Pharmaceuticals and Medicine Manufacturing

The pharmaceutical and medicine manufacturing industry develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases. This industry is primarily engaged in manufacturing biological and medical products, processing and isolating active medical principles from botanical drugs and herbs, manufacturing pharmaceutical products intended for internal and external consumption in such forms as tablets, capsules, ointments, powders and solutions.

HORIBA offers a large choice of innovative technologies such as Fluorescence spectroscopy, Raman spectroscopy, Surface Plasmon Resonance Imaging, Particle Size Analyzers, Capacitance manometer and gas monitor Micropole systems that contribute to the quality and performance of drugs manufacturing.

Browse Applications

Characterization of protective mask fibers by Raman microscopy

Due to Covid-19, a wide choice of protective masks are now on the market. These types of masks are distinguished, in particular, by their different efficiencies linked to their filtration capacity. These differences in protective properties have therefore made it essential to characterize the composition of the masks. In this paper, we present why LabRAM Soleil™ confocal Raman multimode microscope is the perfect tool for studying the distribution and composition of mask fibers.

In this Application Note, we will focus on the importance of monitoring particle size and distribution range throughout two different processing technologies used to improve shelf-life and efficacy of CBD products.

Size matters in vaccine delivery systems. Nanoparticles smaller than 200 nm generally present a greater immunogenic response than micro-particles larger than 1 micron.

Multiple Characterizations of a Blister Pack Using the XGT-9000

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

Raman Analysis of lysozyme

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

In this note, the upstream process of analyzing viral preparations is addressed, as well as the use of multi-laser nanoparticle tracking analysis (NTA) as a cost and time efficient method to measure size, count virus particles, and correlate to infectious titer.

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

Pharmaceutical compounds distribution and cosmetic products analyzed by confocal Raman spectroscopy

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

X-ray Fluorescence photons can be partially absorbed by the encapsulated material and will not show in the spectrum. The X-ray transmission image provides a complete picture.

Polymorphisms characterization: when Raman microscopy supports the pharmaceutical industry

Polymorphisms characterization of active molecules is one piece of important information for the pharmaceutical industry, not only on raw powders, but also in the final form. Raman microscopy remains the most appropriate solution for this application. In this paper, we present an example of polymorphisms characterization by Raman microscopy using the super low frequency module.

Application note: Morphological and chemical characterization of pharmaceutical formulations

In order to control formulations of pharmaceutical products, characterizing their active compounds is critical, especially in terms of morphological and chemical characterization of particles. In this application note, two formulations from a generic and an innovator nasal spray have been analyzed to compare their compounds size and shape, and chemically characterized to compare the two formulations based on the ParticleFinderTM app for LabSpec 6. A focus is done on the active compound.

Protein aggregation is an important concern when developing and manufacturing biotherapeutics. It is important to quantify protein aggregation and particle formulation as this data is needed to guide formulation development, evaluate handling requirements, and monitor product quality.

Resulting from the combination of Raman spectroscopy and optical microscopy, Raman hyperspectral imaging has proven to be an indispensable tool in the pharmaceutical field. This article will broach a number of Raman hyperspectral imaging applications that were developed in our laboratory, in order to demonstrate the significance of the technique.

Many particle size measurements are made to track size reduction operations such as milling, mixing, homogenizing, etc. Laser diffraction is the most common analysis technique for monitoring size reduction operations due to its very broad dynamic range.

The study of protein aggregation encompasses a broad range of interactions and mechanisms. The LA-960 laser diffraction particle size analyzer possesses the unique ability to measure from 10 nanometers to 5 millimeters, accurately detecting the aggregates and, in some cases, the primary protein size.

The size of a protein is an important physical characteristic that provides useful information including the presence of monomers, dimer and trimer, changes in conformation, aggregation state, and denaturation. Protein scientists typically discuss “protein size” or molecular weight, as opposed to using the phrase “particle size”, but particle size analyzers are often used in their studies.

