Analytik, leading suppliers of innovative analytical instrumentation, are pleased to announce further acceptance for ASD's portable NIR drug analysers with the USA's Food & Drugs Administration purchasing two LabSpec systems after the UK's Medicines and Healthcare products Regulatory Authority bought a system earlier this year for counterfeit drug analysis.
There is growing concern over the increases in the number of counterfeit drugs in circulation. The problem is a worldwide one. In fact it is becoming a worldwide epidemic. Globally, an estimated 10% of all drugs are fakes. The situation costs the public billions of dollars and puts the health of millions at risk. The use of spectroscopy is being used in the fight against counterfeit materials and is growing in popularity with the demand for easy-to-use, portable instrumentation being very important.
The ASD LabSpec 5000 portable NIR analyser available from Analytik.
In the UK, the MHRA group chose a portable NIR spectrometer from ASD to complement their range of laboratory based instruments for counterfeit drug detection. As well as being fully portable, ASD systems bring together research-grade near infrared (Vis-NIR) spectrometers, easy to use reflectance accessories for tablets and capsules and a laptop with intuitive library software. The high resolution and extended wavelength range ensures complete Vis-NIR analysis of the suspect sample's active ingredients and excipients including a colour measurement.
In the USA, the FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits. As it says on its web site, "Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to health."
With rugged styling and dual battery/mains power, the FDA has chosen two ASD LabSpec systems to be used in the field by non-technical operators. Samples are kept securely in place using rugged sampling accessories and repeatable analysis can then be carried out wherever and whenever needed in just a few seconds. No sample preparation is required, and the non-destructive analysis ensures any evidence is left intact and uncompromised. ASD's software allows agents in remote locations such as pharmacies or warehouses to save and send data securely over the internet to the central lab for review, removing the need to package up samples and send them back for analysis and thus avoiding any delays.
As part of the MHRA program, an NIR drugs library created over a number of years using a lab based spectrometer from another instrument manufacturer will be transferred to the ASD system, providing continuity in analysis with the benefits of a fully portable instrument.