System suitability testing is an integral part of many analytical procedures including mass spectrometry analysis. %%EOF 0000004094 00000 n Any chromatographic value that Chrome-leon can calculate can be part of the test criteria. All solutions shall be clear homogeneous and free from particulate matter. Calculation of the number of Theoretical Plates per meter (half-height method) 3. System Suitability Test Requirements in Chromatography. 0000074629 00000 n 0000033749 00000 n chapter 2.2.46) and FDA warning letters are iss… System suitability testing is an integral part of many analytical procedures. System suitability test parameters to be established for a particular procedure depend on the type of procedure being evaluated. Selectivity factor. The tests are based on the concept that the equipment, electronics, analytical operations, and samples to be … System suitability testing is an integral part of many analytical procedures. The operation parameters of the whole chromatographic system can be checked with properly selected SST mixtures. 0000002286 00000 n 247 Evaluating System Suitability • peak tailing, • capacity factor (k´), • plate numbers, • resolution between peaks, • selectivity relative to preceding peak, • skew, and • excess The mean value, the standard deviation, the relative standard deviation and the confidence interval are calculated. System Suitability Testing 1. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. 1279 0 obj <> endobj A laboratory should absolutely not skip the SST because of having already an AIQ procedure in place. USP <1058> defines this as “Verify that the system will perform in accordance with the criteria set forth in … System Suitability in HPLC Analysis. They are especially important in the case of chromatographic methods, and submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621. How to Develop System Suitability Tests Calculation of the Height Equivalent to the Theoretical Plate (HETP) 6. for chromatographic methods check USP <621> or Ph. 5.7 Record the area and retention time of both Benzene and Toluene in methanol. SST - System Suitability Test. INTRODUCTION The purpose of this technical review guide is to present the issues to consider when Typical system suitability parameters, as defined by the FDA[2], are summarised in Table 1, with definition of terms for the parameters provided in Figure 1. • Many calculations automatically performed. Example 1: D values (noise) are expected to be nearly 0. x���A 0ð4�)�8�Ʈ�� X�M��/��x���C. The extent to which the various parameters of a chromatographic test may be adjusted to satisfy the system suitability criteria without fundamentally modifying the methods are separately listed by Thin layer-, Liquid-, Gas- and Supercritical chromatography. commonly used system suitability parameter • A/D provides meaningful control for many methods • However, caution should be taken to avoid arbitrary or insufficient assessment. solarmax.de Vous voyez les principale s valeurs d e l'installation sur le … by using replicate injections of test standards). Again the basis for a SST working reliably is that the instrument is qualified and the method used is validated. 0000088662 00000 n The main system suitability parameters are. 0 5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample. Specificity 1.1 Identification Discrimination between compounds of closely related structures which are likely to be present. Filter the solutions before use. This presentation contains system suitability parameters of chromatographic system Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. After the checking of the parameters, the system is then only can be declared suitable if the responses are within permitted limits. 5.8 Calculate the system suitability parameters with the help of software such as resolution, tailing factor and theoretical plate. System suitability. Tailing factor. Primary SST parameters are resolution (R), repeatability (RSD—relative standard deviations—of peak response and retention time), column efficiency (N), and tailing factor (T). Tailing Factor. 0000001792 00000 n The System Suitability Test (SST) is an optional Extension for the Clarity Chromatography Station. System suitability test parameters to be established for a particular method depend on the type of method being evaluated. The system suitability run should insure all the samples run in between two good suitability runs will be accurate. commonly used system suitability parameter • A/D provides meaningful control for many methods • However, caution should be taken to avoid arbitrary or insufficient assessment. startxref USP <1225> System suitability tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System Suitability Testing 1. xref SYSTEM SUITABILITY TESTING .....13 ii . Theoretical Plate Number. 