A Tiered Analytical Approach for Investigating Poor Quality Emergency Contraceptives
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{"title"=>"A tiered analytical approach for investigating poor quality emergency contraceptives", "type"=>"journal", "authors"=>[{"first_name"=>"María Eugenia", "last_name"=>"Monge", "scopus_author_id"=>"7005668444"}, {"first_name"=>"Prabha", "last_name"=>"Dwivedi", "scopus_author_id"=>"7005214514"}, {"first_name"=>"Manshui", "last_name"=>"Zhou", "scopus_author_id"=>"8307888900"}, {"first_name"=>"Michael", "last_name"=>"Payne", "scopus_author_id"=>"55539455800"}, {"first_name"=>"Chris", "last_name"=>"Harris", "scopus_author_id"=>"56145815800"}, {"first_name"=>"Blaine", "last_name"=>"House", "scopus_author_id"=>"56145208700"}, {"first_name"=>"Yvonne", "last_name"=>"Juggins", "scopus_author_id"=>"56145582300"}, {"first_name"=>"Peter", "last_name"=>"Cizmarik", "scopus_author_id"=>"55540611100"}, {"first_name"=>"Paul N.", "last_name"=>"Newton", "scopus_author_id"=>"7103312945"}, {"first_name"=>"Facundo M.", "last_name"=>"Fernández", "scopus_author_id"=>"7401589166"}, {"first_name"=>"David", "last_name"=>"Jenkins", "scopus_author_id"=>"57199319246"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"sgr"=>"84899700273", "doi"=>"10.1371/journal.pone.0095353", "issn"=>"19326203", "pui"=>"372991097", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"24748219", "scopus"=>"2-s2.0-84899700273"}, "id"=>"1db6d95a-d7a3-3494-8217-180200485ffd", "abstract"=>"Reproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS) and direct analysis in real time MS (DART-MS) the unknown compound was identified as the antibiotic sulfamethoxazole. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS) indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY 1H NMR) indicating the presence of lactose and magnesium stearate.", "link"=>"http://www.mendeley.com/research/tiered-analytical-approach-investigating-poor-quality-emergency-contraceptives", "reader_count"=>32, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Student > Doctoral Student"=>2, "Researcher"=>7, "Student > Ph. D. Student"=>8, "Student > Master"=>5, "Other"=>1, "Student > Bachelor"=>6, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Student > Doctoral Student"=>2, "Researcher"=>7, "Student > Ph. D. Student"=>8, "Student > Master"=>5, "Other"=>1, "Student > Bachelor"=>6, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Engineering"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>14, "Agricultural and Biological Sciences"=>3, "Pharmacology, Toxicology and Pharmaceutical Science"=>2, "Physics and Astronomy"=>1, "Chemistry"=>5, "Computer Science"=>1, "Economics, Econometrics and Finance"=>2}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Chemistry"=>{"Chemistry"=>5}, "Physics and Astronomy"=>{"Physics and Astronomy"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>3}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}}, "group_count"=>5}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1552118"], "description"=>"<p>Results for a levonorgestrel standard, sample 1 (positive control), and sample 2a observed under 254 nm light.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography"], "article_id"=>1072287, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_TLC_analysis_/1072287", "title"=>"TLC analysis.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552122"], "description"=>"<p>HPLC chromatograms from assay / content uniformity analysis for a levonorgestrel standard, sample 1 (positive control), and sample 2a.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography"], "article_id"=>1072291, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_HPLC_DAD_analysis_/1072291", "title"=>"HPLC-DAD analysis.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552125"], "description"=>"<p>Extracted ion chromatogram (A) and extracted ion mobility chronogram (B) for a levonorgestrel standard with <i>m/z</i> 313.2168±0.005. Extracted ion chromatogram (C) and extracted ion mobility chronogram (D) for sulfamethoxazole standard with <i>m/z</i> 254.0599±0.005. Extracted ion chromatogram (E) and extracted ion mobility chronogram (F) for sulfamethoxazole in the poor quality contraceptive tablet with <i>m/z</i> 254.0599±0.005. Mass spectra for the target compounds are displayed as insets.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography"], "article_id"=>1072294, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_UHPLC_IMS_TOF_MS_analysis_/1072294", "title"=>"UHPLC-IMS-TOF-MS analysis.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552126"], "description"=>"<p>(A): Mass spectrum of a contraceptive tablet containing levonorgestrel. (B): MS/MS spectrum for the precursor ion with <i>m/z</i> 313.2419 shown in A. (C): Mass spectrum of levonorgestrel standard. (D): MS/MS spectrum for the precursor ion with <i>m/z</i> 313.2190 shown in C. (E): Mass spectrum of sample 2a. (F): MS/MS spectrum for the precursor ion with <i>m/z</i> 254.0646 shown in E. (G): Mass spectrum of sulfamethoxazole standard. (H): MS/MS spectrum for the precursor ion with <i>m/z</i> 254.0630 shown in G.