Elemental Impurities

Elemental impurities have become pivotal in the testing of pharmaceutical products. This is from the requirements in the USP and the ICH Q3D guidelines for heavy metal testing.

BCM uses the following instruments to support you with this testing:

• ICP-MS (Inductively Coupled Plasma – Mass Spectrometry)
• ICP-OES (Inductively Coupled Plasma – Optical Emission Spectroscopy)
• AAS (Atomic Absorption Spectroscopy)

Elemental Impurities Guidelines

The guidelines provide permitted daily exposure (PDE) limits for certain heavy metals. These are dependent on the route of administration. These heavy metals may be introduced to the pharmaceutical product from several sources. These sources can include, but not limited to, contaminants in the raw materials. As well as catalysts used during synthesis, or via interactions with processing equipment.

BCM's Elemental Impurities Detection

BCM Analytical Services ICP-MS capabilities allow the detection of a wide range of elements. We are able to detect a range of concentration levels from low ppt to high ppm. We also have ICP-OES and AAS instrumentation that allows the detection of certain elements from low ppb to high ppm.

BCM's Microwave Digester

What are Elemental Impurities?

Find out more about Elemental Impurity Detection

Having a state of the art microwave digester (closed vessel sample digestion) provides us with the ability to analyse a wide range of samples. These are including solid dose, oral suspensions and soft shell capsules. We have experienced analysts who are proficient in developing methods. As well as validating methods to meet your analytical requirements.

Elemental impurities can have a large negative effect on pharmaceutical products. There are typically trace amounts of metals which can be can be present in pharmaceutical products. They can be from a wide range of sources and can affect the overall performance and safety of the product.

Here at BCM, we work hard to detect these impurities to ensure you know your products are safe for use. For more information get in contact with us.

ALSO SEE:  METHOD DEVELOPMENT   VALIDATION & TRANSFER