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Pharmaceutical, Nutraceutical & Cosmetics

Raman spectroscopy is an invaluable analytical tool used in the pharmaceutical industry from the inspection and verification of incoming raw materials, through stages of product and process development, through to final product testing and counterfeit detection. Raman spectroscopy is a well-established molecular spectroscopic technique for noninvasive and nondestructive chemical analysis, requiring no sample preparation, and with the ability to make measurements through transparent packing such as plastic or glass. The Raman spectrum provides a unique chemical fingerprint that is used in the identity of materials. The chemical information within a Raman spectrum can also be used to elucidate chemical structures, give information on a sample’s chemical composition, a products content uniformity, as well as structural information such as the level of crystallinity and the crystalline form.

The rapid, nondestructive nature of Raman spectroscopy makes it an integral tool in screening of new products for their identity and solid form, and the study of phase transformations. Due to its high chemical specificity, and ability to measure liquids and solids alike, Raman can be used for reaction monitoring to understand chemical reaction kinetics, and formation of intermediates, and end products. It can identify materials including active pharmaceutical ingredients, excipients, intermediates, and solvents. Portable Raman spectrometers such as the i-Raman series, are fiber-optically coupled, and provide versatility for use in lab, pilot plant, production, or field environments Raman has the advantage over other techniques for its ability to provide rapid results with little or sample preparation, and minimal sample handling. It provides fast, accurate results aiding in Pharmaceutical product development, manufacturing and QC for qualitative as well as quantitative analysis.

Products

NanoRam®

Handheld Raman Spectrometer

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i-Raman®

High Resolution TE Cooled Fiber Optic Raman System

i-Raman® high resolution Raman spectrometer by B&W Tek

i-Raman® Plus

Highly Sensitive, High Resolution Fiber Optic Raman System

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STRaman

Portable Raman Analyzer for Rapid Analysis and Identification Through Opaque Barriers

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i-Raman® EX

1064nm Fiber Optic Raman System

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i-Spec® Plus

Diffuse Reflectance NIR Analyzer

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NanoLIBS®

Handheld LIBS Analyzer for the Pharmaceutical Industry

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Testimonials

The NanoRam was the most suitable Raman instrument on the global market, significantly reducing the time spent and as a result increasing the efficiency of our API control process.

— Pharmstandard

The NanoRam is so easy to use, and we are now able to get through hundreds of samples per day, allowing us to fulfill regulatory requirements of 100% identification testing of APIs

— Hetero

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Application Notes

Pharmaceutical tablets consist of an Active Pharmaceutical Ingredient (API) with excipients including fillers, binders, and lubricants which are blended together to form a homogenous mixture. Blending process control is very important for final tablet quality, but detection or characterization of raw material variations and final blend homogeneity can be very challenging. In this app note, blend homogeneity is quantified using a portable Raman spectrometer combined with chemometric software from B&W Tek.
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Ever since the European Medicines Agency (EMA) recommended that all pharmaceutical companies test every raw material that passes through their manufacturing facilities, this practice has attracted great interest in the nutraceuticals, food manufacturing, cosmetics, and agricultural industries, pushing them to strive for more rigorous and technology-oriented quality control standards.
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Competition in the pharmaceutical industry is driving drug companies to spread their manufacturing operations around the globe. Unfortunately, production delocalization results in more testing of the incoming raw materials for quality assurance, product safety and regulatory purposes, which results in an increased cost of doing business. This application note discusses the economic costs and benefits of the implementation of handheld Raman in the warehouse.Read the full application note
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Historically, identification of complex compounds and binding/tableting materials have only been achievable using research-grade, laboratory systems, which offer high resolving power and better signal to noise capability. In this article we set out to demonstrate that the recent technological breakthroughs in the NanoRam are proving that high performance Raman spectroscopy can be combined with simplicity and ease of use in a compact design.
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Moving identity verification of incoming raw materials out of the laboratory and into the warehouse through the use of handheld spectrometers has become an accepted method for obtaining optimal efficiency for testing.  Since multiple sites within an organization often use the same raw materials, transferring identification methods and libraries between spectrometers at receiving sites can help to ensure consistency and reliability of the materials before they reach production, all while maintaining that efficiency.
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In this article, Dr. Bülent Üstün, a senior scientist at Merck Sharp & Dohme, reasons that the most efficient means for identity verification of incoming raw materials is to move it out of the laboratory and into the warehouse.   He discusses the various elements of spectroscopic techniques including Raman spectroscopy, the differences between spectral matching (e.g. “match/no match”) vs. identity verification (e.g. “pass/fail”) and how to utilize these tools to get the best possible results. 
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Today’s Raman instrumentation is faster, more rugged, and less expensive than previous instrumentation. Now, with the advances in component miniaturization, the design of high performance, portable and handheld devices has introduced the technology to new application areas that were previously not possible with older, more cumbersome instruments.  
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Portable Raman spectroscopic devices have become part and parcel of every pharmaceutical manufacturer’s QA/ QC toolbox. These mobile devices are being embraced for an increasing range of applications, from raw materials identification to API classification to counterfeit detection. They may soon become more prevalent even as a means of characterizing finished-dosage forms.  
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In recent years, Raman Spectroscopy has gained a reputation in market segments that require the rapid identification of unknown compounds, such as the testing of chemicals, measurement of pharmaceutical ingredients and characterization of polymers.  
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This article presents the discussion on minimizing risks in quality of pharmaceutical manufacturing using Raman spectroscopy, which provides a rapid, reliable means of testing in many different environments in manufacturing, including the loading dock.  
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One of the most critical factors in developing and marketing pharmaceutical products and dietary supplements today is ensuring that the analytical methodology used for analysis will produce high quality, valid data.  
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Raman spectroscopy is used for material characterization by analyzing molecular or crystal symmetrical vibrations and rotations that are excited by a laser, and exhibit vibrations specific to the molecular bonds and crystal arrangements in the molecules. Due to its excellent spectral specificity, Raman technology is a valuable tool in distinguishing different polymorphs, and can also be used in the study of solvate forms.  
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Raman technology is known for its fast speed and convenience for material identification and verification since Raman measurements can be conducted through transparent containers without any sample preparation. This technical note showcases the NanoRam handheld Raman spectrometer for raw material identification through multiple polyethylene (PE) bags.  
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Raman spectroscopy is a well-suited spectroscopic technique for process development and control within development laboratories in chemical, pharmaceutical and other industries. This article demonstrates the utility of portable Raman spectroscopy as a simple and versatile tool for process analytical technology (PAT) in regards to raw material identification, in-situ monitoring of reactions in developing active pharmaceutical ingredients (APIs), and for real-time process monitoring.  
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Raman Spectroscopy is an advantageous analytical tool that allows for the measurement of molecular structure and identifying chemical composition of materials based on the rotational and vibrational modes of a molecule. Access to lower frequency regions with Raman spectroscopy provides key information for applications in protein characterization, polymorph detection and identification, along with material phase and structure determination.  
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The emergence of counterfeit prescription drugs has become a concern for the pharmaceutical industry. Counterfeit drugs are fraudulently manufactured and/or mislabeled to appear genuine. Due to the prevalence of these potentially dangerous counterfeits, it is necessary to develop a technique that can quickly confirm the identity of a suspected fake drug.  
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In this application note, a new Raman system design is presented that expands the applicability of Raman to See Through diffusely scattering media such as opaque packaging materials, as well as to measure the Raman spectrum and identify thermolabile, photolabile, or heterogeneous samples.  
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