Ryno Swanepoel, Author at Chemetrix https://chemetrix.co.za/author/ryno/ Powerful Partnership, Inspiring Insights Wed, 08 Sep 2021 07:55:12 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.8 Raw Materials & Manufacturing | Raw Materials Verification https://chemetrix.co.za/raw-materials-manufacturing-raw-materials-verification/ https://chemetrix.co.za/raw-materials-manufacturing-raw-materials-verification/#respond Tue, 27 Jul 2021 15:24:00 +0000 http://chemetrix.co.za/?p=4016 Continue reading "Raw Materials & Manufacturing | Raw Materials Verification"]]> To avoid manufacturing errors, accepting incoming materials for pharmaceutical manufacture requires verification of the material’s identity. The resources needed to do this testing can be high, particularly where 100 % testing is mandatory or desirable. Chemetrix offers a range of Spectroscopy and Chromatography based solutions for fast and efficient Raw materials verification.

 

Resources

Verifying Raw Materials Using Spatially Offset Raman Spectroscopy

Technical Overview

Through-Container Identity Verification of Polysorbates 20, 40, 60, and 80 with the Agilent RapID Raman System

Application Note

Raw Material Identity Verification in Biopharmaceutical Production Using the Agilent RapID Raman System

Application Note

Raw Material Identity Verification in Sterile Manufacturing Using the Agilent RapID Raman System

Application Note

Rapid Identification of Polysorbates 20 and 80 Directly Through Amber Bottles

Application Note

Measuring raw materials without sampling—directly through their containers

Application Note

Identifying Raw Materials Directly Through Paper Sacks

Application Note

]]> https://chemetrix.co.za/raw-materials-manufacturing-raw-materials-verification/feed/ 0 Quality Control | Dissolution Testing https://chemetrix.co.za/quality-control-dissolution-testing/ https://chemetrix.co.za/quality-control-dissolution-testing/#respond Tue, 27 Jul 2021 12:41:49 +0000 http://chemetrix.co.za/?p=4074 Drug dissolution testing provides necessary in vitro drug release information for pharmaceutical manufacturing quality control, making it a critical tool for performance characterization of diverse dosage forms. Agilent offers pharmaceutical dissolution testing products for product formulation and other applications.

 

Resources

Merits of Automated Sampling in Dissolution Testing

Technical Overview

Dissolution Systems Source Book

Catalogue

]]> https://chemetrix.co.za/quality-control-dissolution-testing/feed/ 0 Quality Control | Residual Solvent Testing https://chemetrix.co.za/quality-control-residual-solvent-testing/ https://chemetrix.co.za/quality-control-residual-solvent-testing/#respond Tue, 27 Jul 2021 12:37:50 +0000 http://chemetrix.co.za/?p=4067 Continue reading "Quality Control | Residual Solvent Testing"]]> Residual solvent impurities in pharmaceuticals are trace amounts of volatile organic compounds used in drug production that remain in the final drug product. Strict regulations require close monitoring on the presence of residual solvent, as even trace amounts can impact drug safety and efficacy.

 

Resources

Satisfy Requirements for Residual Solvent Analysis

Brochure

Residual Solvents Analysis Using an Agilent Intuvo 9000 GC with 8697 Headspace Sampler

Application Note

Analysis of USP Method <467> 

Application Note

]]> https://chemetrix.co.za/quality-control-residual-solvent-testing/feed/ 0 Quality Control | Elemental Impurities https://chemetrix.co.za/quality-control-elemental-impurities/ https://chemetrix.co.za/quality-control-elemental-impurities/#respond Tue, 27 Jul 2021 12:33:03 +0000 http://chemetrix.co.za/?p=4059 Continue reading "Quality Control | Elemental Impurities"]]> With increasing awareness of the potential harmful effects of inorganic contaminants, regulatory organizations have provided new guidelines recommending analytical techniques, such as ICP-OES and ICP-MS, to monitor elemental impurities. Agilent offers integrated solution for confident elemental impurities testing.

 

Resources

USP <232>/<233> and ICH Q3D Elemental Impurities Analysis by ICP-OES

Application Note

USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: Agilent’s ICP-MS solution

White Paper

Support for 21 CFR Part 11 and Annex 11 Compliance: SDA Module for Agilent ICP-MS MassHunter Software

White Paper

Simplified QC for Pharmaceutical Elemental Impurity Analysis

Overview

]]> https://chemetrix.co.za/quality-control-elemental-impurities/feed/ 0 Quality Control | Nitrosamine Mutagenic Impurities https://chemetrix.co.za/quality-control-nitrosamine-mutagenic-impurities/ https://chemetrix.co.za/quality-control-nitrosamine-mutagenic-impurities/#respond Tue, 27 Jul 2021 12:27:51 +0000 http://chemetrix.co.za/?p=4050 Continue reading "Quality Control | Nitrosamine Mutagenic Impurities"]]> Several drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. Chemetrix offers relevant GC/MS, LC/MS and high-throughput MS-based analytical technologies to accurately detect and quantify trace mutagenic and genotoxic impurities in drug products.

