In the highly regulated pharmaceutical industry, ensuring compliance for every drug substance and, product relies on establishing Identity & Purity. Our comprehensive portfolio of products and services supports efficient and accurate pharmaceutical workflows. Our advanced analytical instruments, including Spectroscopy, Chromatography and Thermal Analysis tools, offer precise and reliable results essential for thorough analysis – from research, development, and manufacturing to packaging.
Ensuring compliance with regulatory requirements is crucial. Our software solutions are designed to meet 21 CFR Part 11 standards, where applicable, providing secure and efficient data management and instrument control. Enhance your laboratory’s efficiency and productivity with our tailored workflow optimization services, offering expert consultation and support to meet your operational goals. Additionally, maintain peak performance with our wide range of high-quality consumables and accessories.
DISSOLUTION TESTING
Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. It makes an impact at almost every step of the journey, from early product development to late-stage quality control in commercial manufacturing. Given its importance throughout the course of drug development and manufacturing, dissolution testing has become a key concern for regulatory bodies – so the dissolution apparatus you depend on must provide the most accurate and reproducible results available
Dissolution is a test used by the Pharmaceutical industry to characterize the dissolution properties of the active drug, the active drug’s release, and the dissolution from a dosage formulation. Different test methods are described in USP, Ph.Eur., and other internationally harmonized Pharmacopeia as well as in FDA guidelines. Whereas standard tablets are typically tested according to the paddle method (USP 2), swelling or floating dosage forms such as capsules are tested using the basket method (USP 1). Paddle-over-disk (USP 5) and rotating cylinder (USP 6) methods are used for transdermal dosage forms.
AT Xtend™ Manual
Easy-to-operate manual dissolution tester with advanced monitoring options.
Dissolution tester automatically withdraws, filters, and collects samples in tubes, capped LC vials, or well plates
Elemental Impurities Testing
Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in the components of the drug product, or even intentionally through residual catalysts added in synthesis. However they get there, the levels of impurities need to be controlled or they can hurt your final drug product.
Avio 500 ICP-OES Instrument
Patented Flat Plate™ plasma technology utilizes maintenance-free induction plates and consumes half the argon of helical coil systems, dramatically reducing operating costs.
Advanced optical system simultaneously collects data on more than 73 elements (UV and visible wavelengths) in a matter of seconds for exceptional sample throughput.
Built-in PlasmaCam™ camera offers continuous viewing of the plasma, simplifying method development and enabling remote diagnostic capabilities for maximum uptime.
Syngistix for ICP Enhanced Security Software delivers 21 CFR Part 11 Compliance
The smallest ICP on the market, the Avio 200 offers efficient operation, reliable data, and low cost of ownership by delivering:
The lowest argon consumption of any ICP: only 9 L/min, compared to 21 L/min required by other systems.
The fastest ICP startup: spectrometer ready in just 10 minutes from power on.
Superior sensitivity and resolution for all elements of interest.
Extended linear range.
Pharmaceutical Raw Material Identification
The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee the safety and efficacy of a finished dosage form which is largely dependent on the purity and quality of the bulk active drug substance and excipient.
The drug substance manufacturer must have complete knowledge of the manufacturing process and the potential impurities that may appear in the drug substance and excipient. It is therefore important to have a high-throughput method by which raw materials may be analysed in a loading bay or warehouse, while also preventing sample exposure to avoid contamination.
Spectrum 3™
The PerkinElmer Spectrum 3™ range of near, mid, and far infrared fourier transform (FT-IR) spectrometers provide the ultimate sampling flexibility and spectroscopic performance you need. The highly configurable platform provides dependable, consistent and trouble-free operation through years of service. Spectrum 3 is loaded with a range of advanced innovations designed to provide you with exceptional performance and flexibility from the configuration you choose.
21 CFR Part 11 Compatible
Exceptional signal-to-noise ratio and photometric performance
High reproducibility of spectral data without spectral interferences
Best-in-class sensitivity, even when using room temperature detectors
Characterize fast reactions with scan speeds up to 100 scans/sec
Drug Substance Assay
An extensive set of analytical testing and acceptance criteria are applicable to drug substances including universal and specific test criteria established by ICH Q6 guidelines and methods described in the specific monograph for the raw API. All drug substances should undergo a specific, stability-indicating assay to determine their strength and content.
All drug products must be GMP-compliant before release for commercial use. We provide the tools you need to release safe and effective medicines, giving you peace of mind when it comes to audits.
Lambda 365
The LAMBDA™ 365 delivers state-of-the-art UV Vis performance that meets the needs of pharmaceuticals, analytical chemists, geneticists, and manufacturing QA/QC analysts everywhere. With 21 CFR part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
LC 300 HPLC System
The next-generation LC 300 HPLC system delivers the accuracy and flexibility needed for routine liquid chromatography applications. With its robust feature set and intuitive operation, the LC 300 HPLC has been designed to increase your laboratory productivity and throughput, even in the face of challenging budget and staffing situations.
Key features of the LC 300 HPLC platform include:
10,000 psi (690 bar) autosampler and pump configuration.
High visibility colour display for immediate assessment of system status without having to log into your CDS software.
Outstanding injection reproducibility – even at low volumes
Three injection modes: full loop, partial fill and µL-pickup for maximum flexibility
Long seal life via a dedicated and automated piston seal wash mechanism
Wide range of detectors: PDA, MWD, UV/Vis, FL and RI
Residual Solvents
The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various solvents that must be removed from the finished product. These solvents and byproducts may be measured with headspace gas chromatography for those volatile residual organic solvents according to the USP chapter <467> method and ICH Q3C guidelines.
GC 2400 System
Designed to address the needs for remote control, and simplified and sustainable operations of analytical laboratories, the PerkinElmer GC 2400™ System provides an innovative user experience with information on the go for effective and faster decision-making and advanced system capabilities for maximized productivity, thanks to reduced technology adoption costs and features supporting sustainability.
