Detrex Chemicals - Pharmaceuticals - Pills

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. 

PHARMACEUTICAL

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

USP VALIDATED
ULTRA-PURE DEIONIZED WATER SYSTEM

ICP-MS TESTED FOR ELEMENTS

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.

Detrex is a fully transparent
partner in your success. 

 

All internal analytical results are verified annually by accredited third-party testing labs and posted online for easy access.

DON'T SEE THE FORMULATION YOU NEED? CONTACT US TO DEVELOP A CUSTOM GRADE FOR YOU. 

PHARMACEUTICAL GRADE
HYDROCHLORIC ACID PRODUCTS

SPECIFICATION SHEETS 

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We offer samples that specifically meet your needs.

 

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Detrex Chemicals
A Division of Detrex Corporation
1000 Beltline Street 
Cleveland, Ohio 44109 USA

Phone: 1.800.321.0467
Fax: 1.216.749.7462
Product Inquiries

Detrex Corporate

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DETREX   |   PURITY FROM THE SOURCE   |   ISO 9001: 2015 AND 14001: 2015 CERTIFIED   |   MADE IN THE USA

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