Dissolution Testing

Dissolution testing is a vital technique employed to examine the rate and extent at which a drug's active pharmaceutical ingredient (API) dissolves from a solid dosage (such as tablets and capsules) form. The test simulates human physiology, with variables such as temperature, pH, and agitation speed adjusted to predict a proposed drug's solubility. A well-designed dissolution test provides crucial insights into factors like drug absorption rate, drug release time, and overall efficacy of the medication, and thus, it is crucial in various stages of drug production, including formulation development, stability studies, and quality control. With our extensive experience in dissolution testing, Alfa Chemistry aims to provide top-rated services that meet industry standards. Our dedicated dissolution testing service strictly adheres to United States Pharmacopeia (USP) [General Chapter<711>], European Pharmacopeia (EP), US FDA and ICH guidelines.

Why perform dissolution testing?

Dissolution testing is crucial in drug development and production for various reasons:

• Evaluation of Bioequivalence: It's used in comparing the dissolution profiles of two similar solid dosage forms, containing the same APIs, which could contribute to evaluate bioequivalence.
• Assurance of Bioavailability: This test helps predict how well the drug will be absorbed into the bloodstream when ingested.
• Consistency in Manufacturing: It ensures that the drug produced in different batches have the same dissolution rate which creates consistency in the dosage and efficacy of the drug.
• Product Stability: It guarantees the stability of the product through its specified shelf-life.
• Control Over Manufacturing Process: Regular testing continuously ensures that the manufacturing process remains within acceptable limits.

Alfa Chemistry offers dissolution testing services for any form of solid dosage, including:

Alfa Chemistry provides standard USP apparatus for pharmaceutical dissolution testing, including:

• USP Apparatus 1- Basket: It is suitable for capsules and tablets.
• USP Apparatus 2- Paddle: It is versatile and used most often.
• USP Apparatus 3 - Reciprocating Cylinder: It is mostly used for extended-release dosage forms.
• USP Apparatus 4 - Flow-Through Cell: It offers complete flexibility and is used for poorly soluble drugs such as powders, suspensions, microspheres and medical devices such as drug eluting stents.

By equipped with these cutting-edge analytical tools, our team of expert scientists can help you through every step of your product's development and testing. Moreover, to ensure superior quality and reliability, our dissolution testing systems undergo regular inspection and maintenance.

To serve you at every stage of development

At Alfa Chemistry, our dissolution services extend to all stages in the product lifecycle, from initial stages of characterizing and selecting the API, formulation development, production process validation, through to stability testing and commercial product. Full service helps you ensure the reliable quality and efficacy of your pharmaceutical products.