{"title":"PHARMACEUTICAL TRANSDERMAL DIFFUSION INSTRUMENTS","description":"\u003ch2\u003eTransdermal Diffusion Testers\u003c\/h2\u003e\n\u003cp\u003eIn-vitro diffusion testing measures how an active ingredient releases from a transdermal patch, gel, or topical formulation across a membrane — a core method for TDDS (transdermal drug delivery system) development and QC. Our \u003cstrong\u003eTPY and RYJ series Diffusion Testers\u003c\/strong\u003e are built for this workflow.\u003c\/p\u003e\n\u003ch2\u003eKey Features\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eVertical and horizontal Franz-cell configurations\u003c\/li\u003e\n\u003cli\u003ePrecision temperature and sampling control\u003c\/li\u003e\n\u003cli\u003eMulti-station models for higher-throughput testing (RYJ-12B)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eApplications\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eTDDS patch and topical formulation release testing\u003c\/li\u003e\n\u003cli\u003eIn-vitro permeation studies for R\u0026amp;D\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eExplore the full lineup below to find the right solution for your lab. For quotation or technical support, \u003ca href=\"\/pages\/contact\"\u003econtact our team\u003c\/a\u003e.\u003c\/p\u003e","products":[{"product_id":"ryj-12b-pharmaceutical-transdermal-diffusion-tester","title":"RYJ-12B Transdermal Diffusion Tester – In-Vitro Skin Absorption Testing Instrument","description":"\u003c!-- PRODUCT_ID: 7815966031929 --\u003e\n\u003c!-- TITLE: RYJ-12B Transdermal Diffusion Tester – In-Vitro Skin Absorption Testing Instrument --\u003e\n\u003ch2\u003e\n\u003ca name=\"_Toc187362377\"\u003e\u003c\/a\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan\u003ePharmaceutical Transdermal Diffusion Instruments\u003c\/span\u003e\u003cspan\u003e\u003c\/span\u003e\n\u003c\/h2\u003e\n\u003cp\u003eRYJ-12B Pharmaceutical Transdermal Diffusion Tester\u003c\/p\u003e\n\u003cdiv style=\"margin:1.5rem 0;padding:1rem 1.25rem;background:#f5f9ff;border-left:3px solid #0066cc;border-radius:3px;\"\u003e\n\u003cp style=\"margin:0;\"\u003ePharmaceutical quality control instrument designed to USP \/ FDA \/ GMP standards with comprehensive audit trail support for data integrity.\u003c\/p\u003e\n\u003cp style=\"margin:0.5rem 0 0 0;\"\u003e\u003cstrong\u003eVerify our credentials:\u003c\/strong\u003e \u003ca href=\"\/pages\/certifications\" style=\"color:#0066cc;\"\u003eCertifications\u003c\/a\u003e · \u003ca href=\"\/pages\/patents\" style=\"color:#0066cc;\"\u003ePatent Portfolio\u003c\/a\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cp class=\"\" data-end=\"870\" data-start=\"705\"\u003eThe RYJ-12B Transdermal Diffusion Tester is a specialized \u003cstrong data-end=\"800\" data-start=\"763\"\u003epharmaceutical testing instrument\u003c\/strong\u003e designed to perform \u003cstrong data-end=\"867\" data-start=\"821\"\u003ein-vitro transdermal drug delivery testing\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp class=\"\" data-end=\"1060\" data-start=\"877\"\u003eUtilizing a precision-controlled system and Franz diffusion cells, this device simulates \u003cstrong data-end=\"985\" data-start=\"966\"\u003eskin absorption\u003c\/strong\u003e of topical or transdermal drug formulations under laboratory conditions.\u003c\/p\u003e\n\u003cp class=\"\" data-end=\"1252\" data-start=\"1067\"\u003eThe RYJ-12B is widely used in \u003cstrong data-end=\"1119\" data-start=\"1097\"\u003epharmaceutical R\u0026amp;D\u003c\/strong\u003e, formulation screening, and bioequivalence studies, ensuring reproducibility and compliance with international research standards.\u003c\/p\u003e\n\u003cp class=\"\" data-end=\"1445\" data-start=\"1259\"\u003eAs a core part of our \u003cstrong data-end=\"1319\" data-start=\"1281\"\u003epharmaceutical testing instruments\u003c\/strong\u003e lineup, the RYJ-12B helps pharmaceutical scientists evaluate drug release profiles and optimize transdermal delivery systems.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eDescription\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003eThe RYJ-12B Pharmaceutical Transdermal Diffusion Tester is a collaborative product developed with the National Pharmaceutical Engineering Research Center (NPERC). It adopts an improved vertical Franz diffusion cell structure, where the film is clamped between the donor chamber lid (donor) and the receptor chamber (receptor). The inner surface of the film is immersed in a solution in the receptor chamber under conditions of constant temperature water bath circulation. With precise agitation, it ensures uniform distribution of the medium, simulating the drug’s transdermal penetration and release processes through biological membranes or artificial membranes.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eProduct Features\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003eInnovative Franz Cell Design:\u003c\/b\u003e Features 12 independently improved vertical Franz diffusion cells.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003eMagnetic Stirring Mechanism:\u003c\/b\u003e Stable and uniform agitation ensures consistent dissolution concentration distribution.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003ePrecise Flow System:\u003c\/b\u003e Proprietary design guarantees uniformity in the diffusion medium circulation.