Raw Material Analysis

Raw material testing encompasses a huge variety of chemical analysis from the very simple using basic equipment, to complex methods which can only be implemented by a highly skilled analyst using specialised apparatus. Chemika has made large investments in developing the specialised skills needed to complete the difficult methods. By servicing a large number of manufacturers we have the advantage that these skills are maintained by the analysts because the tests are performed regularly. 

Implementation of a compendial method may require specialised glassware or specialised equipment and Chemika has accumulated a variety of custom made apparatus to allow us to best service our clients. For example, we are equipped with 3 different arsenic apparatus, which allow us to test samples according to either the BP, USP or JP methods. Ethylene oxide in raw materials is routinely tested using GCMS.

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Maybe you are equipped to do the test in house, but have short term capacity constraints? Outsourcing raw material testing is simple because external laboratories such as Chemika may already be carrying out the testing on a routine basis.

Experience and expertise results in predictable reporting times and consistently high quality. Although raw material tests are not routinely re-validated at Chemika, where a new technique is implemented the success of method transfer is verified.

We understand that when we report results with the method referenced to a pharmacopoeia, our client expects that the pharmacopoeial method is followed. Methodologies are specified in a product's marketing authorisation and we understand that our clients are often legally bound to follow the BP or USP. The compendia define what can be considered as an adjustment of a method and what is considered a method deviation. Although adjustments or deviations may be necessary to implement a method (with the client duly informed) Chemika will never substitute a completely different technique without changing the method reference to reflect the changed method.

Working with Chemika, you’re supporting a team with principles, dedicated to meeting your goal of improving the health and happiness, of all people, with over 10 years of experience in the area of chemical analysis. Based in Sydney, we are the pharmaceutical testing laboratory of first choice in Australia.

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.