Metrohm means Spectroscopy

Overview

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  • Source: Metrohm India Private Limited

  • Date: 04 Dec,2022

The Metrohm brand stands for highly accurate, robust instruments and continuous innovation. Our spectroscopy portfolio reflects these standards. We have cutting-edge near-infrared and Raman systems for lab, process, and field operation.

Analytical instrumentation technology has evolved over period of years. The important  reasons for these evolvements are 1. the need for Rapid analysis solution 2. Non destructive and non invasive analysis. The non destructive sample analysis plays an important role in implementation of green chemistry in manufacturing processes and product. Moreover the implementation of Process Analytical Technology needs quick and reliable instrumentation solution which provides real time measurement of critical quality parameters at various stages of the manufacturing process right from Raw material to finished products

Metrohm AG, Switzerland the pioneers in Ion analysis instrumentation, provides comprehensive spectroscopy solutions for Reliable, Rapid and Non destructive sample analysis requirements. Our spectroscopy instrumentation solution includes Near Infrared spectrometers, Handheld and Laboratory Raman spectrometers.

We also provide online spectroscopy instrumentation for real-time process monitoring applications.

Though these instruments cater to various application areas, in this article we will focus mainly on our product and application solution for Pharmaceutical Industry.

Pharmaceutical Industry analysis requirements

Pharmaceutical analysis provides information about the identity, purity, content, and stability of starting materials, excipients, and APIs. Medicinal products come in various forms.  According to the World Health Organization (WHO), specifications and test methods for commonly used active ingredients and excipients are outlined in detail in monographs contained in the national pharmacopoeias of more than 38 countries. The pharmacopoeias are official compendia containing statutory requirements pertaining to identity, content, quality, purity, packaging, storage, and labeling of active pharmaceutical ingredients and other products used for therapeutic purposes. They are essential for anyone seeking to produce, test, or market medicinal products.

1.NIR Spectroscopy for Pharmaceutical Applications

Near-infrared spectroscopy (NIRS) has been an established method for fast and reliable quality control in chemical, Pharmaceutical, Petrochemical, polymer, personal care, Paint and Ink industries for many years now.

The advantages of NIRS are numerous, such as the ability to measure multiple parameters in seconds with no sample preparation! The non-invasive light-matter interaction used by NIRS, influenced by physical as well as chemical sample properties, makes it an excellent method for the determination of both property types.

NIRS is an indispensable analysis technique that can be used along the entire production chain: from checking the incoming materials to the production line, even to the quality control of finished.

1.1.Metrohm NIR Analyzers – Model DS2500

Compact and robust: Near-infrared spectrometers for fast and cost-effective quality control and routine screening of liquid or solid samples.

Available product versions for analyzing liquids (DS2500 Liquid Analyzer) or solids (DS2500 Solid Analyzer)

Choice of sampling tools – selectable as per application requirements.

Peace-of-mind – the DS2500 Analyzers have a IP65/IP54 rating so they withstand harsher conditions Data integrity as well as convenient access and review of data is guaranteed with the user-friendly and GMP/FDA-compliant Vision Air software.

1.2 NIRS compliance with international pharmacopoeias

As a secondary test method, NIRS is recommended in all the key pharmacopoeias – European (Ph. Eur. 2.2.40) as well as American (USP<856/1856>) and Japanese pharmacopoeias (Chapter 6, since 2007).

All Metrohm NIRS instruments are fully compliant with USP <856/1856> and all the other key pharmacopoeias.

Furthermore, all Metrohm NIRS instruments meet the standards for wavelength precision, reproducibility, and photometric noise. Numerous reference standards and user-friendly software make it easy to check the instrument requirements specified in the pharmacopoeias. The pharmaceutical version of the Vision Air software is fully validated and compliant with 21 CFR Part 11.

2.Raman Spectroscopy

Raman spectroscopy another technique which can be useful right from the identification of Raw Materials to the final vaccine product.

