PHR1065

Residual Solvents Mixture - Class IIB

Pharmaceutical Secondary Standard; Certified Reference Material

• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: suitable for USP 467; traceable to USP 1601292
• CofA: current certificate can be downloaded
• application(s): environmental; pharmaceutical (small molecule)
• format: multi-component solution
• storage temp.: 2-30°C

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Sigma-Aldrich offers Fluka brand Certified Reference Materials (CRMs) for the analysis of Residual Solvents. These CRMs are Secondary Pharmaceutical Reference Standards and are traceable and qualified against the corresponding Pharmacopeial standards. A comprehensive Certificate of Analysis offers details of the methodology and results of the qualification.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3700 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analyte

Chloroform 60 μg/mL
1,2-Dimethoxyethane 100 μg/mL
Hexane 290 μg/mL
3-Methyl-2-pentanone 50 μg/mL
Nitromethane 50 μg/mL
Pyridine 200 μg/mL
Tetralin 100 μg/mL
Trichloroethylene 80 μg/mL
See All (8)

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point(F): 188.6 °F
• Flash Point(C): 87 °C