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003eTemperature Insulation:\u003c\/b\u003e Ensures stable minimum temperature deviation during tests.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003eComprehensive Data Export:\u003c\/b\u003e Equipped with USB ports for exporting test records.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"text-indent: -9.75pt;line-height: normal;margin: 9.0pt 0cm 0cm 9.75pt\"\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003e   \u003c\/span\u003e•\u003cspan\u003e  \u003c\/span\u003e\u003cb\u003eUser-Friendly Interface:\u003c\/b\u003e Features a touch-screen interface supporting both English and Chinese operations for enhanced usability.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 0cm;line-height: normal\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpFirst\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eModel\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e    \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003eRYJ-12B\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eProduct Code\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e      \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e10110100\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eNumber of Diffusion Cells\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e  \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e12 groups\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eVolume of Diffusion Cells\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e  \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e8mL\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eDiffusion Area\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e      \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003eApprox. 2.2cm²\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eStirring Speed Range\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e100–800RPM\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eSpeed Stability Deviation\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e  \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e≤±1%\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eTemperature Range\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003eRoom temperature to 45°C\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eTemperature Resolution\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e    \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e0.1°C\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eTemperature Accuracy\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e     \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e≤±0.3°C\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eSample Collection Count\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e≤15 times\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003eSample Collection Timing\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003e≤9999 minutes\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoListParagraphCxSpLast\" style=\"text-indent: -22.0pt;line-height: normal;margin: 0cm 0cm 0cm 22.0pt\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"color: #0e0e0e\"\u003e\u003cspan\u003el\u003cspan\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cb\u003e\u003cspan style=\"color: #0e0e0e\"\u003ePower Supply\u003c\/span\u003e\u003c\/b\u003e\u003cspan style=\"color: black\"\u003e\u003cspan\u003e       \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #0e0e0e\"\u003eAC220V±10%, 50Hz\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"p1\" style=\"margin-top: 15px\"\u003e\n\u003cspan\u003e\n\u003cb\u003eData Integrity:\u003c\/b\u003e Designed with features that support a 21 CFR Part 11 workflow — USB-based data export for traceable test records.\n  \u003c\/span\u003e\n\u003c\/p\u003e\n\n\u003chr\u003e\n\u003ch2\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What is the regulatory pathway for transdermal patch approval?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eA: In the US, transdermal patches are regulated as drug products under FDA 21 CFR Parts 210\/211. New patches typically require an ANDA (for generic) or NDA (for novel formulations). Key dossier requirements include in vitro permeation testing (IVPT) data using Franz diffusion cells (USP \u0026lt;724\u0026gt;), comparative adhesion studies, and stability data at ICH conditions. The \u003ca href=\"https:\/\/drugmachines.com\/products\/ryj-12b-pharmaceutical-transdermal-diffusion-tester\"\u003eRYJ-12B Franz Cell Tester\u003c\/a\u003e generates the IVPT data required for regulatory submissions, using 12-cup vertical diffusion geometry conforming to FDA guidance. \u003ca href=\"https:\/\/drugmachines.com\/pages\/contact\"\u003eContact us for pricing.\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What is in vitro permeation testing (IVPT) and why is it required?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eA: IVPT measures the rate and cumulative amount of API that permeates through a membrane (synthetic or excised skin) over time, using a Franz diffusion cell setup. For transdermal patches, IVPT data: (1) establishes in vitro release specifications for batch release; (2) supports bioequivalence claims for generic patches; (3) monitors manufacturing consistency batch-to-batch. FDA's 2022 draft guidance on topical drug bioavailability recommends IVPT as the primary method for many dermatological products. The \u003ca href=\"https:\/\/drugmachines.com\/products\/ryj-12b-pharmaceutical-transdermal-diffusion-tester\"\u003eRYJ-12B\u003c\/a\u003e supports 12 parallel diffusion cells with temperature-controlled receptor compartments (37°C ± 0.5°C).