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  • Seminar: Characterisation of non-compendial reference standards for impurities: How good is good enough?

Seminar: Characterisation of non-compendial reference standards for impurities: How good is good enough?


Do you want to know how primary reference standards for drug substances should be characterised?
To give you an idea about what extent of characterisation is necessary for this, you can consult for example the general text 5.12. of the European Pharmacopoeia. Also ICH Guideline Q7 refers to reference standards for drug substances.

And how are reference standards for impurities characterised?
For this kind of work, information and guidance is less easily at hand, and less detailed. The European Pharmacopoeia states that “a CRS corresponding to an impurity is characterised for identity and purity”. The ICH just requires in the impurity guidelines Q3A/Q3B that “reference standards used … for control of impurities should be … characterised according to their intended uses”. National regulatory authorities also do not provide further guidance on the topic. Not surprisingly therefore, approaches to impurity standards vary widely, from both manufacturers of such standards and users as well.

This contribution explains the different approaches to impurity reference standards. The focus is on analytical characterisation, and on the question which level of characterisation is adequate for the corresponding purpose. It will also point out the risks connected to the quantitative use of a qualitative impurity reference standard.


Poster #OT05: Characterisation of impurity standards: How good is good enough?

Topic:  Impurity Reference Standards

Poster board number: OT05

Author: Dr. Christian Zeine

Abstract-ID: 7875_16100

Poster #OT06: Metals Impurities: Efficient USP 232 and ICH Q3D Quantification

Topic:  Metal impurities quantification

Poster board number: OT06

Author: Dr. Christian Zeine

Abstract-ID: 7875_16101



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