Comprehensive Pharmaceutical Testing From Formulation and R&D to QC and Process Engineering

TA Instruments | Waters have put together two lab packages designed specifically for your pharmaceuticals lab. Pairing DSC and TGA techniques along with Rheology will accelerate pharmaceutical development within your lab.

CHARACTERIZING DRUG COMPOSITION PACKAGE

Study Material Properties for Improved Product Performance

Quantify APIs and Formulation Purity During Development and QC

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.

Characterize Drug Composition and Stability

  • Examine the change in heat capacity and get clear detection of material compatibility as well as storage stability with DSC and MDSC
  • Measure thermal stability without any baseline/blank runs using the TGA
  • Combine the DSC and TGA to get complete control over environmental conditions during testing to predict product behavior throughout processing, storage, and delivery to customers

Thermal stability can easily be measured via the TGA without any baseline/blank runs required for baseline subtraction. DSC and MDSC can examine the change in heat capacity, allowing for clear and easy detection of material compatibility as well as storage stability. Both techniques offer complete control over the environmental conditions so you can predict product behavior throughout processing, storage, and delivery to customers.

DSC and TGA

TRIOS Guardian for 21 CFR Part 11 Data Integrity and 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.

DRUG FORMULATION PACKAGE

Key Data for Formulation and Delivery

Rheology measurements are crucial for optimizing pharmaceutical products’ processability and stability. Injectables and topicals need to flow appropriately, and powder for tablets must offer ideal compressibility.

Viscosity, flowability and shear measurements help users choose the right APIs and excipients to ensure successful drug performance. Rheology data also helps manufacturers prevent processing issues and predict product performance across all stages of production and delivery.

The Discovery Core Rheometer ensures successful drug formulation by helping users:

  • Characterize the shear thinning viscosity profile under storage, mixing, and spreading conditions
  • Optimize shelf-stability through yield stress and viscoelastic measurements
  • Match the rheology profile of generic topicals formulations with reference products for FDA, EMA submission

The typical Discovery Core Rheometer configuration for battery slurries is the Advanced Peltier Plate with a 40 mm plate geometry or concentric cylinder with a DIN rotor.

DCR

DRUG FORMULATION PACKAGE WITH POWDER TESTING

Characterize Your Entire Portfolio with One Rheometer

The Discovery Hybrid Rheometer uniquely enables you to measure critical attributes of drug products across your entire portfolio with one rheometer. The DHR powder rheology accessory uses the smallest sample volume of any powder flow cell system on the market, delivering reliable data without consuming expensive product.

In addition to the benefits listed above for the Core Rheometer, Discovery Hybrid Rheometer with the Powder Accessory helps users:

  • Easy to use – prepare powder samples 5x faster & start testing instantly
  • Get insights faster with one click analysis of powder rheology results
  • Test liquids, pastes, gels, powders, and solids with DMA – the only rheometer with all in one!

Build your Discovery Hybrid Rheometer package with the accessories you need. View the full accessory list here.

DHR with Accessories

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