Pharmaceutical aerosols including metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices that deliver a specific quantity of drug to the lungs. The particle size distribution and shape of the delivered dose is more critical for inhalation aerosols than for most other conventional drug products because these factors greatly influence the deposition profile in the lungs of the patient.

The particle size distribution of active ingredients and excipients is an important physical characteristic of the materials used to create pharmaceutical products. The size, distribution and shape of the particles can affect bulk properties, product performance, processability, stability and appearance of the end product.

Vitamins are classified by their biological and chemical activity, not by their structure. They are grouped under an alphabetized generic descriptor title such as vitamin A that includes the compounds retinal, retinol, and four carotenoids.

Nutraceuticals are food extracts that have been demonstrated to produce a physiological benefit or provide some protection against chronic disease. Nutraceuticals are the intersection of nutrition and pharmaceutical and can also include functional foods and dietary supplements.

This Application Note outlines three different kinds of spectroscopic tools being used for the characterization of sunscreens, and discusses the obtained results. These include Fluorescence spectroscopy for photoactivity, Particle Size analysis for composition and Raman microscopy for formulation investigation.

Laser diffraction particle size analyzers offer the same benefits in speed, precision, and reliability to nutraceutical materials that have made the technique popular in the pharmaceutical industry.

Liposomes are bilayer vesicles made of phospholipids derived from natural or man-made materials. They are mainly used in the pharmaceutical field for treatment of cancers as carriers of chemotherapeutic drugs to the tumor area.

This application note summarizes the reasons why static image analysis is becoming a popular technique for characterizing APIs.

The ViewSizer™ 3000 enables scientists to visualize and quantify the kinetics of protein aggregation in real-time for biologic therapeutics under a variety of stress conditions.

Fast and non-invasive determination of skin

Biological tissues contain chromophores that absorb light, as well as fluorophores that absorb and reemit light (fluorescence effect). Light absorption depends on the chromophores’ content and their distribution within the organic matter.

The choice of protecting group is of crucial importance in the success of many steps in organic synthesis and the manipulation of polyfunctional molecules, since they can prevent the formation of undesired side products and reactions.

Freeze Dry_Pharma

Pharmaceutical compounds distribution and cosmetic products analyzed by confocal Raman spectroscopy

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

Iron oxides are magnetic black materials. The methicone treatment adds a degree of “slip” to the particles allowing for better color saturation although they still remain magnetic.

This Application Note outlines three different kinds of spectroscopic tools being used for the characterization of sunscreens, and discusses the obtained results. These include Fluorescence spectroscopy for photoactivity, Particle Size analysis for composition and Raman microscopy for formulation investigation.

Many cosmetic products include particulate material or emulsions. Some examples of cosmetic products consisting of or including particulates include facial powders, moisturizers, and lipstick. The particle size distribution of these components effects appearance, stability, and protection.

Confocal Raman Spectroscopy is an important analytical tool in various fields and it has shown high efficiency for specific applications in the cosmetic and/or pharmaceutical fields. Its non-invasive behavior, and its high molecular sensitivity make it one of the preferred label-free analytical techniques to characterize materials such as skin and cosmetic products.

This study utilizes the PSA300 automated image analysis system to quantify the size and shape of various ointments and creams.

Fast and non-invasive determination of skin

Biological tissues contain chromophores that absorb light, as well as fluorophores that absorb and reemit light (fluorescence effect). Light absorption depends on the chromophores’ content and their distribution within the organic matter.

The fluorescence spectra of intrinsic protein fluorophores have been studied extensively and used in investigating biological events.

Noninvasive In-Vivo Determination of Sunscreen-UVA Protection Factors

The development and evaluation of UVA (320–400 nm) sunscreens is important because UVA sunlight can penetrate deep into human skin and cause severe internal damage, as well as erythema and photoaging.

Confocal Raman spectroscopy is beginning to be recognized as a high potential technique for the non invasive study of biological tissues and human skin under in vivo conditions. Raman spectroscopy can be applied to obtain information regarding the molecular composition of the skin down to several hundred micrometers below the skin surface.

