European Pharmacopoeia Testing

The EU Pharmacopoeia (EP) provides standardized methods and specifications for generic pharmaceutical raw material and finished products.

EU regulatory guidance for pharmaceuticals.

The purpose of the tests is analyzing for relative differences in visual appearance, acidity/ alkalinity, reducing substances, relative density, volatile matter, mineral oil, substances soluble in hexane, phenylated compounds, optical absorbance additives, and extractable heavy metals.

3.1 Series; Materials used in the Manufacture of Pharmaceutical Containers

The materials described in this monograph are used for the manufacture of containers for pharmaceutical use. Their use may also be considered for the manufacture of part or all of objects used in medico-surgical purposes.

Testing Capabilities and Specifications

Test NameSample NeededTurn-Around Time
3.1.1.1 Materials Based on Plasticized Poly(Vinyl Chloride) for Containers for Human Blood and Blood Components50 gApproximate turnaround time is based upon study specific parameters.
3.1.1.2 Materials Based on Plasticized Poly(Vinyl Chloride) for Tubing Used in Sets for the Transfusion of 50 gApproximate turnaround time is based upon study specific parameters.
3.1.3 Polyolefins200gApproximate turnaround time is based upon study specific parameters.
3.1.4 Polyethylene without Additives for Containers for Parenteral Preparations and Ophthalmic Preparations200gApproximate turnaround time is based upon study specific parameters.
3.1.5 Polyethylene with Additives for Containers for Parenteral Preparations and Ophthalmic Preparations200gApproximate turnaround time is based upon study specific parameters.
3.1.6 Polypropylene for Containers and Closures for Ophthalmic Preparations200gApproximate turnaround time is based upon study specific parameters.
3.1.9 Silicone Elastomer for Closures and Tubing50gApproximate turnaround time is based upon study specific parameters.
3.1.14 Materials Based on Plasticized Poly(Vinyl Chloride) for Containers for Aqueous Solutions for Intravenous Infusion40gApproximate turnaround time is based upon study specific parameters.
3.1.15 Polyethylene Terephthalate for Containers not for Parenteral Use75gApproximate turnaround time is based upon study specific parameters.

3.2 Series; Containers

A container for pharmaceutical use is an article that contains or is intend to contain a product and is, or may be, in direct contact with it. The closure is part of the container.

Testing Capabilities and Specifications

Test NameSample NeededTurn-Around Time
3.2.2.1 Plastic Containers for Aqueous Solutions for Infusion
Sample needed depended on nominal volume of container
Approximate turnaround time is based upon study specific parameters
3.2.3 Sterile Plastic Containers for Human Blood & Blood Components
Sample needed depended on nominal volume of container
Approximate turnaround time is based upon study specific parameters
3.2.4 Empty Sterile Containers of Plasticized Poly(Vinyl Chloride) for Human Blood and Blood Components
Sample needed depended on nominal volume of container
Approximate turnaround time is based upon study specific parameters

3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders

Sample needed depended on nominal volume of container
Approximate turnaround time is based upon study specific parameters