{"id":15789,"date":"2019-01-18T08:31:11","date_gmt":"2019-01-18T08:31:11","guid":{"rendered":"http:\/\/organistry.com.mialias.net\/our-services\/identificacion-de-impurezas-desconocidas\/"},"modified":"2019-12-27T14:46:03","modified_gmt":"2019-12-27T14:46:03","slug":"identification-of-unknown-impurities","status":"publish","type":"page","link":"https:\/\/www.organistry.es\/en\/our-services\/identification-of-unknown-impurities\/","title":{"rendered":"Identification of unknown impurities"},"content":{"rendered":"

[vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1548850765807{padding-top: 50px !important;padding-bottom: 30px !important;background-color: #f4f4f4 !important;}”][vc_column offset=”vc_col-md-offset-2 vc_col-md-8″][vc_column_text]In Organistry we perform studies in order to identify unknown impurities of API\u2019s caused either by degradation or by interaction with an excipient.<\/strong><\/p>\n

You can send a sample with an impurity (\u2265 0.1%) to identify it by HPLC-MSn<\/sup>, and then, we can prepare it by synthesis in order for you to determine its response factor<\/strong> in the analytical method and qualify it.<\/p>\n

Under one roof, we cover the analytical and the synthetic areas<\/strong>, allowing us to rapidly resolve the problems associated with the impurities of your products.<\/p>\n

We work with more than 20 pharmaceutical companies (manufacturers of active ingredients and formulators) conducting this type of work.<\/p>\n

We have a wide experience in identification with several families of products and various types of formulations<\/strong> (tablets, syrups, gels, etc.). Also we identify extractables and leachables that can be contained in pharmaceutical products.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1548850780207{padding-top: 30px !important;padding-bottom: 30px !important;}”][vc_column][vc_custom_heading text=”Phases of the process of identification and obtaining your unknown impurity:” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_row_inner el_class=”tld-two-blocks tld-two-blocks-reverse”][vc_column_inner width=”1\/2″][vc_custom_heading text=”HPLC-MSn<\/sup>” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_column_text]Our organic chemists propose structures for your unknown impurity using the information of the API, the excipients and the conditions of impurity generation<\/strong> (including forced degradation studies if available). We carry out bibliographic searches<\/strong> that support our proposals.<\/p>\n

Then studies are performed in the HPLC-MS Ion Trap + Orbitrap (MSn<\/sup>; exact mass)<\/strong> of the impurity to identify including MSMS fragmentation to obtain structural information.<\/p>\n

If there is consistency with any of the proposed structures we can directly move onto to the synthesis of the impurity, without previous isolation.<\/p>\n

If your analytical method were not compatible with MS, we would adapt it previously (using a volatile buffer).[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_single_image image=”15857″ img_size=”large” add_caption=”yes” alignment=”right” css_animation=”right-to-left”][\/vc_column_inner][\/vc_row_inner][vc_separator][vc_row_inner el_class=”tld-two-blocks tld-two-blocks-reverse”][vc_column_inner width=”1\/2″][vc_custom_heading text=”Isolation and characterization” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_column_text]In some cases the study of HPLC-MSn<\/sup> does not allow us to identify your unknown impurity<\/strong> (eg. Due to the existence of isomers).<\/p>\n

This problem is solved by isolating the impurity in our preparative HPLC Waters and identifying it by Nuclear Magnetic Resonance (NMR).<\/strong><\/p>\n

For the 1D and 2D-NMR studies, we access to the equipment of Services to Support Research (SAI) of University of A Coru\u00f1a (UDC) in self-service mode.<\/strong><\/p>\n

Thus, we can offer competitive prices on all our analysis (MS, NMR, EA, FTIR, etc.) and with a short delivery time.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_single_image image=”15850″ img_size=”large” add_caption=”yes” alignment=”right” css_animation=”right-to-left”][\/vc_column_inner][\/vc_row_inner][vc_separator][vc_row_inner el_class=”tld-two-blocks tld-two-blocks-reverse”][vc_column_inner width=”1\/2″][vc_custom_heading text=”Obtaining impurity” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”][vc_column_text]In our organic synthesis laboratory we can prepare your previously identified impurity.<\/strong><\/p>\n

If we can not carry out a directed synthesis or it is not efficient, specific forced degradation experiments are designed to generate the impurity and obtain a standard<\/strong> after its isolation by preparative HPLC.<\/p>\n

The impurities are supplied with a certificate of analysis<\/strong> that includes NMR, HPLC, MS, AE, KF and all the analytical data necessary for its complete characterization.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_single_image image=”15714″ img_size=”large” alignment=”right” css_animation=”right-to-left”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” bg_type=”image” parallax_style=”vcpb-vz-jquery” bg_image_new=”id^15619|url^https:\/\/www.organistry.es\/wp-content\/uploads\/2019\/02\/CTA-Impurezas-2.jpg|caption^null|alt^null|title^CTA-Impurezas|description^null” bg_image_repeat=”no-repeat” el_class=”tld-cta tld-cta-green tld-cta-two-col”][vc_column width=”3\/4″][vc_custom_heading text=”We identify your unknown impurity,” font_container=”tag:h3|text_align:center” use_theme_fonts=”yes”][vc_custom_heading text=”let us show you how we do it!” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes”][\/vc_column][vc_column width=”1\/4″][vc_btn title=”Contact” link=”url:%2Fen%2Fcontact%2F|||”][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1548850765807{padding-top: 50px !important;padding-bottom: 30px !important;background-color: #f4f4f4 !important;}”][vc_column offset=”vc_col-md-offset-2 vc_col-md-8″][vc_column_text]In Organistry we perform studies in order to identify unknown impurities of API\u2019s…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":15760,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-15789","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/pages\/15789","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/comments?post=15789"}],"version-history":[{"count":8,"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/pages\/15789\/revisions"}],"predecessor-version":[{"id":15979,"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/pages\/15789\/revisions\/15979"}],"up":[{"embeddable":true,"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/pages\/15760"}],"wp:attachment":[{"href":"https:\/\/www.organistry.es\/en\/wp-json\/wp\/v2\/media?parent=15789"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}