{"id":6356,"date":"2022-10-14T12:31:03","date_gmt":"2022-10-14T12:31:03","guid":{"rendered":"https:\/\/www.impactanalytical.com\/?page_id=6356"},"modified":"2022-11-09T20:30:05","modified_gmt":"2022-11-09T20:30:05","slug":"pharmaceutical-testing-and-raw-material-characterization","status":"publish","type":"page","link":"https:\/\/www.impactanalytical.com\/pharmaceutical-testing-and-raw-material-characterization\/","title":{"rendered":"Pharmaceutical Testing and Raw Material Characterization"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Header&#8221; _builder_version=&#8221;4.16.0&#8243; background_color=&#8221;rgba(30,30,30,0.85)&#8221; background_enable_image=&#8221;off&#8221; background_position=&#8221;center_right&#8221; background_blend=&#8221;overlay&#8221; custom_padding=&#8221;||||true|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;7px||7px|||&#8221; 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custom_margin=&#8221;||0px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; text_font_size_tablet=&#8221;16px&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;44px&#8221; header_font_size_phone=&#8221;26px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6>&#8211; Services &#8211;<\/h6>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.18.0&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#1E1E1E&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;|600|||||||&#8221; header_text_align=&#8221;center&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_font_size=&#8221;70px&#8221; header_line_height=&#8221;1.3em&#8221; text_orientation=&#8221;center&#8221; max_width=&#8221;700px&#8221; module_alignment=&#8221;center&#8221; text_font_size_tablet=&#8221;16px&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;58px&#8221; header_font_size_phone=&#8221;32px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1><span>Pharmaceutical Testing and <\/span><\/h1>\n<h1><span>Raw Material Characterization<\/span><\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; admin_label=&#8221;About&#8221; _builder_version=&#8221;4.16&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_right&#8221; custom_padding=&#8221;||||false|false&#8221; custom_padding_tablet=&#8221;||||false|false&#8221; custom_padding_phone=&#8221;&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.18.0&#8243; custom_margin_tablet=&#8221;&#8221; custom_margin_phone=&#8221;&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/02\/21-IMP-1207-IMPACT-WEBSITE-SHOOT-88-scaled.jpg&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#a6d5f3&#8243; divider_weight=&#8221;8px&#8221; _builder_version=&#8221;4.16&#8243; max_width=&#8221;40px&#8221; module_alignment=&#8221;left&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.18.0&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Rubik|500|||||||&#8221; header_text_color=&#8221;#1a3066&#8243; header_font_size=&#8221;54px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;|700|||||||&#8221; header_2_text_color=&#8221;#1E1E1E&#8221; header_2_font_size=&#8221;38px&#8221; header_2_line_height=&#8221;1.3em&#8221; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;44px&#8221; header_font_size_phone=&#8221;34px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;24px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span style=\"font-size: xx-large;\"><strong>Pharmaceutical Testing and Material Characterization<\/strong><\/span><\/p>\n<p>The ability to characterize pharmaceutical products and identify any unknown component or impurity is crucial for product development and release. The presence of an unknown or impurity even at trace levels might render the material unusable depending on the product application and toxicological properties. Unknowns and impurities can come from several sources and require various techniques to identify. Element labs like Impact Analytical offer full analytical capabilities to assist in testing at all stages of drug development including:<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Pharmaceutical discovery and development including formulation<\/li>\n<li>Method validation<\/li>\n<li>Stability storage and testing<\/li>\n<li>Lot testing for QC release<\/li>\n<li>Extractable and Leachable<\/li>\n<li>Small batch manufacturing for Phase I clinical studies<\/li>\n<li>Container testing<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; admin_label=&#8221;About&#8221; _builder_version=&#8221;4.16&#8243; background_color=&#8221;#e8e8e8&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_right&#8221; custom_padding=&#8221;||||true|false&#8221; custom_padding_tablet=&#8221;||||false|false&#8221; custom_padding_phone=&#8221;&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.18.0&#8243; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#a6d5f3&#8243; divider_weight=&#8221;8px&#8221; _builder_version=&#8221;4.16&#8243; max_width=&#8221;40px&#8221; module_alignment=&#8221;left&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.18.0&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Rubik|500|||||||&#8221; header_text_color=&#8221;#1a3066&#8243; header_font_size=&#8221;54px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;|700|||||||&#8221; header_2_text_color=&#8221;#1E1E1E&#8221; header_2_font_size=&#8221;38px&#8221; header_2_line_height=&#8221;1.3em&#8221; hover_enabled=&#8221;0&#8243; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;44px&#8221; header_font_size_phone=&#8221;34px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;24px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2>cGMP testing<\/h2>\n<p>For clients needing cGMP testing it is important to partner with a lab that has the proper quality system in place and understands the regulatory guidelines in 21 CFR for US, FDA testing. Also, Impact&#8217;s quality systems and procedures are compliant with other regulatory bodies such as Health Canada.