Pharmaceuticals | PerkinElmer
PerkinElmer

Pharmaceuticals

Optimize Pharmaceutical Workflows with Advanced Analytical Solutions

 

In the highly regulated pharmaceutical industry, ensuring compliance for every drug substance and, the 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.

Regulatory & Compliance

Helping our customers meet compliance in a regulated environment

Given today’s evolving and increasingly complex regulatory environments, a whole new mindset to auditing, moving away from traditional instrument validation approaches and concentrating on the data lifecycle to detect gaps or fraud in product development and quality control are critical to compliance.

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Drug Substance & Excipients

Ensuring purity & assuring compliance

In order to comply with GMP standards, including identification of incoming raw material testing, drug substance assay and excipient quality, you need the latest analytical tools and data to meet compliance.

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Drug Product

Mitigating risk while maximizing production

Drug product or finished dosage form (tablet, capsule, injectables) contains a drug substance and excipient. All drug products must be GMP compliant to be released for commercial use. PerkinElmer provides the tools you need to release safe and effective medicines giving the peace of mind you need when it comes to audits.

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Control of Impurities

Keeping impurities and compliance under control

The control of impurities is mandatory for both drug substance and drug product testing. QA/QC laboratories need to guarantee impurity levels are below the threshold established by regulatory authorities such as FDA, EMA, MHRA to ensure GMP compliance.

At PerkinElmer, we provide the tools you need for you to take control of your impurities testing.

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Stability Testing

Monitoring and measurement for shelf-life and storage

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability at a long period of time.

To highlight its importance, ICH provides a dedicated section to Stability - at PerkinElmer, we provide the tools you need so you have your shelf-life and storage temperature under control.

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Explore Our Solutions

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 ...

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Elemental Impurities Testing

Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in ...

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Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to ...

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Pharmaceutical Raw Material Identification

The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is la ...

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Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations. An extensive se ...

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Drug Product Assay

An extensive set of analytical testing and acceptance criteria is applicable to drug products –including universal and specific test criteria established by ICH ...

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Excipients Characterization

The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the indus ...

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Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various sol ...

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Explore Our Instruments

Chromatography

Whatever your application, industry requirements or regulations, we have a breadth of solutions designed to solve your separation and detection challenges. Our ...

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Atomic Spectroscopy

If you're looking for proven AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. PerkinElmer has been at the forefront of atomic s ...

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Molecular Spectroscopy

Today’s advanced and increasingly diverse Advanced Materials laboratories are facing new challenges daily – starting from raw materials right up to the finished ...

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Thermal Analysis

Elevate your research and quality control with our state-of-the-art Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Simultaneous Ther ...

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