Extraction
ARDL offers qualitative and quantitative analysis of the composition of natural and synthetic polymers. We perform extract analysis using ASTM and USP methods to determine the amount and type of some or all major constituents of a polymer compound. To perform the analysis, a sample is placed in filter paper, extracted for 16 hours with acetone or diethylether at reflux conditions using an extraction apparatus and the weight percent of extractables is determined after the solvent is removed. The solvent removes plasticizers, processing aids, organic accelerators or their decomposition products, fatty acids, antioxidants, antiozonants, resins, free sulfur, flame retardants and other organic additives. These additives are identified when ARDL's complete chemical analysis is ordered. The extractable content must be carried out if the rubber hydrocarbon content (RHC) is to be determined.
Available Methods
Extraction - Good Manufacturing Practices
Good Manufacturing Practices • Drug product container and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements. • Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
21CFR211.94(a)(b)USP 381: Elastomeric Closures - Extraction - Total Extractables, Heavy Metals, Reducing Agents, pH Change
USP 381: Elastomeric Closures
USP 381USP 381: Elastomeric Closures - Extraction - Total Extractables, Heavy Metals, Reducing Agents, pH Change
USP 381: Elastomeric Closures • Absorbance • Acidity or Alkalinity • Ammonium • Extraction - Drug Vehicle - IPA - Purified Water • Determination of Color • Extractable Zinc • Fragmentation • Heavy Metals • Identity Test • Opalescence • Penetrability • pH Change • Reducing Substances • Self-Sealing Capacity • Total Extractables • Turbidity • Volatile Sulfides
USP 381USP 661: PET and PETG - Extraction - Total Moieties, EG, Spectrophotometry
USP 661: PET and PETG
USP 661USP 661: Physicochemical (PE and PP) - Extraction - Nonvolatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity
USP 661: PE and PP • Buffering Capacity for Containers – Plastics • Colorant Extraction (PET and PETG) • Differential Scanning Calorimetry for Plastics • Ethylene Glycol in PET and PETG Extracts • Extraction (10 days @ 49°C) - 25% Alcohol - 50% Alcohol - Purified Water - n-Heptane • Extractions and Heavy Metals for PET and PETG • Heavy Metals for Containers – Plastics • Nonvolatile Residue: Containers – Plastics • Physicochemical Test Extract – Plastics • Plastics – Infrared Spectroscopy Identity Test • Residue on Ignition: Containers – Plastics • Total Terephthaloyl Moieties in PET and PETG
USP 661
