The increasing importance of pharmaceutical impurity reference materials is reflected in the EP monographs, and is also becoming apparent in the registration of drugs
LGC Promochem has published the latest edition of the 'Pharmaceutical reference substances and impurities' catalogue, which reflects a product range of more than 5000 individual standards.
Approximately 1400 of these new products are from the Mikromol range of impurity standards.
LGC Promochem will be exhibiting the new catalogue at the Impurities Conference in Amsterdam on 23-26 September and at CPhI in Frankfurt on 27-29 October 2003.
The increasing importance of pharmaceutical impurity reference materials is reflected in the European Pharmacopoeia (EP) monographs, procedures as described in the pharmacopoeia, and is also becoming apparent in the registration of drugs, where an exact identification and quantification of susceptible impurities is required for assured documentation.
The use of impurity standards is considered to be the most reliable and secure way to determine impurities in drug substances or drug products.
An appropriate standard allows the analyst to use different instrumentation or measuring conditions or even a different valid analytical method while still obtaining reproducible results.
A wide range of known impurities are listed in individual pharmaceutical monographs.
Impurities that are still protected by a patent as well as those that are only known to the manufacturer are not listed, and only a few of the listed compounds are available from the EP as impurity standards. Mikromol, which started making impurity standards for the pharmaceutical industry in 1995, has responded to the market needs by developing new impurity standards whenever an impurity is mentioned in the EP or United States Pharmacopoeia (USP), or when the regulatory authorities have requested evidence of an impurity for official approval.
This ever-increasing range of standards is available Europe-wide from LGC Promochem.
Mikromol, an ISO 9001 certified company recently acquired by the LGC group, follows the Good Manufacturing Practice guidelines.
Each delivered unit is accompanied by a detailed certificate of analysis, which gives information on the identity and purity, together with the various analytical methods and their conditions.
Most of the products are available from stock with others generally available within four weeks.
Mikromol can also custom-synthesise standards.
Claiming to be the leading reference materials supplier in Europe, LGC Promochem offers the widest range of certified pharmaceutical chemical reference substances (CRS) and pharmaceutical impurities available from a single source.
LGC Promochem supplies products from the world's leading manufacturers, ensuring that they meet the exacting needs of its customers.
LGC Promochem's network of offices across Europe and India and experience in reference materials distribution means the company can provide faster delivery, local technical support and assistance with import requirements.
Orders for the new catalogue can be placed via LGC Promochem's interactive website, which offers an advanced search facility and online ordering to account holders for over 11,000 reference materials in English, French or German.
