Q3C Tables and List Rev. 4

Issue Date: August 1, 2018
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Quality
Status: Final

Q3C Tables and List Rev. 4

This is the companion document for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance for industry Q3C Impurities: Residual Solvents, which makes recommendations as to what amounts of residual solvents are considered safe in pharmaceuticals.

Download the Guidance Document

webmaster2026-08-05T19:01:53+00:00

ABOUT US

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.

NEWSLETTER SIGNUP

CONTACT US

5500 NW Central Dr, Houston TX 77092

(832) 968-8698

sales@avancebio.com

Q3C Tables and List Rev. 4

ABOUT US

NEWSLETTER SIGNUP

CONTACT US

RECENT NEWS

We’re Hiring: Scientific Account Manager – Biopharma

Bioprocess and Cell & Gene Therapy International 2026

CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts

Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry