Residual Solvents Class 2 According to Ph. Eur. Version 10

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88217.001EA 167 GBP
88217.001 88219.001 88216.001 88218.001
Residual Solvents Class 2 According to Ph. Eur. Version 10
Standards Organic Standards
The level of volatile organic solvents in pharmaceutical raw materials or finished product is defined and monitored. Residual solvents are classified according to their risk assessment classes. A selection of residual solvent standards is now available from VWR.

Residual Solvents Class 2 acc to Ph Eur Ver 10 Mix A: 14 components; chlorobenzene 360 ug/ml; cyclohexane 3880 ug/ml; cis-1,2-dichloroethene 1870 ug/ml; dichloromethane 600 ug/ml; ethylbenzene 369 ug/ml; n-hexane 290 ug/ml; methylcyclohexane 1180 ug/ml; dimethylformamide (N,N - dimethylformamide) 880 ug/ml; toluene 890 ug/ml; trichloroethene (1,1,2-trichloroethene) 80 ug/ml; m-xylene 1302 ug/ml; o-xylene 195 ug/ml; p-xylene 304 ug/ml; tetrahydrofuran 720 ug/ml in dimethylsulphoxide.

Residual Solvents Class 2 acc. to Ph Eur Ver 10 Mix B: 11 components; acetonitrile 410 mg/L; chloroform 60 mg/L; 1,2-dimethoxyethane 100 mg/L; N,N-dimethylacetamide 1090 mg/L; dioxan 380 mg/L; 2-hexanone 50 mg/L; methanol 3000 mg/L; nitromethane 50 mg/L; pyridine 200 mg/L; 1,2,3,4-tetrahydronaphthalene 100 mg/L; isopropylbenzene (cumene) 70 mg/L in dimethylsulphoxide / water (9/1).

Residual Solvents Class 2 acc. to Ph Eur Ver 10 Mix C: 7 components; ethyleneglycol-monoethyl ether (2-Ethoxyethanol) 160 mg/L; ethylene glycol 620 mg/L; formamide 220 mg/L; ethyleneglycol-monomethyl ether (2-methoxyethanol) 50 mg/L; 1-methyl-2-pyrrolidon (N-methyl pyrrolidone) 530 mg/L; sulfolan 160 mg/L; 4-methyl-2-pentanone 4500 mg/L in water.

Residual Solvents Class 2 acc to Ph Eur 8.8 MIX C: 6 components ethyleneglycol-monoethyl ether (2-ethoxyethanol)160 mg/L; ethyleneglycol 620 mg/L; formamide 220 mg/L; ethyleneglycol-monomethyl ether (2-methoxyethanol) 50 mg/L; 1-methyl-2-pyrrolidone 4840 mg/L; sulfolan 160 mg/L in water.

Certifications: All Solutions are Certified Reference Materials, produced and calibrated under a quality system that is:
- ISO 9001 certified.
- accredited according to ISO/IEC 17025 - Testing
- accredited according to ISO 17034 - Reference Material Producer
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