Teledyne LABS has dissolution testers that cover the basket method (USP 1) for capsules, the paddle method (USP 2) for standard tablets​, and paddle-over-disk (USP 5) and rotating cylinder (USP 6) methods for transdermal dosage forms. You can trust the results gained from these robust instruments, engineered for ease of use, with pharmaceutical testing and production regulations and the needs of laboratory personnel in mind.​

Quality Control

At Teledyne LABS, strict protocols are in place to meet USP apparatus, quality control and drug development guidelines. This enables you to follow them, too. All Teledyne LABS dissolution apparatus meet USP specifications, and our quality control department assures approved drug dissolution testing can be accomplished in labs using designated dissolution methods that meet USP dissolution guidelines.​​​ 

The Role of Dissolution Testing in Drug Development and Quality Control

Dissolution testing is a pivotal part of both the drug development process and ongoing quality control in the pharmaceutical industry. During drug development, it helps formulate and optimize new drug products by providing critical data on how the drug's active ingredient is released over time. This information is essential for determining the intended therapeutic effect and ensuring proper absorption by the human body.

As a drug moves from the development phase to production, dissolution testing becomes an indispensable tool for quality control. It ensures that every batch of the drug maintains the same quality standards and efficacy as its predecessors. Regulatory bodies require strict adherence to dissolution profiles for a drug to be approved and remain on the market. This testing checks the consistency and uniformity of the product, identifying any deviations from established benchmarks and preventing substandard products from reaching consumers.​ 

Functions of Dissolution Testing in Drug Development

Dissolution testing is a critical quality control measure throughout the pharmaceutical development process, providing data about how drug products release their active ingredients. By automating these crucial tests, Teledyne LABS helps pharmaceutical manufacturers streamline their development workflow while adhering to acceptance criteria. Our testing systems ensure consistent, reliable results that support both innovative drug development and ongoing quality assurance processes.

Optimizing Drug Release and Bioavailability

Our dissolution testing systems measure how active pharmaceutical ingredients become available at the site of action, allowing developers to fine-tune their formulations. This measurement ensures drug products deliver the right amount of medication at the right time, maintaining both efficacy and patient safety through automated, reliable testing processes.

Meeting Regulatory Requirements and Industry Standards

Modern pharmaceutical development demands rigorous dissolution test protocols that meet strict acceptance criteria. Regulatory bodies worldwide, including the FDA and EMA, require dissolution testing data for drug products. Teledyne's advanced testing solutions help manufacturers achieve and maintain compliance while streamlining the testing process. Our systems support performance verification testing across multiple dosage form types, ensuring consistent quality that builds market confidence and regulatory trust.

Ensuring Product Quality Through Automated Testing

Dissolution testing serves as a critical quality indicator throughout a drug product's lifecycle. Our automated systems enable manufacturers to verify dissolution profiles across batches with unprecedented accuracy. This automation is especially valuable for stability studies, where precise measurements track changes in drug release patterns over time and varying conditions. Teledyne LAB's testing solutions eliminate manual error and provide consistent, reliable data for quality assurance teams to support informed decisions about product stability and shelf life.​

Understanding Modern Dissolution Testing

At Teledyne LABS, our advanced dissolution testing systems automate this critical process, precisely measuring drug release patterns from solid oral dosage forms while eliminating manual testing variables. Through automated, reliable testing procedures, we help pharmaceutical manufacturers maintain consistent quality standards and meet regulatory requirements with unprecedented efficiency.

Fundamentals of Dissolution Testing

Dissolution testing is a cornerstone of pharmaceutical quality control, measuring how effectively drug products release their active ingredients. Our automated testing systems precisely evaluate drug release patterns from solid oral dosage forms, providing critical data about product performance and therapeutic potential. By automating this essential process, Teledyne LAB's solutions deliver consistent, reliable results that meet strict acceptance criteria while eliminating manual testing variables.

Advanced Dissolution Testing Methods

Modern dissolution testing employs several sophisticated techniques, each designed for specific dosage form requirements. Teledyne LABS systems support all major testing approaches, including:

• USP Apparatus 1 (Basket Method): Ideal for capsules and floating dosage forms.

• USP Apparatus 2 (Paddle Method): Optimized for standard tablets and drug products.

• USP Apparatus 3 (Reciprocating Cylinder): Specialized for modified release formulations.

• USP Apparatus 4 (Flow-Through Cell): Perfect for low-solubility drug products. 

Our au​​tomated systems ensure control over test conditions, maintaining consistency across all dissolution test procedures while significantly reducing operator intervention.

Comprehensive Testing Throughout Product Development

Dissolution testing is vital at every stage of pharmaceutical development and manufacturing. During initial development, our systems help optimize drug release profiles and formulation characteristics. In production, they ensure consistent quality through automated performance verification testing. Post-market, our technology supports ongoing quality control and stability testing, maintaining compliance with regulatory standards while maximizing efficiency. This approach helps manufacturers maintain product quality from development through commercial production.

Frequently Asked Questions​

What is dis​​solution testing?

Dissolution testing is used in drug development to determine the release rate of an active pharmaceutical ingredient in tablet or capsule form as it dissolves into a dissolution media. Drug dissolution testing is one indicator of how, and how well, a drug will work in a person’s system.

How do you perform a dissolution test​?

Per the USP, “A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. USP dissolution apparatus includes 4 standardized pieces of equipment: basket, paddle, reciprocating cylinder, and flow-through cell.”

To perform drug dissolution testing, the drug to be tested is usually in solid oral dosage form (this includes modified release dosage forms and others). The desire is to obtain a dissolved active ingredient. The drug is placed into a rotating cylinder containing a dissolution medium using the “standardized apparatus” described above. The process can then be accomplished using a manual system or an instrument such as those offered by Teledyne LABS. These instruments meet USP dissolution apparatus criteria while significantly increasing the speed and accuracy of the test. Just step away and accomplish other tasks while the paddle apparatus does the work. We stand by our products, so you don’t have to.

What is dissolution testing as per ​USP?

Quoting the USP, “Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution and drug release are terms used interchangeably...

“Where specified​ in a monograph, USP dissolution tests are legal requirements. USP training and service are designed to help you meet regulatory compliance requirements while strengthening your quality standards.” All Teledyne LABS dissolution apparatus meet USP dissolution test apparatus requirements.​