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Chiral Method Development

Analytical >> Analytical Method Development >> Chiral HPLC & SFC Method Development

We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

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Chiral Analysis

Analytical >> Analytical Method Development >> Chiral HPLC & SFC Method Development

Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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Chiral Analysis

Analytical >> Analytical Method Development >> Chiral HPLC & SFC Method Development

Zenvision has standalone analytical services including complete analytical support for dossier filing.

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Chiral Separation

Analytical >> Analytical Method Development >> Chiral HPLC & SFC Method Development

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

Analytical service providers offer a wide range of chiral method development service. They develop a chiral method for separation of racemic or isomeric mixtures suited to your analytical, semi-preparative or preparative applications. They have vast experience in analytical and bioanalytical method development, validation, and sample analysis - specializing in HPLC method development and validation. As both an in vivo and analytical CRO, they support product development of a variety of pharmaceuticals, biologics and medical devices. Method development and validation is an important first step to determine that analytes of interest can be reliably detected and quantified during routine sample analysis. A team of chromatographers quickly screens all available DAICEL chiral HPLC columns with all possible mobile phase combinations: normal phase, polar organic mode and reverse phase, dependent upon your requirements. In order to proof consistent quality of pharmaceutical raw materials, intermediates and finished products, analytical test methods (ATM) must provide reliable results. A full ICH-compliant validation of ATMs is mandatory in the pharmaceutical development program. Many test methods fail during validation because they were designed for a current and not a future need. Knowing the regulatory requirements and understanding the development pathway greatly facilitates the design of test methods that can be validated and transferred between laboratories without delaying the approval process. Analytical test methods comprise a broad range of applications, a.o. residual solvents, impurities, assays, stability studies, leachables and extractables. Each application has its own specific requirements. Sinensis can assist you in every aspect of analytical test method development. LCMS compatible mobile phases are included in the column selection service if requested. We will screen Daicel polysaccharide-derived (immobilised and coated), protein, anion exchange, zwitterionic and crown ether chiral phases until we find a suitable chiral method. For semi-preparative HPLC applications, custom method development focuses on semi-preparative stationary phases to find the best column possible. Data obtained will accurately reflect projections of the preparative separations (milligrams to tens of grams) on 1-, 2-, and 5-cm I.D. columns. Depending on your particular requirements, custom method development can also focus on loading and solubility studies for use in SFC and Simulated Moving Bed (SMB) systems. The column selection service is performed under strict confidentiality with a Confidential Disclosure Agreement (CDA) being executed, when necessary, prior to the commencement of the project. In addition, you can utilise separation services, carried out by the team of chemists and engineers, which allows you to benefit from the combination of our technical expertise and well-known DAICEL technology. Analytical laboratories can use HPLC, GC, GC-MS or a range of other chemical analyical techniques in its method development and method validation activities. Parameters included are Accuracy, Repeatability/Reproducibility, Precision, Specificity/Selectivity, Limit of Detection (LOD), Limit of Quantitation (LOQ), Linearity, Range, Robustness, System Suitability, Sample Stability, Method Development/Validation Analytical Techniques Available, High Performance Liquid Chromatography (HPLC), Liquid Chromatography/Tandem Mass Spectrometry (LC/MS), Gas Chromatography /Mass Spectrometry (GC/MS) with headspace sampler, Inductively Coupled Plasma /Mass Spectrometry (ICP/MS), Enzyme Linked Immuno Sorbent Assay (ELISA), Method Development and Validation Related Testing, Biomarker Analysis, Immunogenicity Testing, Identity and Purity - Large Molecules, Identity and Purity - Small Molecules, PK Bioanalysis, Extractable Leachable Testing, Device Chemical Characterization, Biosimilar Development Support, Method Validation Testing Standards, ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology, FDA Guidance for Industry: Bioanalytical Method Validation, USP <1225> Validation of Compendial Procedures. Supercritical Fluid Chromatography (SFC) expedites both chiral and achiral separations by enabling analysts to resolve the more challenging sample mixtures rapidly with less solvent usage than with conventional HPLC. SFC methods development can be time consuming as small changes in method parameters such as modifier strength, column type, pressure and flow rate conditions can greatly impact the separation. In addition, the desired resolution can be unpredictable and challenging to obtain for chiral and achiral separations. For preparative scale separation, even higher resolution is often required for high sample load capacity. Therefore, investigating column and mobile phase selectivity is a necessary and crucial step to achieve resolution in SFC method development. Screening multiple columns simultaneously could significantly increase method development efficiency. This study introduces a novel, flexible parallel/multi-column setup for method development screening that is four times faster than traditional single column methods development.

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