Small Molecules

Insights into Synthesis, Formulation, and Quality Control to Ensure Optimal Drug Potency and Safety

Small molecules have many important functions in nature, medicine, and technology.

They have been the basis of drug development for the past century and represent most drugs patented on the market nowadays.

Small molecules are also extensively used in research to better understand biological processes and cellular mechanisms.

METTLER TOLEDO provides high-quality instruments to follow the synthesis of small molecules and help ensure the quality of the final active pharmaceutical ingredient (API) before the final dosage form and finish.

What Are Small Molecules?

Pharmaceutical scientists define small molecules as drugs with a size below 1 kilodalton made through organic chemistry synthesis.

Small molecules have several advantages:

They are typically given orally but can also be formulated in many other dosage forms (pills and capsules, intravenous, subcutaneous injectable, transdermal, inhalable medicines, or suppositories), which provides clinical flexibility.
They can pass through the cell membrane and reach intracellular targets.
They can be manufactured easily through a replicable and predictable chemical synthesis process.
They are easy to ship, store, and use.

Small molecules have diverse structures, and researchers must customize the synthesis process for each drug target.

By adding or modifying specific building blocks in the initial molecules, scientists can optimize the potency and toxicity of the drug.

After most of the synthesis steps, a purification process is performed, and each purification process is customized for a specific intermediate or final compound.

Before releasing a batch of small molecule API, pharmaceutical companies must be absolutely certain that they are dealing with a product of irreproachable quality.

Besides basic tests such as water and moisture, assay/purity, or microbial testing, polymorphic structures, particulate matter, and chirality must be verified before batch release.

Therefore, the successful release of an API lot depends on efficient analytical technologies.

Commonly Used Analytical Techniques

Thermal Analysis

Thermal analysis is used to investigate active compounds' chemical and physical properties.

Using thermogravimetric analysis (TGA) or differential scanning calorimetry (DSC), purity, stability, polymorphism, and compatibility of the API can be characterized.

UV-Vis Spectrophotometry

UV-Vis spectrophotometry is commonly used for the quantitative analysis of small molecules.

Titration

Titration has long been a standard method utilized to evaluate the level of active ingredients in pharmaceuticals and the content and purity of medicine additives used in the manufacturing of medicinal compounds.

FTIR Spectroscopy

In-situ Fourier transform infrared (FTIR) spectroscopy is widely used in process development due to its direct, nondestructive measurement principle.

This direct measurement permits real-time determination of key reaction parameters such as kinetics, mechanism, endpoint, transient intermediates, and reaction pathway.

Process Analytics

Process analytic sensors are widely used in process development and API manufacturing to monitor synthesis parameters in-line, allowing decisions on product quality to be made in situ, without relying on offline quality assurance and control.

Raman Spectroscopy

In-situ Raman is routinely used in process development for all the same reasons as in-situ FTIR for reaction monitoring, but it also enables in-situ measurement of the desired compound polymorphic form.

The desired product form is vital to knowing and reproducibly controlling it, not only for scale-up but also to ensure it is the correct form. Other forms may not have comparable efficacies for their intended purposes and can also be toxic to humans.

How to find the right tool for your application?

METTLER TOLEDO solutions are an excellent fit for your synthesis case, and will help to ensure the quality of the final active pharmaceutical ingredient (API) before the final dosage form and finish.

METTLER TOLEDO Solutions For Pharmaceutical Industry

Laboratory Weighing

Balances and Scales for the Laboratory

UV/Vis Spectrophotometry

Instruments, Accessories, Services, and Software for UV Vis Spectrophotometry

Rainin Liquid Handling Solutions

Liquid Handling Instruments and Consumables for Life Sciences

Automated Lab Reactors and In-Situ Analysis

Instruments for Chemical Synthesis, Process Development, and R&D

Process Analytics

Process Instrumentation for measuring pH, Dissolved Oxygen, Conductivity, Turbidity, TOC, Sodium, Silica, Gas Analyzer

Refractometer / Brix Meter

Benchtop and Portable Digital Refractometers

Analytical Instruments

Analytical Instruments - More than a Guarantee for Accurate Measurement Results

Industrial Weighing Scales and Systems

Accurate weighing scales and reliable weight scale for various scale base types

Calibration, Qualification and Maintenance for Your Solutions

METTLER TOLEDO Service is your one-stop shop for all your balance service, scale service, and inspection device service needs. From installation and initial calibration to preventive maintenance and timely upgrades, we ensure your operations run smoothly and efficiently.

Achieve and maintain compliance through consistent procedures and adhere to local and global regulations and standards, such as:

ISO 17025

EURAMET

USP, GLP and GMP

NIST Handbook 44 and OIML

Measuring Instruments Directive (MID)

Ensure a perfect start and ongoing, worry-free use with immediate and long-term benefits:

Assurance that the equipment is fit for use

Cost-savings through manufacturer's qualification services

Confidence that the equipment meets process requirements

Identification of needed calibration and maintenance

Pre-plan your periodic maintenance that provides you with complete trust that your equipment achieves:

Consistent, accurate results

Safe and reliable operation

Optimal performance possible

A longer equipment lifespan, resulting in a higher ROI

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Small Molecules

Insights into Synthesis, Formulation, and Quality Control to Ensure Optimal Drug Potency and Safety

What Are Small Molecules?