Pharmaceutical Impurity Testing

Ensuring the purity of pharmaceutical products is paramount to patient safety and regulatory compliance. At Apta Labs Pvt Ltd, we provide comprehensive pharmaceutical impurity testing services to identify, quantify, and analyze impurities in drug substances and products.

Our Capabilities Include:

Identification of Impurities:
Using advanced techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS), we identify both known and unknown impurities.
Quantification of Impurities:
Accurate quantification of impurities, including degradation products, residual solvents, and elemental impurities, ensuring compliance with regulatory limits.
Method Development and Validation:
Custom development and validation of analytical methods to ensure precise and reliable impurity detection.
Regulatory Compliance:
Adherence to ICH guidelines and regulatory requirements from agencies such as the FDA, EMA, and WHO.

Types of Impurities Tested:

Organic Impurities:
Including starting materials, by-products, intermediates, and degradation products.
Inorganic Impurities:
Such as reagents, ligands, catalysts, and residual metals.
Residual Solvents:
Volatile organic compounds used or produced during manufacturing.
Elemental Impurities:
Trace elements and heavy metals that may contaminate drug products.

Contact US

Reach Out To Us For More Information

Email us, We will get back to you as soon as possible..!!

Your Company Name

Your email

Your Phone Number

Choose One
ChemicalMicrobiologicalOther

Select Chemical Services

Select Microbiological Services

Subject

Your message (optional)

Apta Labs Pvt Ltd is a premier contract research and testing laboratory providing a comprehensive range of services to the pharmaceutical, biopharmaceutical, and packaging industries.