Protheragen-ING Lab provides comprehensive disintegration testing services designed to meet the stringent requirements of the pharmaceutical industry. Our state-of-the-art laboratory is equipped with an advanced disintegration testing apparatus, allowing us to deliver precise and reliable measurements. Our team of experienced scientists follows rigorous protocols to ensure that all results are accurate and reproducible.
Disintegration of Pharmaceuticals
Disintegration is an important first step in the drug dissolution process, as it allows the active pharmaceutical ingredient (API) to be released from the dosage form and become available for absorption.
Disintegration testing is a key analytical method used to evaluate the performance of solid oral dosage forms such as tablets and capsules. The disintegration test measures the time it takes for a solid drug product to break apart and dissolve when placed in a liquid medium under standardized experimental conditions.
- Verifying compliance with pharmacopeia standards.
- Evaluating the impact of formulation changes on product performance.
- Detecting potential quality issues like improper manufacturing or degradation.
- Supporting bioavailability and bioequivalence assessments.
- Ensuring batch-to-batch consistency for commercial drug products.
Protheragen-ING Lab's disintegration testing capabilities
Our pharmaceutical analysis laboratory is equipped with state-of-the-art disintegration testing instruments and staffed by experienced scientists to provide comprehensive disintegration testing services, including:
- USP and EP compliant disintegration testing of tablets, capsules, suppositories, and other solid dosage forms
- Evaluation of the effects of media pH, temperature, and other test parameters on disintegration
- Disintegration testing to support formulation development, scale-up, and stability programs
- Custom disintegration testing protocols tailored to your specific drug product needs
Protheragen-ING Lab's disintegration testing methods
We employ advanced methods to determine the disintegration time of pharmaceutical dosage forms:
USP Apparatus Method
This method involves using a USP (United States Pharmacopeia) disintegration apparatus, which consists of a basket-rack assembly containing six open-ended tubes. The tubes are immersed in a water bath, and the time taken for the dosage forms to disintegrate and pass through the mesh at the bottom of the tubes is recorded.
EP Method
Similar to the USP method, the European Pharmacopoeia (EP) method also uses a disintegration testing apparatus, but with specific guidelines and requirements set by the EP. The procedure and acceptance criteria may vary slightly based on the pharmacopoeial standards.
Disintegration Testing for Special Dosage Forms
We also perform disintegration tests for special dosage forms such as orally disintegrating tablets (ODTs) and buccal tablets, following specific regulatory guidelines.
For more information or to request our disintegration testing services, please contact us.