残留溶剂测试- USP 467 & 我Q3C

Regulatory agencies require the control of residual solvents in pharmaceuticals, ensuring finished products are free from toxicologically significant levels of volatile organic compounds, as they provide no therapeutic effect 和 present a risk to patient health. im体育APP provides residual solvents testing services per USP <467> 和 我Q3C residual solvents guidelines.

Solvents are often necessary for the production, 制造业, 或药品的纯化, 赋形剂, 还有药物, 因为它们可以提高收率和溶解度, 除了增强结晶. 然而, 这些溶剂中有许多是有害的, 和 may be present in materials 和 finished products as process residuals. A determination of the risk to patient health can be made based upon on the toxicity 和 concentration of residual solvents present.

Permitted daily exposure (PDE) limits for commonly used solvents have been defined by the United States Pharmacopeia (USP) 和 the International Council for Harmonization (ICH) in USP <467> 和 我Q3C 指导. Analytical methodology for testing of common residual solvents is detailed within the USP guidelines for residual solvents as well as Ph. 欧元./EP 5.4. The USP 和 ICH guidelines for residual solvents limits have divided solvents into three classes:

第一类溶剂 -应避免使用1类溶剂. This class of solvents includes known human carcinogens, 强烈怀疑是人类致癌物, 环境危害.

第2类溶剂 -限制使用2类溶剂. This includes non-genotoxic animal carcinogens as well as other agents that could possibly cause other irreversible toxicity, 如致畸性或神经毒性. 另外, this category extends to solvents that are suspected of other significant, 但可逆, 毒性.

3类溶剂 - 3类溶剂具有低毒潜能. Solvents included in this classification have a PDE of 50mg or more per day, as there is no need for a health-based exposure limit.

Residual solvent testing 方法 for unique solvents 

然而, if solvents other than those included in 我Q3C or USP <467> residual solvents 指导 are used, the manufacturer of the drug product is required to establish a suitable residual solvent testing method, as well as determine the acceptable PDE for that particular solvent. As some unique solvents are not addressed in the regulatory 指导, im体育APP’s consultative regulatory 和 scientific experts offer product-specific analytical method development for residual solvents, as well as method validation according to ICH Q2 guidelines for the validation of analytical procedures. Our experienced scientists also conduct residual solvents testing using our internal internal 气相色谱质谱(GC/MS) 方法. 另外, existing 方法 can be transferred to im体育APP’s laboratories. 今天就和专家谈谈 to explore im体育APP’s residual solvent testing services. 

Control residual solvents with USP <467> 和 我Q3C residual solvents testing

The identification 和 determination of residual solvents is critical to ensuring that finished products are safe. 为此目的, the control of residual solvents in pharmaceutical raw materials 和 赋形剂 is often part of a robust quality control strategy. im体育APP has deep expertise 和 experience conducting residual solvent testing in compliance with USP <467> 和 我Q3C in pharmaceuticals 和 other finished products. Our experience extends to the quantitation of residual solvents in medical tubing, as well as the modification of USP <467> for use with a water insoluble medical device.

im体育APP优势 

With decades of experience developing 和 validating product-specific residual solvent testing 方法, 除了利用现有的方法, including USP <467> 和 我Q3C to identify 和 quantitate residual solvents to the lowest possible levels of detection, im体育APP is the preferred partner of leading organizations for residual solvent testing. Working closely 和 collaboratively with our customers, our regulatory 和 scientific experts look for potential sources of solvent contamination 和 assist in working to eliminate 和 control residual solvents. We also help to resolve difficult out of specification (OOS) issues related to solvents. 此外, testing to USP <467> 和 我Q3C 指导 for residual solvents can be performed on a rush basis to meet the needs of your business.

For more information about our USP <467> residual solvent testing 和 ICH residual solvents testing services, 或者找我们的专家谈谈, 立即im体育APP.