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SOTAX Corporation, (Horsham, PA, USA), SOTAX (Canada) Ltd., (Brampton, ON, Canada) SOTAX AG (Basel, Switzerland), and SOTAX China, (Shanghai, China) the worldwide market leader in USP Apparatus 4 Flow Through Dissolution has released its new and improved CE 7 smart USP 4 Apparatus with new micro volume autosampler.

In recent years, the Flow Through Dissolution method has been used for a variety of products for submission including the first approved elution method for a drug eluting stent, implants, suppositories, MR tablets and a number of injectable suspensions.

As a result of a commitment to our existing customers in the medical device industry as well as our customers performing small volume dissolution, SOTAX has engineered a new automated sampling solution to increase performance, productivity and ease of use for the R&D and QC labs.

With a minimum volume of 5 ml in a closed loop set up, the upgraded apparatus can now be controlled via firmware only eliminating the need of software control further improving the ease of use and transition from R&D to QC. Methods can be programmed within the touch screen of the CE 7 smart with sampling times as well as a print out report of temperature. Further improvements have been made internally, to improve robustness, minimize tubing volumes for smaller volumes as well as for use with solvents. New cell types include optional glass for 12 and 22.6 mm flow cells as well as a variety of custom manufactured cells and holding devices.

Our new small volume autosampler can accurately take up to 29 samples points as low as 150 ul into capped HPLC vials. Using a syringe module, samples are withdrawn from the closed loop media reservoirs with extreme accuracy. Special attention was also taken to prevent carryover with a rinse and blow out function. Studies have shown comparable data between manual and automated sampling with minimal carryover. Withdrawn samples can also be cooled with an optional Peltier cooling rack if drug degradation is an issue.

To further increase productivity in the QC lab, a single system can also be easily converted into a double system allowing for up to 14 samples being tested at one time.

These improvements add to the many advantages and flexibility of USP 4 testing allowing for discriminatory and reproducible results that are easily validated and automated for a robust and rugged QC method.

Interested in feasibility studies or development assistance with USP 4, contact our new development lab at contact@sps-pharma.com or visit us at www.sps-pharma.com.

Source: SOTAX Corporation