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Please contact us if you need compendial sample quantity requirements for container and closure testing.
USP Container Tests
- Container Permeation Test (multiple unit containers for capsules and tablets)
- Container Permeation Test (single unit and unit dose containers)
SGS can provide moisture indicating desiccant pellets.
- Light Transmission Test (glass or plastic)
Chemical Resistance Tests – Glass Containers
- Powdered Glass Test
- Water Attack at 121°C
- Arsenic (when water attack test is also performed)
- Arsenic (when water attack test is not performed)
Polyethylene Containers Tests
- Multiple Internal Reflectance
- Thermal Analysis (sample and reference standard)
- Water Vapor Permeation
- Heavy Metals and Non-volatile Residues
- Light Transmission Test
- Buffering Capacity
- Polyethylene Terephthalate or Polyethylene Terephthalate G Bottles
- Includes multiple internal reflectance, thermal analysis, light transmission, water vapor permeation, colorant extraction, heavy metals, total terephthaloyl moieties and ethylene glycol.
Physicochemical Test Procedures – USP
- Plastics (water extract)
- Includes buffering capacity, heavy metals, non-volatile residue and residue on ignition.
- Elastomeric Closures for Injections (water and isopropyl alcohol extracts)
- Includes heavy metals, pH change, reducing agents, total extractables and turbidity.
- Elastomeric Closures for Injections (drug product vehicle)
- Includes heavy metals, pH change, total extractables and turbidity.
European Pharmacopeia Container/Closure Testing
- Glass Containers for Pharmaceutical Use <3.2.1>
- Includes surface hydrolytic resistance, arsenic, hydrolytic resistance of powdered glass and hydrolytic resistance of the etched glass.
- Rubber Closures Testing <3.2.9>
- Includes preparation of solution S, characters, identification A, identification B, identification C, acidity or alkalinity, appearance of solution, absorbance, reducing substances, extractable heavy metals, extractable zinc, ammonium, residue on evaporation, volatile sulphides, penetrability, fragmentation and self-sealing test.
- Plastic Container Closures <3.1.4> and <3.1.5>
Japanese Pharmacopeia Container/Closure Testing
- Test for Glass Containers for Injections
- Includes visual inspection, soluble iron, light transmission and soluble alkali
- Rubber Closures for Aqueous Injections
- Test for Plastic Containers
Container Closure Integrity
- Dye Immersion with pressure and vacuum challenge (with quantitative validation)
- MicrobialChallenge with B. diminuta (20 samples plus positive and negative controls)
- Static immersion or pressure and vacuum challenge
Extractable and Leachable Studies
GC MS and LC MS Identification capabilities
Method Development and Validation
Stability Storage
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