PEP019

Residual Solvents Class IIA PT

Proficiency Testing Material

• NACRES: NA.24

Properties

• Quality Level: 100
• packaging: ampule of 1 g
• suitability: suitable for (suitable for 467 per USP)
• application(s): pharmaceutical
• format: matrix material

Description

General description

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

Application

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

Preparation Note

General Instructions
1. Standard Preparation

• Add about 50 mL of water to a 100 mL volumetric flask and accurately transfer 1.0 mL of Residual Solvent Class IIA Standard to the flask, keeping the tip of the pipet below the water. Dilute to volume with water. This represents the Standard Solution.
• 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.

2. Sample Preparation

• Add about 10 mL of water to a 25 mL volumetric flask and accurately transfer 1.0 mL of Residual Solvent Class IIA Sample to the flask, keeping the tip of the pipet below the water. Dilute to volume with water. This represents the PT Sample.
• Add 5.0 mL of water to an appropriate headspace vial and accurately add 1.0 mL of the PT Sample.

Analysis Procedure

• Perform the Gas Chromatography from USP general chapter <467> for Procedure A, or by using an in-house validated method for residual solvent analysis.
• Calculate and report the amount of each residual solvent that is found in the Residual Solvent Class IIA PT Sample.

Reported Data
The concentration of each residual solvent present in Residual Solvents Class IIA PT Sample (Data=Numeric)

Calculations

• 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 IIA PT Concentration = C*(Rsa/Rst)

Note: 1 ampule of product PHR1064 (Residual Solvents Mixture - Class IIA) is being supplied as the standard for this proficiency test. The COA for this material can be downloaded at sigmaaldrich.com using the lot number that you receive.

Storage and Stability

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

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.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 (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)

Legal Information

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

Analyte

Chlorobenzene .0001-720 ppm
Cyclohexane .0001-7000 ppm
1,4-Dioxane (1,4- Diethyleneoxide) .0001-760 ppm
Ethylbenzene .0001-740 ppm
Methanol .0001-6000 ppm
Methylcyclohexane .0001-2500 ppm
Methylene chloride (Dichloromethane) .0001-1200 ppm
Tetrahydrofuran (THF) .0001-1500 ppm
Toluene .0001-2000 ppm
o-Xylene .0001-2000 ppm
1,2-Dichloroethylene, total .0001-3000 ppm
m+p-Xylene .0001-3000 ppm
Acetonitrile .00001-820 ppm
See All (13)

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1