Extractable and Leachable study
The harmful leachable impurities which migrate from the pharmaceutical container closure systems,medical device packaging and process equipment can pose risk to health and hamper the quality of pharmaceutical products. Our Extractable and Leachable (E&L) studies with all the essential facilities is indispensable for your pharmaceutical business. It is a safety precaution which you can’t afford to miss. E&L study reveals any impurities related to container closure in drug products. Moreover, it is essential to get regulatory approval from the FDA.
Need for E&L Study
E&L Studies are used to test product packaging to ensure the packaging will not leach harmful chemicals into the product during usage. These studies are extremely important for many industries, but in the pharmaceutical and medical device industry it is essential as packaging safety and toxicology studies are required. Every new and generic drug product must be assessed for extractability and leachable to evaluate the safety concern before approval to enter the market.
Method of testing
E&L studies are carried out as per guidance document of USFDA, EP, and USP & PQRI
Overall methodology followed
- Extractable/Leachable evaluations & screening
- Method development & validation for leachable studies
- Developing routine leachable control methods
- Ensuring safety relative to packaging leachable.
Sample quantity required
The sample quantity for analytical purposes is required as per the study design beside it depends on various parameters .
Turnaround time
Extractables are carried out in quick turnaround time & leachable studies are actually based on the stability design of drug products.
Purpose of testing
The purpose of extractable and leachable study is regulatory compliance , safety and efficacy of the drug. Besides, to assess potentially harmful leachable impurities which could migrate from pharmaceutical container closure systems, medical devices, packaging (includes inks and label adhesives) or process equipment to contaminate pharmaceutical products.
Regulatory requirements
ICH-Genotoxic Impurities & PQRI derived ‘safety’-based guidance- SCT (Safety Concern Threshold) & AET (Analytical Evaluation Threshold), threshold below which a leachable would have a dose as low as to present negligible safety concerns from carcinogenic and no carcinogenic toxic effects.
How are results used?
Regulatory Submission of New drugs (NDA) and Abbreviated New Drugs (ANDA), to get marketing authorizations.
Major equipment used for Extractable and Leachable study
HPLC, LC-MS, GC, GC-MS with Headspace, ICP-OES/MS or AAS
Industries we serve
For extractables and leachables study we serve Pharmaceutical industries if anybody is interested we have the facility for other industries too.
Products which we test
We have the testing facilities for a risk based approach for drug products. High to medium risk drug products are tested in our laboratories. (Injectable suspension, aerosols, Ophthalmic, Transdermal, Ointments etc.)
What types of studies do we support?
Based on extractable test results, determine what chemical entities need to be evaluated over product shelf-life. Hence following extractable studies are conducted using following solvents and methods.
- Polar and Nonpolar matrices
- Solvents Varying in Polarity for extraction with varying-Time and Temp (PQRI, BPOG, USP, ISO)
- Polar (DI Water)-varying pH
- Non Polar (Hexane, Heptane)
- Mixed Polarity(Ethanol/water, IPA/water)
- Times and Temperatures
& Suitable analytical technique used for the analysis
Guidelines which we follow
- FDA Guidance for industry – Container Closure Systems for Packaging Human Drugs and Biologics
- EMEA Guideline– Guideline on Plastic Immediate Packaging Materials
- USP <661.1><661.2> <381><1663>, <1664>
- PQRI – Safety Thresholds and Best Practices for Extractable and Leachable in Orally Inhaled and Nasal Drug Products
- ICH Q6A – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Product.
E&Ls contaminants are a range of chemicals, covering inorganics, organics with a wide range of molecular weights and physico-chemical properties. The combination of our experience in method development coupled with our knowledge of leachable compounds, mean that we can anticipate and identify potential contaminants & risk through strategic screening studies.
ANALYTICAL PROGRAMS
- Method Development
- Method Validation
- Chemical Characterization
- Impurity Identification
- Elemental Impurities Analysis
Auriga research has all necessary facility for the study:
EXTRACTION EQUIPMENTS
- Accelerated solvent extraction technique
- Soxhlet extraction system/Refluxes
- Sonication
- Microwave digester
- Rotovapors
- Agitated water bath
Analytical Instruments
- HPLC-UV/DAD
- LC-MS/MS
- GC-FID/TCD
- GC-MS
- ICP-MS/OES/AAS
- FT-IR
- UV-VIS Spec
- XRD
- DSC/TGA
Guidelines
Protocols and methods are not one-size-fits all. Our skilled chemists are flexible with protocols and methods.
Our presence in pan India locations helps to provide bespoke and comprehensive service. We collaborate with pharmaceutical manufacturers to develop analytical methods, method validation needs, impurity profiling for new products or studies of leachable compounds in existing products in compliance with regulatory requirements and flourish your business.
We help you meet and exceed safety, quality and regulatory standards. drug manufacturers aim for the development of high quality, safe, and efficacious medicines that improve patient health and quality of life. However, during the drug development process it is important to identify any element which could affect product’s stability or efficacy. The manufacturers must consider the impact of impurities that may arise from packaging materials, drug delivery systems, manufacturing conditions, and storage.
Contact us for Extractable and leachable studies and analysis.
