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For regulated dosage forms
Pharmaceutical grade nicotine for NRT
Monograph grade material for gums, lozenges, patches, oral sprays and pouches, supplied with the documentation a filing and an audit will ask for.
- GradeUSP / EP reference
- Assay99.9% min
- Dossier supportOn request
- AuditCustomer audits welcome
Built for the dossier
The material is half of it. The file is the other half
An NRT programme does not stall because nicotine is hard to find. It stalls because a supplier cannot produce a method of analysis, a stability summary or a change control commitment when the regulator asks for them.
Documentation we support
Batch certificate of analysis, method of analysis, specification sheet, MSDS, stability data summary, elemental impurity and residual solvent statements, TSE/BSE and allergen declarations, and regulatory support documents on request. If you require a drug master file reference for your market, raise it at enquiry stage so we can confirm what we hold before you plan around it.
Change control
Material used in a registered dosage form cannot quietly change. We will agree written notification of changes to specification, process or packing that could affect a registered product.
Dosage forms this grade goes into
Nicotine gums and lozenges, transdermal patches, oral and nasal sprays, inhalers, oral pouches and pharmaceutical research formulations.
Purity and specification
Monograph grade specification
Tell us the monograph and the market you are filing into, and we will confirm the parameters and documents we can support before you sample.
| Parameter | Method | Specification |
|---|---|---|
| Assay, nicotine | GC | 99.9% min |
| Identification | IR / GC | Conforms to reference standard |
| Appearance | Visual | Clear, colourless to pale yellow oily liquid |
| Specific optical rotation | Polarimetry | Within monograph range |
| Refractive index | Refractometry | Within monograph range |
| Related alkaloids | GC / HPLC | Within monograph limit |
| Water content | Karl Fischer | Within monograph limit |
| Elemental impurities | ICP-MS | Within ICH Q3D limits |
| Residual solvents | GC headspace | Within ICH Q3C limits |
| Microbial limits | Pharmacopoeial method | Conforms, where applicable |
Packaging, storage and documents
How it is packed, stored and documented
Packaging
- Amber glass bottles100 g, 500 g and 1 kg, induction sealed
- HDPE / fluorinated drums5 kg, 10 kg and 25 kg
- Stainless steel drums50 kg and 200 kg for bulk offtake
- Inert headspaceNitrogen blanketed and sealed at filling
- LabellingBatch number, manufacturing and retest date, UN hazard labels
- Export packingUN certified outer packing with dangerous goods declaration
Storage and shelf life
- TemperatureCool, dry store, away from direct sunlight and heat
- LightKeep in original light protected packing
- AtmosphereReseal under nitrogen after sampling to limit oxidation
- QuarantineHold in quarantine until your own incoming release
- SegregationStore away from oxidising agents, acids and foodstuffs
- Retest period24 months from manufacture in unopened original packing
Documentation with every batch
- Certificate of analysisBatch specific, issued with every despatch
- Method of analysisShared under confidentiality for incoming testing
- Stability summarySupporting the stated retest period
- Material safety data sheetGHS format, 16 section MSDS
- DeclarationsTSE/BSE, allergen, non GMO, elemental impurity and solvent statements
- Regulatory supportDossier documents and DMF reference discussed at enquiry stage
Ordering
Minimum order, samples and lead time
Pharmaceutical programmes start with a qualification sample and a documentation review, usually under a confidentiality agreement, before any commercial commitment.
Send your requirement
Grade, quantity, destination market and intended application, with your company details.
Compliance check
We verify licence, import permit and end use, then share the specification sheet, MSDS and a recent CoA.
Sample despatch
A qualification sample is packed and shipped under dangerous goods rules with full paperwork.
Qualification and order
You test against your own method, we confirm price, batch size and despatch schedule.
Buyer questions
Frequently asked
Can you supply nicotine to USP or EP monograph requirements?
Yes. Confirm the monograph and the destination market at enquiry stage and we will set out the parameters and supporting documents we can provide.
What regulatory documentation is available for a filing?
Certificate of analysis, method of analysis, specification, stability summary, MSDS and the standard declarations. Drug master file support is discussed case by case for your market.
Will you notify us before changing the specification or process?
Yes. For registered products we agree written change notification so your regulatory team is never surprised by a change to material in a filed dosage form.
Do you accept customer audits?
Yes. Quality audits by customers and their appointed auditors can be arranged by appointment.
Derived from nature, delivered to the world
Start with a documentation review
Send your monograph, dosage form, destination market and projected volume, and we will come back with documents, sample terms and pricing.
Request COA & price Email info@mccoynic.com Contact us
Business to business supply only. Nicotine is a regulated substance and is toxic in concentrated form. We supply licensed manufacturers, formulators and research institutions against verified end use, valid import permits and applicable local law. We do not sell to individuals or for consumer use, and we do not provide production methods.