Small Molecule Analytical Development & Testing Services
Tailored Analytical Solutions for Small Molecules
Partnering with a CDMO for small molecule analytical development, API contract testing, and other analytical services can help drugmakers access deep expertise and extensive testing capacity to accelerate their path to market or empower continued commercial success.
Small Molecule Analytical Development & Testing Tailored to Your Needs
Leveraging decades of industry experience, we work closely with clients to develop, validate, and optimize analytical methods for raw materials, intermediates, APIs, and drug products. From initial research, with a quality-by-design approach and subsequent validation, through to lifecycle method improvements, we work closely with customers to produce methods that meet or exceed their analytical testing needs.
Our analytical services team can also support clients in determining phase-appropriate method validations to support pharmaceutical product development, from preclinical and Phase 1 IND-enabling validations through New Drug Application (NDA)-enabling and commercial support. Typical validation properties include specificity, linearity, accuracy, precision, limit of detection/limit of quantitation, and forced degradation studies. SK pharmteco can draft the necessary validation documentation to support your regulatory and filing needs and, upon validation, support the transfer of methods to external manufacturing or testing sites.
Leveraging decades of industry experience, we work closely with clients to develop, validate, and optimize analytical methods for raw materials, intermediates, APIs, and drug products. From initial research, with a quality-by-design approach and subsequent validation, through to lifecycle method improvements, we work closely with customers to produce methods that meet or exceed their analytical testing needs.
Our analytical services team can also support clients in determining phase-appropriate method validations to support pharmaceutical product development, from preclinical and Phase 1 IND-enabling validations through New Drug Application (NDA)-enabling and commercial support. Typical validation properties include specificity, linearity, accuracy, precision, limit of detection/limit of quantitation, and forced degradation studies. SK pharmteco can draft the necessary validation documentation to support your regulatory and filing needs and, upon validation, support the transfer of methods to external manufacturing or testing sites.
- Fourier transform infrared spectroscopy (FTIR)
- Nuclear magnetic resonance (NMR) spectroscopy, including 1H, 13C, 31P, and 19F NMR
- Ultraviolet-visible spectroscopy (UV)
- X-ray powder diffraction (XRPD)
- Differential scanning calorimetry (DSC)
- Thermogravimetric analysis (TGA)
- ICP-MS and ICP-OES for elemental impurities and composition analysis
- Non-combustible impurity analysis by residue on ignition
- Optical rotation
- Particle size distribution (wet and dry)
- Liquid chromatography (UHPLC/HPLC)
- Gas chromatography (GC-MS/GC-FID)
- Ion chromatography (IC)
- Mass spectrometry (MS), including LC-MS, LC-MS/MS, and GC-MS
- Karl Fischer titration, including KF Oven (coulometric and volumetric)
Verifying the quality, purity, and integrity of every component involved in manufacturing small molecule intermediates, drug substances, and drug products. Leveraging the chemistry, microbiology, and regulatory expertise of our analytical services division, we can develop the methods and assays necessary to help clients accurately verify and characterize starting materials. Our small molecule raw material testing capabilities comprehensively assess APIs, reagents, solvents, excipients, packaging components, and more, ensuring every material used to make your drug product ultimately maximizes its safety and quality.
Our raw material testing capabilities span the areas of:
- Physical properties testing
- Material identification
- Assay & impurity testing
- Extractables & leachables
- Pharmacopeia testing
SK pharmteco’s analytical services team boasts rich experience in comprehensively investigating and confirming structural and physical properties of APIs and pharmaceutical intermediates.
Using a broad range of compound characterization services, our experts can generate a thorough and accurate assessment of your compound and any impurities present. This information can identify sources of chemical contamination and minimize the risk of defective products, furthering your ability to reliably produce safe, high-quality products.
