CD Formulation Begins to Offer Dosage Unit Uniformity Test

Having a cGMP-compliant laboratory and a series of state-of-the-art analytical instruments, CD Formulation recently announces to provide dosage unit uniformity test for scientists or companies that are engaged with drug development projects.

Each unit-dose must have uniform active pharmaceutical ingredients (APIs) to ensure that the drug product meets relevant quality specifications. Poor quality drugs will bring unwanted side effects to patients and thus should not be released to the market.

“At present, uniformity of dosage unit test is viewed as a must-do step in drug formulation. The content uniformity or weight variation of different dosage units, such as tablets and capsules, must be carefully evaluated,” commented one of the senior scientists from CD Formulation. “Our dosage unit uniformity test is conducted in compliance with pharmacopeia methods. Moreover, the final data and report we provide is accurate and reliable, which can help our clients better assess the potential risks of the finished drug.”

The uniformity of the dosage unit can be measured by two methods, namely, weight variation or content uniformity. These two methods apply to both dosage forms containing a single active ingredient and dosage forms containing two or more active ingredients. There is a threshold limit between content uniformity (for dosage units containing < 25 mg or < 25 %) and weight variation (for dosage units containing ≥ 25 mg and ≥ 25% of API except for sugar-coated tablets requiring content uniformity).

At CD Formulation, different dosage forms can be tested in terms of unit uniformity, including tablets, capsules, solids in single-unit containers, suspension, emulsion, or gel for systemic use only and packaged in single-unit containers, solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers, and oral solutions packaged in unit-dose containers and into soft capsules, etc.

To test content uniformity, appropriate analytical methods are Raman spectroscopy, transmission Raman spectroscopy and high-performance liquid chromatography. With in-depth market research and also past contract research experiences, CD Formulation can provide a full range of customized drug analysis services. Please visit https://www.formulationbio.com/ to learn more.

About CD Formulation

As a science-driven company, CD Formulation is a trustworthy partner for pharmaceutical companies, providing CRO services to develop, design, and produce pharmaceutical excipients to meet different customers’ needs. Motivated by an innovative spirit and a down-to-earth attitude, the company spares no effort to address the long-standing issues that arise from drug dosage development stages, whether it’s initial pre-formulation trials or commercial manufacturing.