol (1.0%) | 1.41–1.45 | 1.00 | 0.319 | 0.317 | 0.328 | 0.331 | 0.316 |
Paclitaxel C (0.1%) | 1.89–2.08 | 1.80 | Not detected | Not detected | Not detected | Not detected | Not detected |
N-methyl-paclitaxel C (0.1%) | RT = 57-60 min | 1.68 | Not detected | Not detected | Not detected | Not detected | Not detected |
Other single impurities (0.1%) | – | 1.00 | 0.016 | 0.020 | 0.021 | 0.019 | 0.022 |
Total impurities (1.5%) | – | – | 0.4 | 0.4 | 0.4 | 0.4 |  |