HPLC <621> PT
SIAL/PEP015 - Proficiency Testing Material
EC Number: 200-362-1
Product Type: Chemical
| agency | suitable for USP 621 |
| application(s) | pharmaceutical |
| format | matrix material |
| packaging | ampule of 2 × 1 g |
| Quality Level | 100  |
| Application: | HPLC under USP 621 pharmaceutical proficiency testing material is used to test analytes in pharmaceutical products. Have any questions? Explore our FAQs .For more information on this product, please contact our PT Service Team . |
| Features and Benefits: | We have a vast portfolio of environmental PT schemes with "fit-for-purpose" samples to help you meet the needs of the laboratory. Our proficiency testing (PT) program is a benchmark to: • provide staff with an insight into their laboratory′s performance, to verify the accuracy and reliability of their testing process • provide a comparison of performance with that of other laboratories, nationally and internationally • test and educate staff, provide a better understanding of the impact of incorrect results and identify areas where there may be problems • provide an independent evaluation of laboratory performance • demonstrate to clients, colleagues and accreditation bodies that there is a commitment to quality |
| General description: | HPLC under USP 621 proficiency testing material is produced in accordance with ISO/IEC 17043:2010. The PT portfolio allows our test components to offer significant performance data to monitor and prove competency to customers, accreditation bodies or both. This proficiency test can be used to comply with ISO 17025 requirements for proficiency testing, demonstration of capability, and analysts training for HPLC technologies by the methodology described by USP <621>. Supelco® Pharmaceutical Proficiency Testing scheme is mainly designed to meet the needs of the pharmaceutical industry. The pharma PT samples allow laboratories to demonstrate their competence in following compendial USP methods of analysis. They can be used to assure accreditors or auditors that the lab processes are followed accordingly. Our pharmaceutical PT scheme covers products under categories such as Chemical Tests and Assays, Physical Tests and Determinations and Microbiological Tests. Type of PT Scheme: Pharmaceuticals Analyte/s: Values of analytes vary lot to lot. All information regarding the use of HPLC under USP 621 proficiency testing material can be found in the reporting packet which will be available to download at PT Portal . |
| Legal Information: | Supelco is a registered trademark of Merck KGaA, Darmstadt, Germany |
| Other Notes: | Are you new to Supelco® Proficiency Testing? Be sure to register your account details in the PT Portal before placing your order. This will provide access to data entry, reporting packets and final reports. Registrations will be approved shortly after your order is placed. For further questions, write to us at ptservice@milliporesigma. When placing your order online, please indicate your study preference under the ′your reference′ column. Available studies can be viewed at the bottom of the page. Click here to learn more about Quick-Turn Studies (on-demand proficiency tests that are offered depending on lot availability). The Quick-Turn results are released within 48-72 hours whereas scheduled study reports are released within 21 days.Proficiency Testing Schedule (2022-2023) Pharma PHARM22-2 April 6 - May 20, 2022 PHARM22-4 October 5 - November 18, 2022 PHARM23-2 April 5 – May 19, 2023 PHARM23-4 October 4 – November 17, 2023 Quick-Turn Study (on demand proficiency test that is offered depending on lot availability) |
| Preparation Note: | Description 1. Preparation of Mobile Phase a) Dissolve 1.64 g of anhydrous sodium acetate in 2 L of water (Soln. A) b) Transfer 1910 mL of Soln. A to a 2 L volumetric flask, add 50 mL of acetonitrile and 40 mL of tetrahydrofuran and mix. c) Adjust to pH 4.5, mix, filter and degas. 2. Preparation of Test Solutions a) Test Solution 1: Transfer 40 mg of Caffeine Sample 1 to a 200 mL volumetric flask and dissolve in about 50 mL of mobile phase (sonicate if necessary), dilute to volume with mobile phase and mix. b) Test Solution 2: Transfer 40 mg of Caffeine Sample 2 to a 200 mL volumetric flask and dissolve in about 50 mL of mobile phase (sonicate if necessary), dilute to volume with mobile phase and mix. 3. Perform the liquid chromatography according to the USP Caffeine Monograph for Related Compounds, or the company′s SOP for HPLC analysis of Caffeine impurity analysis. 4. Identify which Caffeine Sample passes according to the Caffeine Monograph (NMT 0.1% Impurities). Reported Data: Identify which Caffeine Sample is passing (Data = 1 or 2) |
| Storage and Stability: | Please refer to sample label for expiration date, specific storage temperature, and specific storage conditions. |
| Symbol |  GHS07 |
| Signal word | Warning |
| Hazard statements | H302 |
| Precautionary statements | P301 + P312 + P330 |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 1 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| UNSPSC | 41116107 |
| Components | Identification of Passing Caffeine Sample (1 or 2) 0.00 - 0.00 |