Analytical Services
SK pharmteco supports all analytical requirements for pharmaceutical intermediates, Active Pharmaceutical Ingredients, cell and gene therapies, and formulated drug products. From Analytical Method Development and Implementation to Analytical Method Validation and stability, SK pharmteco Analytical is fully equipped with fully compliant CGMP instrumentation geared toward product analysis and product release. We support spectroscopy, chromatography, particle size distribution, calorimetry, osmolality, mass spectrometry and ICH Stability project requirements.
Reference
Standard
Qualifications
SK pharmteco conducts reference standard qualifications for proprietary customer compounds, including novel raw materials, intermediates, and active pharmaceutical ingredients. We offer CGMP qualification and characterization services to establish the identity and potency for Certified Reference Standards (CRS). We apply multiple spectroscopic techniques (including IR, NMR, and MS) to establish identity and apply titration, HPLC, GC, and other techniques to establish potency values.
Elemental
Impurities Testing & Analysis
SK pharmteco is your premier site for the development of methods for the determination of elemental impurities. USP Chapters <232> and <233>, along with ICH Q3D standardize the allowable limits of elemental impurities. With these limits it is critical to get your APIs, Drug Products, and excipients compliant.
AMPAC Analytical leverages years of sample digestion and preparation experience to develop and validate robust elemental impurity methods. For limits less than 5 ppm, AMPAC Analytical recommends ICP-MS for the determination of elemental impurities. AMPAC Analytical maintains a dedicated elemental impurities laboratory to ensure the most reliable results. In addition, AMPAC Analytical is well suited to routinely test and release your products in compliance with USP <232>, <233>, and ICH Q3D regulations for elemental impurity control in a cGMP laboratory.
Nitrosamine
Impurities
Testing
Pharmaceutical products have been on the news as these products are taken for chronic diseases, medications taken multiple times a day, and in varying dosages. Regulatory agencies are actively involved in addressing the issue by detecting, testing, and quantifying these impurities. New applications, renewal, synthetic route modifications, and sourcing of material modifications can be subject to evaluation for the presence of Nitrosamines.
SK pharmteco has implemented test methods using LC-HRMS and GC-MS to identify trace Nitrosamines in drug substances, drug products, and cell and gene therapy components.
Stay compliant with the FDA and get your active pharmaceutical ingredient (API), drug product, and cell and gene therapy components tested for NDMA.
NDMA and Nitrosamines in general, are genotoxic impurities and have been classified by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) as probable human carcinogens. Nitrosamines, such as N-Nitrosodimethylamine (NDMA), can be found at low levels in numerous items of human consumption, including cured meat, fish, beer, tobacco smoke, and most recently, as an impurity in various pharmaceuticals.
In recent reports, there have been several Angiotensin-II-receptor antagonists, AKA “Sartans”, which have been contaminated with NDMA. The EPA has determined that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.
All conditions are maintained at set points and tolerances outlined in the ICH guidelines. All chambers have controlled access and are fully mapped and qualified. Temperature and humidity are continuously monitored by a validated computerized chart recorder. Alarms are set for out-of-tolerance events, and notifications are generated and sent to responsible personnel. All chambers and electronic chart recorders have a redundant backup power supply.
Stability Testing
SK pharmteco offers ICH stability storage and testing to support all of your CGMP stability requirements.
We offer a wide range of ICH storage conditions for stable storage of long-term, intermediate, and accelerated testing. Our facilities are also capable of performing stability storage for drug products packaged in semi-permeable containers as well as DEA schedule II –V controlled substances.
Available Stability Services:
- Protocol writing
- Report writing
- Long-Term Stability Storage and Testing
- Intermediate Stability Storage and Testing
- Accelerated Stability Storage and Testing
- Forced Degradation Studies
- Temperature Excursion/Cycling Studies
Available ICH Storage Conditions:
- 5°C
- 25°C/60%RH
- 30°C/65%RH
- 40°C/75%RH
- -20°C
- 25°C/40%RH
- 40°C/NMT 25%RH
- Photostability per ICH Q1B
- Custom Storage Conditions upon request
Extractables and
Leachables
A thorough review of all materials used in packaging and production, and their equipment to predict the compatibility of your packaging system with your product. SK pharmteco can provide reports for items from each step.
- Extraction studies on the materials used.
- Leachable studies to identify any impurity resulting from those materials found in the final product under normal usage conditions.
- If impurities are detected, SK pharmteco can provide toxicological evaluations, including profiles of the impurities and the risks they pose for the patients, establish safety limits, or adjust for different forms of medication application.
- We can assess risks created by various exposure levels due to the impurity in the finished product.
- Finally, SK pharmteco provides a detailed report of our findings in accordance with the applicable governing bodies (e.g., FDA, EMA, PQRI, PDA).
Extractables and Leachables (E&L) are essential areas of concern for the pharmaceutical and food industries, specifically regarding their packaging, usage components (e.g., medical devices or syringes), and the manufacturing chain.
