Potency Testing

The potency of a drug refers to the efficacy or pharmacological effect of the drug in the treatment. The terms "potency" and "strength" are often used interchangeably, with "potency" being used more by the general public and "strength" being used more by practitioners and official compendia ^[1]. Each drug has its own specific chemical composition and structure, which determine its mechanism of action and the strength of its effect. Related analysis technology can be used to quantitatively analyze the chemical composition of drugs in order to evaluate their potency. Therefore, potency testing is designed to determine the amount of active ingredient (API) in the sample and is a quantitative test. Potency testing is very important to ensure that the product meets the quality standards and the related requirements and standards.

Our company focuses on the development and validation of quantitative methods for potency testing. We offer potency testing for a wide range of formulations and active ingredients. Up to now, we have accumulated a lot of successful experience in potency testing and have unparalleled expertise to ensure the successful and timely completion of your test program.

How Can Potency Testing Help You?

Potency testing is a valuable tool for measuring concentrations of active pharmaceutical ingredients (API). Thus, this essential test can (including but not limited to):

Potency Testing at Our company

Our potency testing service involves customized extractions and specialized instrumental techniques to identify and quantify the active ingredients present in various drug samples.

The samples we can test include many drugs with different formulation formats, including:

• Raw Powders
• Triturates
• Tablets
• Capsules
• Pellets
• Controlled Release Products

• Blend Powders
• Troches
• Suppositories
• Suspensions
• Solutions
• …

• Granulations
• Gels
• Lotions
• Creams
• Ointments

The instrumental techniques we use include:

• Chromatography: At Our company, high-performance liquid chromatography (HPLC), ion chromatography (IC), and gas chromatography (GC) are preferred methods to measure API concentration because they are specific and efficient. These techniques are performed by comparing a known reference standard at a known concentration to the sample (drug substance or product).
• Spectrophotometry: Our company also uses ultraviolet (UV)-visible spectrophotometry to determine potency.
• Other Methods: Other methods used to test potency include titration, which uses the principles of chemistry, and microbial assays, which are sometimes used to test antibiotics.

Sample Amounts for Potency Testing

The sample amounts have a crucial influence on the accuracy and reliability of the potency testing results, and different formulation formats may require different sample amounts. To obtain accurate results of potency testing of the compounded preparation, Our company has provided recommended sample amounts for potency testing, details of which can be found in the table below.

Note: These sample amounts are not the minimum required for potency testing, but the minimum amount recommended by Our company to obtain the truly result. If you need more information about the sample amounts of potency testing, please contact us.

Our company performs hundreds of potency tests each year, so our scientists have extensive experience in performing potency tests for a wide range of drugs that can meet your testing needs quickly and with high quality. In addition, our scientists are committed to developing new detection platforms and methods, so we have the ability to carry out any potency testing project. If you are interested in our services or have any questions or needs, please feel free to contact us. We will be happy to provide you with support and services.

Reference

1. Allen L. V., et al. Strength and stability testing for compounded preparations[J]. US Pharmacop, 2014: 1-7.

It should be noted that our service is only used for research, not for clinical use.