Bromobutyl Rubber Bottle Stopper
Serum stoppers 13mm & 20mm
Lyo stoppers 13mm & 20mm
Infusion stoppers 28mm & 32mm
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Description
Serum stoppers 13mm & 20mm
Lyo stoppers 13mm & 20mm
Infusion stoppers 28mm & 32mm
Bromobutyl Rubber Bottle Stopper
USP <381> · EP 3.2.9 Certified
All of our proposed elastomeric formulations are fully compliant with international standards, including the USP, EP, JP, and ISO 8871. This means they meet or exceed the requirements set forth by these respected organizations for quality and safety.
As your drug delivery partner, we are committed to helping you overcome any injectable challenges you may face. We will work closely with you to understand your unique needs and create custom formulations that meet your specific requirements. Our team of experts has years of experience developing and testing elastomeric materials, so you can trust us to provide solutions that are both reliable and effective.
Bromobutyl rubber bottle stopper · low metal ion extractables · USP <381> · EP 3.2.9 · material certification
Bromobutyl Rubber
Bottle Stopper
Low Metal Ion Extractables · USP <381> / EP 3.2.9 Compliant · Material Certification
Pharmacopoeial-grade elastomer · documented extractables data · dual-standard compliant
|
Bromobutyl Elastomer base |
< 1 ppm Metal ion extractables |
USP <381> Test compliant |
EP 3.2.9 Test compliant |
CoA Lot documentation |
13/20/32mm Standard sizes |
Very low metal ion extractables - what the data shows
Metal ion extractables are a critical evaluation point for injectable and parenteral closure materials - trace metals from vulcanisation catalysts, fillers, or pigments can migrate into the contacting liquid and, at sufficient concentration, affect formulation stability or patient safety. The bromobutyl compound is formulated and tested to keep these levels far below pharmacopoeial acceptance limits.
Where metal ion extractables come from
Trace metals can originate from vulcanisation accelerators and activators (zinc oxide is a common cure activator in rubber compounding), residual catalyst from the polymerisation process, or impurities in carbon black and mineral filler additives. A well-controlled bromobutyl formulation minimises these inputs at the raw material level and verifies the resulting extractables profile through analytical testing on every production batch.
how extractables testing is performed
Metal ion extractables are quantified by extracting the stopper material under standardised conditions (typically aqueous extraction at elevated temperature for a defined period, per the relevant pharmacopoeial method) and analysing the extract using inductively coupled plasma (ICP) spectroscopy or atomic absorption spectroscopy - both capable of detecting metal concentrations at sub-ppm resolution.
USP <381> and EP 3.2.9 - what each standard requires
USP General Chapter <381> and European Pharmacopoeia 3.2.9 are the two primary pharmacopoeial standards governing rubber closures for injectable products - both addressing similar physicochemical and biological requirements through slightly different test methodologies, reflecting the US and European regulatory frameworks respectively.
USP <381>
Elastomeric Closures for Injections
United States Pharmacopeia
Covers physicochemical testing (extractable metals, ammonium content, reducing substances, pH change) and functional testing (self-sealing capacity, fragmentation) for elastomeric closures intended for use with injectable products marketed in the US.
✓ Extractable metals testing (incl. heavy metals)
✓ Self-sealing and fragmentation testing
✓ Biological reactivity (Class VI basis)
EP 3.2.9
Rubber Closures for Aqueous Parenteral Preparations
European Pharmacopoeia
Covers similar physicochemical parameters (extractable metals, pH, absorbance, reducing substances) with methodology aligned to European regulatory expectations - required for products marketed under EU and many other regions referencing the European Pharmacopoeia framework.
✓ Extractable metals testing (EU methodology)
✓ Penetrability and fragmentation testing
✓ Aligned to EU regulatory expectations
Why dual-standard compliance matters
If your product is marketed in both the US and EU (or other markets that reference either pharmacopoeia), a stopper compliant with both USP <381> and EP 3.2.9 from a single formulation avoids the need to source or qualify two different elastomer compounds for different markets. This bromobutyl formulation is tested and documented against both standards concurrently.
