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ISO FDIS 11418-3

M00020318

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ISO FDIS 11418-3 2016 Edition, August 19, 2016 CONTAINERS AND ACCESSORIES FOR PHARMACEUTICAL PREPARATIONS - PART 3: SCREW-NECK GLASS BOTTLES (VERAL) FOR SOLID AND LIQUID DOSAGE FORMS

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Description / Abstract: This document specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug.

This document is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.