Multiple Characterizations of a Blister Pack Using the XGT-9000

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

The LA-960 Particle Size Analyzer and SZ-100 Nanoparticle Analyzer may be used to measure the particle size distribution and zeta potential for drug delivery vehicles. These characteristics directly affect bioavailability, dissolution, immunotoxicity, amongst other critical formulation factors.

This application note describes two experiments where laser diffraction proved capable of determining both the base biopolymer nanoparticles and also larger particles outside of the range of DLS.

The choice of protecting group is of crucial importance in the success of many steps in organic synthesis and the manipulation of polyfunctional molecules, since they can prevent the formation of undesired side products and reactions.

Identification and Quantification of Potential Adulterants in Cranberry Fruit Juice Dry Extracts

The Aqualog A-TEEM spectrometer has the capacity to specifically identify and sensitively quantify key adulterants that are most commonly detected in Cranberry dietary supplements, including Pine Bark, Grape Seed and Peanut Skin extracts.

Multiple Characterizations of a Blister Pack Using the XGT-9000

The XGT-9000 is HORIBA’s new X-ray microscope. Its analytical versatility allows, multiple characterizations to be performed on a blister pack, from mapping of the full pack to particle size measurements of the capsule content.

Pharmaceutical compounds distribution and cosmetic products analyzed by confocal Raman spectroscopy

In the final step of the formulation process, pharmaceutical and cosmetic industries have to control their products to check if the compounds' distribution in the final product, or in its application form, i.e. dispersed on a skin for an intracutaneous product, are homogenous and stable in order to guarantee the product's efficacy. In this paper, we present why confocal Raman microscopy is an excellent tool for product characterization after formulation.

Raman Microscopy in Pharmaceutical Salt Analysis

Pharmaceutical and crystallographic samples typically require detailed characterization and analysis to optimize a samples stability, physical properties and indeed general efficacy where an active drug substance is involved.

Samples can be valuable. Either you don’t want to waste them, or you may not have very much starting material. Biological proteins and enzymes, for example, are often obtained in small volumes and may be expensive.

Determination of pH as Quality Control Test in Culture Media-01

Raman Analysis of lysozyme

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

The use of low molecular weight molecules in the industries of drug discovery and agri-food has become increasingly important over the course of a century of drug research and science development in agriculture and in pharmaceutical field.

Monitoring Cell Culture Media Variability using A-TEEM Spectroscopy

With the rise of protein production using mammalian cell culture, it has become increasingly important to control the quality of the cell culture media for use in production processes. Cell culture media are usually prepared as aqueous solutions and should provide everything a cell line needs for optimal cell growth as well as product yield and quality.

Holistic Analysis of Mammalian Cell Proliferation using Fluorescence Spectroscopy

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HD-480

Panel-mount Type Dissolved Oxygen Meter (Four-Wire Transmission, Membrane Type)

2.50 mmol/L Calcium Ion Standard Solution Y052H

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OpenPleX

Manual label-free molecular interaction analysis machine Flexible Research Platform

Reference Electrode 2060A-10T

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Standard type

TW-150

Online Water Quality Monitor

Aqualog - A-TEEM Industrial QC/QA Analyzer

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A Simple, Fast, “Column Free” Molecular Fingerprinting Technology

Ammonia Electrode Filling Solution

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9425-10C (for general-purpose use)

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Reference Electrode 2565A-10T

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Double-junciton type

9300-10D ORP Electrode

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Calcium ion sensor S051

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1.25 mmol/L Calcium Ion Standard Solution Y052L

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HE-960RW

Panel-mount Type Resistivity Meter(Four-Wire Transmission, 2-channel)

TW-100

Water Distribution Monitor

Chloride ion electrode (combination) 6560S-10C

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100 mg/L Ammonium Ion Standard Solution

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pH Sensor S010

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Temperature Compensation Electrode 4163-10T

