PHR1063

Residual Solvents Mixture - Class I

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Organic Volatile Impurities Class I Mix
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: suitable for USP 467; traceable to Ph. Eur. R0250000; traceable to USP 1601102
• CofA: current certificate can be downloaded
• concentration: in DMSO
• 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. Residual Solvents Mixture - Class I are CRMs and Secondary Pharmaceutical Reference Standards, traceable and qualified against the corresponding Pharmacopeial standards. Sigma-Aldrich offers Certified Reference Materials (CRMs) for the analysis of Residual Solvents. 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 LRAC0266 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analyte

Benzene 11 mg/mL
Carbon tetrachloride 20 mg/mL
1,2-Dichloroethane 27 mg/mL
1,1-Dichloroethene 25 mg/mL
1,1,1-Trichloroethane 50 mg/mL

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H317,H340,H350,H372,H373,H420
• Precautionary Statements: P202 - P260 - P280 - P302 + P352 - P308 + P313 - P502
• Hazard Classifications: Carc. 1A - Muta. 1B - Ozone 1 - Skin Sens. 1 - STOT RE 1 - STOT RE 2 Inhalation
• Target Organs: Liver,Kidney, Nose,Liver,Kidney
• WGK: WGK 3
• Flash Point(F): 197.6 °F
• Flash Point(C): 92 °C