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography", "ms", "collision", "20"], "article_id"=>1072295, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.g004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_DART_MS_and_MS_MS_analysis_using_a_collision_energy_of_20_eV_/1072295", "title"=>"DART MS and MS/MS analysis using a collision energy of 20 eV.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552138"], "description"=>"<p>Spectra (log D vs. chemical shift) for levonorgestrel-containing (A) and sample 2a (B) contraceptive tablets dissolved in CD<sub>4</sub>O:D<sub>2</sub>O (80∶20 v/v). Signals observed at 3.3 ppm and in the range 4.6–5 ppm are due to the deuterated solvent mixture.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography", "dosy", "nmr"], "article_id"=>1072299, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.g005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_2D_DOSY_1_H_NMR_analysis_/1072299", "title"=>"2D DOSY <sup>1</sup>H NMR analysis.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552139"], "description"=>"Q<p>Quantifying ion; <sup>C</sup> Confirming ion.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography", "fragmentor", "collision", "ions", "sulfamethoxazole", "mrm"], "article_id"=>1072300, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Precursor_ion_fragmentor_voltage_collision_cell_voltage_and_product_ions_for_sulfamethoxazole_MRM_analysis_/1072300", "title"=>"Precursor ion, fragmentor voltage, collision cell voltage, and product ions for sulfamethoxazole MRM analysis.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552140"], "description"=>"a<p>Product Labels – number indicates a different brand, where a subsequent letter indicates a different batch. Bold text indicates non-compliance. With the exception of 2a, all samples yielded compliant results for identification (TLC and confirmation of levonorgestrel through the HPLC evaluation for dextronorgestrel). No sample showed evidence of dextronorgestrel.</p>b<p>Dissolution presented with the stage required and average result.</p>c<p>Related Substances – the level of any single related substance (S) should be less than 1.0% and the total amount of related substances (T) should be less than 2.0%.</p>d<p>Assay and Content Uniformity results presented as the average results and the minimum / maximum result found.</p>e<p>Only Stage 1 was conducted because 3 tablets were found to be below 60%.</p>f<p>No active release was observed on the 6 tablets tested. Additional tablets were tested for longer periods of release (1 hour) and observed ∼2–5% release of active.</p>g<p>A single peak was observed in the chromatogram (other than for levonorgestrel) which made a large contribution to the level of observed impurities.</p>h<p>30 tablets tested.</p>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography", "ecp"], "article_id"=>1072301, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_results_for_the_ECP_quality_survey_a_/1072301", "title"=>"Summary of results for the ECP quality survey<sup>a</sup>.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-04-18 09:37:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/1552150", "https://ndownloader.figshare.com/files/1552152", "https://ndownloader.figshare.com/files/1552153"], "description"=>"<div><p>Reproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS) and direct analysis in real time MS (DART-MS) the unknown compound was identified as the antibiotic sulfamethoxazole. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS) indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY <sup>1</sup>H NMR) indicating the presence of lactose and magnesium stearate.</p></div>", "links"=>[], "tags"=>["toxicology", "Forensic toxicology", "Public and occupational health", "women's health", "chemistry", "Analytical chemistry", "Chemical analysis", "Applied chemistry", "medicinal chemistry", "Chromatographic techniques", "Liquid chromatography", "tiered", "analytical", "investigating"], "article_id"=>1072311, "categories"=>["Biological Sciences"], "users"=>["María Eugenia Monge", "Prabha Dwivedi", "Manshui Zhou", "Michael Payne", "Chris Harris", "Blaine House", "Yvonne Juggins", "Peter Cizmarik", "Paul N. Newton", "Facundo M. Fernández", "David Jenkins"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0095353.s001", "https://dx.doi.org/10.1371/journal.pone.0095353.s002", "https://dx.doi.org/10.1371/journal.pone.0095353.s003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_A_Tiered_Analytical_Approach_for_Investigating_Poor_Quality_Emergency_Contraceptives_/1072311", "title"=>"A Tiered Analytical Approach for Investigating Poor Quality Emergency Contraceptives", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-04-18 09:37:42"}

PMC Usage Stats | Further Information

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Relative Metric

{"start_date"=>"2014-01-01T00:00:00Z", "end_date"=>"2014-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences", "average_usage"=>[291]}, {"subject_area"=>"/Biology and life sciences/Biotechnology", "average_usage"=>[310, 499]}, {"subject_area"=>"/Engineering and technology", "average_usage"=>[282]}, {"subject_area"=>"/Medicine and health sciences/Medical devices and equipment", "average_usage"=>[258, 406]}]}
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