PHARMACEUTICALS LAB PACKAGE
Develop your formulations and therapies faster by combining techniques
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Complete picture of product composition with easily resolved polymorphic peaks in the DSC and microgram-level weight loss detection on the TGA

The DSC 2500 with T4P Heat Flow provides the best true resolution between polymorphic peaks that allows for a clear and accurate measure of the crystalline forms that exist in a sample, and the high-sensitivity balance on the TGA5500 can reproducibility detect even the smallest weight change associated with compounds found in a sample.

Easy storage and stability examination under a wide array of environments with TGA and Modulated DSC

Thermal stability can easily be measured via the TGA without any baseline/blank runs required for baseline subtraction. DSC and MDSC to examine the change in heat capacity allows for clear and easy detection of material compatibility as well as storage stability.

TRIOS Guardian for 21 CFR Part 11 data integrity and data tracking.

TRIOS Guardian plugs into the systems and technologies already in place; TRIOS Guardian is a true file-based system with encapsulated data files, which means audit-controlled data is stored with the file. Free your data and leverage any LIMS, Laboratory notebook, Cloud service, or data processing tools to control when and where you access your data files.


Differential Scanning Calorimeters (DSC) measure temperatures and heat flows associated with thermal transitions in a material. Common usage includes investigation, selection, comparison and end-use performance evaluation of materials in research, quality control and production applications. Properties measured by TA Instruments’ DSC techniques include glass transitions, “cold” crystallization, phase changes, melting, crystallization, product stability, cure / cure kinetics, and oxidative stability.

Temperature Range: -180°C to 725°C

Detectable Information: Glass transitions, melting, crystallization, phase changes, heat capacity, cure kinetics, oxidative induction time

Thermogravimetric Analyzers measures temperatures and weight changes associated transitions in a material. Common usage includes decomposition, volatilization, residue, material composition analysis, decomposition kinetics, thermal and oxidative stabilities.

Temperature Range: 30°C to 1200°C

Detectable Information: weight change temperature, weight change amount, decomposition kinetics, residue.

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.

At a high level, Part 11 is a law that ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows any paper records to be replaced by an electronic record, and allows any handwritten signature to be replaced by an electronic one.

Key Features

  • No Database, No licenses and uses existing already defined users.
  • Simple, easy to understand
  • Allows for normal file handling operations at the IT level.
  • LIMS, Cloud and Lab notebook friendly
  • No redundancy of storage.





Technology

How the DSC, TGA, and TRIOS Guardian will benefit your lab:


High sensitivity for detection and accurate quantification of APIs and purity of new formulations during the development and quality control areas of pharmaceuticals

Market leading baseline flatness on both the DSC and TGA create opportunity for easy detection of transitions related to the sample (APIs, excipients, impurities, volatiles) and accurate quantification of those transitions. Understanding the fingerprint of pharmaceutical materials is critical during development/formulation as well as in the area of QC.

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Learn how the instrument package below will accelerate your drug development from formulation to storage optimization, and ensure 21CFR11 compliance.


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