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FDCA Form 37 Approved21 CFR Part 11 Compliant
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IVRT & IVPT Studies

In-Vitro Release Testing and In-Vitro Permeation Testing for topical semi-solid products using Franz diffusion cells.

IVRTIVPTFranz CellTopical
Cell Configuration6 and 12-cell Franz apparatus
Dosage FormsCreams, Gels, Ointments, Patches
Turnaround Time15–25 working days
Regulatory AcceptanceUSFDA, EMA
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen specializes in In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT) for topical semi-solid dosage forms including creams, gels, ointments, and transdermal patches. Using validated Franz diffusion cell methodology, we support bioequivalence studies, formulation development, and regulatory submissions for topical products.

Compendial Standards & Regulatory Alignment:
✓ FDA SUPAC-SS✓ EMA Topicals Guidance✓ USP <724>✓ FDA BE Guidance for Topicals
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Cell Configuration6 and 12-cell Franz apparatus
Dosage FormsCreams, Gels, Ointments, Patches
Turnaround Time15–25 working days
Regulatory AcceptanceUSFDA, EMA
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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IVRT for creams, gels, ointments, lotionsExecuted with validated SOPs and full raw data audit trails.
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IVPT using human cadaver or animal skinExecuted with validated SOPs and full raw data audit trails.
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Synthetic membrane IVRT (cellulose acetate)Executed with validated SOPs and full raw data audit trails.
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Flux calculation and permeation profilingExecuted with validated SOPs and full raw data audit trails.
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Comparative IVRT for bioequivalenceExecuted with validated SOPs and full raw data audit trails.
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Formulation optimization supportExecuted with validated SOPs and full raw data audit trails.
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Transdermal patch testingExecuted with validated SOPs and full raw data audit trails.
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Temperature-controlled Franz cell setupExecuted with validated SOPs and full raw data audit trails.
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Statistical analysis (f2 similarity factor)Executed with validated SOPs and full raw data audit trails.
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FDA SUPAC-SS compliant protocolsExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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Franz Diffusion Cells (6/12-cell)

IVRT and IVPT studies for topical products

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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HPLC (UV/PDA)

Drug quantification in receptor fluid

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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UV-Vis Spectrophotometer

Rapid screening and quantification

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Synthetic Membranes

IVRT using cellulose acetate/polysulfone membranes

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Protocol Design

Study protocol designed per FDA/EMA guidance; membrane and receptor fluid selected.

02
Stage 02

Cell Setup & Equilibration

Franz cells assembled, membrane equilibrated, temperature controlled at 32°C.

03
Stage 03

Sample Application & Sampling

Formulation applied; receptor fluid sampled at defined time points.

04
Stage 04

Analysis & Report

HPLC quantification; flux, permeation profile, and f2 analysis; full study report.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 15–25 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your IVRT & IVPT Studies Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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