PEP015

Supelco

HPLC <621> PT

Proficiency Testing Material

EC Number:
NACRES:
NA.24

Quality Level

Agency/Method

suitable for USP 621

packaging

ampule of 2 × 1 g

Featured Industry

Pharmaceutical

format

matrix material

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.

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

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.

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 (2021-2022)


Pharma
PHARM21-4 October 6 - November 19, 2021

PHARM22-2 April 6 - May 20, 2022

Legal Information

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

Analyte

Description

    Identification of Passing Caffeine Sample (1 or 2) 0.00 - 0.00

pictograms

Exclamation mark

signalword

Warning

hcodes

hazcat

Acute Tox. 4 Oral

storage_class_code

13 - Non Combustible Solids

WGK Germany

WGK 1

Flash Point F

Not applicable

Flash Point C

Not applicable

Certificate of Analysis

Certificate of Origin

  1. Which document(s) contains shelf-life or expiration date information for a given product?

    If available for a given product, the recommended re-test date or the expiration date can be found on the Certificate of Analysis.

  2. How do I get lot-specific information or a Certificate of Analysis?

    The lot specific COA document can be found by entering the lot number above under the "Documents" section.

  3. How do I find price and availability?

    There are several ways to find pricing and availability for our products. Once you log onto our website, you will find the price and availability displayed on the product detail page. You can contact any of our Customer Sales and Service offices to receive a quote.  USA customers:  1-800-325-3010 or view local office numbers.

  4. What is the Department of Transportation shipping information for this product?

    Transportation information can be found in Section 14 of the product's (M)SDS.To access the shipping information for this material, use the link on the product detail page for the product. 

  5. Are Certificates of Analysis created for  RTC proficiency testing products?

    Certificates of Analysis are not available for RTC proficiency testing products. Those are the samples with the SPE or PE prefix in the part number.

  6. My question is not addressed here, how can I contact Technical Service for assistance?

    Ask a Scientist here.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service