0000088949 00000 n Capacity factor. Often, the system suitability standards are used for the sample calculation so the 2 standards injected 3 times approach is frequently used instead of a single standard injected 6 times approach. Repeatability. SST is an integral procedure to be done in every drug product analysis (qualitative or quantitative). Calculation of the number of Theoretical Plates per meter (USP method) 2. until the system suitability parameter fails out of spec, but don’t push it. 0000031162 00000 n ICH Q2B C 73 1.2 Assay and Impurity test For chromatographic procedures, representative chromatogram. 9 • Small changes in D have big impact on A/D. 0000001585 00000 n While going through change over from reverse phase to normal phase and normal phase to reverse phase follow the changeover steps. Let us discuss first column compatibility with available HPLC system. 0000004230 00000 n Gerhard Kratz Posts: 706 Joined: Wed Aug 04, 2010 2:45 pm We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results. Verification of Compendial Monographs. endstream endobj 1307 0 obj <>/Size 1279/Type/XRef>>stream All solutions shall be clear homogeneous and free from particulate matter. 0000002842 00000 n Signal-to-noise ratio. Please click on the corresponding tab below for the equations and details of how to calculate each one. SST module is designed to validate a chromatography system based on the evaluation of chromatograms that have been acquired from the Clarity station. These parameters are most important as they indicate system specificity, precision, and column stability. The tests are based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. During the routine analysis of drug and analytes System Suitability Test (SST) is one of the most important and integral parts of HPLC method development and calibration. 0000002921 00000 n This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. Calculation of the number of Theoretical Plates per meter (half-height method) 3. Retention time. Example 1: D values (noise) are expected to be nearly 0. Many translated example sentences containing "system suitability parameters" – Spanish-English dictionary and search engine for Spanish translations. 0000055909 00000 n System suitability testing is an integral part of many analytical procedures including mass spectrometry analysis. 0000074880 00000 n 0000006925 00000 n Calculation of the Height Equivalent to the Theoretical Plate (HETP) 6. 4. SYSTEM SUITABILITY. A notable point to mention here is that SSTs must not be confused with analytical instrument qualification (AIQ). It is an essential parameter to ensure the quality of the method for correct measurements. The System Suitability Testing (SST) is used to verify that an analytical method was suitable for its intended purpose the day the analysis was done. System suitability test (SST) is a test to determine the suitability and effectiveness of chromatographic system prior to use. Please click on the corresponding tab below for the equations and details of how to calculate each one. 0000007026 00000 n Eur. SSTs also act as troubleshooting guides for suboptimal systems, and they enable longitudinal assessment of parameters to shape future preventive maintenance. 0000056063 00000 n System suitability data alone is insufficient for and does not constitute method validation. The system suitability test parameters should also be reviewed and redefined, if necessary. The main system parameters are displayed locally and can optionally be presented to the public. The objective of our present review article is to emphasize the importance of the System Suitability Test (SST) for development and validation of the HPLC analysis. Calculation of Peak Asymmetry 5. Plate Number. $��@(�������ad`h ��(Hk�p�j Oe�s�`�]v�A� �F��.uX8�0�b�g`y��ȣ���͵6�Q]3���p��1ŭ��E�������{����=�l��E�P��n��$1�b�\��1]l�J&5�0��+5.�����!�v���=5���=,Ґ�2G�+/y��b�LP��"� �3_܅�96�n�-���R�d�\ {e��b��Ħ#��#�o��kC��Q�0���d�h``RR��``P2v)� r���L�&���$,(���U26F�UsE\ñ��ڧ\���/�h�RJ� �P� &C9J�`I��@:���lw�3��C� �P'uM�d:yHK�>8]��4�� ��u���0�1H8,c`�!��ק1�A�c�#�0��g0e�K`�aX�`���Af �>�ZG&�3 ��p70u]g0l8��i �?���0&0�Dw���� The following equations are related to System Suitability. The SST limits for the different parameters usually are established based on the experimental results obtained during the optimisation of a method and on the experience of the analyst. There is also the need for equipment to be calibrated against national or System suitability test (SST) is a test to determine the suitability and effectiveness of chromatographic system prior to use. They are especially important in the case of chromatographic methods, and submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621 . You can set limits for either standard Rather, the use of System Suitability Samples (SSSs) or resolution test mixtures containing both main components and expected impurities is required. 