-- Today, Alfa Chemistry Testing Lab, the professional analytical testing platform of Alfa Chemistry, highlighted its efforts in leveraging cutting-edge analytical instruments to help drive precise and dependable potency testing of compounded formulations.
The potency of a given formulation can be determined using quality control methods and procedures to establish the API concentration in a compounded formulation or sample. Establishing the potency of a pharmaceutical formulation is essential to ensure the medication contains the correct concentration of the active pharmaceutical ingredient, in accordance with the formulation’s intended design. Variability in the concentration of the active pharmaceutical ingredient in a pharmaceutical formulation can lead to reduced product efficacy or, in some cases, potential safety issues. As such, there are several techniques and methods for analytical testing throughout the compounding process to support the production of reliable and accurate compounded formulations.
Leveraging its experience in analytical testing, Alfa Chemistry Testing Lab will employ various validated instrumental methods to help establish the potency of APIs within pharmaceutical formulations. This can include analytical techniques such as chromatography, HPLC, IC, and GC, among other methods. Chromatography methods are a cornerstone of potency testing services, with HPLC, IC, and GC often being used in pharmaceutical analysis due to their ability to accurately identify and quantify APIs, even when present within complex compounded formulations. These chromatography methods work by separating the sample into its component parts, with the API being identified by comparing the chromatogram from the test sample to a reference standard or standard solution. As such, they are highly effective in assessing API concentration and ensuring that there is consistency between different batches of a given compound.
When appropriate, ultraviolet-visible (UV-Vis) spectrophotometry will be used as a secondary method to confirm potency testing results. Spectrophotometry, alongside other methods including titration and microbial assays, can be used for quality control or quality assurance when developing compounded formulations. A broad variety of dosage forms can be analyzed, including powders, capsules, tablets, solutions, suspensions, creams, ointments, gels, and controlled-release systems. Potency testing methods can be used on both sterile and non-sterile pharmaceutical products. This means that across the product development process and routine production, consistent quality control procedures can be followed to ensure a given pharmaceutical product is made to a reliable standard.
As sample amount can impact the reliability of testing methods, Alfa Chemistry Testing Lab has established sample amount guidelines to help clients establish the required sample amount for a particular analysis. The platform will also make recommendations on the appropriate sample amount for each method to help ensure accurate and reproducible data.
The team of analytical professionals within Alfa Chemistry Testing Lab is supported by a variety of modern laboratory instruments to help deliver a reliable and informed analytical testing experience. By following quality assurance and regulatory standards, the team aims to help clients make well-informed decisions throughout pharmaceutical development and quality control, compliance, and beyond.
About Alfa Chemistry Testing Lab
Alfa Chemistry Testing Lab is an analytical testing platform operated by Alfa Chemistry, providing one-stop testing, analysis, and technical support services across pharmaceutical, environmental, consumer product, food, and material analysis fields. The platform is supported by professional technical teams and advanced analytical equipment to meet diverse testing needs.
Contact Info:
Name: Tylor Keller
Email: Send Email
Organization: Alfa Chemistry
Address: New York, US
Phone: +1 516 734 6573
Website: https://www.alfachemic.com/testinglab
Release ID: 89179746
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