\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: Why does the RYJ-12B use vertical Franz cells instead of horizontal diffusion cells?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eA: Vertical Franz-type diffusion cells are the standard IVPT configuration for most transdermal and dermal formulations: the donor compartment holds the test formulation (patch, gel, ointment, cream) above the membrane, while the receptor compartment below collects permeated drug in a stirred buffer. The RYJ-12B is configured with 12 vertical wet-type cells for this standard workflow. For applications that also require horizontal (dry-type) diffusion testing — such as buccal or oral mucosal permeation studies — Huanghai's \u003ca href=\"https:\/\/drugmachines.com\/products\/tpy-2-pharmaceutical-transdermal-diffusion-tester\"\u003eTPY-2 dual-method diffusion tester\u003c\/a\u003e combines 12 vertical cells with 6 horizontal cells in a single instrument.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What receptor temperature should IVPT studies use, and how does the RYJ-12B control it?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eA: Most IVPT protocols (following OECD 428 and FDA SUPAC-SS guidance) run the receptor compartment at 32°C ± 0.5°C to simulate normal skin surface temperature. The RYJ-12B's thermostatic water bath circulates across all 12 cells from room temperature up to 45°C, with ±0.3°C accuracy — comfortably within the typical 32°C target range needed for consistent, comparable permeation data across parallel cells. \u003ca href=\"https:\/\/drugmachines.com\/pages\/contact\"\u003eContact us for method-specific parameter guidance.\u003c\/a\u003e\u003c\/p\u003e\n\u003cscript type=\"application\/ld+json\"\u003e{\"@context\": \"https:\/\/schema.org\", \"@type\": \"FAQPage\", \"mainEntity\": [{\"@type\": \"Question\", \"name\": \"What is the regulatory pathway for transdermal patch approval?\", \"acceptedAnswer\": {\"@type\": \"Answer\", \"text\": \"In the US, transdermal patches are regulated as drug products under FDA 21 CFR Parts 210\/211. New patches typically require an ANDA (for generic) or NDA (for novel formulations). Key dossier requirements include in vitro permeation testing (IVPT) data using Franz diffusion cells (USP \u0026lt;724\u0026gt;), comparative adhesion studies, and stability data at ICH conditions. The RYJ-12B Franz Cell Tester generates the IVPT data required for regulatory submissions, using 12-cup vertical diffusion geometry conforming to FDA guidance. Contact us for pricing.\"}}, {\"@type\": \"Question\", \"name\": \"What is in vitro permeation testing (IVPT) and why is it required?\", \"acceptedAnswer\": {\"@type\": \"Answer\", \"text\": \"IVPT measures the rate and cumulative amount of API that permeates through a membrane (synthetic or excised skin) over time, using a Franz diffusion cell setup. For transdermal patches, IVPT data: (1) establishes in vitro release specifications for batch release; (2) supports bioequivalence claims for generic patches; (3) monitors manufacturing consistency batch-to-batch. FDA's 2022 draft guidance on topical drug bioavailability recommends IVPT as the primary method for many dermatological products. The RYJ-12B supports 12 parallel diffusion cells with temperature-controlled receptor compartments (37°C ± 0.5°C).\"}}, {\"@type\": \"Question\", \"name\": \"Why does the RYJ-12B use vertical Franz cells instead of horizontal diffusion cells?\", \"acceptedAnswer\": {\"@type\": \"Answer\", \"text\": \"Vertical Franz-type diffusion cells are the standard IVPT configuration for most transdermal and dermal formulations: the donor compartment holds the test formulation above the membrane, while the receptor compartment below collects permeated drug in a stirred buffer. The RYJ-12B is configured with 12 vertical wet-type cells for this standard workflow. For applications that also require horizontal (dry-type) diffusion testing, Huanghai's TPY-2 dual-method diffusion tester combines 12 vertical cells with 6 horizontal cells in a single instrument.\"}}, {\"@type\": \"Question\", \"name\": \"What receptor temperature should IVPT studies use, and how does the RYJ-12B control it?\", \"acceptedAnswer\": {\"@type\": \"Answer\", \"text\": \"Most IVPT protocols (following OECD 428 and FDA SUPAC-SS guidance) run the receptor compartment at 32°C ± 0.5°C to simulate normal skin surface temperature. The RYJ-12B's thermostatic water bath circulates across all 12 cells from room temperature up to 45°C, with ±0.3°C accuracy, comfortably within the typical 32°C target range needed for consistent, comparable permeation data across parallel cells.\"}}]}\u003c\/script\u003e","brand":"Huanghai","offers":[{"title":"Default Title","offer_id":44205715980345,"sku":null,"price":3351.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0704\/2495\/2889\/files\/ryj-12b-diffusion-tester-franz-cell.jpg?v=1744297959"}],"url":"https:\/\/79dv0w-hi.myshopify.com\/collections\/pharmaceutical-transdermal-diffusion-instruments.oembed","provider":"Huanghai Pharmaceutical Instruments","version":"1.0","type":"link"}