SK pharmteco can also assist clients in establishing detailed physical characterizations of pharmaceutical compounds. We offer tailored characterization packages to elucidate properties such as shape, particle size distribution, surface area, porosity, thermal behavior, and flow pattern. Our physical characterization services are powered by advanced instrumentation and methodologies, including:
- Microscopy, including scanning electron microscopy (SEM), optical microscopy, and hot stage microscopy
- Malvern Mastersizer and Morphologi G3
- Fourier transform infrared spectroscopy (FTIR) and Raman spectroscopy
- Nuclear magnetic resonance (NMR) spectroscopy, including 1H, 13C, 31P, and 19F NMR
- Dynamic vapor sorption (DVS)
- Powder rheology
- X-ray powder diffraction (XRPD)
- Differential scanning calorimetry (DSC)
- Thermogravimetric analysis (TGA)
We support clients in cGMP product testing and release services for all phases of drug development and commercial manufacturing. SK pharmteco offers a wide array of release testing services for raw materials, intermediates, APIs, and drug products, as well as high potency/cytotoxic APIs and controlled substances. Our release testing covers the required parameters to establish the identity, strength, purity, impurities, and physical properties of pharmaceutical compounds under strict CGMP compliance. Because time is of the essence in every step of pharmaceutical development and manufacturing, we deliver release testing reports on schedule and with the highest commitment to quality.
Our comprehensive analytical release testing services include:
- Appearance/description
- Color and clarity of solution
- Fourier transform infrared spectroscopy (FTIR)
- Nuclear magnetic resonance (NMR) spectroscopy
- Ultraviolet-visible spectroscopy (UV)
- Particle size distribution (wet and dry)
- Liquid chromatography (UHPLC/HPLC)
- Gas chromatography (GC-MS/GC-FID)
- Ion chromatography (IC)
- X-ray powder diffraction (XRPD)
- ICP-MS and ICP-OES for elemental impurities
- Non-combustible impurity analysis by residue on ignition
- Karl Fischer titration
- Dissolution testing
- Content uniformity
- Osmolality
- Liquid particle counting (USP 788 and 789)
- Container closure integrity testing
- Microbial enumeration USP <61> and USP<62>
SK pharmteco’s analytical services team can also successfully qualify and implement monographs and testing chapters from the various global pharmacopoeias and standards.
Powered by best-in-class technology and expert guidance, we provide a full suite of stability and forced degradation testing services to ensure safety and quality and secure the commercial success of your pharmaceutical products. SK pharmteco’s facilities are also capable of performing stability storage for drug products packaged in semi-permeable containers, as well as controlled substances.
Our stability services include:
- Protocol writing
- Report writing
- Forced degradation studies
- Long-term stability storage & testing
- Intermediate stability storage & testing
- Accelerated stability storage & testing
- Temperature excursion/cycling studies
- Photostability studies
Nitrosamines and Nitrosamine Drug Substance Related Impurities (NDSRIs) are genotoxic impurities classified by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) as probable human carcinogens. Nitrosamines and other genotoxic impurities are typically present at low levels in various consumables, including pharmaceutical products. Although they are common, nitrosamines are difficult to detect. Regulatory agencies are actively involved in addressing the issue by detecting, testing, and quantifying these impurities. New applications, renewals, synthetic route modifications, and sourcing of material modifications may be subject to evaluation for the presence of nitrosamines.
SK pharmteco offers analytical testing methods using LC-HRMS, LC-MS/MS, and GC-MS to identify trace nitrosamines and other genotoxic impurities in drug substances and drug products.
What Sets SK pharmteco Apart?
We pride ourselves on the level of commitment, quality, and transparency we provide to clients in small molecule analytical development and manufacturing. Rather than transactional relationships, we build close collaborations that help clients navigate the challenges of analytical development and adhere to changing global regulatory demands.
Guided by deep expertise and comprehensive capabilities, we build bespoke analytical solutions for our clients across the drug development and manufacturing spectrum. We’re flexible and agile, staying time- and resource-efficient without compromising quality and security.
Our offerings are strong, but we’re devoted to continuous improvement, investing in development to keep our teams, facilities, and instrumentation on the cutting edge of the ever-changing industry.
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