{"id":164964,"date":"2023-05-10T23:13:44","date_gmt":"2023-05-10T17:43:44","guid":{"rendered":"https:\/\/pharmint.co\/product\/dapagliflozin-propanediol-monohydrate\/"},"modified":"2025-08-04T23:24:43","modified_gmt":"2025-08-04T17:54:43","slug":"dapagliflozin-propanediol-monohydrate","status":"publish","type":"product","link":"https:\/\/pharmint.net\/ar\/product\/dapagliflozin-propanediol-monohydrate\/","title":{"rendered":"Dapagliflozin propanediol monohydrate"},"content":{"rendered":"<h2 style=\"text-align: center;\"><a href=\"https:\/\/pharmint.net\/product\/dapagliflozin-propanediol-monohydrate\/\"><strong>Dapagliflozin Propanediol Monohydrate (CAS 960404-48-2)<\/strong><\/a><\/h2>\n<p><strong>Dapagliflozin Propanediol Monohydrate<\/strong>&nbsp;(CAS 960404-48-2) is a crystalline co-form of&nbsp;<strong>Dapagliflozin<\/strong>,&nbsp;<strong>a prescription medication<\/strong>&nbsp;used to treat type 2 diabetes. It is formulated with (S)-propanediol and water in a 1:1:1 ratio. As a potent&nbsp;<strong>sodium-glucose cotransporter 2 (SGLT2) inhibitor<\/strong>, it plays a critical role in developing oral antidiabetic therapies including&nbsp;<strong>Dapagliflozin Propanediol (100 mg)<\/strong>&nbsp;tablets.<\/p>\n<h3><strong>What Is Dapagliflozin Used For in Pharmaceutical Manufacturing?<\/strong><\/h3>\n<p><strong>Dapagliflozin<\/strong>&nbsp;is a medication used to treat type 2 diabetes. It&nbsp;<strong>is used together with proper diet and exercise to treat type 2 diabetes<\/strong>, reducing renal glucose reabsorption and improving glycemic control. The API supports cardiovascular and renal risk mitigation and is widely used in commercial formulations such as&nbsp;<strong>Farxiga<\/strong>&nbsp;and&nbsp;<strong>Xigduo XR<\/strong>.<\/p>\n<h3><strong>What Are the Technical Specifications?<\/strong><\/h3>\n<ul>\n<li><strong>Chemical Name<\/strong>:&nbsp;<strong>Dapagliflozin Propanediol Monohydrate<\/strong><\/li>\n<li><strong>Molecular Weight<\/strong>: ~502.99 g\/mol<\/li>\n<li><strong>CAS Number<\/strong>: 960404-48-2<\/li>\n<li><strong>Appearance<\/strong>: White crystalline powder<\/li>\n<li><strong>Purity<\/strong>: &ge;99.5% (HPLC)<\/li>\n<li><strong>Solubility<\/strong>: Soluble in DMSO, ethanol<\/li>\n<li><strong>Storage<\/strong>: &ndash;20&#8239;&deg;C, moisture-controlled conditions<\/li>\n<\/ul>\n<h3><strong>Why Source Dapagliflozin Propanediol from Pharmint?<\/strong><\/h3>\n<ul>\n<li><strong>GMP-certified supply chain<\/strong>&nbsp;with validated traceability<\/li>\n<li><strong>USDMF, CEP, KDMF<\/strong>&nbsp;and CTD-format documentation available<\/li>\n<li><strong>Bulk availability<\/strong>&nbsp;from 100 g R&amp;D packs to 50+ kg commercial lots<\/li>\n<li><strong>Analytical documentation<\/strong>&nbsp;including COA, MSDS, NMR, HPLC<\/li>\n<li><strong>Support for ANDA and MA filings<\/strong>&nbsp;with end-use declaration<\/li>\n<\/ul>\n<h3><strong>How Is It Packaged and Supplied?<\/strong><\/h3>\n<ul>\n<li><strong>MOQ<\/strong>: 100 g (R&amp;D) up to multi-kg commercial scale<\/li>\n<li><strong>Packaging<\/strong>: LDPE\/HDPE triple-layer containers with tamper-evident seal<\/li>\n<li><strong>Shelf Life<\/strong>: &ge;36 months with ICH stability data<\/li>\n<li><strong>Shipping<\/strong>: Export-ready, includes MSDS, COA, and customs documents<\/li>\n<\/ul>\n<h3><strong>What Quality and Compliance Standards Are Met?<\/strong><\/h3>\n<ul>\n<li>Produced under&nbsp;<strong>ICH Q7\/Q11<\/strong>&nbsp;GMP<\/li>\n<li>Full&nbsp;<strong><a href=\"https:\/\/pharmint.net\/ar\/glossary\/impurity-profile\/\" target=\"_self\" title=\"What Is an Impurity Profile? An&nbsp;impurity profile&nbsp;is a comprehensive characterization of&nbsp;identified and unidentified impurities&nbsp;in a drug substance or pharmaceutical product. According to ICH Q7, this profile should include qualitative or structural identification (like retention time), observed impurity ranges, and classification of impurities (e.g., organic, inorganic, solvent). Why Is Impurity Profiling Critical in Pharmaceuticals? Impurity profiling&hellip;\" class=\"encyclopedia\">impurity profile<\/a> and polymorph analysis<\/strong><\/li>\n<li><strong>USP\/Ph. Eur\/ICH-compliant<\/strong>&nbsp;test methods<\/li>\n<li>Audit-ready with QP documentation and TSE\/BSE statements<\/li>\n<\/ul>\n<h3><strong>Can It Be Used in Formulation Development?<\/strong><\/h3>\n<p>Yes,&nbsp;<strong>Dapagliflozin Propanediol Monohydrate<\/strong>&nbsp;supports:<\/p>\n<ul>\n<li>Generic API-to-formulation projects<\/li>\n<li>Fixed-dose combinations with metformin, saxagliptin, etc.