Final Product

Batch testing ensures compliance with standards and regulations, ensuring consumer safety. Given the variability between batches of raw materials and finished products, manufacturers are required to perform constant checks during production.

LabAnalysis Life Science can support the pharmaceutical company in quality control and batch release through:

• Development, validation of ad hoc methods
• Verification of applicability, transfer/validation of methods provided by the customer

LabAnalysis Life Science has expertise in testing all types of finished products, being authorized to handle narcotic and oncology products.

LabAnalysis Life Science is GMP certified to perform routine and batch release tests in the EU and worldwide.

This activity also includes batch release testing, for products manufactured outside the EU, scheduled for import and release into the European market.

The dissolution test evaluates the dissolution rate of oral solid drugs.

LabAnalysis Life Science supports the pharmaceutical company to ensure:

• Administration Effectiveness: Highlighting critical data on dissolution rate, influencing drug effectiveness.
• Bioequivalence: demonstrating parity between generic and branded drugs in the release of the active ingredient.
• Quality Control: integrating quality control, ensuring compliance with dissolution standards during production.
• Formulation Optimization: helping to improve formulations, considering particle size and excipients.
• Stability of the Drug: evaluating stability over time, detecting possible alterations in the formulation.
• Regulatory Compliance

The D value expresses the resistance of a microorganism to sterilizing heat treatment (the higher the D, the more resistant the microorganism).

The D121-value is calculated with the Holcomb-Spearman-Karber method in accordance with ISO 11138-1 Annex D.

LabAnalysis Life Science can support the pharmaceutical company with the aim of:

• Confirm the supplier's value on bioindicators
• Evaluate with the Overkill method whether the characteristics of the sterilized material can significantly influence the resistance/lethality of microorganisms, especially for liquid products on products not sensitive to heat

Metal tests, in accordance with the indications of the ICH Q3D (Guidelines for Elemental Impurities), are indispensable in the pharmaceutical sector to evaluate the presence of metallic impurities in pharmaceutical products. This directive, developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides guidelines for the evaluation and control of metallic elements potentially present in active pharmaceutical ingredients (APIs) and finished products.

The risk assessment and the definition of specific limits for metals must be anchored to the intrinsic characteristics of the product, its method 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.

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 according to needs.

The proposed parameters are: specificity, linearity, accuracy, instrumental precision, repeatability, intermediate precision, LOQ, LOD, robustness, stability of the standard and sample solution.

LabAnalysis Life Science 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 also supports customers in the transfer of analytical methods (internal procedure/customer procedure).

Microbiological tests conducted on pharmaceutical products aim to evaluate the presence of microbes, such as bacteria and fungi, which could impact the safety and effectiveness of such products. These tests are crucial to ensuring high standards of quality, safety and efficacy in drugs, medical devices and other related products in the pharmaceutical industry.

LabAnalysis Life Science provides support to pharmaceutical companies in quality control according to the microbiological parameters indicated by the various Pharmacopoeias (EP, USP and JP) for pharmaceutical products. Furthermore, it offers microbiological control services of working and production environments, essential in the pharmaceutical industry to ensure safety, quality and compliance with regulations.

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.

In vitro permeation testing (IVPT) is a laboratory technique used to evaluate the permeability of a substance through a biological membrane, typically the skin or mucous membranes. This testing is particularly important in the pharmaceutical and cosmetic industries for evaluating the performance of transdermal drug delivery systems, topical formulations, and other products that come into contact with biological membranes.

Principles of in vitro permeation testing:

• Membrane Selection: Membrane selection is critical and depends on the intended application. To evaluate transdermal drug delivery, human or animal skin is often used. Other membranes, such as synthetic membranes, can be used for different purposes.
• Setup: The test typically involves a two-compartment system in which the substance is applied to one side of the membrane (donor compartment) and permeation is measured on the other side (receptor compartment).
• Sample application: the substance (drug, cosmetic ingredient) is applied to the donor compartment. The formulation used for the application must be as similar as possible to real conditions.
• Temperature and environmental control: the test is usually conducted at a controlled temperature to simulate physiological conditions. This helps maintain the integrity of the biological membrane and ensures that the results are relevant to real in vivo conditions.
• Specimen Collection and Analysis: Specimens are collected from the receptor compartment at specific time intervals. The collected samples are then analyzed to determine the amount of the substance that has permeated through the membrane. Analytical techniques may include chromatography, spectroscopy, or other methods depending on the nature of the substance.
• Data Interpretation: Permeation parameters such as flow, permeability coefficient and lag time are calculated from the collected data. These parameters provide insights into the rate and extent of permeation of the substance across the membrane.
• Quality Control: IVPT is often used for quality control to ensure consistency and reproducibility of formulations. It can also be used for comparative studies between different formulations or products.
• Regulatory Compliance: IVPT is often a regulatory requirement for the approval of transdermal drug delivery systems and some topical formulations. It helps demonstrate the safety, effectiveness and reliability of the product.

In summary, in vitro permeation testing is a valuable tool in pharmaceutical and cosmetic research to understand and predict the behavior of substances that permeate through biological membranes. It provides important data that can guide the development and optimization of various formulations and delivery systems.

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.

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.

Over the last few years, authorities around the world have applied increasingly stringent rules, requiring increasingly higher quality standards. In this context, the stress tests performed on active pharmaceutical ingredients and formulated products have required ever greater attention

The stress test is a procedure that allows us to study the degradation of a pharmaceutical product by subjecting it to conditions that are worse than those of normal use. It is advisable to perform it not only on the finished product, but also on the placebo and the API.

LabAnalysis Life Science, after hundreds of stress tests, and with the support of cutting-edge instrumentation, is able to perform any type of stress test, based on the regulations at national and international level (AIFA, FDA, ANVISA).

To carry out stress tests, LabAnalysis Life Science uses:

• Use of the best cutting-edge 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 of the main degradation products obtained
• Isolation and characterization of the most representative impurities by NMR

At the end of the process, LabAnalysis Life Science shares with the customer the results obtained and the technical process followed to obtain them, as well as drafting a final report.