CD formulation expands particle testing capability …

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Drug safety is of vital importance to patient safety. Many factors can affect drug safety during pharmaceutical manufacturing. As a New York-based CRO company, CD Formulation always places a high priority on drug safety issues and recently announced its ability to perform particulate testing in accordance with applicable regulations, particularly USP. .

Particulate matter analysis is useful in identifying the potential source of particulates, as well as determining the risk of a product to a patient. The accurate and robust data generated and obtained from particle testing can help pharmaceutical companies perform a proper risk assessment for their finished pharmaceutical products.

“In injections, parental infusions and ophthalmic solutions, there may be undissolved mobile particles present involuntarily, which are what we call particulate matter. Performing particle testing is a necessary step to remove, count and size particulate contaminants to reduce patient harm. Too many particles can clog capillaries in the blood system,” said CD’s Formulation Marketing Manager.

Currently, the USP requires drug manufacturers to adhere to their strict regulations on the number of particles present in the final drug when performing injections and infusions. “Our laboratory is GMP compliant and equipped with state-of-the-art analytical instruments. With the concerted efforts of our experienced analytical experts, formulation and manufacturing team, the optimal particle testing plan can be established and implemented,” added the Head of Marketing.

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

A wide range of analytical chemistry techniques can be used to detect particles, and the following two methods are specified by USP :

Method 1 – Light darkening: 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 do not respect the limits prescribed during the first test by method 1.

Please visit https://www.formulationbio.com/particulate-matter-test.html to further explore CD Formulation’s particle testing capabilities.

About CD wording

Over the past few years, CD Formulation has made commendable achievements in serving as a custom service provider for excipient development and drug formulation. Several research projects on drug formulation have been carried out for its contract customers. Encouraged by these positive results as well as the continued confidence of its partners, the company decides to provide a more comprehensive portfolio of services to its valued customers worldwide.



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