Potency Testing

In the field of drug compounded preparations, potency testing is a quality control method used to determine the concentration of active ingredients in a compounded medication. This testing ensures that the medication is prepared accurately and contains the correct amount of active ingredients as prescribed by a healthcare provider. Potency testing is essential to guarantee the effectiveness and safety of the compounded medication for the patient. Alfa Chemistry takes pride in providing premium potency testing services for compounded medications. Our state-of-the-art laboratory is fully equipped with technically advanced instruments and manned by a team of elite professionals who ensure the accuracy of testing.

Potency testing offers a plethora of benefits:

• The primary advantage of potency testing is that it ensures the quality and safety of the product, thereby reducing the risk of adverse reactions or consequences. This is critical as significant variations in the potency of compounded preparations could lead to therapeutic failures or toxicities.
• Secondly, potency testing supports regulatory compliance. As it verifies the active ingredient and its concentration, it aids in meeting the requirements set by regulatory authorities such as the FDA. This assists businesses in avoiding legal troubles and maintain their credibility in the market.
• Moreover, potency testing generates a comprehensive understanding of the pharmaceutical preparation, validates its stability, and reveals any inconsistency in the mixing procedure.
• Finally, potency testing also boosts customer confidence. Gaining the approval of potency testing sends a powerful message to the customer about the vendor's commitment to quality and safety. This not only improves the reputation of the vendor but also results in higher customer satisfaction and loyalty.

Alfa Chemistry offers potency testing on a wide assortment of compounded preparations:

Essentially, our potency testing can be performed on virtually any compounded preparation, whether sterile or non-sterile.

Our advanced instrumental techniques for potency testing

To maintain the viability and quality of compounded drugs, we use various instrumental techniques in potency testing. The primary technology is chromatography methods, such as HPLC, IC, and GC, which allow us to accurately measure the concentration of active pharmaceutical ingredients (API) in drug preparations. By comparing a sample to a known reference standard, we can determine the potency of the drug substance or product with precision and efficiency. In addition, we use spectrophotometry, specifically UV-visible spectrophotometry, for potency testing to further guarantee the quality of compounded drugs. Moreover, these advanced techniques, combined with other methods like titration and microbial assays, reinforce our commitment to delivering high-quality and reliable potency testing to our customers.

Sample amounts guideline for potency testing

The accuracy and reliability of potency testing results are significantly impacted by the sample amounts, and varying formulation formats may necessitate distinct sample quantities. To help our customers obtain precise and reliable results, Alfa Chemistry has provided recommended sample amounts for details, please refer to the table provided below (Note: These sample amounts are not the minimum required for potency testing, but the minimum recommended by Alfa Chemistry to achieve accurate results. For more information on sample amounts for potency testing, please reach out to us.).