The only global FDA registered and inspected high purity hydrochloric acid for the pharmaceutical APIs and Excipients, manufactured in full compliance with FDA cGMP requirements.
Do you require hydrochloric acid for pharmaceutical ingredient production or processing and are worried about FDA compliance?
Detrex Chemicals’ hydrochloric acid is FDA registered and inspected so you can relax and let us protect your products and company. Detrex produces the highest quality hydrochloric acid in the world under cGMP. No other hydrochloric acid producer matches our quality and purity under a proven FDA quality management system auditable by you and your customers. Everything we do is traceable to all source raw materials.
FDA REGISTERED AND INSPECTED
USP VALIDATED PROCESS
ULTRA-PURE DEIONIZED WATER SYSTEM
ICP-MS TESTED FOR ELEMENTS
Detrex hydrochloric acid can deliver anywhere on earth.
Detrex delivers hydrochloric acid around the globe.
Our Quality Assurance guarantees your success.
Master Validation Plan of QMS & SAP
QT9 QMS Software Management System
Master Calibration Program
CAPA System and Continual Improvement Program
Retrospective Process Validation
Documentation Control System
You require the highest quality hydrochloric acid in your production of APIs or Excipients, period.
Our synthetic hydrochloric acid is produced under cGMP and far exceeds all pharmaceutical monograph specification for any country. This fact ensures that you will pass customer and FDA audits and be fully compliant.
Customers come first in everything we do.
Detrex Chemicals produces custom dilutions from 0.1N – 37.5%, custom packaging, custom testing and custom compendials. We offer additional low trace metal FCC grades to meet the future demands of our customers.
We have no volume requirements and produce your products with short lead times. We are the only hydrochloric acid producer in North America that packages directly from our batch tanks into your final package thereby eliminating any risk of contamination.
Our Quality Control procedures and lab documentation protects your investment.
Batch and lot production tracking.
Full traceability of components/ingredients, from raw materials to finished product shipments to customers.
All documentation second person inspected and verified.
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