Pharmaceuticals
Rising to the challenge to ensure the quality and compliance of pharmaceutical products
In the highly regulated pharmaceutical sector, quality and safety are the guiding principles. Innovation, high efficiency, and the highest quality products are on the agenda, always within the framework of the requirements of 21 CFR Part 11, driven by the FDA as well as by diverse Pharmacopoeia. A wide range of parameters need to be monitored, checked, and counter-checked; the resulting data has to be relevant, reliable, and in accordance with ALCOA+ principles. Anton Paar has numerous solutions for use in quality and production control, in research and development – and even better: Anton Paar qualifies your newly purchased instrument on-site and brings it into your workflow within a short period of time.
Anton Paar Products
Abel Flash Point Tester: ABA 4
Automated flow chemisorption analyzer: ChemBET Pulsar
Automated representative sampler: Micro Rotary Riffler
Automated tapped density analyzers: Autotap
Ball mill: BM500
Combined density and sound velocity sensor: L-Com 5500
Compact Raman spectrometers: Cora 5001
Cryo & Humidity Chamber: CHC plus⁺
Density and sound velocity meter: DSA 5000 M
Density meter: DMA 4100 M
Density meter: DMA 4500 M
Density meter: DMA 5000 M
Density sensor: L-Dens 3300
Digital heavy duty refractometer: Abbemat
Digital performance refractometer: Abbemat
Dynamic shear rheometer measuring head: DSR 502
Foam testing Pycnometer: PentaFoam
Fully customizable laboratory automation solution: HTX
Gas Pycnometer: PentaPyc
Gas sorption analyzer: QUADRASORB evo
Handheld alcohol meter: Snap
Handheld density meter: DMA 35 Basic
Handheld Raman spectrometer: Cora 100
HTR Compact: Rheometer autosampler for high sample throughput
HTR: Rheometer automation for high sample throughput and complex sample handling
Inline Refractometer: L-Rix
Kinematic viscometer: SVM
Low-Temperature Chamber: TTK 600
Mercury intrusion porosimeters: PoreMaster
Micro Combi Tester: MCT³
Micro Scratch Tester: MST³
Microindentation Tester: MHT³
Micropore physi-/chemisorption analyzers: autosorb iQ
Microwave digestion rotor: Rotor 16HF100
Microwave digestion rotor: Rotor 16MF100
Microwave digestion system: Multiwave GO Plus
Microwave extraction rotor: Rotor 16SOLV HF100
Microwave extraction rotor: Rotor 16SOLV MF100
Microwave reactor for microwave-assisted extractions: Monowave 450
Microwave Synthesis in the Kilolab: Masterwave BTR
Microwave Synthesis: Monowave 400/200
Microwave-assisted drying rotor: Rotor 1DRY
Millikelvin thermometers: MKT
Modular circular polarimeter: MCP
Modular Compact Rheometer: MCR 72/92
Modular Compact Rheometer: MCR 102/302/502
Motorized alignment for XRD: z-alignment stage
Multiparameter Analyzing System: Modulyzer
Multiwavelengths Refractometer: Abbemat MW
Nanoindentation tester: NHT³
Particle size analyzer: Litesizer
Penetrometer: PNR 12
Pensky-Martens flash point tester: PMA 5
Pensky-Martens flash point tester: PMA 500
pH value measuring module: pH ME
Pin-on-disk tribometer: TRB³
Portable density meter: DMA 35
Revetest® Scratch Tester: RST³
Rolling-ball viscometer: Lovis 2000 M/ME
Rotational Rheometer: RheolabQC
Rotational viscometer: ViscoQC
Rotor 4X24MG5
Rotor 64MG5
Sample changer: Xsample 320
Sample changer: Xsample 530
SAXS/WAXS/BioSAXS system: SAXSpace
SAXS/WAXS/GISAXS/RheoSAXS laboratory beamline: SAXSpoint 5.0
Single-station gas pycnometers for true density: Ultrapyc
Software for particle analysis: Kalliope™
Surface area analyzer: AutoFlow BET+
Surface area and pore size analyzers: NOVAtouch
T-probe
T-probe S
Tag Flash Point Tester: TAG 4
Ultra nanoindentation tester: UNHT³
Vacuum and Flow Degasser: FloVac
Vacuum Degasser: XeriPrep
Vacuum Tribometer: VTHT / VTRB
Vapor sorption volumetric gas sorption analyzer: VSTAR
Quantachrome Products
Anton Paar Applications
Application PNR 12: Consistency of Carboxymethylcellulose Sodium Paste
The penetrometer PNR 12 allows a rating of the plasticity or consistency of carboxymethylcellulose sodium paste containing products.
