Abstract：
:As the global market for pharmaceuticals increases, the adverse consequences of different regulations and requirements are becoming more obvious. Discussions between the regulatory authorities for the European Community, United States and Japan under the International Conference on Harmonization (ICH) intended to remove some of these differences are mirrored by similar discussions between the corresponding pharmacopoeial authorities. Moves towards harmonized requirements in pharmacopoeial monographs depend on a consensus view of the purpose and scope of their contents. Aspects of the construction of the four main elements (identification, characterization, control of impurities and assay) of a monograph for an active substance or excipient are considered. The choice of analytical methods is influenced by their availability, the level of control required and their transfer reproducibility between laboratories. Some activities of the Pharmacopoeia Discussion Group, involving the European, United States and Japanese Pharmacopoeias, and their present status are surveyed.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Calam DHdoi
10.1016/0731-7085(95)01578-7subject
Has Abstractpub_date
1995-12-01 00:00:00pages
1-5issue
1-2eissn
0731-7085issn
1873-264Xpii
0731-7085(95)01578-7journal_volume
14pub_type
杂志文章abstract：:Cobalt content (as vitamin B12 and inorganic cobalt) in two nutritional supplements, namely Spirulina platensis and Saccharomyces cerevisiae known as a "superfood", has been determined using inductively coupled plasma optical emission spectrometry (ICP-OES). Several sample pre-treatment protocols have been applied and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.03.058
更新日期：2018-06-05 00:00:00
abstract：:Etimicin intermediate 3,2″,6″-N,N,N-triacetyl gentamicin C1a (P1), is a key intermediate of etimicin, which is a semi-synthetic aminoglycoside antibiotic effective to both gram-positive and gram-negative bacteria infections. Four major related impurities of P1 were detected by HPLC-ELSD and ESI-MS(n) methods. Weakly a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.04.024
更新日期：2014-08-01 00:00:00
abstract：:Glimepiride (Amaryl), which is a new oral antidiabetic drug in the sulfonylurea class, was analysed by using second order derivative UV spectrophotometry. The quantification of glimepiride in dimethylformamide was performed in the wavelength range of 245-290 nm at N = 6, ?lambda = 21. The second order derivative spect...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00445-3
更新日期：2001-01-01 00:00:00
abstract：:Antibody charge heterogeneity is one of the major product-related variants in recombinant biopharmaceuticals, which has been commonly monitored by imaged capillary isoelectric focusing (icIEF). Due to the challenges with sample recovery and fractionation, other charge-based analytical approaches have been explored as ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113217
更新日期：2020-06-05 00:00:00
abstract：:Three methods are described for the simultaneous determination of mebeverine hydrochloride (MB) and sulpiride (SU) in combined pharmaceutical tablets. The first method depends on first-derivative ultraviolet spectrophotometry, with zero-crossing measurement method. The first derivative amplitudes at 214.2 and 221.6 nm...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00176-4
更新日期：1999-11-01 00:00:00
abstract：:Mobile phase optimization and reversed-phase column characteristics were used to separate photodegradation products from the parent compound, 24-cyclopropyl-9-,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol (calcipotriol). Separation between calcipotriol and its degradation products was obtained with an ace...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00390-9
更新日期：2001-08-01 00:00:00
abstract：:A simple, rapid and sensitive method termed as dispersive liquid-liquid microextraction (DLLME) combined with high-performance liquid chromatography-ultraviolet detector (HPLC-UV) has been proposed for the determination of three psychotropic drugs (amitryptiline, clomipramine and thioridazine) in urine samples. The de...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.11.036
更新日期：2009-02-20 00:00:00
abstract：:Homochirality is essential for life. For a long time, it was considered that d-amino acids were excluded from living systems. In the past 30 years, however, d-amino acids have been found in living organisms in the form of free amino acids, peptides and proteins, owing to advances in the analysis of optical isomers of ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2015.04.029
更新日期：2015-12-10 00:00:00
abstract：:The characterization and quantification of the metabolites of chiral drugs still remain a great challenge due to the complexity of the metabolites and most of them are not commercially available. In this study, a practical approach based on the combinatory liquid chromatography-mass spectrometric techniques has been p...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.01.045
更新日期：2014-06-01 00:00:00
abstract：:A method based on capillary zone electrophoresis (CZE) was used to study the interaction between low molecular weight heparin (LMWH) and interleukin 2 (IL-2). The results showed that the increase of the concentration of LMWH led to the decrease of the peak height and the increase of the peak width of IL-2, but the pea...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.01.019
更新日期：2005-07-01 00:00:00
abstract：:The development of a new HPLC-UV diode array procedure applied to follow the hydrolytic degradation of two well-known 4-nitrophenyl-1,4-dihydropyridine derivatives, nitrendipine and nisoldipine is reported. Hydrolysis of each drug were carried out in ethanol/Britton-Robinson buffer at different pHs, stored into amber ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00703-8
更新日期：2002-06-01 00:00:00
abstract：:Capillary isotachophoresis (ITP) with conductimetric detection has been used for separating and determining bopindolol (I) in commercial mass-produced pharmaceutical preparations. The optimised operational electrolyte system consisted of 5 mM potassium picolinate and 5 mM picolinic acid (leading electrolyte, LE; pH 5....
