Dissolution Bath Qualification Services
Quick turn-around services available for the this service line
Off-the-shelf executable protocols are approved and ready to go. Providing you with properly documented evidence your equipment is meeting its acceptance criteria
Dissolution Bath Qualification
Dissolution Bath Mechanical Qualification (MQ) Services
Our Dissolution Bath services support your routine calibration and mechanical qualifications services requirements. Quantus validation service personnel have been trained on providing Dissolution Equipment Services, including: Calibration, Installation Qualification (IQ), Operation Qualification (OQ), and Mechanical Qualification (MQ) to meet FDA 21 CFR 211.160 and ASTM E2503 Guidance.
As of December 01, 2009, the use of Salicylic Acid Tablets RS is no longer mandatory for USP Dissolution Apparatus 1 and 2 during the Performance Verification Test (PVT). It has been determined the use of USP calibration tablets can lead to variability in the dissolution measurement system. The FDA has also determined that an "appropriately rigorous mechanical calibration method properly executed will satisfy the CGMP requirement for dissolution apparatus calibration under § 211.160(b)(4)". Since the variability of the USP tablets makes it difficult for the chemical calibration to assess the calibration/qualification of apparatuses for dissolution testing, the FDA provided supporting guidance on the use of mechanical calibration/qualification as an alternate approach.
We have off-the-shelf protocols and service documentation ready to go for the following Dissolution Bath Brands:
additional brand support available upon request