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EG-100

Washwater Monitoring System

1000 mg/L Ammonium Ion Standard Solution

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Calcium Electrode Filling Solution

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Salt electrode S021

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HE-480R

Panel-mount Type Resistivity Meter(Four-Wire Transmission)

5402 DO Electrode Tip

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100 mg/L Calcium Ion Standard Solution

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Sodium ion electrode S022

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TPNA-500

Automatic Total Nitrogen/Phosphorus Monitoring

Chloride ion electrode tip 7660S

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Chloride Electrode Filling Solution

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1000 mg/L Calcium Ion Standard Solution

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Potassium Ion Sensor S030

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CODA-500

Automatic COD Monitor

100 mg/L Chloride Ion Standard Solution

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Fluoride ion electrode (combination) 6561S-10C

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1000 mg/L Chloride Ion Standard Solution

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NIST pH Buffer Solution Kit

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Nitrate ion electrode S040

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OPSA-150

Organic Pollutant Monitor

Partica LA-960V2

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Laser Scattering Particle Size Distribution Analyzer

100 mg/L Fluoride Ion Standard Solution

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USA pH Buffer Solution Kit

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LAQUAtwin pH-33

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Pocket Water Quality Meters

Calcium Ion Sensor S050

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HE-960CW

Panel-mount Type Conductivity Meter (Four-Wire Transmission, 2-channel)

1000 mg/L Fluoride Ion Standard Solution

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pH 1.68 Buffer Solution

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LabRAM HR Evolution

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Confocal Raman Microscope

Fluoride ion electrode tip 7661S

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pH 4.01 Buffer Solution

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HE-480C

Panel-mount Type Conductivity Meter (Four-Wire Transmission, For Low-concentration)

Nitrate Electrode Filling Solution

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100 mg/L Nitrate Ion Standard Solution

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LAQUAtwin pH-22

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Pocket Water Quality Meters

HE-300R

Field-installation Type Electric Resistivity Meter (Two-Wire Transmission)

XploRA™ PLUS

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Raman Spectrometer - Confocal Raman Microscope

Partica LA-960

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Laser Scattering Particle Size Distribution Analyzer

Ammonia electrode (combination) 5002S-10C

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9520-10D DO electrode

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1000 mg/L Nitrate Ion Standard Solution

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LabRAM Soleil

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Raman Microscope

Ammonia Ionic Strength Adjustor

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Calcium Ionic Strength Adjustor

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Chloride Ionic Strength Adjustor

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pH 6.86 Buffer Solution

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Powder for ORP Standard Solution 160-51

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HE-200C

Field-installation Type Electric Conductivity Meter (Four-Wire Transmission, For Low-concentration)

Potassium Electrode Filling Solution

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LAQUAtwin pH-11

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Pocket Water Quality Meters

HE-480H

Panel-mount Type Conductivity Meter (Four-Wire Transmission, For Low-concentration)

SmartSampling

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Turns Raman Imaging from Hours to Minutes

Fluoride Ionic Strength Adjustor

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Nitrate Ionic Strength Adjustor

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Potassium Ionic Strength Adjustor

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pH 7.00 Buffer Solution

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7541 DO Electrode Tip

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3551-10D Conductivity Cell (Submersible Type)

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Ammonia electrode membrane caps

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pH 9.18 Buffer Solution

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Powder for ORP Standard Solution 160-22

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LAQUAtwin Ca-11

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Pocket Water Quality Meters

Nitrate ion electrode (combination) 6581S-10C

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pH 10.01 Buffer Solution

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9551-20D DO Electrode

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3552-10D Conductivity Cell (Submersible Type)

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pH 12.46 Buffer Solution

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HP-960FTP

Panel-mount Type pH Meter (Four-Wire Transmission, 4 point ararm, Time sharing Proportional Control)

PSA300*

Static Image Analysis System Particle Size

9551-100D DO Electrode

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3553-10D Conductivity Cell (Submersible Type)

