Essential Pharmaceutical Materials

Quality Pharmacopeia, CRM and Impurity Standards

Novachem distributes world class pharmaceutical reference standards, including pharmacopoeias, LGC and Acanthus.

A pharmacopoeial reference standard is a reference standard for active ingredients, excipients and impurity substances established under the aegis of and approved by the relevant Pharmacopoeia, such as USP (United States), EP (Europe), BP (Brittish) and JP (Japanese). Australia's TGA recognises European Phamacopeia materials and standards as relevant in Australia. Pharmacopoeial reference standards should only be used for the purposes which are described in the relevant monograph, for which they can be considered a primary reference standard. They should not be considered CRMs. This is because they have been characterised and tested only for suitability for the official purpose, and they are not supplied with a detailed certificate of analysis thus significantly limiting their usability and value.

LGC Standards produce and certify one of the largest collections of primary reference standard CRMs under the QUANT brand, each supplied with one of the most extensive certificate of analysis (CoA), giving customer greater analytical flexibility and certainty. LGC Standards provides supplementary products such as secondary reference standards which are compared to USP, EP or BP and accompanied with an advanced certificate of analysis. 

Acanthus synthesizes and quantifies reference standards of drug metabolites, stable-isotope labelled analogues, degradation products and related compounds for pharmaceutical industries. Many of these molecules are not available from any other source. For example, new releases of a large selection of Clindamycin, Lincomycin, and Desoximetasone Impurity Reference Standards.

All of the catalogue products are fully certified. We also have flexibility of offering custom synthesis products. 

In addition to pharmaceutical standards, we offer Proficiency Testing schemes for pharmaceutical customers. It is a comprehensive range of chemical, microbiological and sterility test materials for pharmaceutical laboratories, as one of LGC PT schemes.

Primary reference standards

What is a primary reference standard?

According to definitions by ICH (Guideline Q7), FDA and WHO, primary reference standards of active pharmaceutical ingredients stand at the top (primary position) of any given classification or comparison chain of pharmaceutical standards for active ingredients, based on the methods that are used to characterise them. The term “primary standard” is also used within ISO metrology definitions to describe a high quality range of reference materials. Pharmaceutical primary standards are reference standards which are established by a thorough qualitative and in most cases quantitative characterisation of the candidate material. Their assay value (or identity only) has been established without the need to compare it to any other material of the same structure.

Pharmaceutical Proficiency Testing (PT)

What is PT?

Proficiency testing (PT) is often referred to as external quality assessment (EQA) especially in the medical /clinical arena. PT is a key element in the laboratory accreditation process, alongside reference materials, enabling laboratories to monitor the quality of their analytical results as stipulated in ISO/IEC 17025.  stipulated in ISO/IEC 17025.

Proficiency testing is a key element in the laboratory accreditation process, alongside reference materials, enabling laboratories to monitor the quality of their analytical results as stipulated in ISO/IEC 170Pharmaceutical PT scheme (PHARMASSURE) is designed to offer a comprehensive range of chemical, microbiological and sterility test materials for pharmaceutical laboratories. 

If you would like any of these materials, search our web shop above or contact us for a detailed and customised quotation.