Waters Corporation

The development and validation of a robust, quantitative method for the routine determination of a wide range of LC-amenable pesticides following QuEChERS (DisQuE dispersive sample preparation) procedure and LC-MS/MS

This document is designed to help the user performing intact and/or subunit protein analysis evaluate the performance or suitability of the instrument by undertaking a simple system check (SC) and running of QC standards.

Waters’ experts will illustrate the challenges of keeping computerized systems which are critical to regulatory compliance, under control. The CDRH Medical device group at FDA, are drafting an update for their guidance on computerized system validation. Primarily this is to promote a smarter risk-based approach to encourage the life science industry to adopt new technologies and automation opportunities, while remaining in compliance with regulations. How could a fresh look at available technology be used to innovate how such systems are deployed, allowing them to be regularly updated without creating a significant validation burden? Live: Thursday, Oct. 3, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Oct. 3, 2020 Register free

In this webcast, learn about the development of a fast and robust CQA monitoring method based on multi-attribute monitoring principles using a compact, compliance-ready LC-MS system. The presentation will demonstrate how the method can be easily transferred from development to manufacturing through commercial product lifecycle management. Live: Tuesday, Sept. 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 10, 2020 Register free

Data Integrity has become a critical issue in the pharma industry as a result of increased regulatory scrutiny stemming from Data Integrity-related violations. This ebook provides insight on a variety of important topics within this space.

Ever wished you could improve detection of data manipulation and yet still reduce review time for chromatography data? Charlie Wakeham and Gary Cameron will explain how to leverage exception reporting tools to optimize your review process. Wednesday, Nov. 21, 2018 at 7:30am IST | 10am CST | 11am JST / On Demand: available until Nov. 21, 2019. Register free: http://www.chromatographyonline.com/lcgc/data_review

There is a struggle to adequately “document” audit trail review, which leads to the wider concern-how to adequately document any kind of quality review. What exactly does “signing a document” indicate? On Demand available until Jun. 1, 2018 Register Free: http://www.chromatographyonline.com/lcgc_w/data

Method transfer or method scaling across different LC instruments can be affected by both dwell volume and extra-column dispersion. Each characteristic will have a different effect on the chromatographic separation.

This application note describes a UPLC-MSE analysis of monoclonal antibody (mAb) disulfide bond. This study demonstrates that UNIFI-a compliance-ready software-is designed to support biopharmaceutical laboratories in performing fast peptide mapping and monitoring of mAb disulfide linkages.

This whitepaper provides a summary of the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerised Systems. It includes a high-level foundation to understand how pharmaceutical manufacturing companies are being regulated, what PIC/S means for common requirements across different countries, and how these requirements relate to expectations for data from computerised systems/electronic records.

Historically, UV detection has been favored in many laboratories for its ease of use, robustness, and reliability. However, some of the inherent challenges include analytes that do not have a response in a UV channel, coelutions, and unknowns, any of which can require an orthogonal approach such as mass detection. While mass detection offers a number of benefits when used in tandem with UV detection, incorporating it into an existing UV workflow can be time-consuming and laborious.

The objective of this application note is to demonstrate that the ACQUITY QDa Detector provides a simple and cost-effective solution for detecting oligonucleotides across a wide molecular weight range and can be readily integrated into existing UV-based workflows.

The validation process of an analytical method is a complex and demanding activity, consisting of many time-consuming steps. Empower® 3 Method Validation Manager (MVM) automates the method validation workflow within a single software environment, reducing time and ensuring conformance to the validation requirements and acceptance criteria defined in the protocol. This application note demonstrates validation of a UPLC® method for metoclopramide HCl and related substances using Empower 3 MVM.

Waters Corporation

Insulin was the first recombinant pharmaceutical produced. Currently, one of the critical quality control attributes of therapeutic insulin in the US and European Pharmacopoeia (USP and EP) monograph is the level of covalent high molecular weight (HMW) insulin as determined by HPLC size-exclusion chromatography.

The migration to chromatographic methods utilizing smaller particle sizes has been well demonstrated to increase productivity through faster, more efficient separations.

For the analysis of biotherapeutics, size-exclusion and ion-exchange chromatography are typically conducted under native separation conditions, requiring high ionic strength, 100% aqueous eluents.

Fast, flexible platforms for peptide quantification are needed, particularly for a discovery setting. This type of methodology would be especially advantageous in the case of amyloid beta (a?) peptides.

In the past decade, supercritical fluid chromatography (SFC) has been established as a cost-effective, sustainable, and green purification technology for pharmaceutical and related industries.

Morphine is an effective pain-relieving drug that is primarily metabolized into morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G). The highly potent M6G may have adverse effects, such as respiratory depression and renal failure, if accumulated in the body. As morphine abuse continues to affect modern society, an effective method must be established to analyse morphine and its structurally related compounds in biological fluid samples. In this work, a UPLC–MS-MS method was developed to separate six morphine-related compounds on a 2.1 Ã- 100 mm, 1.8 μm ACQUITY UPLC HSS T3 column in a single run using an ACQUITY UPLC system connected to a fast-scanning triple-quadrupole MS detector (TQD). The method achieved adequate retention of these very polar compounds by reversed-phase (RP) chromatography in an 8-min total run time.