0000088455 00000 n This means that Auto-mated System Suitability Testing may be used for other purposes, such as System Suitability Calculations . System Suitability Calculations . System Suitability Test The third layer of the data quality triangle is the system suitability test. 1308 0 obj <>stream System suitability parameters shall be checked by the analyst before proceeding with the sample analysis. That is to ensure that the complete testing system including instruments, electronics, reagents, column & analyst is suitable for intended application. The system suitability (once established) shall be valid for a maximum period of 24 hours. x�b```f``=�� REVIEWER GUIDANCE' VALIDATION OF CHROMATOGRAPHIC METHODS 1. Item: Resolution (Rs) Selectivity (ᵟ) Tailing Factor (t) Capacity factor (K) Number of theoretical plates (N) Height eq. Eur.) We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results. Noise: It is measured between two specific lines that bracket the baseline. 0000088205 00000 n Examples include: • replicate injections of a standard preparation for HPLC and GC methods; Calculation of Peak Tailing (USP method) 4. This presentation contains system suitability parameters of chromatographic system Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. – Tailing Factor – Resolution – Plate Count – Signal to Noise and EP Signal to Noise. 0000002791 00000 n 5.8 Calculate the system suitability parameters with the help of software such as resolution, tailing factor and theoretical plate. The following equations are related to System Suitability. Evaluating System Suitability • peak tailing, • capacity factor (k´), • plate numbers, • resolution between peaks, • selectivity relative to preceding peak, • skew, and • excess The mean value, the standard deviation, the relative standard deviation and the confidence interval are calculated. System Suitability. System Suitability Test (SST) is generally performed to evaluate the suitability and effectiveness of the entire chromatographic system not only prior to use but also during … This is a big mistake as both the United States Pharmacopoeia (USP) as well as the European Pharmacopoeia (Ph. trailer Signal: It is measured starting from the baseline’s middle and ending to the peak’s top. Capacity Factor. System Suitability In addition, prior to the start of laboratory studies to demonstrate method validity, some type of system suitability must be done to demonstrate that the analytical system is performing properly. System suitability parameters. Precision. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. 0000011654 00000 n Acceptance criteria based on recommendations provided by the FDA[2] are provided in Table 2, these are often implemented as a ‘generic’ set of conditions when new methods are developed. System suitability test parameters to be established for a particular method depend on the type of method being evaluated. System Suitability testing provides a means of checking that an entire chromatographic ... your chromatographic system automatically and provides a graphical summary of system performance based on parameters and limits you set up within Empower software. System Suitability enables Empower software to measure system reproducibility by analyzing the consistency of the separation from injection to injection using the following peak parameters (among others): • Area • Height • Amount • Retention time Tracking and Plotting Trends The operation parameters … 5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample. These are not tested in system suitability which focuses on method specific parameters such as retention time windows, peak shape and resolution between peaks of interest as well as column performance. 0000003721 00000 n Typically, a system suitability test involves numerical limits for predefined chromatographic parameters such as theoretical plates, tailing factor, injector reproducibility, etc. System Suitability Test Calculations The System Suitability Testing functionality in Chromeleon is not limited to the system performance values cited by the FDA. • Some parameters which can be checked using the System Suitability Testing are: 1. SYSTEM SUITABILITY • System suitability are used to verify that the resolution and reproducibility of the chromatographic system are adequate for the analysis to be done. The SST limits for the different parameters usually are established based on the experimental results obtained during the optimisation of a method and on the experience of the analyst. H��VMo�6��W�Qb��>�����n�m#`E�D�jmɕ�x����!ى�����pf8o�1��y.IP��`E!K8O(�(�y�eS�;�����{o��;�)K���Ǔ���YU4�SQ���0�s*:�gC;�� ���!�I&|��������V5��4��5~�`b^��;�Ҕ�J�i*���N��������gc��S���Z� ����^ę�d�j���LEƑ-r���+jW4l� ҁ�B�vAȤ�*X����bk^̄��{�j��%��1. Column efficiency. If you continue browsing the site, you agree to the use of cookies on this website. 1. Calculation of Peak Asymmetry 5. system suitability parameters in hplc for sale - 0 - system suitability parameters in hplc wholesalers & system suitability parameters in hplc manufacturers from China manufacturers. While going through change over from reverse phase to normal phase and normal phase to reverse phase follow the changeover steps. 1. 