<\/li>\n<li>Chronic care, cardiovascular and renal co-indication therapies<\/li>\n<li>Submission-ready data for global DMF filings<\/li>\n<\/ul>\n<h3><strong>How to Procure Dapagliflozin API in Bulk?<\/strong><\/h3>\n<p>Pharmint offers seamless <a href=\"https:\/\/pharmint.net\/ar\/glossary\/api-sourcing\/\" target=\"_self\" title=\"What is API Sourcing? API Sourcing&nbsp;refers to the process by which pharmaceutical companies,&nbsp;CDMOs, or buyers identify, evaluate, select, qualify, and procure&nbsp;Active Pharmaceutical Ingredients&nbsp;(APIs) from reliable manufacturers or suppliers. It encompasses regulatory, quality, ethical, logistical, and supply chain risk aspects to ensure that APIs meet pharmacopeial,&nbsp;GMP, safety, and specification requirements before being used in drug formulations.&hellip;\" class=\"encyclopedia\">API sourcing<\/a> with:<\/p>\n<ul>\n<li>A network of audited global manufacturers<\/li>\n<li>Regulatory and quality documentation for ANDA\/MA submissions<\/li>\n<li>Logistics support including cold-chain, customs, and multilingual coordination<\/li>\n<li>Procurement support for EU, LATAM, MENA, and APAC markets<\/li>\n<\/ul>\n<h3><strong>Dapagliflozin Propanediol FAQs&nbsp;<\/strong><\/h3>\n<h4><strong>Can I use Dapagliflozin Propanediol for fixed-dose combination (FDC) development?<\/strong><\/h4>\n<p>Yes, Dapagliflozin Propanediol is commonly used in FDC formulations with metformin or saxagliptin for type 2 diabetes, supported by stability data and regulatory filings.<\/p>\n<h4><strong>Does this API meet ICH Q11 expectations for development stage?<\/strong><\/h4>\n<p>Dapagliflozin Propanediol meets ICH Q11 criteria with complete impurity profiling, process validation, and lifecycle management documentation for API control strategy.<\/p>\n<h4><strong>Is a DMF available for Dapagliflozin Propanediol Monohydrate?<\/strong><\/h4>\n<p>Yes, DMFs including USDMF, CEP, and KDMF are available from select GMP-qualified manufacturers and are aligned with CTD module 3 requirements.<\/p>\n<h4><strong>How do I verify the polymorphic form of Dapagliflozin Propanediol?<\/strong><\/h4>\n<p>The supplied API includes polymorph characterization via XRPD and DSC, ensuring the hydrate form aligns with reference listed drug (RLD) standards.<\/p>\n<h4><strong>Does Pharmint offer audit support for this API supplier?<\/strong><\/h4>\n<p>Yes, Pharmint coordinates GMP site audits or QP declarations and provides audit reports, quality agreements, and compliance history to facilitate qualification.<\/p>","protected":false},"excerpt":{"rendered":"<p>API (Active Pharmaceutical Ingredients) used for Medicinal Purpose<\/p>\n<p>High-purity Dapagliflozin Propanediol Monohydrate (CAS 960404-48-2) \u2013 a GMP-certified SGLT2 inhibitor API used in type 2 diabetes formulations. Available in bulk with COA, DMF, and regulatory support for formulation development and global sourcing.<\/p>","protected":false},"featured_media":164814,"comment_status":"open","ping_status":"closed","template":"","meta":{"rank_math_lock_modified_date":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}}},"product_cat":[316,764],"product_tag":[],"class_list":{"0":"post-164964","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharma-ingredients-raw-materials","7":"product_cat-api-active-pharmaceutical-ingredients-2","8":"desktop-align-left","9":"tablet-align-left","10":"mobile-align-left","11":"ast-product-gallery-layout-vertical","12":"ast-product-gallery-with-no-image","13":"ast-magnify-disabled","14":"ast-product-tabs-layout-distributed","16":"first","17":"instock","18":"shipping-taxable","19":"purchasable","20":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product\/164964","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/comments?post=164964"}],"version-history":[{"count":2,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product\/164964\/revisions"}],"predecessor-version":[{"id":1738745,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product\/164964\/revisions\/1738745"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/media\/164814"}],"wp:attachment":[{"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/media?parent=164964"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product_cat?post=164964"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pharmint.net\/ar\/wp-json\/wp\/v2\/product_tag?post=164964"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}