Chemical Testing: Extractables and Leachables Methods Available at ARDL

Extractables and Leachables Methods Available at ARDL Include:

Extraction Studies per 21CFR
§177.2600, §177.1520 and many more...

USP 381: Elastomeric Closures
• Extraction
    - IPA (30 min @ Reflux Temperature)
    - Purified Water (4 Hours @ 121°C)
    - Drug Vehicle (30 min @ Reflux Temperature)
• Turbidity
• Heavy Metals
• Reducing Agents
• pH Change
• Total Extractables (Gravimetry, mg)

USP 661: PET and PETG
• Extraction (10 days @ 49°C)
    - Purified Water
    - 25% Alcohol
    - 50% Alcohol
    - n-Heptane
• Total Terephthaloyl Moieties (Spectrophotometry, ppm)
• EG (Spectrophotometry, ppm)

USP 661: Physicochemical (PE and PP)
• Extraction
• Nonvolatile Residue
• Residue on Ignition
• Heavy Metals
• Buffering Capacity

ARDL can test to additional standardized specifications as well as custom specifications. If you are interested in a method that is not listed here, please do not hesitate to call (330) 794-6600 or toll free (866) 778-ARDL to find out if we can perform your test. Chances are we can help and if not, we may know someone who can.

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ARDL is accredited by A2LA for the test methods listed in this scope