Raman spectrometers can be used for identification of active ingredients, preservatives, adjuvants, antibiotics etc.

Raman spectroscopy is a valuable technique for process analytical technology (PAT) in the pharmaceutical industry due to its capacity for non-destructive, real-time measurements, as well as its ability to be implemented for online and inline monitoring. Prior to large-scale implementation of a new process or product

Biopharmaceutical’s manufacturing is an industry that has adopted Raman spectroscopy measurements for PAT studies, particularly for cell culture and fermentation monitoring.

Raman spectroscopy can be used to monitor the growth media components (including glucose) and metabolic products (such as lactate) in cell culture upon development of a multivariate statistical model.

Metrohm and B&W tek offers a range of Raman spectrometers which includes handheld Raman spectrometers, Portable Raman spectrometers and a dedicated Process development Raman analyzer Instrument. The Handheld and Portable Raman systems come with a choice of either 785nm laser or 1064 laser, wide range of sampling accessories. Our Process development Raman analyzer comes with a rack mountable sturdy design, Self-calibrating, self-monitoring facility to ensure the validity of each measurement. We also offer 21CFR Part 11 compliant software’s and complete IQ/OQ support.

2.1 Handheld Raman instruments: MIRA P and NanoRam

All MIRA P and NanoRam devices ( NanoRam and NanoRam-1064) for the pharmaceutical industry are designed and tested to meet stringent requirements.

These systems comes with  Flexible sampling capabilities for handling various types of samples in packaging, vials, bottles etc and complies with 21 CFR Part 11 requirements and Meets the requirement of USP 858, EP.2.2.48, JP Ch 2.26,  PPRC 0421 and IP 2.4.47.

Laboratory and Portable  Raman instruments:

1.Small, portable, and powerful Raman instrumentation with performance equivalent to benchtop systems at and affordable cost

2.Unprecedented utility in environments across the lab and the field that is perfect for both research and other point-of-need applications

3.Flexible sampling capabilities (with fiber optics, or through transparent packaging such as glass, plastics, etc.)

4.Enables both qualitative and quantitative analysis

5.Expanded information content, including non-chemical info such as polymorphs, crystallinity, and orientation.

6.State-of-the-art software and chemometrispecificr specific application needs.

7.Models Available with a choice of lasers: 785nm or 532nm or 1064 nm

8.Based on the Laboratory Raman platforms Metrohm also provides specialized application-oriented system solutions in the form of ST Ram and QT Ram.

The STRam is a “See-through” portable Raman system with rapid material identification capabilities through a variety of barrier layers and packaging previously impenetrable by Raman spectroscopy. The STRam provides easy identification of materials through a variety of packaging and barrier layers utilizing 785 nm or 1064 nm wavelengths.

The QTRam portable transmission Raman spectrometer is ideal for rapid and non-destructive quantitative analysis of solid samples. In this transmission Raman system, scattered light penetrates through solid samples, allowing for measurement of the active pharmaceutical ingredients for content uniformity testing of finished products such as tablets and capsules.

Summary

Metrohm NIR and Raman Instruments offer comprehensive solutions for Rapid, Reliable, and Non-destructive sample analysis.  These instruments offer unprecedented sampling flexibilities thus ideally suited for point-of-need applications and research needs.

For more information contact us at info@metrohm.in or visit us at www.metrohm.in

About Metrohm:

Metrohm India Private Limited is a total analytical solution provider, serving Indian market for more than 2 decades. We are immensely proud to have all the major companies from public and private sector, spanning across almost all the industries, as our customers. Our operations cover all the zones in the country with 12 offices coupled with 10 resident offices at remote locations. All the offices are well- equipped with best-in-class infrastructure to support training, demonstrations and meetings. We also have our application laboratory in Chennai, with dedicated sections for major techniques to serve our customers with application support, method development and technical training. Our team of professionals also cater to the training needs of customers, apart from the application support.

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