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[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” admin_label=”About” _builder_version=”4.16″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png” background_size=”initial” background_position=”top_right” custom_padding=”||||true|false” custom_padding_tablet=”||||true|false” custom_padding_phone=”” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” text_text_color=”#FFFFFF” text_font_size=”18px” text_line_height=”1.8em” header_font_size=”27px” header_line_height=”2em” header_2_font_size=”25px” header_2_line_height=”1.4em” background_color=”#009dd5″ custom_margin=”0px|||0px|false|false” custom_padding=”14px|17px|14px|17px|true|true” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Impact Analytical\u00a0partners with our customers\u00a0to develop methods that meet the customer\u2019s\u00a0validation needs.\u00a0 Whether you are\u00a0bringing new products to market, looking for\u00a0impurities\u00a0in existing products,\u00a0or leachable compounds in a drug product,\u00a0the skills of the Impact Analytical team join forces with our\u00a0customer\u2019s\u00a0experts to become an extension of your own in-house team.<\/p>\n
Count on Impact Analytical to provide extensive assistance in the development and validation of analytical methods.<\/p>\n
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It is critical in the development of new methods that the analytes of interest be clearly identifiable prior to performing\u00a0a validation\u00a0study. The new methodology must be capable of not only\u00a0observing\u00a0the analytes in question,\u00a0but that they are quantifiable,\u00a0and not obstructed by\u00a0other components in the matrix.\u00a0 The Study Directors at Impact Analytical work with our\u00a0customers to determine\u00a0the best technique for analysis\u00a0(given a full understanding of the manufacturing process, the matrix,\u00a0\u00a0and what could potentially be present). Our extensive knowledge in this field helps us to design a testing protocol that will be\u00a0scientifically\u00a0defensible when our clients submit their product for approval to the\u00a0regulatory\u00a0agencies. The laboratory will develop methods capable of detecting these analytes using the most\u00a0appropriate\u00a0sample preparation\u00a0and analysis\u00a0techniques.\u00a0When a suitable method has been defined, a protocol will be provided and the method evaluated in compliance with\u00a0ICH guidelines.<\/p>\n
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\u00a0Advanced analytical techniques\u00a0and state-of\u2013the-art equipment\u00a0are employed to perform the analysis required:<\/strong><\/span><\/p>\n <\/strong><\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”4.16″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”||||false|false” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_blurb title=”Case Studies” icon_placement=”left” image_icon_width=”80px” content_max_width=”100%” image_icon_width_tablet=”80px” image_icon_width_phone=”40px” image_icon_width_last_edited=”on|phone” _builder_version=”4.17.3″ header_font=”|600|||||||” header_text_color=”#1E1E1E” header_font_size=”18px” header_line_height=”1.2em” body_font=”||||||||” body_text_color=”#1E1E1E” body_line_height=”2em” background_color=”#FFFFFF” custom_padding=”10px|10px|10px|10px|true|true” animation=”off” border_width_all=”1px” border_color_all=”#E5E5E5″ box_shadow_style=”preset3″ box_shadow_vertical=”8px” image_max_width=”80px” image_max_width_tablet=”” image_max_width_phone=”40px” image_max_width_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n Industry: Medical Device<\/strong>\n
Problem: <\/strong>Residual Solvents per USP method <467>
Solution: <\/strong>Modified (467> – read full case study\u00a0<\/strong><\/a><\/span><\/p>\n