{"id":2986,"date":"2025-04-09T15:07:20","date_gmt":"2025-04-09T19:07:20","guid":{"rendered":"https:\/\/az.research.umich.edu\/animalcare\/document\/guidelines-preparation-injectable-substances-and-agents-administered-animals\/"},"modified":"2025-04-09T15:07:59","modified_gmt":"2025-04-09T19:07:59","slug":"guidelines-preparation-injectable-substances-and-agents-administered-animals","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/animalcare\/guidelines\/guidelines-preparation-injectable-substances-and-agents-administered-animals\/","title":{"rendered":"Guidelines on the Preparation of Injectable Substances and Agents Administered to Animals"},"template":"","categories":[5,6,7,8,9,10,11,12,13,14,15,16,17,18,19],"tags":[],"content-type":[39],"topic":[],"update-type":[],"class_list":["post-2986","document","type-document","status-publish","hentry","category-cats","category-chickens-avian","category-cows","category-dogs","category-ferrets","category-fish-amphibians-and-reptiles","category-guinea-pigs","category-hamsters","category-mice","category-other-rodents","category-primates","category-rabbits","category-rats","category-sheep","category-swine","content-type-guidelines"],"acf":{"use_legacy_editor":true,"updated_date":"2025-03-21 00:00:00","update_notice":true,"author":"Unit for Laboratory Animal Medicine","summary":"This guideline outlines the expectations for the preparation of injectable substances and agents intended for use in animals.","button_links":null,"related_content":[2885,3576,3614,3473,3477,3479,3475],"legacy_path":"guidelines-preparation-injectable-substances-and-agents-administered-animals","legacy_node_id":138,"legacy_related_nids":"1434, 1435, 1436, 1437, 1552, 1699","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Glossary Definitions","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"glossary_terms","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":[2726,2725,2724,2850,2851],"legacy_glossary_nids":"1421, 1420, 1419, 1690, 1691","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Preparing Substances and Agents to be Administered to Animals","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol style=\"list-style-type: decimal\" start=\"1\">\r\n \t<li><a class=\"gtip\" href=\"\/animalcare\/glossary\/pharmaceutical-grade\">Pharmaceutical Grade<\/a> drugs should be purchased in sterile, rubber topped vials in the smallest volume available that is appropriate for the intended use.<\/li>\r\n \t<li>More information on the use of non-pharmaceutical grade substances or agents in animal can be found in the <em><a href=\"https:\/\/az.research.umich.edu\/animalcare\/policies\/policy-use-non-pharmaceutical-grade-drugs\">Policy on the Use of Non-Pharmaceutical Grade Drugs<\/a><\/em><\/li>\r\n \t<li>Prior to preparation, review the <a class=\"gtip\" href=\"https:\/\/az.research.umich.edu\/animalcare\/glossary\/environment-health-safety-ehs\/\">EHS<\/a> safety findings in eRAM to determine if a specific substance or agent must be prepared in a chemical fume hood or biological safety cabinet.<\/li>\r\n \t<li>Prepare all agents and substances in a manner that ensures the final product is sterile prior to being used in an animal.<\/li>\r\n \t<li>Calculate the weight of the agent or substance needed to prepare the desired volume\u00a0at the necessary concentration.\u00a0See <em><strong>Appendix A<\/strong><\/em> for example pharmaceutical calculations.<\/li>\r\n \t<li>In a sterile container, dissolve the measured amount of substance or agent in the appropriate volume of <a class=\"gtip\" href=\"\/animalcare\/glossary\/diluent\">diluent<\/a>.\r\n<ol class=\"rteindent1\" style=\"list-style-type: lower-alpha\" start=\"1\">\r\n \t<li>Whenever possible, use a sterile, pH balanced (6.8 \u2013 7.2), osmotically balanced (approx. 300 mOsm), pyrogen-free diluentlabeled for injection for humans or animals (e.g. 0.9% Sodium Chloride, Sterile water.<\/li>\r\n \t<li>For non-aqueous formulations, the IACUC may request\u00a0additional information describing assurances for sterility, potential adverse consequences, etc.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>As needed, adjust pH close to physiologic pH (7.4).<\/li>\r\n \t<li>Dissolve the formulation in an appropriate solvent until particles are not visible. Filter through a 0.2 um filter into a sterile container (a sterile glass vial with a crimped rubber closure is recommended).