Impurity and Contamination in Pharmaceuticals | Test Methods

What are Impurities and Contamination in Pharmaceuticals?

As medicinal products directly affect the safety of patients, the highest quality standards must be applied in their production. Two important risk factors that can be encountered in this process are impurities and contamination.

An impurity is the presence of unwanted chemical compounds other than the active substance of the medicine. These can result from the manufacturing process, raw materials or storage conditions.
Contamination refers to biological, chemical or physical substances that contaminate medicines from the external environment. This includes microbiological contamination, cross-contamination from particles or other products.

Why Are Medicinal Drugs Tested?

Impurity and contamination testing is critical for the following reasons:

Patient Safety: To prevent harmful side effects.
Legal Compliance: To ensure that medical products comply with national and international regulations (GMP, ICH, etc.)
Product Quality: For verification of efficacy, stability and shelf life.
Reducing the Risk of Recalls: Through early detection of quality deviations.

What is the Scope of the Relevant Standards?

The analysis processes of medicinal drugs are based on various international quality and safety standards, mainly ICH Q3A/B, USP <467>, Ph. Eur., and GMP, and are based on various international quality and safety standards. These standards are

Organic and inorganic impurity limits,
Residual solvent levels,
Microbiological contamination criteria,
Particulate matter limits.

Nanolab provides services with an analysis infrastructure in compliance with all these regulations.

What Do We Offer as Nanolab?

Nanolab, as a laboratory specialized in quality control processes of medical drugs, offers the following analysis services:

Nitrosamine Analysis: EP, USP, BP, JP
Pharmacopoeia analysis (EP, USP, BP, JP...)
Impurity and contamination tests
Conformity tests according to ICH Guidelines (Stability Tests, Bioavailability Tests, Content and Quantity Analysis)
Release tests
Validation Service
All tests required for licensing
Stability tests
Stress (Degradation) Studies
Method Development and Validation Studies (ICH Q2)
Pharmaceutical Juice Analysis
Microbiological Tests

With our modern laboratory infrastructure and expert team, we provide reliable and timely test results to pharmaceutical manufacturers. You can contact us for your analysis needs in accordance with GMP and ICH standards.

For more information, please contact us.
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