Delapril and manidipine characterization and purity evaluation in raw materials
Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (D...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Todeschini, Vítor [verfasserIn] Oliveira, Paulo Renato de [verfasserIn] Bernardi, Larissa Sakis [verfasserIn] Pereira, Rúbia Lazzaretti [verfasserIn] Campos, Carlos Eduardo Maduro de [verfasserIn] Silva, Marcos Antonio Segatto [verfasserIn] Volpato, Nadia Maria [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2013 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Journal of thermal analysis and calorimetry - Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969, 115(2013), 3 vom: 07. Apr., Seite 2295-2301 |
|---|---|
| Übergeordnetes Werk: |
volume:115 ; year:2013 ; number:3 ; day:07 ; month:04 ; pages:2295-2301 |
| Links: |
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| DOI / URN: |
10.1007/s10973-013-3139-7 |
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| Katalog-ID: |
SPR01548713X |
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| 520 | |a Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. | ||
| 650 | 4 | |a Delapril |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Manidipine |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Purity evaluation |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Raw materials |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Solid-state characterization |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Oliveira, Paulo Renato de |e verfasserin |4 aut | |
| 700 | 1 | |a Bernardi, Larissa Sakis |e verfasserin |4 aut | |
| 700 | 1 | |a Pereira, Rúbia Lazzaretti |e verfasserin |4 aut | |
| 700 | 1 | |a Campos, Carlos Eduardo Maduro de |e verfasserin |4 aut | |
| 700 | 1 | |a Silva, Marcos Antonio Segatto |e verfasserin |4 aut | |
| 700 | 1 | |a Volpato, Nadia Maria |e verfasserin |4 aut | |
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10.1007/s10973-013-3139-7 doi (DE-627)SPR01548713X (SPR)s10973-013-3139-7-e DE-627 ger DE-627 rakwb eng 660 ASE 35.00 bkl Todeschini, Vítor verfasserin aut Delapril and manidipine characterization and purity evaluation in raw materials 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 Oliveira, Paulo Renato de verfasserin aut Bernardi, Larissa Sakis verfasserin aut Pereira, Rúbia Lazzaretti verfasserin aut Campos, Carlos Eduardo Maduro de verfasserin aut Silva, Marcos Antonio Segatto verfasserin aut Volpato, Nadia Maria verfasserin aut Enthalten in Journal of thermal analysis and calorimetry Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969 115(2013), 3 vom: 07. Apr., Seite 2295-2301 (DE-627)315295422 (DE-600)2017304-0 1572-8943 nnns volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 https://dx.doi.org/10.1007/s10973-013-3139-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 35.00 ASE AR 115 2013 3 07 04 2295-2301 |
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10.1007/s10973-013-3139-7 doi (DE-627)SPR01548713X (SPR)s10973-013-3139-7-e DE-627 ger DE-627 rakwb eng 660 ASE 35.00 bkl Todeschini, Vítor verfasserin aut Delapril and manidipine characterization and purity evaluation in raw materials 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 Oliveira, Paulo Renato de verfasserin aut Bernardi, Larissa Sakis verfasserin aut Pereira, Rúbia Lazzaretti verfasserin aut Campos, Carlos Eduardo Maduro de verfasserin aut Silva, Marcos Antonio Segatto verfasserin aut Volpato, Nadia Maria verfasserin aut Enthalten in Journal of thermal analysis and calorimetry Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969 115(2013), 3 vom: 07. Apr., Seite 2295-2301 (DE-627)315295422 (DE-600)2017304-0 1572-8943 nnns volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 https://dx.doi.org/10.1007/s10973-013-3139-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 35.00 ASE AR 115 2013 3 07 04 2295-2301 |
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10.1007/s10973-013-3139-7 doi (DE-627)SPR01548713X (SPR)s10973-013-3139-7-e DE-627 ger DE-627 rakwb eng 660 ASE 35.00 bkl Todeschini, Vítor verfasserin aut Delapril and manidipine characterization and purity evaluation in raw materials 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 Oliveira, Paulo Renato de verfasserin aut Bernardi, Larissa Sakis verfasserin aut Pereira, Rúbia Lazzaretti verfasserin aut Campos, Carlos Eduardo Maduro de verfasserin aut Silva, Marcos Antonio Segatto verfasserin aut Volpato, Nadia Maria verfasserin aut Enthalten in Journal of thermal analysis and calorimetry Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969 115(2013), 3 vom: 07. Apr., Seite 2295-2301 (DE-627)315295422 (DE-600)2017304-0 1572-8943 nnns volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 https://dx.doi.org/10.1007/s10973-013-3139-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 35.00 ASE AR 115 2013 3 07 04 2295-2301 |
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10.1007/s10973-013-3139-7 doi (DE-627)SPR01548713X (SPR)s10973-013-3139-7-e DE-627 ger DE-627 rakwb eng 660 ASE 35.00 bkl Todeschini, Vítor verfasserin aut Delapril and manidipine characterization and purity evaluation in raw materials 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 Oliveira, Paulo Renato de verfasserin aut Bernardi, Larissa Sakis verfasserin aut Pereira, Rúbia Lazzaretti verfasserin aut Campos, Carlos Eduardo Maduro de verfasserin aut Silva, Marcos Antonio Segatto verfasserin aut Volpato, Nadia Maria verfasserin aut Enthalten in Journal of thermal analysis and calorimetry Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969 115(2013), 3 vom: 07. Apr., Seite 2295-2301 (DE-627)315295422 (DE-600)2017304-0 1572-8943 nnns volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 https://dx.doi.org/10.1007/s10973-013-3139-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 35.00 ASE AR 115 2013 3 07 04 2295-2301 |
