PE5001

Heavy Metals in Pharmaceutical Raw Material

proficiency testing material

Properties

• Quality Level: 100
• form: solid
• packaging: pack of 1 × 2 g
• application(s): pharmaceutical

Description

General description

Heavy Metals in Pharmaceuticals Raw Material 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 Heavy Metals in Pharmaceuticals Raw Material proficiency testing standard can be found in the reporting packet which will be available to download at PT Portal.

Application

Heavy Metals in Pharmaceuticals Raw Material pharmaceutical proficiency testing material is used in the pharmaceutical analysis for the detection of Heavy metals including Cadmium, Lead, Arsenic and Mercury.

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

Description

• The sample contains Cd, Pb, As and Hg in different concentration levels
• Each unit PE5001 consists of 2 G of solid material.
• The matrix material is Nicotinic acid.
• The sample can be stored at room temperature.
• The number of samples analyzed and the number of repetitions per sample are defined by the user.
• Please refer to the Safety Data Sheet for detailed information about the nature of any hazard and appropriate precautions to be taken.

Sample preparation

• Please be aware that the sample might react strongly when treated with acids, e.g. for sample preparation. Respective safety precautions need to be applied.
• Te sample needs pretreatment. This could be either a dissolution in a suitable solvent, a digestion oranother suitable method. The pretreatment needs to be evaluated by the user.
• The determination should be done using appropriate procedures and suitable for the intended purpose. Please refer to ICH Q3D for further information.
• Use your standard sample preparation procedure.
• After pretreatment, perform ICP or any other suitable elemental analysis to determine the levels of Cd, Pb, As and Hg present in the sample.

Measurement

• Use your standard instrument parameters for measurements.
• It is recommended to match the matrices of calibration and sample solutions.

Analysis
Data Processing and Integration:

• Use your standard processing procedure for your elemental analysis.
• The results should be reported as mg/kg in the Proficiency Testing Portal.

Item Analyte Ranges

• 0.1-1 mg/kg for Cd
• 0.1-1 mg/kg for Pb
• 0.1-3 mg/kg for As
• 0.1-3 mg/kg for Hg

Storage and Stability

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

Analysis Note

Proficiency Test containing one matrix material sample for the measurement of Cd, Pb, As and Hg.
Concentration ranges:
0.1-1.0 mg/kg for Cd, Pb
0.1-3.0 mg/kg for As, Hg

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

Pharma
PHARM22-2 April 6 - May 20, 2022

Legal Information

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

Safety Information

• Pictograms: GHS05,GHS08
• Signal Word: Danger
• Hazard Statements: H290 - H315 - H319 - H340 - H350 - H373 - H412
• Precautionary Statements: P202 - P234 - P273 - P302 + P352 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Aquatic Chronic 3 - Carc. 1B - Eye Irrit. 2 - Met. Corr. 1 - Muta. 1B - Skin Irrit. 2 - STOT RE 2
• Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable