{"id":4747,"date":"2022-05-16T15:55:41","date_gmt":"2022-05-16T15:55:41","guid":{"rendered":"https:\/\/www.impactanalytical.com\/?page_id=4747"},"modified":"2022-08-25T16:36:28","modified_gmt":"2022-08-25T16:36:28","slug":"usp","status":"publish","type":"page","link":"https:\/\/www.impactanalytical.com\/usp\/","title":{"rendered":"USP <661>"},"content":{"rendered":"\n[et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”4.16.0″ background_color=”rgba(30,30,30,0.85)” background_enable_image=”off” background_position=”center_right” background_blend=”overlay” custom_padding=”||||true|false” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_padding=”7px||7px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ z_index=”11″ custom_padding=”||||false|false” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_text _builder_version=”4.17.3″ text_font=”||||||||” text_text_color=”#1E1E1E” text_font_size=”18px” text_line_height=”2em” header_font=”|600|||||||” header_text_align=”center” header_text_color=”#FFFFFF” header_font_size=”54px” header_line_height=”1.3em” header_6_font=”|600||on|||||” header_6_text_color=”#009dd5″ header_6_font_size=”20px” header_6_letter_spacing=”1px” text_orientation=”center” max_width=”700px” module_alignment=”center” custom_margin=”||0px||false|false” custom_padding=”||0px||false|false” text_font_size_tablet=”16px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”44px” header_font_size_phone=”26px” header_font_size_last_edited=”on|phone” global_colors_info=”{}”]
-Services-<\/span><\/h6>[\/et_pb_text][et_pb_text _builder_version=”4.17.3″ text_font=”||||||||” text_text_color=”#1E1E1E” text_font_size=”18px” text_line_height=”2em” header_font=”|600|||||||” header_text_align=”center” header_text_color=”#FFFFFF” header_font_size=”70px” header_line_height=”1.3em” text_orientation=”center” max_width=”700px” module_alignment=”center” text_font_size_tablet=”16px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”58px” header_font_size_phone=”32px” header_font_size_last_edited=”on|phone” global_colors_info=”{}”]

USP <661><\/strong><\/h1>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” 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=”||||false|false” custom_padding_tablet=”||||false|false” custom_padding_phone=”” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.17.3″ custom_margin_tablet=”” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.17.3″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/05\/19-IMP-0619-ASSET-LOCKER-2-90-scaled.jpg” global_colors_info=”{}”][et_pb_divider show_divider=”off” _builder_version=”4.17.3″ _module_preset=”default” custom_padding=”150px||150px||true|false” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_divider color=”#a6d5f3″ divider_weight=”8px” _builder_version=”4.16″ max_width=”40px” module_alignment=”left” locked=”off” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.17.3″ text_font=”||||||||” text_font_size=”16px” text_line_height=”2em” header_font=”Rubik|500|||||||” header_text_color=”#1a3066″ header_font_size=”54px” header_line_height=”1.3em” header_2_font=”|700|||||||” header_2_text_color=”#1E1E1E” header_2_font_size=”38px” header_2_line_height=”1.3em” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”44px” header_font_size_phone=”34px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]

Is your plastic material suitable for pharmaceutical use?<\/strong><\/h2>\n

As of May 2016, a revision in the U.S. Pharmacopeia\u2019s monograph for <661> changes the requirements \u00a0for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, \u201cPlastic Materials of Construction,\u201d and <661.2> \u201cPlastic Packaging Systems for Pharmaceutical Use.\u201d In order that a plastic material be considered suitable for pharmaceutical use, it should be thoroughly characterized.\u00a0 While not all polymers are cited specifically in the monograph, those that\u00a0are most commonly used in the pharmaceutical industry for packaging systems. Plastic materials of construction not included in this list must be characterized with the same intent. The evaluation of a polymer material of construction, according to USP <661.1> is extensive, and includes identification, physico-chemical testing, biological reactivity, additives analysis, and extractable metals.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][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=”4.17.3″ _module_preset=”default” text_font_size=”16px” text_line_height=”2em” global_colors_info=”{}”]

