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.

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Raman Hyperspectral Imaging: An essential tool in the pharmaceutical field

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.

Spectroscopic Methods for Sunscreens Characterization

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.

For determination of grain size and roundness of globules, quick and objective measurement methods are required to guarantee high analytical accuracy as well as high product throughput.

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.

In this study, dynamic image analysis is used in the pharmaceutical industry to define the size and shape of granules created through a dry granulation process.

API image taken by PSA300

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

Sub-visible Particles from ViewSizer 3000

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

Spectroscopic Methods for Sunscreens Characterization

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.

Valuable analysis tool for cosmetics and skin characterization

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.

Teeth are naturally fluorescent and changes in their composition, caused by decay for example, affect their fluorescence behavior.

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.

Many solid oral dosage forms are based upon coating sugar spheres with layers of active ingredient, binders, and coatings. The size and shape of the beginning sugar spheres (also called nonpareil beads) are critical physical characteristics that should be carefully measured and controlled.

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.

For determination of grain size and roundness of globules, quick and objective measurement methods are required to guarantee high analytical accuracy as well as high product throughput.

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.

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.

In this study, dynamic image analysis is used in the pharmaceutical industry to define the size and shape of granules created through a dry granulation process.

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

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

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5402 DO Electrode Tip

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Fluoride ion electrode (combination) 6561S-10C

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

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Organic Pollutant Monitor OPSA-150

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

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pH 1.68 Buffer Solution

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3551-10D Conductivity Cell (Submersible Type)

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Nitrate ion electrode tip 7681S

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

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pH 6.86 Buffer Solution

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9551-20D DO Electrode

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3552-10D Conductivity Cell (Submersible Type)

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Reference Electrode 2060A-10T

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LAQUAtwin Ca-11

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9551-100D DO Electrode

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Potassium ion electrode tip 7682S

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XGT-9000

X-ray Analytical Microscope

Calcium ion electrode (combination) 6583S-10C

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LAQUA PC1100

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

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pH 7.00 Buffer Solution

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Powder for ORP Standard Solution 160-51

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5401 DO Electrode Tip

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Reference Electrode 2565A-10T

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Double-junciton type

9300-10D ORP Electrode

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

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SEC-R100 Series

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VG Series

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84 uS/cm Conductivity Standard Solution

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3553-10D Conductivity Cell (Submersible Type)

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1413 uS/cm Conductivity Standard Solution

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100 mg/L Ammonium Ion Standard Solution

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LAQUA DS-72

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

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pH 9.18 Buffer Solution

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Powder for ORP Standard Solution 160-22

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LAQUA WQ-320-K

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LAQUAtwin K-11

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pH Sensor S010

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Temperature Compensation Electrode 4163-10T

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9382-10D Conductivity Cell (Submersible Type)

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12.88 mS/cm Conductivity Standard Solution

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3561-10D Conductivity Cell (Flow Type)

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3562-10D Conductivity Cell (Flow Type)

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1000 mg/L Ammonium Ion Standard Solution

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

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pH 10.01 Buffer Solution

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LAQUA F-74

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3573-10C Conductivity Cell (Flow Type)

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LAQUA WQ-310-K

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LAQUAtwin Na-11

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111.8 mS/cm Conductivity Standard Solution

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Salt electrode S021

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3574-10C Conductivity Cell (Flow Type)

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pH 12.46 Buffer Solution

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LAQUA F-73

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Calcium ion electrode tip 7683S

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100 mg/L Calcium Ion Standard Solution

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LAQUAtwin Salt-22

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Sodium ion electrode S022

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Partica LA-960

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Laser Scattering Particle Size Distribution Analyzer

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9625-10D (for general-purpose use)

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Electrode protector cap (3 pcs/pack)

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LAQUA PD210

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1000 mg/L Calcium Ion Standard Solution

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LAQUAtwin Salt-11

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100 mg/L Chloride Ion Standard Solution

