Extractable and Leachable Studies

Carcinogenic and non-carcinogenic impurities during manufacturing, transportation, and storage may leach into the drug product causing serious health issues for patients.

The Product Quality Research Institute (PQRI), US Pharmacopeia (USP), International Harmonisation (ICH), and several other regulatory bodies have developed guidelines and best practices for Extractable and Leachable Studies.

The selection of the guideline(s) to be followed is based on the component to be evaluated, drug product formulation, the route of administration, dosage regimen, and credibility with the applicable governing agency. The resulting study design must scientifically justify the approach to sample handling, analysis, and reporting to help ensure regulatory compliance specifically tailored for the drug product packaging system.

Shiva Anlyticals has years of experience in handling Extractable and Leachable Studies of:

• Ophthalmic Solutions
• Inhalation Aerosols and Sprays
• Injections and Injectable Suspensions
• Inhalation Powders & Solutions
• Sterile Powders and Powder for Injection
• Transdermal Ointments and Patches
• Topical Powders, Solutions & Suspensions
• Topical and Lingual Aerosols
• Oral Powders, Solutions & Suspensions
• Oral Tablets and Oral Hard & Soft Gelatin Capsules

No single analytical technique in the study of extractables and leachables can be used for all categories of compounds. As a result, testing for extractables and leachables is achieved by complementary use of a variety of analytical techniques:

• TDS-GC MS/MS: Volatile and semi volatile impurities
• UPLC-UV/MS/MS: Non-volatile impurities
• HPLC-UV/PDA-FLD: Non-volatile impurities
• GC-FID: Volatile and semi volatile impurities
• Ion chromatography: Anionic impurities
• ICP-MS: Elemental impurities

Shiva Analyticals is having expertise in the Extractable study of Packaging Materials like:

• Rubber stoppers
• EPDM packaging
• Gaskets & O-rings
• Inhalation devices
• Prefilled syringes
• Glass vials
• Syringes
• Injectable bags/vials
• Films, blister packs
• Laminated tubes
• Tubing & filters
• Large volume containers
• Disposables (Bioprocess – single use)
• HDPE, LDPE, PP, Plastic bags & containers
• Cartons & Labels
• Gum and Ink migration studies

Please contact us for Extractable and Leachable Studies of your Packaging material, Drug Product, and disposable Medical Devices.