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LAQUAtwin NO3-11C/NO3-11S/NO3-11

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Pocket Water Quality Meters

Nitrate ion electrode tip 7681S

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HP-480TP

Panel-mount Type pH Meter (Four-Wire Transmission, Industrial Time sharing Proportional Control)

ViewSizer 3000

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Multi-Laser Nanoparticle Tracking Analysis (NTA)

Potassium ion electrode (combination) 6582S-10C

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5401 DO Electrode Tip

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9382-10D Conductivity Cell (Submersible Type)

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LAQUAtwin K-11

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Pocket Water Quality Meters

pH Standard Solution 100-2

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Electrode protector cap (3 pcs/pack)

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HP-480PL

Panel-mount Type pH Meter (Four-Wire Transmission, Pulse Proportional Control)

VG Series

Capacitance Manometer

3561-10D Conductivity Cell (Flow Type)

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LAQUA PH1500

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Benchtop Water Quality Meters

LAQUAtwin Na-11

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Pocket Water Quality Meters

pH Standard Solution 100-4

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HU-200TB-W

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Field-installation Type Turbidity Meter (Four-Wire Transmission, For Wide Range)

Potassium ion electrode tip 7682S

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HP-480

Panel-mount Type pH Meter (Four-Wire Transmission)

Calcium ion electrode (combination) 6583S-10C

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3562-10D Conductivity Cell (Flow Type)

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LAQUAtwin Salt-22

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Pocket Water Quality Meters

pH Standard Solution 100-7

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HU-200TB-IM

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Field-installation Type Turbidity Meter (Four-Wire Transmission, Immersion Type)

Printer (for GLP/GMP compliance)

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3573-10C Conductivity Cell (Flow Type)

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84 uS/cm Conductivity Standard Solution

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pH Standard Solution 100-9

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Calcium ion electrode tip 7683S

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LAQUAtwin EC-33

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Pocket Water Quality Meters

LAQUA PH1300

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Benchtop Water Quality Meters

3574-10C Conductivity Cell (Flow Type)

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Cyanide ion electrode 8001-10C

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HE-300C

Field-installation Type Electric Conductivity Meter (Two-Wire Transmission, For Low-concentration)

pH Standard Solution 100-10

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1413 uS/cm Conductivity Standard Solution

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Condensed pH Standard Solution 110-4

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LAQUA PH1200

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Benchtop Water Quality Meters

12.88 mS/cm Conductivity Standard Solution

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Condensed pH Standard Solution 110-7

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HP-300

Field-installation Type pH Meter (Two-Wire Transmission)

Digital simulator X-51

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Condensed pH Standard Solution 110-10

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HE-200R

Field-installation Type Electric Resistivity Meter (Four-Wire Transmission)

LAQUA PH1100

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Benchtop Water Quality Meters

Digital simulator X-52

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111.8 mS/cm Conductivity Standard Solution

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LAQUA EC1100

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Benchtop Water Quality Meters

Powder for pH Standard Solution 150-4

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HE-200H

Field-installation Type Electric Conductivity Meter (Four-Wire Transmission, For High-concentration)

USB cable

LAQUA PC1100

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Benchtop Water Quality Meters

Powder for pH Standard Solution 150-7

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HD-200

Field-installation Type Dissolved Oxygen Meter (Four-Wire Transmission, Membrane Type)

Chloride ion electrode 8002-10C

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Powder for pH Standard Solution 150-9

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LAQUA DS-72

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Benchtop Water Quality Meters

Sulfide ion electrode 8003-10C

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LAQUA F-74

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Benchtop Water Quality Meters

AC adapter cable set

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Iodide ion electrode 8004-10C

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LAQUA F-73

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Benchtop Water Quality Meters

HD-300

Field-installation Type Dissolved Oxygen Meter(Two-Wire Transmission, Membrane Type)

ICP Neo

ICP Software

LCD protection sheet

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Bromide ion electrode 8005-10C

