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 381

USP 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 381

USP 661: PET and PETG – Extraction – Total Moieties, EG, Spectrophotometry

USP 661: PET and PETG
USP 661

USP 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

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