Dissolution testing is a routine test conducted in the pharmacy industry to identify the way a drug breaks down from its dosage form into a solution. We, at Chromak Research, provide top-notch dissolution analysis services that are compliant with international regulatory requirements and enhance the performance, quality, and marketability of your product.

Since our company has been in business for more than 40 years, our laboratory offers accurate, reproducible, and regulatory-specified dissolution testing of various dosage forms, such as tablets, capsules, ointments, and suspensions. Our tests are conducted following USP <711> and other international pharmacopeial standards.

What is Dissolution Analysis?

A laboratory method is applied to simulate the conditions of the human digestive tract to measure the rate and amount of the active pharmaceutical ingredient (API) to dissolve in an aqueous environment. This knowledge is critical to estimate the bioavailability of the drug—how rapidly and efficaciously it will perform within the body.

Significance of Dissolution Analysis

Dissolution analysis plays a critical function in:

  • Forecasting in-vivo performance and bioavailability of drug products

  • Ensuring batch-to-batch consistency of drug release

  • Facilitating formulation development and optimization

  • Compliance with regulatory requirements from agencies like the FDA, EMA, and WHO

  • Comparative studies for generic drug development

  • Stability and shelf-life studies

Without dissolution testing, a product might not get approved or may not perform therapeutically in patients.

How Dissolution Analysis Works

In dissolution testing, the dosage form is introduced into a vessel filled with a dissolution medium, which is generally held at 37°C to replicate body temperature. With USP Apparatus I (Basket) or Apparatus II (Paddle):

  • 1

    The dosage form is submerged in the medium.

  • 2

    The device agitates the solution at a set rate of rotation.

  • 3

    Samples are collected at fixed intervals.

  • 4

    The amount of drug dissolved is quantitated by UV-Vis spectrophotometry or HPLC.

  • 5

    The release rate and amount of drug released are plotted against time to develop a profile graph.

Such information is crucial in determining if a product meets the established drug release criteria.

Dissolution Testing Equipment

To achieve correct results while complying with regulations, we have invested in high-end devices for dissolution analysis, which include:

  • Multi-vessel automated dissolution testers

  • I & II USP apparatus baskets and paddles

  • High Precision temperature-regulated Water Baths

  • Online sampling, filtration systems

  • UV vis, and quantitative HPLC systems

Our laboratory ensures that every instrument is calibrated, validated, and maintained by qualified analysts to provide reliable results.

Why Chromak Research?

These in-unit offers more than simply testing. With our results, you shall have utmost confidence and industry-leading compliance, which easily turn into a competitive marketing edge. That is the reason we are the best of the best.

In excess of four decades gives us deep insight into the pharma testing industry and offers highly intricate knowledge. Many decades of staying in the industry come with experience and know-how with numerous products and formulation types

We conduct dissolution testing according to USP <711>. With strict international regulations and standards set forth by the FDA, EMA, ICH, and WHO, inclusion makes their data ready for submission and capable of audit.

Our lab is designed with dissolution testing, making precision reproducibility and rapid turnaround a goal.

Our tests are customized to the chemistry and regulatory needs of your product. If you are testing an R&D batch or a stability sample, we will get it done the way you need it.

From method development & validation through to standard batch analysis and regulatory report generation, our helpful support is provided throughout your product life cycle.

We provide prompt, brief, and exhaustive reports to ensure your development schedules remain on time.

Our professionals are committed to building long-term relationships through reliability, responsiveness, and in-depth technical expertise.

Join Hands with Chromak Research Today

Whether you’re designing a new product or confirming an existing product, Chromak Research is your single source for precision and reliable dissolution testing. We’ll help you achieve quicker regulatory approval, enhanced product performance, and better readiness for the marketplace.

Contact us today to learn more about our Dissolution analysis capabilities.