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LAQUA WQ-330-K

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Handheld Water Quality Meters

LAQUA F-72

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Benchtop Water Quality Meters

Protection cover

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Copper ion electrode 8006-10C

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SEC-N100 Series

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Digital Mass Flow Controller

HD-200FL

Field-installation Type Dissolved Oxygen Meter (Four-Wire Transmission, Optical Type)

9480-10C Long ToupH electrode (for large containers and long test tubes)

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Electrode hook for D-70 Series, ES-71, and OM-71

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Cadmium ion electrode 8007-10C

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9481-10C Sleeve ToupH electrode (for viscous and non-aqueous samples)

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HP-200

Field-installation Type pH Meter (Four-Wire Transmission)

9418-10C Micro ToupH electrode (for low-volume samples)

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Lead ion electrode 8008-10C

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HR-200RT

Field-installation Type Residual Chlorine Meter (Four-Wire Transmission, Rotating Type)

9415-10C Standard ToupH electrode (for general laboratory application)

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FA-70A Integrated Electrode Stand

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Thiocyanate ion electrode 8009-10C

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Fluoride ion electrode 8010-10C

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FA-70S Electrode stand (adjustable type)

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9615S-10D Standard ToupH electrode (for general laboratory application)

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Silver ion electrode 8011-10C

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DP-50S Electrode stand

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TDM - The Time-Domain Monochromator

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9618S-10D Micro ToupH electrode (for low-volume samples)

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Sodium ion electrode 1512A-10C

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DP-70S Electrode Stand

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9680S-10D Long ToupH electrode (for large containers and long tubes)

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Nitrate ion electrode 8201-10C

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9681S-10D Sleeve ToupH electrode (for viscous and non-aqueous samples)

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Potassium ion electrode 8202-10C

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Calcium ion electrode 8203-10C

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9625-10D (for general-purpose use)

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LAQUA WQ-320-K

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Handheld Water Quality Meters

9630-10D (for low conductivity samples)

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LAQUA WQ-310-K

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Handheld Water Quality Meters

LAQUA PD220

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Handheld Water Quality Meters

9631-10D (for hydrofluoric acid or HF samples)

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LAQUA PD210

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Handheld Water Quality Meters

LAQUA PC220

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Handheld Water Quality Meters

9632-10D (for strong alkali samples)

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LAQUA PC210

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Handheld Water Quality Meters

XGT-7200

X-ray Analytical Microscope

LAQUA EC220

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Handheld Water Quality Meters

LAQUA 21 CFR Part 11 Software

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6367-10D (for high accuracy pH measurement)

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LAQUA EC210

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Handheld Water Quality Meters

LAQUA DO220

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Handheld Water Quality Meters

LAQUA DO210

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Handheld Water Quality Meters

LAQUA PH220

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Handheld Water Quality Meters

6252-10D (for food samples)

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LAQUA PH210

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Handheld Water Quality Meters

9651-10D (for field testing)

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Glass Electrode 1066A-10C

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Standard type

Glass Electrode 1076A-10C

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For measurement of low-conductivity water and non-aqueous solvents.

6069-10C (for very slender test tubes)

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MICROPOLE System

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Compact Process Gas Monitor

6261-10C (for flat surface measurement)

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Ultima

Ultra Fast TCSPC Lifetime Fluorometer

SpectraLED

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LED Phosphorescence Light Sources

DeltaTime

TCSPC Lifetime Kit

DeltaPro

TCSPC Lifetime Fluorometer

DeltaFlex

TCSPC Lifetime Fluorometer

XploRA INV

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Inverted Raman Microscope

Aqualog - Water Treatment Plant Analyzer

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Automated Organic Analysis & Early Warning Sentinel

HT-110

Total Organic Carbon Monitor

Sanitary Conductivity Sensor (Ferrule Clamp type) FES-210L

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Insertion sensor type for wide-range conductivity meter HE-960HI

XGT-9000

X-ray Analytical Microscope (Micro-XRF)