<\/li>\r\n \t<li>Discard any solutions or formulations that show signs of contamination, breach of sterility, or compromised integrity (e.g., cloudiness, precipitation, order, visible growth, color change).<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Dilution of injectable drugs intended for clinical purposes","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol>\r\n \t<li>Several commonly used drugs (e.g., carprofen, ketamine, xylazine) are readily available in commercially produced formulations for human and veterinary clinical use. These products often require dilution to facilitate accurate dosing in small species like rodents.<\/li>\r\n \t<li>All solutions used for dilution must be pharmaceutical grade and intended for injectable use in humans or animals (e.g. sterile 0.9% Sodium Chloride or sterile water). These fluid diluents must be in sealed, rubber topped vials or bags and must be used within the expiration date. Fluids intended for other laboratory use are not appropriate diluents for these drugs.\r\n<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>See <strong>Appendix B<\/strong> for acceptable and unacceptable diluents.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>Drugs and diluents should be placed into a sterile, rubber stoppered vial and labeled with the following information:\r\n<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>All names of drugs in diluted mixture.\u00a0Write drug names in full, do not abbreviate.\r\n<ol style=\"list-style-type: lower-roman\">\r\n \t<li>Concentration of drug mixture<\/li>\r\n \t<li>Preparation date and expiration date\r\n<ol>\r\n \t<li>The expiration date for the diluted solution is determined by the earliest expiration date of any of its component drugs or diluents. (Manufacturer\u2019s expiration date for the vial or the vial\u2019s beyond-use-date)<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>Store solutions according to the manufacturer\u2019s directions per label.<\/li>\r\n<\/ol>","legacy_media_position":"media-full","legacy_media_file":3186,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/Pharmaceutical%20Calculations.pdf","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":[{"legacy_button":{"title":"Pharmaceutical Calculations for Diluting and Combining Drugs","url":"https:\/\/az.research.umich.edu\/animalcare\/wp-content\/uploads\/sites\/2\/2025\/01\/Pharmaceutical-Calculations-for-Diluting-and-Combining-Drugs.pdf","target":""},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Appendix A: Pharmaceutical Calculations for Diluting and Combining Drugs","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol start=\"1\" style=\"list-style-type:decimal\">\r\n\t<li>Blood DC, Studdert VP. 1999.&nbsp;<em>Saunders comprehensive veterinary dictionary<\/em>. London ; New York: WB Saunders.<\/li>\r\n\t<li>Lake T. 2003.&nbsp;<em>Dosage calculations for veterinary nurses and technicians<\/em>. Edinburgh ; New York: Butterworth-Heinemann.<\/li>\r\n\t<li>Matthews, K. and Taylor, D., Assessment of Sterility in Fluid Bags Maintained For Chronic Use; J. American Association for Laboratory Animal Science, Vol. 50, No. 5, Pages 708-712, September 2001.<\/li>\r\n\t<li>Plumb DC. 2005.&nbsp;<em>Plumb's veterinary drug handbook<\/em>. Stockholm, Wis. Ames, Iowa: PharmaVet ; Distributed by Blackwell Pub.<\/li>\r\n\t<li>Office for Animal Care and Use, NIH. Updated February 19, 2009. (<a href=\"http:\/\/oacu.od.nih.gov\/\" rel=\"nofollow\">http:\/\/oacu.od.nih.gov\/<\/a>)<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":[{"legacy_button":{"title":"Pharmaceutical Calculations for Diluting and Combining Drugs","url":"https:\/\/az.research.umich.edu\/animalcare\/wp-content\/uploads\/sites\/2\/2025\/01\/Pharmaceutical-Calculations-for-Diluting-and-Combining-Drugs.pdf","target":""},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Appendix B: Acceptable and Unacceptable Diluents for Clinical Injectable Drugs","legacy_subheading":"","legacy_section_text":"","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"Acceptable Diluents","legacy_subheading":"Acceptable Diluents","legacy_section_text":"","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":4769,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"Unacceptable Diluents","legacy_subheading":"Unacceptable Diluents","legacy_section_text":"","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":4770,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"References","legacy_subheading":"","legacy_section_text":"","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol>\r\n \t<li>Blood DC, Studdert VP. 1999. Saunders comprehensive veterinary dictionary. London ; New York: WB Saunders.