Application PNR 12: Consistency of Pharmaceutical Products
The Penetrometer PNR 12 is suitable for consistency measurements required in the pharmaceutical industry. Various test kits are available for different pharmaceutical products and standards like the official WHO method European Pharmacopoeia 2.
Applications of nanoindentation in biology and medicine
Nanoindentation for biological materials
Continuous Monitoring of Hydrogen Peroxide
Relevant for detergents/cleaners, descaling agent, beverages, food industry, pharmaceuticals, personal care
Correlating Viscosity and Particle Size Parameters determined by Small Angle X-Ray Scattering Studies of concentrated MAb Solutions
Monoclonal antibodies (MAb) solutions are a major class of biopharmaceuticals with various applications. However, challenges like a high viscosity at the required MAb concentrations need to be addressed at an early development stage.
Cross-selling with MCP | Reliable Partner for Pharmaceutical Industries
The pharmaceutical market shows a strong demand for efficient and improved synthesis methods of active components (APIs) as well as for effective analysis methods.
Determination of Camphor by Polarimetry
Camphor is naturally produced by trees of the laurel family. It has a strong aromatic odour and is used for various medical and non-medical applications.
Determination of Glucosamine via Polarimetry
Glucosamine is used as a joint supplement for the treatment of arthralgia and osteoarthritis. In order to have high-quality products the optical rotation of glucosamine needs to be analyzed via polarimetry.
Determination of the Enantiomeric Purity of Dextromethorphan Hydrobromide
Dextromethorphan, the dextrorotatory enantiomer of methorphan, serves as an antitussive drug. According to the US pharmacopoeia, the optical rotation of dextromethorphan hydrobromide has to be measured at a wavelength of 325 nm whereas the EU pharmacopoeia
Fast Structure Analysis of Pharmaceutical Excipients by SWAXS for Product Quality Control
The nanostructure of pharmaceutical excipients used as taste masking agents was rapidly determined for quick quality control with the SAXSpace system.
Glycerol
Glycerol is used in various industries as a moisturizer, a thickener, as antifreeze or as a precursor for explosives. Its quality as well as its concentration in solution can be determined by using refractometry.
Gold nanoparticles: Size matters, and so does stability
Gold nanoparticles are now used in many fields, from medicine to electronics, but each application has specific particle-size and stability requirements. Gold nanoparticles can be easily monitored with the Litesizer™ 500.
Identifying three different particle sizes in one sample with DLS
Particle suspensions often contain more than one size of particle. However, many particle analyzers cannot resolve particle mixtures, instead they detect an average of all sizes. The Litesizer™ 500 can detect three sizes in one sample.
Improve Digestion Quality and Save Money – Microwave Digestion rules out Open Digestion
Reliable elemental analysis results need robust sample preparation to destroy sample matrices or to separate matrix from analytes. The sample preparation step is by far the most error-prone and critical step of the analytical procedure.
Intelligent Quartz Control Plates for Polarimetric Calibration and Adjustment
Modern polarimeters are calibrated or adjusted with intelligent quartz control plates that do not require manual data entry in order to ensure data traceability.
L-Rix 510: Determination of Concentration on Producing Dialysis Products
L-Rix 510 – Enjoy the simplicity of refractive index measurements without maintenance or adjustments.
Mesoporous thin films - Investigating the structure of multi-layered films by GISAXS
Single- and double-layered mesoporous thin films have been analyzed by GISAXS for their structural properties using the SAXSpoint system.
Nanoparticles for Ceramics: Size, Stability & pH
In nanoparticle suspensions that will be used in ceramics, particle size and stability are of vital importance. Suspension stability is essential to ensure that the particles to stay in suspension, and maintain constant particle size.
Nanotribological properties of Diamond like carbon thin flexible films on ACM rubber
Pharma, Cosmetics - Determining the Rheological Properties of Pharmaceutical Products
The rheological characterisation of microemulsions with the Rotational Rheometer RheolabQC gives essential information about their properties and the customer’s evaluation of the end product.
Polarimeters for Processing Applications
The Propol process polarimeter is ideal for process applications on chiral compounds such as sugars and pharmaceuticals. It is designed to be placed inline or in bypass allowing continuous measurements.
Polarimetric Determination of Lactose Content in High Lactose Dairy Products
The quality of milk and milk powders depends, among others, on the lactose content. The lactose needs to be extracted from dairy products having high lactose content (e.g. milk and milk powders) before using the polarimeter for concentration determination.
Quality Control in Drugs
Polarimeters are essential in drug quality control to ensure the enantiomeric purity and therefore efficacy of pharmaceutical drugs.
