CD Formulation Enlarges Particulate Matter Testing Capability

The safety of a medicine is of vital importance to the safety of patients. Many factors may affect drug safety during pharmaceutical manufacturing. As a New York-based CRO company, CD Formulation always gives high priority to drug safety issues and recently announced its capability of performing particulate matter testing in compliance with relevant regulations, in particular USP <788>.

Particulate matter testing proves to be useful for identifying the potential source of particles, as well as determining a product’s risk to a patient. The accurate and robust data generated and obtained from particulate matter testing can help pharmaceutical companies make an appropriate risk assessment for their finished drug products.

“In injections, parental infusions, and ophthalmic solutions, there may be mobile undissolved particles unintentionally present, which are what we call particulate matter. Conducting particulate matter testing is a necessary step to remove, count and size particulate contaminants to reduce harm to patients. Too many particles may clog the capillaries of the blood system,” said Marketing Chief of CD Formulation.

At present, USP requires drug manufacturers to comply with their strict regulations on the number of particles present in the final drug when they perform injections and infusions. “Our laboratory is cGMP-compliant and equipped with state-of-the-art analytical instruments. With concerted efforts from our experienced analysis experts, formulation and manufacturing team, the optimal particulate matter testing plan can be settled and implemented,” further added the Marketing Chief.

Sources of particulate matter contaminants may come from: the solution itself and its ingredients, the production process and its variables such as environment, equipment, and personnel, the product's packaging, and the preparation of the product for administration.

A wide range of analytical chemistry techniques may be employed to detect particles, and the following two methods are specified by USP <788>:

Method 1 - Light Obscuration: a preferred method unless the product is unsuitable due to viscosity or transparency.
Method 2 - Microscopic Analysis: a second choice to detect non-viable particles if they fail to meet prescribed limits in the first test by method 1.
Please visit https://www.formulationbio.com/particulate-matter-test.html to explore more of CD Formulation’s particulate matter testing capabilities.