8RRA12-03 198_Autopol5_Plus.qxd:Layout 1 12/11/12 1:38 PM Page 2 For Pharmaceutical Applications Tw T o Great Solutions The Autopol® l V and Autopol® l V PLUS United States Department of Commerce National Institute of Standards and Technology NVLAP LAB CODE: 200898-0 Accreditation to ISO/IEC 17025:2005 The brand of polarimeter used T E C H N I C A L B U L L E T I N 9 2 8 *Emmes Survey in more labs than any other.* 8RRA12-03 198_Autopol5_Plus.qxd:Layout 1 12/11/12 1:38 PM Page 3 Two excellent polarimeter choices to satisfy the most stringent pharmaceutical requirements Autopol® V Autopol® V PLUS With Hastelloy™ acid resistance and three rotation NIST calibration standard The Industry Standard Polarimeter Standard Accessories The Autopol® V has the validation tools and features to satisfy today’s global pharmaceutical companies, including: instrument level 21CFR Part 11 compliance, NIST traceable calibration standards and a global list Two One or of installations. Rudolph Research has thousands of satisfied customers TempTrol™ three NIST who praise the Autopol® V’s quality, accuracy and reproducibility. Validation Traceable Cells Certificates** Autopol® V Standard Features And Accessories • TempTrol™ – Electronic cooling & heating from 15°-35°C • Six Standard Wavelengths: 365nm, 405nm, 436nm, 546nm, 589nm and 633nm • 21CFR11 Compliance: Electronic Signature and secure local electronic data storage TempTrol™ Hastelloy™ • Domestic 3-year warranty and 20-year support guarantee Measurement Cell* • International warranty varies by country *Option on the Autopol® V, TempTrol™ NIST Traceable standard on the Autopol® V Plus • Standard Accessories: TempTrol™ NIST Traceable Quartz Standard Quartz Calibration Standard **Single rotation on the Autopol® V, (single rotation), TempTrol™ 100mm Polarimeter Cell, TempTrol™ three rotations on the Autopol® V Plus Temperature Validation Cell, Built-In Sample Measurement Probe Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com 8RRA12-03 198_Autopol5_Plus.qxd:Layout 1 12/11/12 1:38 PM Page 4 The Autopol® V and V Plus Use Rudolph’s Exclusive TempTrol™ Electronic Temperature Control System THE AUTOPOL® V PLUS ADVANTAGE The USP <781> requires optical rotation measurements at 25°C ± .5°C • 6m HCl acid resistance: Silco Steel coating on the chamber (unless another temperature is specified). The European temperature transfer surface and a Hastelloy measurement Pharmacopoeia requires optical rotation measurements made at 20° ± cell with NIST certificate certifying optical path length. .5°C (unless another temperature is specified). • To meet the FDA’s latest position on measurement Whatever your temperature control needs are, the Autopol® V bracketing, the Autopol® V Plus comes with a NIST traceable and the Autopol® V Plus’ exclusive TempTrol™ System (Patent No. quartz plate with three rotations: +0.998° Arc, +10.998° Arc, 6,717,665) makes your measurement in a few minutes without a -10.000° Arc. Each rotation has a NIST certificate. waterbath or any type of water circulation. The TempTrol™ System allows push-button temperature control of your 100mm cell, 200mm cell or Quartz Plate. Set the temperature, push “measure” and walk away. The Autopol® will heat or cool to a predefined temperature and then provide you with the result all in one easy step. +10.998° Arc +0.998° Arc -10.000° Arc Patented TempTrol™ Technology Eliminates the Need for a Water Bath. Here is How the TempTrol™ System Works: • Windows based navigation architecture is so intuitive that most operators will never read the manual. But should you wish to reference the manual, it is stored right on the Autopol® V Plus’ internal memory. • Available with automated sampling TempTrol™ active surface TempTrol™ Hastelloy™ with Silco Steel™ coating passive surface TempTrol™ heating and cooling TempTrol™ cell with mating transfer surface heating & cooling transfer surface manufactured with acid resistance materials: Hastelloy™ and Peek™. ECS Easy Clean Sampling System Temperature is selected via • Three USB ports allow quick and easy connection to a touch screen. Temperature mouse, keyboard, printer, bar code scanner, or memory selection of 20°C shown left. stick. One USB port is located on the front of the unit (shown above) and two USB ports are located on the back of the unit (shown below). Place the TempTrol™ cell in your TempTrol™ equipped Autopol® sample chamber to Temperature measure to within ±0.2°C of the Cell cap measurement USP, EP, JP or BP specified port temperature (normally 20°C or 25°C ±0.5°C). For improved