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00671-9
更新日期：2002-05-15 00:00:00
abstract：:HA was quantified in pharmaceutical formulations using HPLC-UV-detector and spectrophotometrically after the digestion with concentrated H(2)SO(4). Intact HA was quantified by capillary zone electrophoresis (CZE) using direct and indirect methods. The results were compared with the carbazole reaction established by Bi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00329-1
更新日期：2002-11-07 00:00:00
abstract：:Determination of drugs in foods. In foods, drugs can come from different sources: animal therapeutics, zootechnical feed supplementation or human food additives. The possible consequences arising from the presence of drugs in food are considered. The quantitative determination of drugs in feeds or in human foods must ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(83)80055-7
更新日期：1983-01-01 00:00:00
abstract：:The equivalent response of evaporative light scattering detector (ELSD) for compounds of similar structure is exploited to develop an LC/ELSD method for the simultaneous quantitation of the four main components of gentamicin sulfate, using as external standard the one main component kanamycin. A C18 column was used al...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.05.018
更新日期：2004-09-21 00:00:00
abstract：:This report describes the development of a potency ELISA using a peptide derived from the motavizumab binding epitope of respiratory syncytial virus (RSV) F-protein. Motavizumab is an antibody therapeutic studied for the prevention of RSV disease. It binds to the RSV glycoprotein F (F-protein), blocking the ability of...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.09.008
更新日期：2011-02-20 00:00:00
abstract：:Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.12.034
更新日期：2016-03-20 00:00:00
abstract：:The current study dealt with the degradation behavior of lacosamide (LAC) under ICH prescribed stress conditions. LAC was found to be labile under acid and base hydrolytic stress conditions, while it was stable to neutral hydrolytic, oxidative, photolytic and thermal stress. In total, seven degradation products (DPs) ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.03.010
更新日期：2014-07-01 00:00:00
abstract：:In human respiratory disease studies, liquid samples such as nasal secretion (NS), lung epithelial lining fluid (ELF), or upper airway mucosal lining fluid (MLF) are frequently collected, but their volumes often remain unknown. The lack of volume information makes it hard to estimate the actual concentration of recove...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.11.001
更新日期：2017-01-30 00:00:00
abstract：:A new carbon paste electrode selective for piribedil (PD) was prepared and fully characterized in terms of composition, usable pH range, response time and thermal stability. The electrode active recognition is by liquid ion-exchange mechanism via the use of piribedil phosphomolybdate as ion-exchanger dissolved in tric...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.02.006
更新日期：2005-07-15 00:00:00
abstract：:Gastrodin is the major and bioactive component in Tianma (Gastrodia elata Bl.) and has sedative, anticonvulsive and neuroprotective effects. Since little is known about its neuropharmacokinetics and brain metabolism, this study was undertaken to investigate the kinetic inter-relationship of gastrodin in rat plasma, ce...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.10.017
更新日期：2008-01-22 00:00:00
abstract：:The electroreduction of ethinylestradiol at the hanging mercury drop electrode in the Britton-Robinson universal buffer of pH 2-11 was studied and its interfacial adsorptive character onto the mercury electrode surface was identified. A validated simple, rapid, sensitive, specific, precise and inexpensive square-wave ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.07.024
更新日期：2006-02-13 00:00:00
abstract：:Attachment of antibodies to liposomes endows target specificity to liposomes for a certain cell or organ that express the targeted antigenic determinant. These so-called immunoliposomes hold high promise as targeted drug carriers. One approach of immunoliposome preparation involves conjugating antibodies to hydrophobi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00101-5
更新日期：1997-11-01 00:00:00
abstract：:A HPLC-MS/MS Electrospray (ESI) method was developed and validated to quantify a peptide conjugate prodrug of doxorubicin (Dox-Con) and its active metabolites leucine-doxorubicin (Leu-Dox) and doxorubicin (Dox) in dog and rat plasma. The analytes were extracted from plasma by solid-phase extraction on a Bond Elut C8 c...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00434-5
更新日期：2003-12-04 00:00:00
abstract：:Biosensors containing cytochrome P450cam in a didodecyldimethylammonium bromide vesicular system were prepared by cross-linking onto a glassy carbon electrode (GCE) with glutaraldehyde in the presence of bovine serum albumin. Cyclic voltammetric responses of the sensor in air-free buffer solution showed that the senso...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00076-4
更新日期：1998-09-01 00:00:00
abstract：:A refined toxic fraction, Fr-2, from the ethanol extract of Aster tataricus roots was obtained by a toxic tracing isolation. The hepatotoxic effects of Fr-2 were proved by the level elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) in mice serum and further co...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.04.034
更新日期：2012-08-01 00:00:00
abstract：:Praziquantel, a broad spectrum anthelmintic drug, is extensively metabolized in the liver, yielding mainly monohydroxylated and dihydroxylated phase-I metabolites. However, the exact chemical structure of most metabolites is still unknown. One of these unidentified phase-I metabolites was isolated from human urine by ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00470-8
更新日期：2001-12-01 00:00:00
abstract：:Under positive-ion fast atom bombardment (FAB) mass spectrometric conditions, benzalkonium chloride (BAK) afforded intense peaks at m/z 304 and 332, corresponding to the intact cations [M--Cl]+ of C12 and C14 homologues, respectively. The use of benzethonium chloride as an internal standard and thioglycerol as a FAB m...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(89)80172-4
更新日期：1989-01-01 00:00:00
abstract：:An accurate, precise and sensitive method was developed and validated for the simultaneous quantification of the flavonoid glycoside robinin, and its algycone kaempferol in human breast cancer MCF-7 cells. The application of liquid chromatography-tandem mass spectrometry (LC/MS/MS) with a TurboIonspray interface in ne...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.12.021
更新日期：2011-04-28 00:00:00
abstract：:Organic compounds extracted into metered dose inhalers (MDIs) from the rubber components of the metering valve are of increasing interest in the development of these formulations. Polycyclic aromatic hydrocarbons (PAHs) are a class of extractable organic compounds whose source is the carbon black commonly used as a re...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01273-n
更新日期：1995-03-01 00:00:00
