Gas Chromatography <621> PT
SIAL/PEP014 - Proficiency Testing Material
EC Number: 200-659-6
Product Type: Chemical
agency | suitable for USP 621 |
application(s) | pharmaceutical |
format | matrix material |
packaging | ampule of 2 × 1 g |
Quality Level | 100 ![]() |
Application: | Gas Chromatography <USP 621> pharmaceutical proficiency testing material is used in pharmaceutical analysis using gas chromatography technique. Have any questions? Explore ourFAQs ![]() 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: | Gas Chromatography 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. 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 All information regarding the use of Gas Chromatography under USP 621 proficiency testing standard 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 ![]() 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 ![]() 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: | Components supplied SAMPLES: Note: The sample designation is indicated on the individual ampule label. Glycerin Sample 1 (~1.2mL) at 0.5 g/ml in Methanol Glycerin Sample 2 (~1.2mL) at 0.5 g/ml in Methanol General Directions 1. Preparation of the Test Solutions: a. Test Solution 1 - Transfer 1.0 mL of Glycerin Sample 1 into a 10 mL volumetric flask, dilute with methanol to volume and mix to give a concentration of 50 mg/mL. b. Test Solution 2 - Transfer 1.0 mL of Glycerin Sample 2 into a 10mL volumetric flask, dilute with methanol to volume and mix to give a concentration of 50 mg/mL. 2. Perform the gas chromatography according to the Current USP Glycerin Monograph - Related Compounds or the company′s SOP for gas chromatographic analysis of Glycerin impurity analysis. 4. Identify which Glycerin Sample passes according to the Glycerin Monograph (Not more than 1.0% total impurities). Reported Data Identify which Glycerin Sample is passing according to the Glycerin Monograph for Related Compounds. (Data = 1 or 2) Calculation: x = Area counts of Glycerin y = Sum of area counts of all peaks in chromatogram (excluding peaks,due to Methanol) % = {x/y} *100 |
Storage and Stability: | Please refer to sample label for expiration date, specific storage temperature, and specific storage conditions. |
Symbol | ![]() ![]() |
Signal word | Danger |
Hazard statements | H301 + H311 + H331 - H370 |
Precautionary statements | P260 - P264 - P280 - P301 + P310 - P302 + P352 + P312 - P304 + P340 + P311 |
Hazard Codes | F,T |
Risk Statements | 11-23/24/25-39/23/24/25 |
Safety Statements | 7-16-36/37-45 |
RIDADR | UN1230 - class 3 - PG 2 - Methanol, solution |
WGK Germany | WGK 2 |
Flash Point(F) | Not applicable |
Flash Point(C) | Not applicable |
UNSPSC | 41116107 |
Components | Identification of passing Glycerin Sample (1 or 2) 0.00 - 0.00 |