Good, strong control of metallic elements in generic drug formulations provides maximum safety to patients. Over the past few decades, progressive advances in detection technology and analytical methods have enabled pharmaceutical manufacturers to better and more comprehensively assess metal elements in formulations. USP allows manufacturers to use any method or instrument they wish, as long as they can demonstrate accuracy, sensitivity, and specificity. However, USP recommends the use of plasma spectrochemistry and atomic absorption spectroscopy for the detection of metallic elements. Alfa Chemistry offers a complete elemental analysis solution for metals in the Reference Listed Drugs (RLDs), combining simplicity and innovative design for superior performance. Our Consistency Evaluation Laboratory introduces advanced Atomic Absorption Spectrometry (AAS), Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis technologies to assist you in the rapid detection and analysis of metal elements in the RLD formulations in the consistency evaluation. Our method strictly follows the USP-NF process and meets all the FDA requirements.
Our Services
AAS Solution
AAS, which detects metal elements in liquid or solid samples by applying characteristic wavelengths of electromagnetic radiation from a light source, remains the routine choice for simple trace element analysis. Alfa Chemistry provides accurate, high-precision and simple AAS service by measuring elements at parts per billion (ppb or µg/l) concentrations in solid and liquid samples.
Our testing process:
- The method is established based on the reaction of the RLDs with reagents to obtain binary or ternary complexes under appropriate pH environment
- These complexes are easily extracted with organic solvents, and estimated by indirect atomic absorption via measuring the metal content of the complexes formed after extraction in hydrochloric acid
Advantages of our AAS methods:
- Support for metallic elements requiring flame analysis
- Superior detection limits: Parts-per-billion ultra-trace detection capability
- Optimization routines can be included in the method to ensure desire optimization of parameters
ICP-OES Solution
According to USP<232><233>, our experts optimize the method development for the determination of elements including method validation and method transfer. We offer ICP-OES analysis services to identify the presence of free metal atoms in the RLD formulations, thereby helping to determine the concentration of the element of interest.
ICP-MS Solution
ICP-MS is a multi-element detection technique with very high sensitivity and a wide linear dynamic range. Therefore, ICP-MS has always been the technology of choice in the pharmaceutical industry. Alfa Chemistry offers reliable ICP-MS analysis services for simultaneous analysis of major metal components and ultra-trace elements in the RLDs. Our experts accurately measure the RLD's target element according to the stringent criteria specified in USP 233.
Advantages of Our Technology
- High detection limit: There are still good detection limits for As, Cd, Hg, Pb and other elements specified in USP
- Extend the linear range of multi-element, wide linear range: from ppt to ppm level
- Support the combination with other techniques such as HPLC, IC, etc.
