Dissolution Profile

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Pharmaceutical dissolution testing for solid dosage forms including routine dissolution and advanced methods for immediate or controlled release systems, delivered from our GMP laboratories.

Pharmaceutical dissolution testing plays a key role in drug development and across the drug product lifecycle. In early phase development, dissolution helps to establish the dissolution mechanism, in later stages (stage II to III) dissolution testing helps to drive insight into key formulation or process parameters and also an in vitro-in vivo correlation. Supporting product registration and beyond, the focus is on identifying a quality control dissolution test method to verify process and product consistency.

Our scientists provide standard dissolution testing according to Indian Pharmacopeia (IP), United States Pharmacopeia (USP), European Pharmacopeia (EP) and other regulatory guidelines for solid dose products. We are experienced in the development of specific dissolution approaches that are matched to the product’s specified release characteristics, in order to identify changes in critical quality attributes. This includes selection of the dissolution media, the dissolution apparatus and agitation rates.

There are multiple ‘official’ types of dissolution test apparatus, each with key features and benefits. They include:

Basket Apparatus: used frequently for capsules and floating drug delivery systems. The Basket Apparatus features a coated wire mesh basket that holds the sample and rotates in the dissolution medium.

Paddle Apparatus: commonly used for tablets. Paddle Apparatus (Apparatus 2), preferred for tablet dissolution tests, employs a cylindrical glass vessel with a rotating paddle that spins the dissolution medium around the tablet.

We use SMEs in dissolution testing to drive greater efficiency and productivity. UV/Vis spectrophotometric determination of absorbance has been the traditional analytical method for dissolution testing and is the preferred method for efficiency and automation.

The right apparatus for a dissolution test largely depends on the type and properties of the tablet or other solid dosage form being tested. While the Paddle Apparatus is widely utilized for testing rapidly disintegrating tablets due to its suitability for most dissolution conditions, the Basket Apparatus can be a better pick when dealing with floating tablets or capsules that tend to stick to vessels’ walls.

Disintegration Testing
Our physico-chemical property team also provides disintegration tests which may be used to substitute for dissolution (ICH Q6A), for example, when immediate release solid oral drug products, made from highly water soluble drug substances, have been demonstrated to have consistently rapid drug release characteristics.

Our expertise in dissolution testing will allow you to accelerate your drug development and support your quality control or release testing programs. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

Testing Locations
Baddi, Himachal Pradesh

Contact Us
If you have additional questions about pharmaceutical testing or would like to consult with experts at Zexa Labs, just send us a request or call us at + 0179 545 6944.

Testing Options
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, fill out the Sample Submission Form.