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Songshan Enterprise Group
[China]
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Sanlizhuang High & New Tech. Zone, Dengfeng Zhengzhou Henan 452483 China
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86-371-62768046
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Yang Xuehao , Imp & Exp Manager
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Songshan Enterprise Group
 
Butyl Rubber Stoppers (Pharma-Closures)

Chemical Requirements
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Chemical Requirements
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1. the chemical requirements of closure for injection vials:
Volatile sulphides(calculated as the rubber surface -
Na2S/20cm2) ?50?g;
Ultraviolet absorbance (220nm-360nm) ?0.2;
Reducing matter (Count of 1/5KMnO4 =0.01mol/L per 20 ml
extracting solution) ?7.0ml;
Conductivity ?4.0ms/m;
Turbidity ?3class;
Acidity/alkalinity ?1.0;
Heavy metals (calculated as the Pb2+) ?1.0mg/L;
Ammonia (calculated as the NH4+) ?2.0mg/L;
Zinc (calculated as the Zn2+) ?3.0mg/L;
non-volatile matter (Per 100 ml extracting solution) ?
4.0mg.
2. the chemical requirements of closure for infusion
bottles:
Volatile sulphides(calculated as the rubber surface -
Na2S/20cm2) ?50?g;
Ultraviolet absorbance (220nm-360nm) ?0.1;
Reducing matter (Count of 1/5KMnO4 =0.01mol/L per 20 ml
extracting solution) ?3.0ml;
Conductivity ?4.0ms/m;
Turbidity ?2class;
Acidity/alkalinity ?1.0;
Heavy metals (calculated as the Pb2+) ?1.0mg/L;
Ammonia (calculated as the NH4+) ?2.0mg/L;
Zinc (calculated as the Zn2+) ?3.0mg/L;
non-volatile matter (Per 100 ml extracting solution) ?
4.0mg.

Related Keywords: butyl stopper


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