Dissolution Test

Drug dissolution test is a standardized method for measuring the release rate of a drug from a given dosage form, which helps to evaluate the performance of a drug, because the rate and degree of drug absorption depend on its dissolution from the formulation. In the pharmaceutical industry, drug dissolution test is usually used for quality control to ensure consistency between production batches.

CD Formulation can provide analytical services for a variety of dosage forms. Our laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with oral formulations dissolution testing services. Our dissolution testing is performed under specified conditions according to specific applicable pharmacopoeial standards. In addition, all our standard solutions and reagents for dissolution testing comply with the regulations of the Pharmacopoeia.

We Can Provide Dissolution Testing According the Following Pharmacopoeias

• European Pharmacopoeia (Ph. Eur.)
• United States Pharmacopoeia (USP)
• Japanese Pharmacopoeia (JP)
• Chinese Pharmacopoeia (ChP)

Four Dissolution Apparatuses Standardized

• USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5°C)
• USP Dissolution Apparatus 2 – Paddle (37°C ± 0.5°C)
• USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5°C)
• USP Dissolution Apparatus 4 – Flow-Through Cell (37 °C ± 0.5°C)

Deliverable

• Data analysis
• Provide full study report

Our Advantages

If you have a requirement about dissolution test services, please contact us by phone or email, our colleagues will reply to you within three working days.

Reference

1. Gao Z. In Vitro Dissolution Testing with Flow-through Method: A Technical Note[J]. Aaps Pharmscitech, 2009, 10(4): 1401.