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/06\/21-IMP-1207-IMPACT-WEBSITE-SHOOT-100-scaled.jpg&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Why Us&#8221; _builder_version=&#8221;4.18.0&#8243; background_color=&#8221;#009dd5&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.18.0&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/02\/21-IMP-1207-IMPACT-WEBSITE-SHOOT-56-scaled.jpg&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#FFFFFF&#8221; divider_weight=&#8221;8px&#8221; _builder_version=&#8221;4.16&#8243; max_width=&#8221;40px&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.18.0&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Rubik|500|||||||&#8221; header_text_color=&#8221;#1a3066&#8243; header_font_size=&#8221;54px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;|600|||||||&#8221; header_2_text_color=&#8221;#FFFFFF&#8221; header_2_font_size=&#8221;38px&#8221; header_2_line_height=&#8221;1.3em&#8221; hover_enabled=&#8221;0&#8243; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;44px&#8221; header_font_size_phone=&#8221;34px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;24px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2>Techniques used for the\u00a0process<\/h2>\n<p>Going beyond the commonly used techniques to characterize active pharmaceutical ingredients (APIs) such as LC-MS, GC-MS and ICP-MS, \u00a0Impact Analytical specialize in techniques such as:<\/p>\n<ul>\n<li>Scanning Electron Microscopy with EDS Detection\n<ul>\n<li>Imaging of conductive and non-conductive samples<\/li>\n<li>Elemental Analysis<\/li>\n<li>Contamination Analysis<\/li>\n<li>Glass Delamination studies -USP&lt;1660&gt;<\/li>\n<\/ul>\n<\/li>\n<li>Particle Size Distribution\n<ul>\n<li>Powders, suspensions and emulsions<\/li>\n<li>Method development, validation and routine testing<\/li>\n<\/ul>\n<\/li>\n<li>Xray Diffraction (XRD)\n<ul>\n<li>ID and quantification of APIs<\/li>\n<li>Identification of crystalline form of API<\/li>\n<li>ID of crystalline unknown samples<\/li>\n<li>Testing to USP &lt;941&gt; and other monographs<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; admin_label=&#8221;About&#8221; _builder_version=&#8221;4.16&#8243; background_color=&#8221;#e8e8e8&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_right&#8221; custom_padding=&#8221;||||true|false&#8221; custom_padding_tablet=&#8221;||||false|false&#8221; custom_padding_phone=&#8221;&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.18.0&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#a6d5f3&#8243; divider_weight=&#8221;8px&#8221; _builder_version=&#8221;4.16&#8243; max_width=&#8221;40px&#8221; module_alignment=&#8221;left&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.18.0&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Rubik|500|||||||&#8221; header_text_color=&#8221;#1a3066&#8243; header_font_size=&#8221;54px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;|700|||||||&#8221; header_2_text_color=&#8221;#1E1E1E&#8221; header_2_font_size=&#8221;38px&#8221; header_2_line_height=&#8221;1.3em&#8221; hover_enabled=&#8221;0&#8243; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;14px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; header_font_size_tablet=&#8221;44px&#8221; header_font_size_phone=&#8221;34px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;24px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2>Final product<\/h2>\n<p>If you are looking for a partner to quickly and reliably clear your testing hurdles, regardless of the developmental stage of your pharmaceutical material, our team can help. <a href=\"https:\/\/www.impactanalytical.com\/contact-us\/\" title=\"Contact Us\">Contact us<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; background_image=&#8221;https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/05\/Service-018-1.jpg&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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header_font=&#8221;|700|||||||&#8221; header_font_size=&#8221;36px&#8221; body_font_size=&#8221;16px&#8221; background_enable_color=&#8221;off&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;14px&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;|600||on|||||&#8221; button_icon=&#8221;&#x3d;||divi||400&#8243; button_on_hover=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_bg_color__hover_enabled=&#8221;on|hover&#8221; button_bg_color__hover=&#8221;#009dd5&#8243; button_bg_enable_color__hover=&#8221;on&#8221;]<\/p>\n<p><span>Give us a call and speak with an actual scientist.<\/span><\/p>\n<p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;off|desktop&#8221; admin_label=&#8221;Footer&#8221; _builder_version=&#8221;4.16&#8243; background_color=&#8221;#E8E8E8&#8243; background_enable_image=&#8221;off&#8221; background_position=&#8221;top_center&#8221; 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