Within the scope of R&D Studies;
• Analytic Method Development - Verification / Validation Studies (ICH Q2 R, USP)
• Extractable, Leachable Analyses (LC-MS/MS, LC-HRMS, GC-MS, GC-MS/MS, ICP-MS, FTIR, IC Devices)
• Nitrosamine Impurity Analyses (Sartan Groups / Finished Product / Auxiliary Materials)
Our Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) infrastructure has been put into service by late 2020 for providing Phase 1 Clinical Research - Bioequivalence and Bioavailability Laboratory to the pharmaceutical industry.
YU-AGAM Pharmaceutical Analysis Laboratory provides service for the needs and demands of the sector by following nationally and internationally recognized analysis methods. In our laboratory; At the end of August 2020, the Good Laboratory Practices (GLP) authorization audit was carried out by TÜRKAK and the certification process was successfully completed. With our Good Laboratory Practices (GLP) Declaration of Conformity; The quality, data integrity and validity of the data produced in our analyzes have been internationally approved.
We primarily provide analysis services in the following fields;
• Elemental Impurity and Metal (ICP-MS, ICP-OES),
• Quantitative (UV, UPLC, GC),
• Impurity (UV, UPLC, GC, GC-MS, GC-MS/MS, LC-MS),
• Residual Solvent (GC-FID, GC Headspace),
• Genotoxic Impurities (LC-HRMS-Orbitrap),
• Composition of Fatty acids (GC-FID),
• Ethylene Oxide and Dioxan (GC-FID),
• Hydroxypropoxy-hydroxymethoxy Group (GC-FID),
Morphological, crystallographic and calorimetric analyzes are performed with SEM, TEM, XRF, DSC imaging devices. Microbiological analysis we provide analysis services for pharmaceutical raw materials and finished products in accordance with EP-2.6.12 and EP-2.6.13 pharmacopoeia requirements.
Raw Material Analysis In Pharmaceutical Products
Nitrosamine Analysis, Elemental Impurity Analysis, Quantity Analysis, Impurity Analysis, Solvent Residue Analysis, Wet Chemistry Analysis, Structure Determination and Microbiological Analysis services in raw materials of pharmaceutical products are provided to the pharmaceutical industry on national and international platforms by our expert staff and state-of-the-art devices (HPLC, GC-MS, LC-MS/MS, ICP-OES, ICP-MS) in our laboratory.
Finished Product Analysis In Pharmaceutical Products
Nitrosamine Analysis, Elemental Impurity Analysis, Stability Analysis, Quantity Analysis, Impurity Analysis, Solvent Residue Analysis, Wet Chemistry Analysis, Structure Determination, Dissolution Analysis, Extractables & Leachables Analysis and Microbiological Analysis services in pharmaceutical finished products are provided to the pharmaceutical industry on national and international platforms by our expert staff and state-of-the-art devices (HPLC, GC-MS, LC-MS/MS, ICP-OES, ICP-MS) in our laboratory.
Extractables & Leachables Analysis
Extractable substances are chemical compounds that can contaminate a drug from a packaging product, production surfaces, or distribution system during laboratory work, such as exposure to solvents or heat, and have the potential to cause various problems.
Leachable substances are compounds that leach into the drug over time as a result of contact from the compounds used, the coatings of the container and closure system, or the production surface.
Leachable substances are generally a subset of extractable substances.
Today, every drug product is tested and evaluated for Extractable & Leachable Substances.
Our laboratory provides Extractable & Leachable Analysis services of pharmaceutical raw materials and finished products to the pharmaceutical industry on a national and international platform by means of its expert staff and state-of-the-art devices (LC-MS/MS, GC-MS, Ion Chromatography, ICP-MS).
Elemental Impurity Analysis
Elemental Impurities in Pharmaceutical Products; Additives required for production can come from various sources such as the production of raw materials and auxiliary materials, equipment in the enterprise, and the production steps of the finished product.
These elemental impurities in pharmaceutical products do not provide any therapeutic benefit to the patient, but pose danger against the patient and should be kept within acceptable limits by being strictly followed.
Therefore, to protect human health: This analysis has been used for all new products in the European Union and America since the "Guideline on Elemental Impurities (ICH Q3D - 1 January 2018)" published by the International Council for Harmonization (ICH).
Our laboratory provides services of Elemental Impurity Analysis in pharmaceutical raw materials and finished products to the pharmaceutical industry on national and international platforms by means of our expert staff and state-of-the-art devices (ICP-MS, ICP-OES).
Nitrosamines (N-Nitrosamines) are organic compounds with the formula R2NNO or RNHNO, wherein R is usually an alkyl group. Nitrosamines are a group of organic chemicals formed by the interaction of nitrite preservaties with amines or amides in the body during the fermentation of various foods and tobacco and under acidic conditions in the gastrointestinal tract. They are potent potential carcinogens that cause cancer in various organs such as the brain, nasal sinüs, esophagus, lung, liver, stomach, kidney and bladder.
It is not used in the industry. However, it emerges as a by-product during the prodiction process. Nitrosamines have led to many high-profile product recalls in the pharmaceutical, food, and cosmetic industries. When considered both in terms of human health and production cost, Nitrosamine Impurity Analysis is of great importance. Therefore, it is necessary to evaluate the risk of the presence of Nitrosamine Impurity by pharmaceutical companies.
Our laboratory provides analysis services of nitrosamine impurities in pharmaceutical raw materials and finishes products to the pharmaceutical industry in national and international platforms by means of our expert staff and state-of-the-art-devices (LC-MS/MS, GC-MS).
We provide analysis service for pharmaceutical raw materials and finished products in accordance with EP-2.6.12 and EP-2.6.13 pharmacopoeia requirements.