Catalog excerpts
Driving Results in Pharmaceutical Testing TABLETS & CAPSULES • SUPPOSITORIES • TRANSDERMALS POWDERS & GRANULES • SEMISOLIDS 2020 EDIT
Open the catalog to page 1Pharmaceutical Testing About Us Copley: Driving Results for Over 70 Years Founded in 1946 in Nottingham, UK, Copley remains family owned and managed. We are recognised as the world’s leading manufacturer of inhaler test equipment, in addition to being a trusted provider of test instrumentation for other pharmaceutical dosage forms. We continue to work closely with industry groups and leading experts to bring relevant new products to market, with all equipment backed by expert training and lifetime support. These commitments are exemplified by our investment in the ISO 9001:2015 Quality...
Open the catalog to page 2Pharmaceutical Testing ISO 9001: 2015 Quality Management System The Copley Promise Equipment Selection Guide Organisations and their Roles Disintegration 12 Background: Disintegration Testing Test Apparatus & Method Disintegration Testers: DTGi Series 14 DTGi Series: Key Features 15 DTGi Series: Touchscreen User Interface 16 Key Features 16 Reporting 17 Compliance & Maintenance 17 Choose your DTGi Disintegration System DTG 100i DTG 200i DTG 300i DTG 400i DTG 200i-IS DTGi Series: Technical Specifications Temperature Calibration Choose your DTGi System Accessories 21 Standard Accessories 21...
Open the catalog to page 3Pharmaceutical Testing Equipment Selection Guide United States Pharmacopeia Page No. (in this brochure) GASTROINTESTINAL Tablets & Capsules - Disintegration GASTROINTESTINAL Tablets & Capsules - Dissolution GASTROINTESTINAL Tablets & Capsules - Friability GASTROINTESTINAL Tablets & Capsules - Breaking Force GASTROINTESTINAL Tablets & Capsules - Weight & Thickness GASTROINTESTINAL Powders - Bulk & Tapped Density GASTROINTESTINAL Granules & Pellets - Friability MUCOSAL MEMBRANE Rectal - Drug Release One of the clearest taxonomic guides for the classification of pharmaceutical dosage forms is...
Open the catalog to page 4Pharmaceutical Testing Organisations and their Roles Organisations and their Roles Introduction The ultimate responsibility for the safety, quality and efficacy of medicines and medical devices lies with the various national regulatory bodies designated to safeguard public health. In Europe, Japan and in the USA this function is performed by the European Medicines Agency (EMA), the Ministry of Health, Welfare and Labor (MHWL) and the Food and Drug Administration (FDA) respectively. The regulatory authorities are supported in this role by the Pharmacopoeias whose job is to define the...
Open the catalog to page 5Pharmaceutical Testing Organisations and their Roles Organisations and their Roles 3. DRUG SAFETY, QUALITY AND EFFICACY – THE PHARMACOPOEIAS The main role of the Pharmacopoeias is to define the standards with which medicines must comply and the methods by which compliance will be adjudged. As with the regulatory groups, the leading Pharmacopoeias tend to be those of the European Union, Japan and the USA. a) European Pharmacopoeia This is published by the Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM). In the European Pharmacopoeia (Ph.Eur.), the main...
Open the catalog to page 6Pharmaceutical Testing Background: Disintegration Testing Test Apparatus & Method Before the active ingredient(s) of an oral solid dose drug product can be absorbed into the body, the tablet or capsule in which they are contained must first disintegrate into smaller particles. Typically, the tablets and capsules to be tested are each placed in one of six vertical tubes each measuring approx. 77.5 mm long x 21 mm inside diameter, positioned in a circular basket arrangement. Chapters Ph. Eur. 2.9.1 and USP <701> and <2040> describe reproducible and standardised methods for quantifying the...
Open the catalog to page 7Pharmaceutical Testing Disintegration: DTGi Series Reproducible, standardised and affordable disintegration testing The result of decades of innovation and experience in the field of pharmaceutical testing, the Copley DTGi series of disintegration testers simplifies testing within R&D and QC environments. Suitable for a wide range of tablet and capsule types (e.g. plain-coated tablets, delayed-release, gelatine etc.), the DTGi tester series is an affordable range of disintegration testers, that complies fully with specifications defined in Ph. Eur., USP and associated Pharmacopoeias. DTGi...
Open the catalog to page 8Pharmaceutical Testing DTGi Series: Touchscreen User Interface Extensive data output options are available as standard, including direct reporting to a printer or PC. Reported parameters Setting a test parameter Set v Actual test parameters (before test run) Set v Actual test parameters (during test run, with test progress bar) • Speed (cycles per minute) Set Average Maximum Minimum • Temperature (°C) Set Average Maximum Minimum Settings menu Passcode-protected temperature calibration process • Test Duration (HH:MM:SS) Set Actual • Calibration Data Calibration date Temperature calibrated at...
Open the catalog to page 9Pharmaceutical Testing Choose your DTGi Disintegration System Independent Station Control: DTG 200i-IS With the same standard features as the other DTGi systems, the DTG 200i-IS offers independent control over each test station, making it ideal for the following types of applications: • Comparing one formulation directly against another • Comparing the performance of a single formulation under different conditions Tablet Capacity Tablet Capacity Tablet Capacity Tablet Capacity Tablet Capacity Independent Station Control Independent Station Control Independent Station Control Independent...
Open the catalog to page 10Pharmaceutical Testing Choose your DTGi System Accessories DTGi Series: Technical Specifications Pharmacopoeial Compliance User Interface Resistive touchscreen Basket Rack Assembly Automatically lowered and raised at beginning and end of test run Stroke Frequency Range Stroke Height Heater Type Independent digital heater/circulator Heater Temperature Range Up to 99 hours , 59 minutes, 59 seconds Data Output RS 232 USB A (for connection with a USB printer) USB B (for connection with a PC) 2. Low bath water level warning on-screen indicator Temperature Calibration Single-point electronic...
Open the catalog to page 11All Copley Scientific catalogs and technical brochures
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