Residual Solvents Class 1 PT

NA.24

Residual Solvents Class 1 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.

Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacturing of drug substances, excipients, or dietary ingredients, or in the preparation of drug products or dietary supplement products.

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 Residual Solvents Class 1 proficiency testing standard can be found in the reporting packet which will be available to download at PT Portal.

Residual Solvents Class 1 as a proficiency testing material is used to determine the amounts of residual solvents in pharmaceutical drug products.

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For more information on this product, please contact our PT Service Team.

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

Perform the Gas Chromatography from USP general chapter <467> for Procedure A, or by using an in-house validated method for residual solvent analysis.
General Directions
Standard Preparation
a. Transfer 1.0 mL of Residual Solvent Class I Standard to a 100-mL volumetric flask containing about 9 mL of dimethylsulfoxide, keeping the tip of the pipet below the surface of the dimethylsulfoxide. Dilute with water (dimethylsulfoxide or dimethylformamide are also suitable) to volume, and mix.
b. Add 5 mL of water to an appropriate headspace vial and accurately add 1.0 mL of Standard Solution, apply the stopper, cap, and mix.

Sample Preparation
a. Transfer 1.0 mL of Residual Solvent Class I Standard to a 25-mL volumetric flask containing about 9 mL of dimethylsulfoxide, keeping the tip of the pipet below the surface of the dimethylsulfoxide. Dilute with water (dimethylsulfoxide or dimethylformamide are also suitable) to volume, and mix.
b. Add 5.0 mL of water to an appropriate headspace vial and accurately add 1.0 mL of the PT Sample.

Reported Data
Concentration of each residual solvent present in Residual Solvents Class I PT Sample (Data=Numeric)

Calculation
C = concentration of individual residual solvent from Standard Solution Rst = Area of the individual peak from Standard Solution Rsa = Area of the individual peak from Sample Solution Class I PT Concentration = C*(Rsa/Rst)

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.com.

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 (2021-2022)

Pharma
PHARM21-4 October 6 - November 19, 2021

PHARM22-2 April 6 - May 20, 2022

Supelco is a registered trademark of Merck KGaA, Darmstadt, Germany

100

ampule of 1 g

suitable for (suitable for 467 per USP)

pharmaceutical

matrix material

Please refer to sample label for expiration date, specific storage temperature, and specific storage conditions.

GHS08

Danger

H340 - H350 - H373

P202 - P260 - P280 - P308 + P313 - P405 - P501

Carc. 1A - Muta. 1B - STOT RE 2

Blood

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK 3

188.6 °F - closed cup

87 ℃ - closed cup