Key Laboratory of Polymorph Pharmaceutical of ShanDong Province

Tengzhou, China

Key Laboratory of Polymorph Pharmaceutical of ShanDong Province

Tengzhou, China
SEARCH FILTERS
Time filter
Source Type

Gong N.,Peking Union Medical College | Hu K.,Peking Union Medical College | Jin G.,Peking Union Medical College | Du G.,Peking Union Medical College | And 2 more authors.
RSC Advances | Year: 2016

A novel metastable polymorph and an unstable amorphous phase of methoxyflavone were discovered after a decade since the first report of the X-ray crystal structure of this bioactive compound. The new polymorph (form B) was crystallized from a single solvent that produced two different polymorphs concomitantly, which is different from the reported structure of form A (CCDC code: FATYOP). The two polymorphs crystallized in the same P21/c space group, the asymmetric units in form A contain one and form B contains two molecules with different conformations. The conformational differences and the weak C-H⋯O intermolecular interactions played a major role in generating the methoxyflavone polymorphs. The polymorphs were characterized by X-ray diffraction, differential scanning calorimetry and FT-IR spectroscopy. Thermodynamic properties were unambiguously established using room-temperature competitive slurry experiments, solid-state milling and heating. Form A was more stable than form B, the amorphous phase was unstable and easily converted to form A at room temperature in 30 minutes. Form A had higher absorption area, the Cmax and AUC of form A were approximately two times those of form B. © The Royal Society of Chemistry 2016.


Gong N.,Peking Union Medical College | Guo Y.,Peking Union Medical College | Yang N.,Peking Union Medical College | Gao Z.,Key Laboratory of Polymorph Pharmaceutical of ShanDong Province | And 3 more authors.
Analytical Methods | Year: 2012

Sample preparation, homogeneity study, stability study, value characterization, and evaluation of uncertainty of a new certified reference material (CRM) of puerarin are presented in this paper. The homogeneity was checked by a differential scanning calorimetry method. The stability was tested under different storage conditions. The CRM described above was homogeneous and stable at 25 °C for at least one year. The certified value of puerarin CRM is 99.66% with an extended uncertainty of 0.48% (k = 2). Coulometric titration and differential scanning calorimetry methods are used for purity determination of puerarin for the first time in this paper. The new CRM of puerarin can be used to validate analytical methods, improve the accuracy and comparability of measurement data, establish meteorological traceability of analytical results as well as control the quality of puerarin in relevant food and pharmaceutical formulations. © The Royal Society of Chemistry. 2012.


Zhang L.,Peking Union Medical College | Guo Y.,Peking Union Medical College | Zhou Z.,Peking Union Medical College | Du G.,Peking Union Medical College | And 2 more authors.
Analytical Methods | Year: 2014

This study introduces a purity determination and uncertainty evaluation method for a new certified reference material (CRM) of Pinocembrin (GBW09554), using a mass balance method and differential scanning calorimetry (DSC). Sample preparation, homogeneity and stability studies, value characterization, and evaluation of uncertainty of a new CRM of Pinocembrin are presented in this paper. The homogeneity and stability are checked using a mass balance method and the stability is tested under different storage conditions. The CRM described above was found to be homogeneous and stable at 25°C for at least one year. The certified value of Pinocembrin CRM is 99.7% with an extended uncertainty of 0.5% (k = 2). A DSC method is used for purity determination of Pinocembrin for the first time in this paper. The new CRM of Pinocembrin can be used to validate analytical methods, improve the accuracy and comparability of measurement data, establish meteorological traceability of analytical results as well as control the quality of Pinocembrin in relevant food and pharmaceutical formulations. © 2014 the Partner Organisations.


Zhang B.,Peking Union Medical College | Gong N.,Peking Union Medical College | Yang D.,Peking Union Medical College | Du G.,Peking Union Medical College | And 2 more authors.
Current Analytical Chemistry | Year: 2015

Certified reference materials (CRMs) play vital roles in method validation and quality as surance of assessment measurements. In this paper, a new CRM for sulfamethoxazole (SMZ) was pre-B. Zhang pared. Purity determination and uncertainty evaluation methods were developed using mass balance (MB) and differential scanning calorimetry (DSC) methods. Impurities including moisture, volatile components, and inorganic components were accounted for and deducted from 100% using the MB method. Results were consistent between DSC and MB. Certified value of SMZ was 991.6 ± 4.6 mg g-1 (k = 2, P = 0.95). This new CRM can be used to validate analytical methods, improve the accuracy and comparability of measurement data, establish metro logical traceability of analytical results, and control the quality of SMZ in relevant pharmaceutical formulations. © 2015 Bentham Science Publishers.


Gong N.,Peking Union Medical College | Zhang G.,Peking Union Medical College | Zhang B.,Peking Union Medical College | Du G.,Peking Union Medical College | And 3 more authors.
Food Analytical Methods | Year: 2015

Dietary flavonols have been found to possess preventive and therapeutic potential against several kinds of cancers. According to epidemiologic investigation data, kaempferol is a major component of flavonols present in various natural sources such as herbs, vegetables, and fruits. The purity of kaempferol in candidate certified reference material (CRM) was based on the agreement of results obtained by three different methods, including differential scanning calorimetry (DSC), coulometric titration (CT), and mass balance method. The certified value of kaempferol CRM is 99.5 % with an expanded uncertainty of 0.2 % (k = 2). The new CRM of kaempferol can be used as a valuable tool to validate measurement methods, to evaluate analytical results, and to control the quality of kaempferol-related traditional herbs, foods, dietary supplements, and pharmaceutical formulations. [Figure not available: see fulltext.] © 2015, Springer Science+Business Media New York.


PubMed | Key laboratory of Polymorph Pharmaceutical of Shandong Province and Peking Union Medical College
Type: | Journal: Steroids | Year: 2014

Certified reference materials (CRMs) can be used as a valuable tool to validate the trueness of measurement methods and to establish metrological traceability of analytical results. Diosgenin has been selected as a candidate reference material. Characterization of the material relied on two different methods, mass balance method and Coulometric titration method (CT). The certified value of diosgenin CRM is 99.80% with an expanded uncertainty of 0.37% (k=2). The new CRM of diosgenin can be used to validate analytical methods, improve the accuracy of measurement data and control the quality of diosgenin in relevant pharmaceutical formulations.


Gong N.,Chinese Academy of Sciences | Zhang B.,Chinese Academy of Sciences | Hu F.,Chinese Academy of Sciences | Du H.,Chinese Academy of Sciences | And 4 more authors.
Steroids | Year: 2014

Certified reference materials (CRMs) can be used as a valuable tool to validate the trueness of measurement methods and to establish metrological traceability of analytical results. Diosgenin has been selected as a candidate reference material. Characterization of the material relied on two different methods, mass balance method and Coulometric titration method (CT). The certified value of diosgenin CRM is 99.80% with an expanded uncertainty of 0.37% (k = 2). The new CRM of diosgenin can be used to validate analytical methods, improve the accuracy of measurement data and control the quality of diosgenin in relevant pharmaceutical formulations. © 2014 Elsevier Inc. All rights reserved.

Loading Key Laboratory of Polymorph Pharmaceutical of ShanDong Province collaborators
Loading Key Laboratory of Polymorph Pharmaceutical of ShanDong Province collaborators