<\/li>\r\n \t<li>Lake T. 2003. Dosage calculations for veterinary nurses and technicians. Edinburgh ; New York: Butterworth-Heinemann.<\/li>\r\n \t<li>Matthews, K. and Taylor, D., Assessment of Sterility in Fluid Bags Maintained For Chronic Use; J. American Association for Laboratory Animal Science, Vol. 50, No. 5, Pages 708-712, September 2001.<\/li>\r\n \t<li>Plumb DC. 2005. Plumb's veterinary drug handbook. Stockholm, Wis. Ames, Iowa: PharmaVet ; Distributed by Blackwell Pub.<\/li>\r\n \t<li>Office for Animal Care and Use, NIH. Updated February 19, 2009. (http:\/\/oacu.od.nih.gov\/)<\/li>\r\n<\/ol>","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[51,55,52,53],"update_notice_start":"2025-04-07 21:00:00","update_notice_end":"2025-07-07 21:00:00","update_notice_text_blocks":[{"update_notice_text":"<h3><span style=\"color: #024794\"><strong>Summary of Changes<\/strong><\/span><\/h3>\r\n<ul>\r\n \t<li>Added links for Orange Book and Green Book in the Glossary terms for \"Pharmaceutical Grade\"<\/li>\r\n \t<li>Separated requirements for making injectable dilutions and dilutions for other routes of administration.<\/li>\r\n \t<li>Added a section for making dilutions of injectable clinical drugs<\/li>\r\n \t<li>Added dilution labeling requirements.<\/li>\r\n \t<li>Added Appendix B to show acceptable and unacceptable diluents for injectable dilutions.<\/li>\r\n<\/ul>"},{"update_notice_text":"<h3><span style=\"color: #024794\"><strong>Who is Impacted<\/strong><\/span><\/h3>\r\n<ul>\r\n \t<li>All\u00a0individuals who handle or work with animals as part of their research operations<\/li>\r\n<\/ul>"},{"update_notice_text":"<h3><span style=\"color: #024794\"><strong>Impact<\/strong><\/span><\/h3>\r\n<ul>\r\n \t<li>All\u00a0individuals who handle or work with animals as part of their research operations review the revised policy carefully and implement these changes immediately.<\/li>\r\n<\/ul>"}],"global_contact_block":true,"contact_name":"","contact_email":"","contact_additional_info":"Questions or concerns about the content of this document should be directed to the Unit for Laboratory Animal Medicine (ULAM) at (734) 764-0277 or <a href=\"mailto:ulam-questions@umich.edu\">ulam-questions@umich.edu<\/a>.","global_contact_block_select":[3395]},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/2986","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":4,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/2986\/revisions"}],"predecessor-version":[{"id":4775,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/2986\/revisions\/4775"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/contact-block\/3395"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3475"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3479"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3477"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3473"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3614"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/3576"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/document\/2885"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/update-type\/53"},{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/update-type\/52"},{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/update-type\/55"},{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/update-type\/51"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/media?parent=2986"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/categories?post=2986"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/tags?post=2986"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/content-type?post=2986"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/topic?post=2986"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/animalcare\/wp-json\/wp\/v2\/update-type?post=2986"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}