GLP solutions for purity and nano tests for pharmaceutical products
The efficacy and safety of a pharmaceutical product depend directly on its purity. The purer the pharmaceutical active ingredient (API) in a drug, the more predictable its therapeutic effect and the lower the risk of side effects. GLP Purity Testing for Pharmaceutical Products is the process of detecting, identifying, and quantifying unwanted impurities in an active ingredient or a drug.
Good Laboratory Practice (GLP) ensures that these tests are reliable, reproducible, and performed according to standards recognized by international regulatory authorities (FDA, EMA, TİTCK). The purity test is not only a step in quality control but also an integral part of the drug development process (F&E) and production validation.
Importance and scope of purity tests
The purity of pharmaceutical products is generally evaluated under three main aspects:
- Chemical Purity: This determines the total amount of organic and inorganic impurities (intermediates, by-products, degradation products, heavy metals, solvent residues) present in the product.
- Optical Purity: This is important for chiral molecules. While only one specific enantiomer (mirror image) of a drug shows therapeutic effect, the other can be toxic. The enantiomeric purity is determined by chiral chromatography.
- Physical Purity: Evaluation of physical properties such as particulate impurities, color, clarity, and polymorphic forms.
Purity tests under GLP demonstrate the product's compliance with specifications (product quality standard). For each impurity, there are acceptance limits set by regulatory authorities. For example, ICH guidelines Q3A and Q3B set the reporting, definition, and qualification thresholds for impurities in new active ingredients and products.
Analytical methods for purity tests
Pharmaceutical purity analyses require a combination of high-resolution chromatographic techniques and spectroscopic methods. The method used depends on the structure of the molecule being analyzed and the expected impurity profile.
1. High-performance liquid chromatography (HPLC)
HPLC is the most commonly used technique in pharmaceutical purity tests.
In combination with UV/VIS, DAD (diode array detector) or FLD (fluorescence detector) it enables the detection of both the main component and impurities in very low concentrations. Both reverse-phase (RP-HPLC) and normal-phase (NP-HPLC) modes can be used.
2. Gas chromatography (GC)
Used to analyze volatile and semi-volatile organic impurities (including solvent residues). The headspace GC method is particularly effective in detecting volatile impurities without matrix effects.
3. Mass spectrometry combined methods (LC-MS/MS, GC-MS/MS)
They are essential for the identification and structural elucidation of unknown impurities. They offer high sensitivity for the detection of genotoxic impurities in low concentrations.
4. Chiral chromatography (Chiral HPLC)
It is a method for separating enantiomers and determining their ratios using chiral columns to determine optical purity.
Parameters evaluated in purity tests
The following table summarizes the basic parameters considered when evaluating the purity profile of a pharmaceutical product:
| Parameter | Explanation | Typical analysis method | Acceptance criterion (example) |
|---|---|---|---|
| Chemical impurities | Organic by-products, intermediates, degradation products | HPLC DAD, LC-MS/MS | Total contamination ≤ 0.5% |
| Enantiomeric Purity | Share of unwanted mirror image isomer | Chiral HPLC | Unwanted enantiomer ≤ 0.1% |
| Solvent residues | Organic solvents from the production process | Headspace GC-FID | Compliance with the I-Q3C limit values |
| Heavy metals | Metals from catalyst residues or through contamination | ICP-MS, AAS | Compliance with the I-Q3D limits |
| Water content | Moisture content in the product | Karl Fischer Titration | According to specification (e.g. ≤ 0.5%) |
GLP compliant purity testing services with nano test
The purity profile of your pharmaceutical products has a direct impact not only on your compliance with regulatory requirements but also on the perception of the quality of your brand. Nano-Test is a reliable solution partner for the pharmaceutical industry with its comprehensive purity tests, which are performed in fully GLP-compliant laboratories.
Description of Nano-Test Services
Nano-Test offers GLP-compliant purity tests (Purity Test) for pharmaceutical products. Our service portfolio includes advanced analysis techniques such as HPLC-DAD/FLD, LC-MS/MS, GC-MS/MS, chiral HPLC, ICP-MS, and Karl Fischer titration.
Our analyses are performed with fully validated methods according to the ICH validation guideline Q2(R1). For each study, GLP-compliance reports are created, which can be defended during inspections by regulatory authorities (FDA, EMA, TİTCK) and ensure complete traceability and data integrity (ALCOA+ principles). Regardless of whether it is an active ingredient (API), an excipient, or a finished product, we document your purity profile according to international standards.
As a nano test, we and our specialist staff are also available to you for demanding examinations such as the structural elucidation of unknown impurities and the evaluation of genotoxic contaminants.
Advantages of Purity Analysis in Nano Test:
- Comprehensive analysis: Management of chemical, optical, and physical purity parameters from a single source.
- Ultra-high sensitivity: Detection of even impurities in the trace range (ppm/ppb).
- Rapid reporting: Results delivery within 5-10 working days for standard purity tests.
- Regulatory compliance: Full compliance with ICH guidelines Q3A, Q3B, Q3C, Q3D, and pharmacopeial monographs.
- Identification of unknown impurities: Structural elucidation by HRMS and NMR.
The purity of a pharmaceutical product is directly related to its safety and efficacy. GLP compliance in pharmaceutical purity tests ensures the scientific identification and quantification of all impurities in your product, as well as the detection of compliance with regulatory limits. Even the smallest error in this process can delay the approval of your product or increase the risk of recall.
Nano-Test is a reliable partner for pharmaceutical purity testing with its state-of-the-art analytical infrastructure, GLP-certified procedures and expert team. Have your purity analyzes run with Nano-Test guarantee to ensure smooth access of your products to global markets.