PerkinElmer

Drug Substance & Excipients

Ensuring purity and assuring compliance

Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.

Drug substance is the active pharmacological ingredient used in a finished pharmaceutical product and has a direct effect on both the treatment and prevention of disease. To ensure the purity, quality and safety of a drug substance, it is essential to perform analytical tests to identify if any impurities or adulterants exist.

Our advance analytical tools provide the data to mitigate compliance risk and guide your GMP standards compliance for the identification of incoming raw material testing, drug substance assay and excipient quality.

The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

Explore Our Solutions

Analytical Chemistry Software

Solve problems in almost all areas of chemistry for all kinds of industries with PerkinElmer Informatics solutions. Quickly capture, structure and process analy ...

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Consumables

Partner with us and give your laboratory the benefits of cutting-edge instrumentation, consistently excellent consumables and the industry’s largest, most trust ...

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QA/QC Software

Organize all of the testing and results needed to control manufacturing processes and ensure the quality of raw materials, in process samples, and finished good ...

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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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Cleaning Validation

Regulatory authorities expect pharmaceutical companies to have written standard operating procedures (SOPs) detailing the cleaning processes used for various pi ...

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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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UV/Vis Reference Materials

Accelerate the calibration verification of your materials characterization instruments. Our reference materials provide you with the evidence you need to pass t ...

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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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Polymorphic Forms

During the process of manufacturing finished dosage forms (solids), an organic molecule can adopt more than one crystalline form which can have significant effe ...

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Explore Our Instruments

Chromatography Instruments

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 Instruments

If you're looking for world-leading AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. Tens of thousands of installations worldwi ...

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Molecular Spectroscopy Instruments

Characterize advanced complex materials on any budget. Our comprehensive portfolio of analytical solutions has the ideal molecular spectroscopy instruments for ...

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Thermal Analysis Instruments

Improve accuracy, sensitivity, and performance in thermal analysis using our comprehensive portfolio of instruments. Applications of our industry-leading techno ...

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Organic Elemental Analysis Instruments

For reliable elemental analysis and proven performance when analyzing carbon, hydrogen, nitrogen, sulfur, and oxygen (CHNS/O), we have the right solution for yo ...

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