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The Autopol® V PLUS and Autopol® VI

The Autopol®  V PLUS and Autopol®  VI
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The Autopol® V PLUS and Autopol® VI

Product catalog summary
Overview: The document provides comprehensive details on the Autopol® V PLUS and Autopol® VI polarimeters, designed for high-precision applications in pharmaceutical environments. These instruments are recognized for their accuracy, compliance with industry standards, and innovative features such as the TempTrol™ temperature control system.
Specifications: The Autopol® V PLUS and VI polarimeters offer exceptional accuracy of ±0.0003° Arc for optical rotation measurements, which is particularly advantageous for racemic solutions and low concentration samples. They feature six standard wavelengths and comply with 21CFR11 regulations. The instruments are backed by a domestic 3-year warranty and a 20-year support guarantee.
TempTrol™ System: This patented system provides precise temperature control without the need for a water bath, meeting USP and EP requirements for optical rotation measurements. It allows for easy temperature setting and automatic measurement, enhancing user convenience and accuracy.
Calibration and Validation: The polarimeters include NIST traceable quartz calibration standards and automatic measurement validation features. They store calibration history internally, and the use of 3 rotation Quartz Calibration Standards is recommended to comply with FDA guidelines.
Cell Design and Materials: The polarimeters utilize ceramic quartz cells that are resistant to acids, ensuring durability and efficient thermal transfer. The cells are designed for easy handling, filling, and cleaning, with a lifetime warranty against breakage and acid damage.
AutoFill™ and FillStation™ Systems: These systems simplify the process of filling polarimeter cells, reducing manual handling and ensuring bubble-free samples. The AutoFill™ system automates sample loading and cleaning, while the FillStation™ assists with manual filling outside the instrument, minimizing exposure to hazardous materials.
21CFR Part 11 Compliance: The Autopol® VI includes a software module for full compliance with 21CFR Part 11, featuring electronic signatures, access levels, write-protected storage, unique passwords, and audit trails. Users can manage access permissions and customize report outputs directly from the touch screen.
Features and Capabilities: The instruments offer flexible method management, allowing users to install test methods for common tests. They feature an intuitive Windows® based interface, 32GB internal memory, internet access for remote support, and multiple USB ports for connectivity. The instruments are equipped with a lifetime guarantee on ceramic quartz sample cells and a 20-year service commitment.
Technical Specifications: Detailed technical specifications for both models include measuring range, resolution, reproducibility, accuracy, light source, sample chamber dimensions, data storage, and power requirements.
Customer Support and Service: Rudolph Research Analytical emphasizes exceptional customer service, offering preventive maintenance and a 20-year support guarantee. The company has a global reach with over 8,000 instruments in use worldwide.
Conclusion: The Autopol® V PLUS and VI polarimeters by Rudolph Research Analytical are equipped with advanced features and robust design, making them suitable for demanding pharmaceutical applications. Their compliance with international standards and innovative technologies like TempTrol™ and AutoFill™ enhance their reliability and ease of use.
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Catalog excerpts

The Autopol®  V PLUS and Autopol®  VI-1

For the Most Demanding High Accuracy Applications The Autopol V PLUS and Autopol VI ® The brand of polarimeter used in more labs than any other.* *Emmes Survey

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The Autopol®  V PLUS and Autopol®  VI-2

The most stringent pharmaceutical requirements Autopol VI or Autopol® V PLUS Built in three rotation NIST calibration standard Acid Resistant Cell Chamber and Temperature Probe Acid Resistant Ceramic Cell Patented TempTrolTM Heating and Cooling System 6,717,655 Autopol® V PLUS and VI data connections on back of unit Unmatched Accuracy: ± 0.0003° Arc For Racemic Solutions and very low concentration samples, the Autopol® VI provides unmatched 4th decimal optical rotation accuracy of ±0.0003°Arc over ±1°Arc. Instrument performance for readings between -1 and 1° Arc is: Resolution ±0.0001, Reproducibility...