 

Resources

Nitrosamine Impurities Application Guide

Application Guide

Determination of Nitrosamine Impurities Using the Ultivo Triple Quadrupole LC/MS

Application Note

Quantification of Nitrosamine Impurities in Metformin Using Agilent GC/MS/MS Instrumentation

Application Note

Determine Nitrosamines Using LC/MS in Metformin-Based Drugs

Application Note

Determination of a Genotoxic NDMA Impurity Using the High-Resolution Agilent 6546 LC/Q-TOF in Ranitidine

Application Note

]]> https://chemetrix.co.za/quality-control-nitrosamine-mutagenic-impurities/feed/ 0 Quality Control | Extractables & Leachables https://chemetrix.co.za/quality-control-extractables-leachables/ https://chemetrix.co.za/quality-control-extractables-leachables/#respond Tue, 27 Jul 2021 12:21:14 +0000 http://chemetrix.co.za/?p=4025 Continue reading "Quality Control | Extractables & Leachables"]]> Extractables and leachables (E&Ls) analysis is challenging and requires complete confidence in the results to ensure regulatory compliance. No single analytical tool can analyze all E&Ls; we offer diverse analytical technologies and expertise for the accurate identification and quantification of potential E&Ls.

 

Resources

Analysis of Extractable/Leachable Compounds from Generic Liquid Drug Formulations Using GC/MSD Systems

Application Note

Analysis of Extractable and Leachable (E&L) Compounds Using a Low-Energy EI-Capable High-Resolution Accurate Mass GC/Q-TOF

Application Brief

]]> https://chemetrix.co.za/quality-control-extractables-leachables/feed/ 0 Raw Materials & Manufacturing | TOC Analysis https://chemetrix.co.za/raw-materials-manufacturing-toc-analysis/ https://chemetrix.co.za/raw-materials-manufacturing-toc-analysis/#respond Tue, 27 Jul 2021 10:03:25 +0000 http://chemetrix.co.za/?p=4012 Continue reading "Raw Materials & Manufacturing | TOC Analysis"]]> Pharmaceutical Companies have to meet major global regulatory requirements when using water in their manufacturing processes and final products, including USP <643> and <645>, EP 2.2.44 Total Organic Carbon, IP 2.4.30, CP Appendix VIII R, and JP16 2.59 monographs for Purified Water and Water for Injection. Chemetrix offers the industry leading range of Suez TOC products to help pharmaceutical manufacturers to meet these requirements.

 

Resources

Sievers M9 Portable TOC Analyzer for maintenance and control of pharmaceutical water systems

Fact Sheet

Cleaning Validation (Lab, At-Line, and On-Line) with Sievers M9 TOC Analyzers

Application Note

]]> https://chemetrix.co.za/raw-materials-manufacturing-toc-analysis/feed/ 0 Controlled/Seized Substances | Direct analysis of Controlled Substances https://chemetrix.co.za/controlled-seized-substances-direct-analysis-of-controlled-substances/ https://chemetrix.co.za/controlled-seized-substances-direct-analysis-of-controlled-substances/#respond Tue, 27 Jul 2021 09:59:40 +0000 http://chemetrix.co.za/?p=4008 Continue reading "Controlled/Seized Substances | Direct analysis of Controlled Substances"]]> Is your lab struggling with a growing caseload of samples that require fast, accurate analysis? Identify controlled substances with little or no sample preparation! Agilent QuickProbe technology delivers direct analysis on GC/MS or on a TOF/Q-TOF/MS using the DART (direct analysis in real time) interface. Handheld Raman and FTIR systems for portable or out-of-laboratory measurements are also available. Whichever option is best suited to your needs, Agilent can help you identify your unknowns with confidence.

 

Resources

Fast Analysis Workflow with No Sample Preparation for Forensic Applications Using QuickProbe GC/MS

Application Note

Why Stop at Detection? Start Identifying

Brochure

]]> https://chemetrix.co.za/controlled-seized-substances-direct-analysis-of-controlled-substances/feed/ 0 Controlled/Seized Substances | Seized/Controlled Substances Identification https://chemetrix.co.za/controlled-seized-substances-seized-controlled-substances-identification/ https://chemetrix.co.za/controlled-seized-substances-seized-controlled-substances-identification/#respond Tue, 27 Jul 2021 09:56:20 +0000 http://chemetrix.co.za/?p=4001 Continue reading "Controlled/Seized Substances | Seized/Controlled Substances Identification"]]> Seeking to expand, update, or enhance your lab’s capacity for forensic drug testing? ASTM E2329-17 Standard Practice for the Identification of Seized Drugs describes the minimum criteria and approved technologies required for the qualitative analysis of controlled substances. Learn how Chemetrix can help you comply with this standard and identify your unknowns with confidence.

 

Resources

Analysis of Drugs of Abuse by GC/MS Using Ultra Inert Universal Sintered Frit Liners

Application Note

Forensic Analysis of Drugs of Abuse With the Agilent 8890 GC

Application Note

Rapid LC/TOF MS for Analytical Screening of Drugs in the Clinical Research Lab

Application Note

Cocaine identification in seized drug samples by FTIR

Application Note

]]> https://chemetrix.co.za/controlled-seized-substances-seized-controlled-substances-identification/feed/ 0 Controlled/Seized Substances | Rapid Screening and Identification of Novel Psychoactive Substances https://chemetrix.co.za/controlled-seized-substances-rapid-screening-and-identification-of-novel-psychoactive-substances/ https://chemetrix.co.za/controlled-seized-substances-rapid-screening-and-identification-of-novel-psychoactive-substances/#respond Tue, 27 Jul 2021 09:51:02 +0000 http://chemetrix.co.za/?p=3996 Resources

A Comprehensive Approach to Targeted and Untargeted Screening Methodology for Emerging Synthetic Fentanyl Analogues

Application Note

Quantitative Determination of Drugs of Abuse in Human Whole Blood by LC/MS/MS Using Agilent Captiva EMR—Lipid Cleanup

Application Note

]]> https://chemetrix.co.za/controlled-seized-substances-rapid-screening-and-identification-of-novel-psychoactive-substances/feed/ 0