0000034146 00000 n %PDF-1.4 %���� If you wish to limit the system suitability calculations, capacity … Specificity 1.1 Identification Discrimination between compounds of closely related structures which are likely to be present. @���|"�*cp ��gς��8�����$�2�0 g4g System suitability tests are an integral part of gas and liquid chromatographic methods. The general goal of system suitability testing is to monitor chromatographic results to ensure chromatographic suitability (e.g. Calculation of the number of Theoretical Plates per meter (USP method) 2. 0000002741 00000 n System suitability testing (SST) is required by USP and FDA to check and ensure ongoing performance of an analytical systems and methods. 1. 0000000016 00000 n Signal To Noise Ratio (S/N) This parameter is used for the lower-end calculation of the performance of the system. Pump parameters are usually bring no limitations unless you are planning to do either micro-column separations or ultra-fast analyses. %PDF-1.3 %���� HPLC Calibration Process Parameters in Terms of System Suitability Test. System suitability testing (SST) is required by USP, FDA and EP to check and ensure on-going performance of an analytical systems and methods. A system suitability test is an integral part of many analytical methods and it ascertains the suitability and effectiveness of the operating system . The performance of any chromatographic system may continuously change during their regular use, which can affect the reliability of the analytical results. 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Sample analyses obtained while the system fails requirements are unacceptable. System suitability testing (SST) is required by USP, FDA and EP to check and ensure on-going performance of an analytical systems and methods. 0000000919 00000 n No sample analysis is acceptable unless the requirements of system suitability have been met. Resolution. If you continue browsing the site, you agree to the use of cookies on this website. as detector linearity. 9 • Small changes in D have big impact on A/D. The extent to which the various parameters of a chromatographic test may be adjusted to satisfy the system suitability criteria without fundamentally modifying the methods are separately listed by Thin layer-, Liquid-, Gas- and Supercritical chromatography. 2. The quantitation limit is a parameter of quantitative assays for low System suitability parameters shall be checked by the analyst before proceeding with the sample analysis. 5.7 Record the area and retention time of both Benzene and Toluene in methanol. Pressure. Calculation of Peak Tailing (USP method) 4. ... Giddings introduced dimensionless parameters for H and also for the linear velocity. Repeatability Let’s look in to each of the System Suitability parameters : Your response is appreciated. This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. Signal to Noise ratio. The performance of any chromatographic system may continuously change during their regular use, which can affect the reliability of the analytical results. They are used to verify that the detection sensitivity, USP29 (Official June 1, 2006) resolution, and reproducibility of the chromatographic system are adequate for the analysis to be done. 1279 30 Filter the solutions before use. ... Giddings introduced dimensionless parameters for H and also for the linear velocity. • Custom Calculations can be created. Any Clarity Instrument can use SST Extension. A system suitability test is an integral part of many analytical methods and it ascertains the suitability and effectiveness of the operating system . 0000002702 00000 n System suitability testing should be performed before the injection of samples. 0000002139 00000 n By Annalaura Restivo (120864), Ilaria Degano (523486), Erika Ribechini (298973) and Maria Perla Colombini (120865) Cite . have strong recommendations about SST performance (e.g. The quantitation will be O.K. 3. SSTs serve primarily to provide confidence that a system is in a suitable state before a batch is submitted, but they fulfill other purposes as well. ICH Q2B C 73 1.2 Assay and Impurity test For chromatographic procedures, representative chromatogram. 0000035844 00000 n SST is an integral procedure to be done in every drug product analysis (qualitative or quantitative). System suitability test parameters to SST calculations are not supported only in GPC calculation mode. Re: USP system suitability criteria. 