USP Apparatus 1 & 2

Solid Oral Dosage Testing: In-Vitro Dissolution & Disintegration

In-vitro dissolution serves as the critical surrogate for in-vivo bioequivalence and drug absorption. Satvam Research operates multi-stage dissolution testers supporting both Basket (Apparatus 1) and Paddle (Apparatus 2) configurations across different pH buffer media (0.1N HCl, pH 4.5, pH 6.8) with automated autosampling and spectrophotometric/HPLC quantification.

Standard Turnaround
3 - 5 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Dissolution & Oral Dosage Testing

Satvam Research provides in-vitro dissolution profiling and tablet/capsule physical characterization adhering to USP, BP, and IP standards. Utilizing our Lab India DS 14000 automated multi-vessel dissolution system and Lab India DT 2000S disintegration tester, we evaluate drug release kinetics, multi-point dissolution profiles (f1/f2 similarity factors), hardness, and friability.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Single-point batch release dissolution testing as per compendial monograph
Multi-point dissolution profiling (10, 15, 20, 30, 45, 60 minutes) in diverse buffers
Calculation of Difference Factor (f1) and Similarity Factor (f2) for biowaivers
Tablet disintegration breakdown tracking in water, simulated gastric/intestinal fluid
Tablet hardness, thickness, diameter, and friability determination
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Automated Dissolution Tester - DS 14000 (Apparatus 1 & 2)
Lab India Instruments
Model: DS 14000 (Apparatus 1 & 2)

Automated Dissolution Tester

Multi-vessel automated temperature-controlled dissolution profiling.

Disintegration Tester - DT 2000S High-Precision
Lab India Instruments
Model: DT 2000S High-Precision

Disintegration Tester

Automated basket oscillation with precise immersion temperature tracking.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

USP <711> Dissolution
USP <701> Disintegration
USP <1217> Tablet Breaking Force
FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms
ICH Q6A Specifications: Test Procedures and Acceptance Criteria
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
36 to 72 dosage units (tablets or capsules) depending on pull-points.
Container Type
Original blister packaging or sealed HDPE container with desiccant.
Storage Condition
Controlled room temperature (20-25°C) protected from humidity.
Standard TAT
3 - 5 business days
Special Instruction: Specify monograph medium, rotational speed (RPM), and sampling intervals.
Frequently Asked Questions

Technical & Regulatory Inquiries

Can Satvam Research perform multi-media dissolution for biowaivers?

Yes. We conduct multi-media comparative dissolution across pH 1.2, pH 4.5, and pH 6.8 media to demonstrate similarity between generic and reference listed drugs (RLD).

Initiate Your Dissolution & Oral Dosage Testing Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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