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10.1007/s10973-013-3139-7 doi (DE-627)SPR01548713X (SPR)s10973-013-3139-7-e DE-627 ger DE-627 rakwb eng 660 ASE 35.00 bkl Todeschini, Vítor verfasserin aut Delapril and manidipine characterization and purity evaluation in raw materials 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 Oliveira, Paulo Renato de verfasserin aut Bernardi, Larissa Sakis verfasserin aut Pereira, Rúbia Lazzaretti verfasserin aut Campos, Carlos Eduardo Maduro de verfasserin aut Silva, Marcos Antonio Segatto verfasserin aut Volpato, Nadia Maria verfasserin aut Enthalten in Journal of thermal analysis and calorimetry Dordrecht [u.a.] : Springer Science + Business Media B.V., 1969 115(2013), 3 vom: 07. Apr., Seite 2295-2301 (DE-627)315295422 (DE-600)2017304-0 1572-8943 nnns volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 https://dx.doi.org/10.1007/s10973-013-3139-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 35.00 ASE AR 115 2013 3 07 04 2295-2301 |
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Enthalten in Journal of thermal analysis and calorimetry 115(2013), 3 vom: 07. Apr., Seite 2295-2301 volume:115 year:2013 number:3 day:07 month:04 pages:2295-2301 |
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Delapril Manidipine Purity evaluation Raw materials Solid-state characterization |
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Todeschini, Vítor @@aut@@ Oliveira, Paulo Renato de @@aut@@ Bernardi, Larissa Sakis @@aut@@ Pereira, Rúbia Lazzaretti @@aut@@ Campos, Carlos Eduardo Maduro de @@aut@@ Silva, Marcos Antonio Segatto @@aut@@ Volpato, Nadia Maria @@aut@@ |
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DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. 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Todeschini, Vítor |
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Todeschini, Vítor ddc 660 bkl 35.00 misc Delapril misc Manidipine misc Purity evaluation misc Raw materials misc Solid-state characterization Delapril and manidipine characterization and purity evaluation in raw materials |
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660 ASE 35.00 bkl Delapril and manidipine characterization and purity evaluation in raw materials Delapril (dpeaa)DE-He213 Manidipine (dpeaa)DE-He213 Purity evaluation (dpeaa)DE-He213 Raw materials (dpeaa)DE-He213 Solid-state characterization (dpeaa)DE-He213 |
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Journal of thermal analysis and calorimetry |
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Todeschini, Vítor Oliveira, Paulo Renato de Bernardi, Larissa Sakis Pereira, Rúbia Lazzaretti Campos, Carlos Eduardo Maduro de Silva, Marcos Antonio Segatto Volpato, Nadia Maria |
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Todeschini, Vítor |
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delapril and manidipine characterization and purity evaluation in raw materials |
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Delapril and manidipine characterization and purity evaluation in raw materials |
| abstract |
Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. |
| abstractGer |
Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. |
| abstract_unstemmed |
Abstract This study characterizes the solid-state of delapril hydrochloride (DEL) and manidipine dihydrochloride (MAN) raw materials using different analytical techniques. DEL (D1 and D2) and MAN (M1 and M2) were obtained from different suppliers and submitted to differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffraction (XRPD), diffuse reflectance infrared Fourier transform spectroscopy (DRIFT), Raman spectroscopy (RS), and scanning electron microscopy (SEM). For DEL, the TG/DTG analysis demonstrated three stage of mass loss between 140 and 402 °C. Different DSC curve profiles with melting points at 182.8 °C for D1 and 170.1 °C for D2 were verified. Moreover, incompatible results were also obtained in RS and SEM analysis for this drug. Nevertheless, when analyzed by liquid chromatography (LC), an additional peak was detected, demonstrating that the differences observed can be related to an impurity present in D2 sample and not to a possible polymorphism (as confirmed by XRPD). On the other hand, for MAN evaluation, all results were similar, showing that there were no differences between M1 and M2 samples. Besides the solid-state evaluation, the techniques employed in this study could also be used for quality control, stability studies, and for qualification of raw materials suppliers. Furthermore, for purity evaluations, complementary methods (such as DSC) can be useful, since there are impurities that don’t have UV/Vis absorbance, leading to absence of signal in LC–UV methodologies. |
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Delapril and manidipine characterization and purity evaluation in raw materials |
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Oliveira, Paulo Renato de Bernardi, Larissa Sakis Pereira, Rúbia Lazzaretti Campos, Carlos Eduardo Maduro de Silva, Marcos Antonio Segatto Volpato, Nadia Maria |
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| score |
7.399477 |