temperature performance or when working with acids (HCl) use the Temperature measurement port in the body measurement probe of the cell. This also allows the Autopol® V Plus inlet and outlet ports to be data connections on capped to avoid evaporation, back of unit fumes and spillage. Water Inlet Rudolph provides a • Ethernet Port for Network Cable Connection temperature validation cell • Internet access allowing connection to Rudolph’s service with every TempTrol™ system. department for remote testing and diagnostics The temperature validation • Connect to any Windows® based printer via USB or direct to cell along with an optional the server via Windows® Print Library NIST traceable thermometer is NIST designed to validate the • Save measurement data direct to your Network/Server Thermometer Probe temperature control performance of the polarimeter and cell to ±0.2°C. Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com 8RRA12-03 198_Autopol5_Plus.qxd:Layout 1 12/11/12 1:38 PM Page 1 Specifications Features Autopol® V Autopol® V PLUS Optical Rotation, Specific Rotation, Optical Rotation, Specific Rotation, Measuring Mode: Concentration & User-defined Scales Concentration & User-defined Scales Measuring Scale: Degrees Arc, % Concentration Degrees Arc, % Concentration ±89.9° Arc Optical Rotation, ±999.99° Arc Specific ±89.9° Arc Optical Rotation, ±999.99° Arc Specific Measuring Range: Rotation and 0-99.9% Concentration Rotation and 0-99.9% Concentration 0.01°, 0.001°, 0.0001° Arc Optical Rotation 0.01°, 0.001°, 0.0001° Arc Optical Rotation Selectable Resolution: 0.001% Concentration 0.001% Concentration 0.001° Specific Rotation 0.001° Specific Rotation Reproducibility: 0.002° Arc 0.002° Arc Standard Model Accuracy: 0.002ůp to 1°, 0.2% up to 5°, 0.01° above 5° 0.002ůp to 1°, 0.2% up to 5°, 0.01° above 5° (546nm and 589nm): ±0.002° Arc over ±89.9° Arc. Autopol V Plus Single: ±0.002° Arc over ±89.9° Arc. Accuracy for other wavelengths is the same as the Autopol V Plus Six Wavelength (546nm and 589nm): AP Model Accuracy standard model. ±0.002° over ±89.9° Arc. and Resolution: Selectable Resolution 0.01°, 0.001°, 0.0001° Arc Selectable Resolution 0.01°, 0.001°, 0.0001° Arc Optical Rotation Optical Rotation Prism: Glan Thompson calcite quartz Glan Thompson calcite quartz 365nm, 405nm, 436nm, 546nm, 589nm, 633nm 365nm, 405nm, 436nm, 546nm, 589nm, 633nm Optical Wavelengths: (other wavelengths available) (other wavelengths available) Wavelength Selection: Automatic by push-button Automatic by push-button TempTrol™ Range: Automatic Electronic Heating & Cooling 15°-35°C Automatic Electronic Heating & Cooling 15°-35°C TempTrol™ Accuracy: ±0.2°C ±0.2°C Temp. Probe Range: 10°-40°C 10°-40°C Temp. Probe Accuracy: ±0.1°C ±0.1°C Hastelloy™ measurement cell and Silco Steel™ Hastelloy™ measurement cell and Silco Steel™ Acid Resistance: sample chamber (optional) sample chamber (standard) Measurement Time: 4°/sec. slew rate and 5 sec. nominal settling time 4°/sec. slew rate and 5 sec. nominal settling time Light Source: Tungsten-halogen 6V, 20W, avg. 2,000 hour life Tungsten-halogen 6V, 20W, avg. 2,000 hour life Sample Chamber: Accepts sample tubes up to 200mm Accepts sample tubes up to 200mm Data Storage/Internal Memory: Multimedia Card and/or Secure Digital Card 2 GB Non-removable Compact Flash Touch Screen, 3 – USB Ports, 2 – RS232 Ports, Ethernet Two RS232 serial ports, one parallel printer port Communication Interface: Port for Network Connection, Keyboard, Bar Code and one auxiliary port Scanner, Mouse, Network Capabilities Calibration: Automatic calibration by push-button Automatic calibration by push-button 10.4 inch diagonal, 800-600 pixels, color, Flat Panel 7.5cm x 10cm graphics LCD, Display: Monitor with Resistant Touch Screen Interface, 200 nits 320 x 240 dots cold fluorescent back lit brightness, gasketted for spill protection User Interface: Touchscreen Touchscreen Measures samples with transmittance as low as 0.01% Measures samples with transmittance as low as 0.01% Automatic Sensitivity Control: (up to O.D. 4.0) (up to O.D. 4.0) 85 – 260 VAC; 48 – 62 Hz, Input Power: 100-240VAC, 50/60 Hz 150 – 200 Watts consumption 35"W x 10.5"H x 17"D 32"W x 11.5"H x 18"D Operating Dimensions: 890mm W x 267mm H x 432mm D 813mm W x 292mm H x 457mm D 43"W x 26"H x 23"D 43"W x 28"H x 23"D Shipping Dimensions: 1,025mm W x 625mm H x 625mm D 1,411mm W x 919mm H x 722mm D Operating Weight: 85 lbs. (39kg) 90 lbs. (41kg) Shipping Weight: 115 lbs. (52kg) 140 lbs. (64kg) Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com RRA12-03 12/12