The API (Active Pharmaceutical Ingredient) is the key substance in a drug, responsible for the therapeutic effect. Excipients are non-active substances in drugs that give shape, consistency and stability to the product, while natural products derived from natural sources such as plants and microorganisms often act as precursors for drugs or active ingredients.
Regulations may vary based on geographic region and regulatory authorities involved.
LabAnalysis Life Science, with over 45 years of experience, supports companies in demonstrating compliance with these regulations by providing the following services:
Batch release
Batch checks are essential to ensure products meet standards and regulations, while ensuring consumer safety. Since raw materials may vary between different batches, manufacturers are required to carry out continuous checks during the production process.
LabAnalysis Life Science can support pharmaceutical companies with quality control and batch release, using monograph-compliant methods such as EP, USP, JP, or specific methods requested by the customer.
LabAnalysis' GMP certification allows it to conduct routine batch release testing both in the European Union and globally, with drug and oncology handling approvals.
Metals (ICH Q3D)
Metal testing according to the ICH Q3D Guideline ( Guideline for Elemental Impurities) is required in the pharmaceutical industry to evaluate the presence of metallic impurities in pharmaceutical products. This directive was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and provides guidance on the evaluation and control of metallic elements potentially present in active pharmaceutical ingredients (APIs).
Risk assessment and determination of metal-specific limits should be based on the nature of the product, its route of administration and the duration of treatment.
LabAnalysis Life Science offers analytical support both with the specific method development for the active ingredient and with the subsequent validation for all 24 elements foreseen by the ICH Q3D guideline and further elementary impurities on request. The analyzes are performed with ICP-MS or ICP-OES or AAS depending on the type of matrix and the metal to be analyzed. Our tool park with more than 10 latest generation tools allows us to respond promptly to market requests.
Method development, transfer and validations
Thanks to the laboratory's expertise, acquired and significantly increased over the years, as well as the preparation of dedicated teams, we are able to offer method development and validation services in compliance with the ICH guidelines, customized based on needs.
The proposed parameters are: specificity, linearity, accuracy, instrumental precision, repeatability, intermediate precision, LOQ, LOD, robustness, stability of the standard and sample solution.
LabAnalysis will prepare the validation protocol. Once the customer has approved the protocol, LabAnalysis will perform method validation. A final report will follow with the results obtained.
LabAnalysis Life Science supports customers in the transfer of analytical methods (internal procedure/customer procedure).
Microbiology test
Microbiological monitoring of pharmaceutical products is a crucial step in assessing the presence of microbes, including bacteria and fungi, that could compromise the safety and efficacy of such products. Conducting these tests is imperative in order to ensure the quality and regulatory compliance of drugs, medical devices and other related products in the pharmaceutical industry.
LabAnalysis Life Science acts as a reliable partner for pharmaceutical companies, offering expert support in the control of microbiological parameters compliant with the various Pharmacopoeias (EP, USP and JP) and sterility for pharmaceutical products. Furthermore, it offers microbiological control activities in working and production environments, essential elements to guarantee safety, quality and compliance with current regulations in the pharmaceutical industry.
Micropollutants
LabAnalysis Life Science can support the company producing pharmaceutical products derived from natural extracts in monitoring chemicals at very low concentrations using specific matrix methods, such as:
Pesticides
Dithiocarbamates
Mycotoxins (Aflatoxins, Ochratoxins, etc.)
Alkaloids
Metals
Nitrosamines
Nitrosamines are chemical compounds classified as probable carcinogens by the International Agency for Research on Cancer (IARC). They can form in the presence of a nitroso group within drugs. Since 2018, the FDA and EMA have defined the maximum limit of nitrosamines that can be contained in pharmaceutical products.
LabAnalysis Life Science has already validated internal methods (for the standard solution part) to be used based on the type of sample (API, tablets, injectable solutions, creams) for the determination of nitrosamines listed in the EMA guidelines.
LabAnalysis Life Science has a team of experts dedicated to the development of ad hoc methods for the determination of API-related nitrosamines. More than 25 API-specific methods for the determination of nitrosamines have already been developed.
Stabilty studies
The premises at LabAnalysis Life Science are equipped with climatic chambers designed to simulate different climatic zones, in accordance with the ICH Guidelines: in particular for normal stability, accelerated stability, tropical stability. In addition, we have climatic chambers that can be customized in terms of temperature and humidity, to specific customer requests.
Our laboratory has a total of 49 climatic chambers, of which 9 are walk-in type.
Equipment
Conditions
Type of stability
Climatic Chamber
25°C
60% RH
Long Term
Climatic Chamber
30°C
75% RH
Long Term
Climatic Chamber
40°C
75% RH
Accelerated
Climatic Chamber
30°C
65% RH
Accelerated-Intermediate
The different configurations of the chambers allow us to manage study protocols which can include the storage of the samples and the related analyzes at the defined time points, or just the storage with the subsequent sending of the samples to the customer.
Our facility therefore offers a versatile and fully equipped environment to meet a wide range of needs in the field of climate analysis and studies.
Stress test
In recent years, regulators globally have introduced increasingly stringent regulations that require increasing quality standards in the pharmaceutical industry. In this context, attention towards stress tests conducted on active pharmaceutical ingredients and formulated products has increased significantly.
Stress testing is a procedure that allows you to examine the degradation of an API by exposing it to more severe conditions than those of normal use. LabAnalysis, with its vast experience in hundreds of stress tests and the help of cutting-edge technologies, is able to conduct any type of stress test, adhering to national and international regulations (AIFA, FDA, ANVISA).
To implement stress tests, LabAnalysis Life Science uses:
Use of the best advanced technologies for the qualitative and quantitative evaluation of active pharmaceutical ingredients and their degradation products.
Numerical evaluation and rational discussion of mass balances.
Transfer of analytical methods by adapting them to mass spectrometers to obtain structural information on the main degradation products.
Isolation and characterization of the most representative impurities by NMR.
Sharing the results obtained with the client and including a final report.
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