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Quality control is a fundamental activity of the drug industry. Drugs should be advertised as protected and remedially active formulations whose performance is steady and predictable. New and better therapeutic agents are being delivered at a sped-up rate. Simultaneously really demanding and refined scientific techniques are being created for their assessment.
Quality analysis of pharmaceuticals products required wide range of chemical analysis to ensure the quality assurance before it reach to the end consumer.
What is chemical analysis?
Chemical analysis plays a crucial role in the pharmaceutical industry, providing quality assurance, safety, and efficacy of new drugs. In the pharmaceutical industry, a variety of analytical techniques is utilized, including Titration, Ion Chromatography & Spectroscopy techniques. Metrohm is one of the world’s most trusted manufacturers of high-precision instruments for chemical analysis. Metrohm was founded in 1943 by engineer Bertold Suhner in Herisau, Switzerland.
The chemical industry is highly regulated by a vast body of national and international standards. Metrohm provide the instruments and the know-how that allow you to comply with these standards.
Metrohm provides unparalleled application expertise
The pharmaceutical industry is held to very high standards of quality and safety by authorities around the world. The purpose of these laws is to make sure drugs can be used safely by providing a regulatory framework for consumer protection.
The procedures used for drug testing include testing and measuring methods to identify drugs and determine whether they are safe for use. In order to maintain these strict quality and safety standards, reliable instruments and methods are needed. The challenges you face, as a chemical analysis instrument manufacturer its well known to us. Therefore, Metrohm not only offers the most advanced instruments but also complete solutions for analytical studies.
Discover Metrohm’s solutions for pharmaceutical companies and you in particular for the maintenance of quality and safety.
Pharmacopoeias and drug safety
According to the World Health Organization (WHO), standards and test procedures for frequently used active components and excipients are detailed in monographs published in more than 38 nations’ national pharmacopoeias.
These include the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph.Eur.), derived from harmonization of the regulations of a number of individual states, and the Japanese Pharmacopoeia (JP), to name just a few examples. The pharmacopoeias are official compendia containing statutory requirements pertaining to identity, content, quality, assay, impurities, packaging, storage, and labelling of active pharmaceutical ingredients and other products used for therapeutic purposes. They are essential for anyone seeking to produce, test, or market medicinal products.
Applications in accordance with pharmacopoeias
Metrohm is your qualified partner for all chemical-pharmaceutical analysis issues and for analytical methods validation. In addition to their compliance with official directives, Metrohm instruments and applications comply with many of the quality control and product approval test methods cited in pharmacopoeias.
Metrohm State-of-Art Analytical Instruments for Quality control analysis for the pharmaceutical’s product:
OMNIS – Titration on a whole new level
Faster, safer, easier, and smarter titration. OMNIS is Metrohm’s new, fully integrated titration system that caters to the needs of today’s laboratories. Scale up your lab with complete automation feature. Expand your system as per your requirement. Start with a single OMNIS titrator and add titration and dosing modules when needed. up to 4 fully automated parallel titrations you can at the same time.Working with OMNIS is always easier as it saves more time and gives you reliable and precise result.
Find more applications such as:
Assay of API’s and other Titrations Water determination according to Karl Fischer Photometric titrations with the Optrode Automatic nonaqueous titration.
Ion Chromatography
Ion chromatography (IC) is the method of choice for determining active pharmaceutical ingredients, excipients, traces of impurities, and metabolites in the form of organic and inorganic ions or polar substances – not only in a broad range of pharmaceuticals and pharmaceutical solutions, but also in bodily fluids. Ion chromatography can determine chemically similar substances in a very short time in just a single analysis.
Active Pharmaceutical ingredients
For innumerous API monographs, Metrohm offers you pharmacopeia-compliant analytical instruments.
Active pharmaceutical ingredients in tablets such as gentamicin, neomycin, cefadroxil, or bethanechol chloride can be determined by ion chromatography in accordance with the regulations of the U.S. Pharmacopeia and European Pharmacopoeia.
Impurities in pharmaceuticals
In addition to active pharmaceutical ingredient analysis, ion chromatography can also be used to determine impurities in pharmaceutical products. Even small concentrations of an impurity can cause significant side effects.
For example, the azide used in the synthesis of the antihypertensive Irbesartan can be detected in trace amounts as an impurity in the product.
The U.S. Pharmacopeia recommends ion chromatographic azide determination after direct injection in accordance with USP.
The azide determination is more selective, more sensitive, and most importantly – faster – when using Inline Matrix Elimination, whereby the interfering pharmaceutical matrix is already separated from the target analyte during the sample preparation step.
Spectroscopy
Metrohm offers an extensive range of Near Infrared and Raman spectroscopy products. Speed, versatility, application focus and compliance are essence of our product design. With limited or no sample preparation, our spectroscopy solutions also provide a huge savings in the running cost.
Please find below some salient features and important applications for NIR & Raman Spectroscopy for pharmaceutical analysis
Raman & NIR Spectroscopy
1)100% Raw Material identification (As per USP), through Transparent Container, Plastic Bag, Glass Bottle etc.
2)All kind of samples can be analysed like – Solid, Liquid, Semisolid, or Slurry.
3)Both Qualitative & Quantitative (With NIR and Portable Raman) Analysis is possible
4)Fast Analysis & highly sensitive
5)Non-Destructive technique – no Chemical & sample preparation required.
6)Completely 21 CFR Part 11 Compliance.
7)Raman systems are available in both Handheld and Portable models. Raman System also available for Process Monitoring.
8)NIR systems are available in lab and process versions.
Spectroscopy Major Application
1)Raw Material, In-Process monitoring & Finished product Identification & Quantification
2)Powders or granulates – Drying process & Blending process
3)Tablets or capsules Assay analysis
4)Creams or Gels
5)Injectable solutions or suspensions
6)Pharma Packing material & polymer films
7)freeze-dried samples or Lyophilized sample analysis
8)In-process, Final product quality check.
9)Applications like Blend uniformity and Content uniformity.
Our spectroscopy systems and solutions meet the requirement of international Pharmacopeia’s and guidelines and designed to meet stringent regulatory demands.
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 11 main offices coupled with 7 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.
References:
1.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1927659/
2.https://www.metrohm.com/en-in/industries/pharma/pharma-apis/
Authors: Metrohm India Private Limited
For more information: write us @ info@metrohm.in