Plastic Packaging Systems include any container, whether it is bag, bottle, syringe, or inhaler, which comes into direct or indirect contact with the drug product.\u00a0Evaluation of a plastic packaging system according to USP <661.2> includes biological reactivity, and physicochemical testing. A chemical safety assessment of the plastic packaging system should also be considered, and this could be accomplished through extractables and leachables testing.<\/p>\n

Impact Analytical has the expertise and experience to evaluate your polymer material and container in compliance with USP <661>. From extraction, to analysis, to data evaluation, you can have confidence that your study will meet with USP and cGMP quality standards.<\/p>\n

Impact Analytical is uniquely suited to perform the polymer characterization and quantitative additive analysis required to demonstrate that the raw materials are compliant with <661.1> and \u00a0to ensure that the systems and packaged products that are formed from these materials meet the requirements of <661.2>.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Related Services” button_text=”Click Here” _builder_version=”4.17.3″ _module_preset=”default” min_height=”299px” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]

Thermal Properties<\/a><\/span><\/strong><\/p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Related Testing Techniques” button_text=”Click Here” _builder_version=”4.17.3″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]

DSC Analysis<\/a><\/span><\/strong>
FT-IR Spectroscopy<\/a><\/span><\/strong>
GC-MS Analysis<\/a><\/span><\/strong>
ICP-MS and ICP-OES\/AES Testing<\/a><\/span><\/strong>
LC-MS Analysis<\/a><\/span><\/strong>
Titration<\/a><\/span><\/strong>
UV-Vis Analysis<\/a><\/span><\/strong><\/p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16.0″ _module_preset=”default” background_color=”#009dd5″ background_enable_pattern_style=”on” background_pattern_style=”tufted” background_pattern_color=”rgba(0,0,0,0.06)” custom_padding=”0px||0px||true|false” global_module=”4668″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row _builder_version=”4.16.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Ready to Get Started?” button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjI3MiJ9fQ==@” button_text=”Request a Quote” _builder_version=”4.16.0″ _dynamic_attributes=”button_url” _module_preset=”default” header_font=”|700|||||||” header_font_size=”36px” body_font_size=”16px” background_enable_color=”off” custom_button=”on” button_text_size=”14px” button_border_radius=”0px” button_letter_spacing=”1px” button_font=”|600||on|||||” button_icon=”=||divi||400″ button_on_hover=”off” global_colors_info=”{}” button_bg_color__hover_enabled=”on|hover” button_bg_color__hover=”#009dd5″ button_bg_enable_color__hover=”on”]

Give us a call and speak with an actual scientist.<\/span><\/p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”off|desktop” admin_label=”Footer” _builder_version=”4.16″ background_color=”#E8E8E8″ background_enable_image=”off” background_position=”top_center” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ width=”100%” max_width=”none” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_image src=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg-image-1.png” title_text=”molecules-bg-image (1)” align=”center” _builder_version=”4.16″ transform_origin=”50%|100%” module_alignment=”center” max_height=”300px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"

-Services-USP <661>Is your plastic material suitable for pharmaceutical use? As of May 2016, a revision in the U.S. Pharmacopeia\u2019s monograph for <661> changes the requirements \u00a0for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, \u201cPlastic Materials of Construction,\u201d and <661.2> \u201cPlastic Packaging Systems for Pharmaceutical Use.\u201d […]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"_links":{"self":[{"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/pages\/4747"}],"collection":[{"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/comments?post=4747"}],"version-history":[{"count":8,"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/pages\/4747\/revisions"}],"predecessor-version":[{"id":6016,"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/pages\/4747\/revisions\/6016"}],"wp:attachment":[{"href":"https:\/\/www.impactanalytical.com\/wp-json\/wp\/v2\/media?parent=4747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}