Reference standards of the State Pharmacopoeia of Ukraine (SPhU RS) is a general term for highly characterised chemical substances, herbal reference standards, biological reference preparations and reference spectra provided by State Enterprise “Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines”, the authorised pharmacopeial body of Ukraine.
SPhU RS are globally recognised. A link to the SPhU RS catalogue is available on the WHO website along with the reference standards of other pharmacopoeias (see Section Reference Standards links at https://www.who.int/medicines/areas/quality_safety/quality_assurance/resources/qas_worldpharmmeetings/en/).
SPhU RS are certified for use in tests and assays prescribed either in the State Pharmacopoeia of Ukraine or manufacturer’s specifications (irrespective of the availability of the pharmacopeial monograph). Their fitness for purpose is verified and specified in the certificate. SPhU RS are not for use in humans or animals.
SPhU RS are accompanied by certificates, the information in which includes:
– Intended use (tests, assays, and analytical methods),
– Value assigned to the SPhU RS (for assays of pharmaceutical substances and impurities),
– Maximum Permissible Uncertainty of the value assigned to the SPhU RS,
– Minimum Test Portion that provides sufficient homogeneity of the SPhU RS (if necessary),
which enables users to make an informed decision about their correct use.
Traceability of SPhU RS allows laboratories to implement the uncertainty concept and thereby comply with the requirements of ISO 17025 (clause 7.6 Evaluation of measurement uncertainty).
Combining the compendial status and features characteristic of certified reference materials, SPhU RS fully meet GMP and ISO requirements. Satisfying the recommendation of EU GMP and PIC/S GMP, namely that ‘compendial reference standards from an officially recognised source should preferably be used as primary reference standards’ (Vol. 4, clause 6.20), SPhU RS have advantages over materials certified by non-pharmacopeial bodies.
Most SPhU RS are suitable for assays in finished drug products (both pharmaceutical substances and impurities). They can also be used for validation of analytical procedures, pharmaceutical development, certification of secondary reference standards intended for quantitative analyses and other tasks of pharmaceutical analysis
There are SPhU RS of technological and degradation impurities that have not analogues in other pharmacopoeias. The impurities are synthesised in the Department of Validation and Reference Standards..
There is a wide range of herbal SPhU RS. For the analysis of herbal drugs and herbal drug preparations, standardised herb extracts are proposed as SPhU RS, which allows determining all the standardised herb marker components from one package of the SPhU RS. Individual compounds from herbal drugs can be isolated and characterised.
SPhU RS can be shipped worldwide.
The revised national part to the General Text 5.12 Reference Standards has been included in Supplement 1 to the 2d Edition of the State Pharmacopoeia of Ukraine (SPhU).