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1000 mg/L Chloride Ion Standard Solution

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9630-10D (for low conductivity samples)

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LAQUAtwin EC-33

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Nitrate ion electrode S040

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pH Standard Solution 100-2

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100 mg/L Fluoride Ion Standard Solution

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

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Printer (for GLP/GMP compliance)

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Cyanide ion electrode 8001-10C

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LAQUA PC210

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LAQUAtwin EC-22

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Calcium Ion Sensor S050

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pH Standard Solution 100-4

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1000 mg/L Fluoride Ion Standard Solution

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9632-10D (for strong alkali samples)

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Chloride ion electrode 8002-10C

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LAQUA EC220

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LAQUAtwin EC-11

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pH Standard Solution 100-7

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6367-10D (for high accuracy pH measurement)

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Sulfide ion electrode 8003-10C

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LAQUA EC210

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100 mg/L Nitrate Ion Standard Solution

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[Exclusively for TWIN] Conductivity Cell 0413

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pH Standard Solution 100-9

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PSA300

Static Image Analysis System Particle Size

Digital simulator X-51

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Digital simulator X-52

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USB cable

AC adapter cable set

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LCD protection sheet

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6377-10D (for low-conductivity samples and non-aqeous solvents)

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Iodide ion electrode 8004-10C

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LAQUA DO220

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1000 mg/L Nitrate Ion Standard Solution

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[Exclusively for CARDY] Sodium ion electrode 0221

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For the C-121 and C-122

pH Standard Solution 100-10

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Ammonia Ionic Strength Adjustor

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Calcium Ionic Strength Adjustor

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Chloride Ionic Strength Adjustor

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Protection cover

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Bromide ion electrode 8005-10C

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6252-10D (for food samples)

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LAQUA DO210

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[Exclusively for CARDY] Potassium ion electrode 0231

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For the C-131

Condensed pH Standard Solution 110-4

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Nitrate Ionic Strength Adjustor

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Potassium Ionic Strength Adjustor

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Calcium Electrode Filling Solution

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

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0040-10D ISFET pH electrode

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Copper ion electrode 8006-10C

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LAQUA PH220

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Condensed pH Standard Solution 110-7

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Cadmium ion electrode 8007-10C

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Condensed pH Standard Solution 110-10

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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.

FA-70A Integrated Electrode Stand

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6069-10C (for very slender test tubes)

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Powder for pH Standard Solution 150-4

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Lead ion electrode 8008-10C

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6261-10C (for flat surface measurement)

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LAQUAact PH130

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FA-70S Electrode stand (adjustable type)

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Thiocyanate ion electrode 8009-10C

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Powder for pH Standard Solution 150-7

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LAQUAact PH120

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DP-50S Electrode stand

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Fluoride ion electrode 8010-10C

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Powder for pH Standard Solution 150-9

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LAQUAact PH110

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DP-70S Electrode Stand

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Silver ion electrode 8011-10C

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Sodium ion electrode 1512A-10C

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Nitrate ion electrode 8201-10C

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Potassium ion electrode 8202-10C

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Nitrate Electrode Filling Solution

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LAQUA 21 CFR Part 11 Software

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Handheld Water Quality Meters

Calcium ion electrode 8203-10C

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LAQUAact PD110

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LAQUAact PC110

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TDM - The Time-Domain Monochromator

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ICP Neo

ICP Software

XGT-7200

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MESA-50K

X-Ray Fluorescence Analyzer

9651-10D (for field testing)

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MESA-50

X-Ray Fluorescence Analyzer

Ultima

Ultra Fast TCSPC Lifetime Fluorometer

SpectraLED

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LED Phosphorescence Light Sources

OpenPleX

Manual label-free molecular interaction analysis machine Flexible Research Platform

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Fluorolog

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DeltaTime

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DeltaPro

TCSPC Lifetime Fluorometer

DeltaFlex

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