Corporate Information

Quantus, Inc.

3 Valley Square

Suite 120

Blue Bell, PA 19422

 

MAIN: (866) 876-6537

FAX: (480) 247-4927

info@goquantus.com

Quick Links

Our Services

Remit CUSTOMER Check Payments To:

QUANTUS, INC (#65043)

PO Box 4120

Portland, OR 97208

Mailing Addresses

Send SUPPLIER Bills To:

QUANTUS, INC (#23031)

PO Box 37635

Philadelphia, PA 19101-0635

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. 

 

Starting 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:

 

  • Agilent

  • additional brand support available upon request

 

  • Distek

 

  • Vankle

 
We will route your request quickly to the appropriate representative