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Glass Ampoules (USP Type I)

Open ampoules, one-point-cut ampoules, colour-break ampoules · CAS —

Packaging USP Type I / EP Type I, hydrolytic class I CoA per lotSDSExtractables study summary

Sealed glass with no elastomer and no aluminium, which is why ampoules still dominate small-volume injectables in cost-sensitive markets. Supplied cut and colour-break, with dimensional and hydrolytic resistance data per lot.

Primary packaging in glass. Supplied against the pharmacopoeial hydrolytic-resistance class, with dimensional data per lot because it drives the filling line.

Identity

Catalogue no.BP-PKG-006
HS code7010.90
SynonymsOpen ampoules, one-point-cut ampoules, colour-break ampoules
Product linePharmaceutical Packaging
CategoryGlass Containers

Release specification

Catalogue standard below. For a supply agreement we release against your dossier specification; send it with the enquiry and the CoA will be built around it.

ParameterSpecification
Hydrolytic resistanceUSP <660> / EP 3.2.1, class I
Dimensional tolerancePer DIN ISO 9187
Fill volume range1–20 mL

Application

Small-volume injectables, ophthalmics and inhalation solutions filled on ampoule lines.

Packaging, storage & logistics

Standard packagingShrink-wrapped nest-and-tub, 100–300 pcs per carton
Minimum order20 000 pcs
Lead time20–30 days
Storage conditionsStore at 15–30 °C, low humidity, away from pressure
Shipping documentsInvoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable

Pack sizes available — pick one to prefill the enquiry

Documentation provided

  • CoA per lotLot-specific, with the test methods cited
  • SDSCurrent GHS revision; destination-language version on request
  • Extractables study summaryContainer-closure extractables data supporting your CMC section

Need the DMF open part, a sample CoA or an audit pack before you can qualify us? Ask on the enquiry form — we send those documents before any commercial discussion.

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