Quality Control of Saline Solution
Abbemat refractometers from Anton Paar are valuable instruments for the precise analysis of concentration and purity of saline solutions.
Quality control of pharmaceutical excipients during storage and processing
The structure of pharmaceutical excipients as a function of storage time and temperature was analyzed by small- and wide-angle X-ray scattering using the SAXSpace system.
Refractive Index of Essential Oils
The refractive index of essential oils is a quickly measured, easily generated quality parameter. Moreover, it helps to differentiate between different essential oils.
Refractometric analysis of fats and oils
The refractive index or butyro value of animal and vegetable fats and oils is a quickly measured, easily generated quality parameter value. Moreover, it helps to differentiate between different fats, such as butter and margarine.
SAXSpoint with MetalJet Source
SAXSpoint now integrates the high-brightness MetalJet X-ray source enabling ultra-fast SAXS measurements in the laboratory.
Size and shape of gold nanoparticles in toluene via SAXS
A solution of colloidal gold nanoparticles was characterized for size and shape by the SAXSpace system.
Spherical Nanoindentation of Polyacrylamide Hydrogels using the Bioindenter (BHT)
Starch Decomposition with Subsequent Polarimetric Content Determination
This method is suitable for the determination of starch and high molecular weight starch degradation products in food or feedstuffs in compliance with the EC Commission Directive 86/174/EEC and Council Directive 96/25/EC. Please note that this method requi
Targeting Alzheimer’s disease - studying the fibril structure of the Amyloid beta protein on a laboratory system
The fibril structure of Amyloid beta has been studied with the SAXSpoint 2.0 system.
Temperature-dependent GISAXS studies on thin films
The temperature-induced decomposition of a thin film structure has been studied using the SAXSpoint system with the new temperature-controlled GISAXS stage.
The Ultra Nanoindentation Tester: New generation of thermal drift free indentation
The influence of Surface Roughness on Instrumented Indentation Testing (IIT)
Benefits
Checking the purity and efficacy of drugs from small volumes
In drug discovery and reverse engineering, the samples you have to work with are often small. When measuring optical rotation or specific rotation using polarimeters of the MCP series this problem is solved by using the sample cells of 2.5 mm length. These small cells are also well-suited for measurements on dark-colored samples. Modular systems such as the Modulyzer offer a space- and sample-saving solution for measuring both optical rotation and refractive index in one measuring cycle from the same sample vial.
Accelerating library generation for drug discovery
The generation of compound libraries of substances synthesized simultaneously or sequentially for drug discovery is time-consuming and expensive. Reaction parameters such as temperature, time, and variations in solvents, additives, catalysts or the molar ratios of the substrates have to be optimized in advance. In addition, the required product quantities change during the drug discovery process. Employing microwave-assisted synthesis can dramatically reduce reaction times compared to conventional heating. Due to the expected time savings for a typical library production, for example, the common period of 37 days is reduced to only 2 days. Using Anton Paar’s Monowave 400 with an automated vial handling system, 24-compound libraries can be synthesized sequentially. Multiwave PRO with silicon carbide plates allows reaction screening of up to 192 positions.
Checking the stability of solutions
Consumers will be unhappy if solutions such as eye drops contain agglomerates. To check solutions for agglomerates, the Litesizer particle size analyzer can be used to measure the transmittance. If the transmittance of the solution is low, the product may not meet the high standards demanded by the market.
Instrumentation installed, qualified, and working for you in 1 to 3 days
Compliance is one thing, getting a new measuring instrument set up, integrated, and ready for audits is another. Implementing Anton Paar’s Pharma Qualification Package for selected instruments gets your new instrument up and running within days. It covers all the steps of a complete instrument qualification (DQ, IQ, OQ, PQ, Risk Analysis, 21 CFR Part 11 Checklist, Deviation List, Traceability Matrix, and user SOP as a Word file). The package fulfills the requirements of GMP, 21 CFR Part 11, GAMP 5, USP <1058> and can be used for subsequent requalifications.
Assessing temperature- and humidity-induced changes to formulations
Pharmaceutical drugs can be exposed to humidity and temperature changes during the production process and storage. These conditions may lead to an unexpected phase transition, resulting in a change of effectiveness or, in the worst case, in negative effects. Investigating the influence of temperature and relative humidity on the crystal structure, phase transitions, and polymorphism of drugs can be done using non-ambient X-ray diffraction. Utilizing Anton Paar’s CHC plus+ Cryo & Humidity Chamber, X-ray diffraction data can be recorded at high relative humidity and various temperatures. The chamber enables the variation of the humidity at constant temperature and also the variation of the temperature at constant humidity, by following the dew-point curve.
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