Our company is committed to providing elemental impurities detection services for the pharmaceutical industry according to the USP pharmacopeia and ICH Q3D elemental impurity guidelines. Based on advanced detection technology and laboratory equipment, we are able to detect almost all elemental impurities. If you have any needs, please contact us.
Our Services
Elemental impurities have the potential to catalyze the decomposition of API, leading to reduced shelf life. Moreover, these impurities could introduce adverse effects, resulting in poisoning the human body. Consequently, it is imperative to control and monitored the concentration of elemental impurities in both API and their intermediate byproducts, thereby ensuring the quality, safety, and effectiveness of API.
With rich experience in elemental impurities detection and advanced analysis and sample preparation technology, our company can develop an elemental impurity detection plan for you to achieve API compliance. Our analytical laboratory is equipped with ICP-MS instruments that can be utilized for analyzing challenging and complex API samples. Below are the elemental impurities in API that we can detect.
Our Techniques
Atomic Absorption Spectroscopy (AAS)
AAS detects elements in liquid or solid samples by utilizing the characteristic wavelength of electromagnetic radiation from a light source. Different elements absorb wavelengths differently, and these absorbances are measured against standards. The majority of elements achieve an excitation state at a maximum temperature of 2,600 °C using this source. However, for a few elements like V, Zr, Mo, and B, the source temperature is insufficient to atomize the molecules, resulting in reduced sensitivity.
Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES or ICP-AES)
The source in ICP-OES is a plasma with temperatures as high as 10,000 °C, in which all elements (including refractory elements) can be atomized with higher efficiency than AAS. Therefore, elements can be determined more accurately and the limits of detection can be reduced.
Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
The sample is dissociated into atoms and ions using the same source as ICP-OES. The basic difference between ICP-OES and ICP-MS is that ions are directly detected by the MS detector, rather than being detected by optical emission like in ICP-OES. Due to the high number of ions generated, most elements in ICP-MS can achieve optimal detection limits, although some spectral interferences may be observed, but these interferences are clear and limited.
X-ray Fluorescence (XRF)
XRF is a non-destructive analytical technique used to determine the elemental composition of materials, both qualitatively and quantitatively. By measuring the fluorescence (or secondary) X-rays emitted when the sample is excited by a primary X-ray source, the analyzer discerns the chemical composition of the sample. Each element in the sample produces a unique set of characteristic fluorescent X-rays. Compared to XRF, ICP-OES technology has higher sensitivity and lower detection limits. Therefore, using XRF to determine lower content results in higher errors and a weaker correlation with ICP-OES.
Our Advantages
- Broad impurity coverage: Our company can detect a wide range of elemental impurities, including Class 1, Class 2A, Class 2B, and Class 3 impurities, as well as other miscellaneous elements that can be present as impurities.
- Experienced team: Our team boasts rich experience in elemental impurities detection. They can develop customized impurity detection plans that align with API compliance requirements.
- Variety of detection techniques: Our company employs a range of detection techniques to accurately detect lower levels of elemental impurities.
Delivery
Elemental impurities contained in API
The amount of each elemental impurity contained in the API
Other experimental data
Please kindly note that our services are for research use only.