Material Certification - what's included in the documentation pack
Material certification for the bromobutyl rubber bottle stopper covers the full chain of evidence supporting its suitability for pharmaceutical use - from raw material traceability through finished-product test results.
COA
Certificate of Analysis - per lot
Lot-specific test results
Each production lot is issued a Certificate of Analysis reporting the specific test results for that batch - dimensional measurements, hardness (Shore A), and the extractables data points relevant to USP <381> / EP 3.2.9. Not a generic specification sheet - actual measured values for the lot you receive.
DMF
Drug Master File reference (where applicable)
Regulatory submission support
For customers requiring regulatory submission support, a Drug Master File (DMF) reference or equivalent regulatory support letter can confirm the material's qualification status and provide the documentation chain needed for your own product's marketing authorisation submission.
E & L
Extractables & Leachables study summary
Full chemical characterisation
Beyond metal ions, a full extractables and leachables (E&L) study summary covers organic extractables, residual monomers, and other chemical species - providing the complete chemical characterisation basis for formulation compatibility risk assessment.
Request the documentation package that matches your regulatory pathway
Not every customer needs every document - a research lab may need only a basic CoA, while a regulatory submission for a new drug application may need the full E&L study and DMF reference. Tell us your intended use and regulatory pathway, and we will supply the appropriate documentation tier rather than a one-size-fits-all package.
Bromobutyl bottle stopper - full specification reference
Reference specifications for the bromobutyl rubber bottle stopper, including extractables and standards compliance data.
| Parameter | Specification |
|---|---|
| Material composition | |
| Elastomer base | Bromobutyl rubber ★ |
| Hardness | 40–55 Shore A typical |
| Compounding | Low-extractable formulation |
| Extractables data | |
| Zinc (Zn) | ~0.4 ppm (illustrative) |
| Lead (Pb) | < 0.05 ppm (illustrative) |
| Cadmium (Cd) | < 0.03 ppm (illustrative) |
| Test method | ICP / AAS, per pharmacopoeial protocol |
| Standards compliance | |
| US standard | USP <381> ★ compliant |
| EU standard | EP 3.2.9 ★ compliant |
| Biocompatibility | USP Plastics Class VI basis |
| Documentation & ordering | |
| Lot documentation | Certificate of Analysis per lot |
| Extended documentation | E&L summary, DMF reference available |
| Standard sizes | 13mm · 20mm · 32mm |
| Sample available | Yes - request free sample |
who orders this stopper
Bromobutyl bottle stoppers - across the pharmaceutical supply chain
The bromobutyl rubber bottle stopper with documented low extractables and dual-standard compliance is specified wherever regulatory documentation rigour is a priority.
Pharmaceutical manufacturers
Multi-market · US + EU submission
Manufacturers submitting products in both US and EU markets - using a single dual-standard-compliant stopper formulation to simplify their regulatory documentation across both jurisdictions.
Generic drug manufacturers
ANDA / abbreviated submission support
Generic pharmaceutical manufacturers requiring well-documented packaging component data to support abbreviated regulatory submissions referencing established material certifications.
Biotech & clinical supply
IMP · regulatory dossier support
Biotech clinical supply teams compiling packaging component sections of investigational new drug (IND) or clinical trial application (CTA) dossiers - needing full extractables and standards compliance documentation.
CDMOs & fill-finish
Multi-client regulatory documentation
Contract fill-finish organisations supporting multiple clients with different regulatory pathways - using one well-documented stopper formulation to simplify component qualification across client portfolios.
Quality assurance & regulatory affairs teams
Supplier qualification · audit readiness
QA and regulatory affairs teams conducting supplier qualification audits - requiring complete, audit-ready documentation packages covering material certification, extractables data, and standards compliance.
Packaging component distributors
B2B · documented inventory
Pharmaceutical component distributors stocking well-documented bromobutyl stoppers, able to supply Certificates of Analysis and compliance documentation alongside every order.
Documented. Dual-Certified.
Bromobutyl, properly characterised.
Request a free sample of the bromobutyl rubber bottle stopper - with full metal ion extractables data and USP <381> / EP 3.2.9 compliance documentation. We confirm material certification package to match your regulatory pathway within 48 hours.
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