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  • Temperature Controlled Specific Rotation Measurement in Accordance with EP & USP

Temperature Controlled Specific Rotation Measurement in Accordance with EP & USP

Mar 25 2019 Read 215 Times

Recent changes within pharmacopoeia states that optical rotation measurements for all monographs must be taken at 20 ±0.5 °C. Traditionally laboratories look to external waterbaths to perform such a function but with limited laboratory space and budget in mind, Bellingham + Stanley’s latest ADP450 polarimeter with XPC Technology, Xylem’s patented on-board Peltier temperature control system for measuring optically active samples at stable temperatures, offers a viable alternative to cumbersome peripheral devices.

Capable of measuring up to 3.0 OD at 589nm over a maximum tube length of 200mm, the ADP450 offers three decimal place precision to an accuracy of ±0.01 °Angular, making it ideal for general purpose use across many different industries; especially within pharmaceutical research, production and quality control laboratories.

A "single-shot" reading mode provides a discrete measurement for pharmaceutical controlled conditions; whilst the PHR-Method allows a statistical analysis of up to 10 samples from a production run; with all results recorded along with statistical batch analysis. The Methods system also provides rapid configuration for sample specific scale reading (optical rotation, specific rotation, % sucrose, % glucose, etc.) and experiment temperature set-point (20 or 25 °C) as well as performing sample limit checking against stored assays.

Latest ADP450 models have newly enhanced onboard software to help laboratories comply with FDA regulation 21 CFR Part 11; without the additional costs or data security risks associated with a PC & software. Recording of results, instrument access and configuration is also possible as too is a Review & Approve electronic signature process that may even be achieved remotely. Encrypted Print to Secure PDF, csv and XML outputs makes data integration to LIMS simple, secure and auditable.

For laboratories looking for that extra accuracy or the ability of measuring at other wavelengths, the flagship ADP600 Series polarimeters offer not only the above but also 3-decimal place accuracy and a variety of pharmacopoeia cited wavelengths across the UV and visual spectrum; that is, 325, 365, 405, 436 and 546nm as well as the newly added 633nm wavelength, equivalent to a helium neon laser line. The ADP600 Series incorporates an onboard airflow Peltier temperature control system that stabilises the sample temperature at the pharmacopeia prescribed 20 or 25°C and now has the latest software for operation in FDA controlled environments. As such, the ADP600 series meets all requirements of pharmacopeia for optical and specific rotation (precision, wavelength, temperature), including the ability to measure Dextromethorphan Hydrobromide at 325nm, where readings must be within 1% of readings of a USP Reference Standard of the same material.

The same Method system incorporated in all ADP series polarimeters is also common across the RFM digital refractometer range too. This makes use of refractometer and polarimeter in the same laboratory very familiar to its operators. Connection to LIMS is made easy with a fully configurable XML data output making for easy integration with plant LIMS or generally available software packages including LogiLAB® SDMS and IKA laboratory technology’s Labworldsoft 6.

LogiLAB® is a registered trademark of Agaram Industries.

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