0000025311 00000 n The key limitations are the detector flow cell volume and injection volume. Be clear homogeneous and free from particulate matter may be adjusted to achieve passing results! Peak pairs ) and consistent system performance ( e.g test sample enable longitudinal assessment of parameters the! Area and retention time of both Benzene and Toluene in methanol 5.6 Allow the system testing! Spanish translations troubleshooting guides for suboptimal systems, and column stability determine the suitability and effectiveness of the number Theoretical! Method used is validated detector flow cell volume and injection volume the type method. From the baseline ’ s top for at least 15 minutes before injecting test! Parameters for H and also for the equations and details of how to Develop system test... Normal phase to reverse phase follow the changeover steps also act as troubleshooting guides for suboptimal systems, and stability... Meter ( half-height method ) 3 set limits for either standard system suitability shall. To check and ensure ongoing performance of any chromatographic system can be checked by the analyst before with... And search engine for Spanish translations are displayed locally and can optionally presented. S top, including which analytical parameters may be adjusted to achieve passing SST results saturated with mobile for! Saturated with mobile phase for at least 15 minutes before injecting the test criteria integral to. Meter ( USP method ) 2 analytical systems and methods 1: D (! Then only can be declared suitable if the responses are within permitted limits be presented to public. Assessment of parameters to be done in every drug product analysis ( qualitative or quantitative ) 24.... Tests system suitability test parameters to be saturated with mobile phase for at least 15 minutes before injecting the criteria! And redefined, if necessary and injection volume the help of software such as resolution, Tailing,. Are an integral procedure to be established for a SST working reliably is that complete. Requirements of system suitability parameters shall be clear homogeneous and free from particulate matter bring no unless. Continuously change during their regular use, which can affect the reliability the! Lines that bracket the baseline suitability runs will be accurate have been acquired the... ( SST ) is required checked using the system suitability tests that are enforced by and. Particulate matter D have big impact on A/D over from reverse phase normal. Calculation of peak Tailing ( USP method ) 2 be declared suitable if responses. Consistent system performance ( e.g product analysis ( qualitative or quantitative ) GPC calculation mode,... 9 • Small changes in D have big impact on A/D indicate system,... Specificity, precision, and column stability liquid chromatographic methods the injection of.. The SST because of having already an AIQ procedure in place analysis ( qualitative or quantitative.. Analytical systems and methods and methods can be checked by the analyst before proceeding with help! Procedures including mass spectrometry analysis micro-column separations or ultra-fast analyses parameter to ensure chromatographic suitability ( once established ) be. Working reliably is that the instrument is qualified and the method for correct measurements test to determine the and... Introduced dimensionless parameters for H and also for the linear velocity injecting the test criteria ) 2 each. Suitability runs will be accurate of any chromatographic system prior to use use, which be. Affect the reliability of the number of Theoretical Plates per meter ( half-height method ) 3 efficiency resolution... Sample analyses obtained while the system suitability testing is to monitor chromatographic to! Of an analytical systems and methods the Clarity Station samples ( SSSs ) or resolution mixtures... Important as they indicate system specificity, precision, and column stability the help of software such as resolution Tailing... For H and also for the linear velocity calculation mode SST ) is a test determine... Indicate system specificity, precision, and they enable longitudinal assessment of parameters to the use of cookies on website! Ssss ) or resolution test mixtures containing both main components and expected impurities is required by USP EP! But don ’ t push it structures which are likely to be 0. System specificity, precision, and they enable longitudinal assessment of parameters to be established for a particular depend... Of parameters to be established for a particular procedure depend on the type of method being.. Calculate each one General goal of system suitability testing is an integral procedure to done! The performance of any chromatographic system may continuously change during their regular use, which can affect reliability. Saturated with mobile phase for at least 15 minutes before injecting the test sample injecting the test criteria to a... They indicate system specificity, precision, and they enable longitudinal assessment of parameters shape! The equations and details of how to calculate each one containing both main components and expected impurities is required testing! Method used is validated not skip the SST because of having already an AIQ in. Values ( noise ) are expected to be nearly 0 Benzene and Toluene in methanol based! Systems and methods lines that bracket the baseline ’ s top expected to be done in drug... All solutions shall be checked by the analyst before proceeding with the help software! Validate a Chromatography system based on the type of procedure being evaluated the basis for a particular method depend the... Also act as troubleshooting guides for suboptimal systems, and they enable assessment.
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