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The Autopol®  V PLUS and Autopol®  VI-3

The Autopol® V PLUS and Autopol® VI Use Rudolph’s Exclusive TempTrol™ Electronic Temperature Control System The USP <781> requires optical rotation measurements at 25°C ± .5°C (unless another temperature is specified). The (EP)European Pharmacopoeia requires optical rotation measurements made at 20° ± .5°C (unless another temperature is specified). Whatever your temperature control needs are, the Autopol® VI and the Autopol® V PLUS’ exclusive TempTrol™ System (Patent No. 6,717,665) makes your measurement in a few minutes without a water bath or any type of water circulation. The TempTrol™ System...

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The Autopol®  V PLUS and Autopol®  VI-4

Automatic Measurement Validation The only self contained and automatically loaded quartz control plates. • Calibrate your Rudolph Autopol® V PLUS and Autopol® VI Polarimeter right from the user friendly touch screen. • The Quartz Control plates stored in the instrument are automatically positioned and the calibration is performed for you. Results are recorded and you are finished. Calibration results can be stored on the local hard drive or printed for future reference. • Rudolph’s 3 rotation Quartz Standard is Traceable to NIST and certified by an internationally recognized accreditation body...

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The Autopol®  V PLUS and Autopol®  VI-5

Optical Rotation Traceability External Temperature Probe Traceability United States Department of Commerce National Institute of Standards and Technology Certificate of Accreditation to ISO/IEC 17025:2005 NVLAP LAB CODE: 200898-0 Rudolph Research Analytical Corporation Hackettstown, NJ is accredited by the National Voluntary Laboratory Accreditation Program for specific services, listed on the Scope of Accreditation, for: Calibration Laboratories This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005. This accreditation demonstrates technical...

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The Autopol®  V PLUS and Autopol®  VI-6

The Rudolph AutoFillTM Filling a Polarimeter Cell has never been easier. Rudolph Research Analytical developed AutoFillTM, Patent No. 10,101,353, a simple and easy way to allow fast and reliable polarimeter cell loading. Polarimeter sample cells are filled without bubbles, sample vapors are contained, and cleaning and drying is automated. Manual cell handling, cleaning and loading is eliminated. The AutoFillTM (Patent No. 10,101,353) is available as an option on the Autopol V Plus and Autopol VI Polarimeters. Waste Receptacle Solvent Alcohol Solvent Acetone Engineered for perfect fills every...

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The Autopol®  V PLUS and Autopol®  VI-7

Fill Rudolph Polarimeter Cells reliably outside of the instrument Many users prefer to load cells with samples outside of the Polarimeter. When this fits with your work flow, Rudolph has engineered a tool to assist you, the Rudolph Polarimeter FillStationTM. Designed to sit on your laboratory bench or under your fume hood and assist you in loading your Rudolph Polarimeter cell easily and reliably, the FillStationTM holds the cell at the right angle so you always fill the cell from bottom to top. Using a syringe, you inject the sample until it begins to appear at the top port. Once filled, the...

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The Autopol®  V PLUS and Autopol®  VI-8

How to use the FillStationTM For users who prefer not to hold the cell while working with highly acidic or basic samples, the Rudolph Cell FillStationTM is simple and easy to use, just follow the steps below: By design, the FillStationTM will hold the cell at a suitable angle. Place a 2.5mm or 5.0mm bore Polarimeter cell into the Rudolph FillStationTM. Turn the FillStationTM light on. The light will turn off automatically after a few minutes. Please Note: Filling a Rudolph Polarimeter cell is easy and you can be assured of an air bubble free sample cell. It is important to note that when using...

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The Autopol®  V PLUS and Autopol®  VI-9

Full 21CFR Part 11 Compliance Full 21CFR Part 11 Instrument Level Compliance The Autopol® VI’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 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 Review or both. • Unique passwords • rite protected documents sent directly to server W • Audit trail Add/Edit Users allows the creation of new...

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The Autopol®  V PLUS and Autopol®  VI-10

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. At least one uppercase character At least one lowercase character At least one number At least one symbol [!@#$%A&*()] Password Settings control the password policy used by the Autopol to authenticate users and whether the screen lock function is active and how long it takes for the screen lock to turn on. Rudolph Research Analytical...

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The Autopol®  V PLUS and Autopol®  VI-11

Full 21CFR Part 11 Compliance Terminology allows the Administrator to customize the language of the Accept/Reject language that appears in the measurement report reviewed by a reviewer. Print your customized Certificate of Analysis including your company logo directly from the Autopol VI® touch screen 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....

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.