21CFR Part 11 Pharmaceutical and Nutraceutical Polarimeter
The Rudolph Research Analytical Autopol V is designed for regulated analytical laboratories
21 CFR Part 11 compliant
Polarimeter for pharmaceutical and nutraceutical applications
Electronic temperature control
Acid resistant
21CFR Part 11 Compliant Polarimeter
The Autopol V digital polarimeter is designed for regulated pharmaceutical and nutraceutical analytical laboratories. Standard measurement and compliance features include:
- TempTrol: Electronic cooling and 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
- Standard Accessories:
- TempTrol NIST traceable Quartz standard (single rotation)
- TempTrol 100mm polarimeter cell
- TempTrol temperature validation cell
- Built-in sample measurement probe
Try Before You Buy
The Autopol V is available for a short term trial.
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Polarimeters
Measurement
Fill Station
TempTrol Electronic Temperature Control System
The USP <781> requires optical rotation measurements at 25°C ± .5°C (unless another temperature is specified). The European Pharmacopoeia requires optical rotation measurements made at 20° ± .5°C (unless another temperature is specified). Whatever your temperature control needs are the patented TempTrol system makes measurements in a few minutes without a 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 V will heat or cool to a predefined temperature and then provide the result all in one easy step. TempTrol eliminates the need for a water bath. A temperature validation cell is provided with every TempTrol system. The temperature validation cell along with an optional NIST traceable thermometer is designed to validate the temperature control performance of the digital polarimeter and cell to ±0.2°C.
TempTrol cell with mating heating and cooling transfer surface manufactured with acid resistance materials NEDOX and Peek.
For improved temperature performance or when working with acids (HCl) use the measurement port in the body of the cell. This also allows the inlet and outlet ports to be capped to avoid evaporation, fumes and spillage
The TempTrol cell fits in the Autopol V sample chamber to measure to within ±0.2°C of the USP, EP, JP or BP specified temperature (normally 20°C or 25°C ±0.5°C)
TempTrol heating and cooling transfer surface
21 CFR Part 11 Compliance
The Autopol V’s 21CFR Part 11 software module is easily enabled through the user friendly touch screen. This module gives you full compliance with:
- Electronic signature
- Access levels
- Internal write protected storage
- Unique passwords
- Write protected documents sent directly to server
- Audit trail
21CFR Part 11 By External PC
21CFR11 mode is enabled via the Set 21CFR11 button. After clicking the Enable 21CFR11 button, the user must also select to either Enable Operator, Enable Reviewer or both.
Edit Users allows the creation of new 21CFR11 users, the ability to edit an existing user, and the ability to lock and unlock accounts.
Groups are used to determine the access permissions of the 21CFR11 users. When a group is added or edited, the administrator decides what menus the group will have access to in the Setup menu and sub-menus, and the 21CFR11 Administration Options menu and sub-menus.
Password Settings control the password policy used by the Autopol Digital Polarimeter to authenticate users and whether the screen lock function is active and how long it takes for the screen lock to turn on.
The Format Printing/Output menu lets the user control what information will be contained in the report, if the report will contain a logo image, the page orientation and margin settings and if the user will be prompted for a lot identifier and sample identifier when the measurements are being performed.
Automatic Digital Polarimeter with Acid Resistance and Traceable Quartz Plates
6m HCl acid resistance: Silco Steel coating on the polarimeter chamber temperature transfer surface and a Hastelloy measurement cell with NIST certificate certifying optical path length
Six Wavelengths and Only One Light Source
The AutopolV comes standard with six wavelengths: 365nm, 405nm, 436nm, 546nm, 589nm, 633nm. Wavelength selection is completely automatic and is accomplished by the push of a button. There are no lamps or filters to manually remove or insert.
The tungsten-halogen lamp is a compact, reliable, low-cost, high intensity light source that allows any desired wavelength in the visible spectrum to be selected by means of a narrow band multilayer interference filter. The standard 10nm bandwidth is specified to permit high energy throughput and sensitivity for sample transmittances of only 0.01 % (O. D. = 4), while minimizing the effects of sample ORD and colour.
Standard Accessories, Validation and Calibration
The Autopol V Digital Polarimeter comes standard with the accessories, validation tools and automatic calibration functions necessary to ensure that the temperature control, temperature measurement and optical measurement processes are working correctly and reproducibly. All functions are accessed simply and conveniently through the liquid sealed touchscreen.
In April 2022 there was a change to the European Pharmacopeia regarding the measurement of essential oils such as Sweet Orange Oil. They now need to be measured in a 0.1 dm length cell instead of the standard 100mm polarimeter cell. Compliance with the new European Pharmacopeia requirements can be achieved with the purchase of a Rudolph 0.1dm/10mm length cell for use with Rudolph’s TempTrol® heating and cooling system.
Also available the Autopol IV, Autopol V Plus and Autopol VI
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Specification
Measuring Mode: Optical Rotation Specific Rotation Specific Rotation Plus Concentration User Defined Scale Sugar Degrees °Z(ISS)
Measuring Scale: Degrees Arc, % Concentration
Measuring Range Arc Optical Rotation: ± 89.99°
Measuring Range Arc Specific Rotation: ± 999.99°
Measuring Range Concentration: 0-99.9%
Resolution: 0.001° Arc Optical Rotation 0.001% Concentration 0.001 Specific Rotation
Reproducibility: 0.002° Arc
Standard Model Accuracy: 0.002° up to 1°, 0.2% up to 5°, 0.01° above 5°
AP Model Specs Accuracy: (546nm and 589nm): ±0.002° Arc over ±89.9° Arc Accuracy for other wavelengths is the same as the standard model Selectable Resolution 0.01°, 0.001°, 0.0001° Arc Optical Rotation
Prism: Glan Thomson calcite quartz
Optical Wavelengths: 365nm, 405nm, 436nm, 546nm, 589nm, 633nm (other wavelengths available)
Wavelength Selection: Touchscreen Selectable: 6 standard
TempTrol Range Automatic Electronic Heating and Cooling: 15°-35°C (Standard) ±0.2° C (Standard)
TempTrol Accuracy: ±0.2°C
Temperature Probe Range: 10°-100°C
Temperature Probe Accuracy: ±0.1°C
Acid Resistance: Hastelloy measurement cell and Silco Steel sample chamber (optional)
Measurement Time: 4°/sec slewing rate & 5 sec nominal settling time
Light Source: Tungsten-halogen 6V, 20W, avg. 2,000 hr life
Sample Chamber: Accepts sample tubes up to 200mm
Data Storage: 32 GB Non-removable Compact Flast
Communication Interface: 3 – USB Ports 2 – RS232 Ports Ethernet Port for Network Connection
Calibration: Automatic calibration by push-button
Operating System: Windows Embedded
Display: 8 inch colour LCD with LED backlight providing 800 x 600 resolution with 400 nits of luminance
User Interface: Touchscreen
Automatic Sensitivity Control: Measures samples with transmittance as low as 0.01 % (up to O.D. 4.0)
Input Power: 100-240 VAC, 50/60 Hz
Dimensions: 762mm W x 432mm H x 267mm D
Weight: 39 kg