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Procurement dossier · Pharmaceutical & industrial alkaloids

Nicotine, (S)-(−)-

Assay 99.9% min · liquid alkaloid · grade designation

CAS number
54-11-5
EC number
200-193-3
Molecular formula
C₁₀H₁₄N₂
Molecular weight
162.23 g/mol
UN number
UN 1654
HS code
2939.79 — confirm
Acutely toxic material — restricted supply

Pure nicotine is fatal in small quantities by the oral, dermal and inhalation routes, and is absorbed rapidly through intact skin. It ships as UN 1654, Class 6.1, Packing Group II. McCoy supplies this material business-to-business only, against a completed end-use declaration, and will not quote to private individuals or to buyers who cannot evidence appropriate handling facilities and local authorisation.

01Identity and description

The offered material is levorotatory nicotine — (S)-3-(1-methylpyrrolidin-2-yl)pyridine — the naturally occurring enantiomer used in nicotine replacement products and in regulated nicotine formulations. Racemic and (R)-enriched material is a different article and is not covered by this dossier.

Article identification
Chemical name(S)-3-(1-Methylpyrrolidin-2-yl)pyridine
SynonymsNicotine; L-nicotine; (−)-nicotine; β-pyridyl-α-N-methylpyrrolidine
CAS / EC54-11-5 / 200-193-3
Formula / MWC₁₀H₁₄N₂ / 162.23
AppearanceColourless to pale yellow oily liquid; darkens on exposure to air and light
OdourCharacteristic, pungent
SolubilityMiscible with water below 60 °C; freely soluble in ethanol, chloroform, ether
Boiling point246–247 °C (decomposes)
Flash pointper issued SDS §9
HygroscopicityHygroscopic

02Specification

The table below is McCoy's offered commercial specification. Note the distinction buyers should carry into their own incoming-goods spec: the pharmacopoeial assay window for nicotine is 99.0–101.0%, while the 99.9% figure in this listing is a tighter commercial minimum. Where a buyer requires release against a named monograph, the monograph limits govern and the edition in force at the date of manufacture is stated on the COA.

Offered specification — release parameters
ParameterLimitMethod
DescriptionColourless to pale yellow oily liquidVisual
Identification AIR spectrum conforms to referenceFTIR
Identification BRetention time conforms to referenceGC
Assay (anhydrous basis)99.9% minGC, area normalisation or titrimetric — state
Specific optical rotation−169° to −164°Polarimetry state solvent & conc.
Refractive index, nD201.5240–1.5280Refractometry
Relative density, 20 °C1.005–1.015Densitometry
Water content0.5% maxKarl Fischer
Sulphated ash / residue on ignition0.1% maxGravimetric
Total related substancesSee §03GC / GC-MS
Elemental impuritiesPer ICH Q3D, option appliedICP-MS
Residual solventsPer ICH Q3C, Class 2 solvents usedGC headspace
Microbial limitsapplicable? state limitsUSP <61> / <62>
Retest / shelf lifemonths, on stability dataStability study

Do not publish a monograph compliance statement (USP / EP / BP / JP) on this page until the corresponding release testing and monograph-edition reference exist in McCoy's own batch records. Where material is compendial, replace the placeholder above with the monograph name and edition; where it is not, list it as a technical grade against this in-house specification.

03Impurity profile

Nicotine from tobacco carries a characteristic set of minor alkaloids, and buyers formulating for inhalation or oral delivery generally specify these individually rather than accepting a single "total impurities" figure. Two families matter and they are controlled separately.

Related alkaloids and degradation products

Organic impurities — quantified by GC or GC-MS
ImpurityOriginLimit
NornicotineCo-extracted alkaloidlimit
AnabasineCo-extracted alkaloidlimit
AnatabineCo-extracted alkaloidlimit
MyosmineCo-extracted alkaloidlimit
β-NicotyrineOxidative degradationlimit
CotinineOxidative degradationlimit
Nicotine N-oxideOxidative degradationlimit
(R)-nicotine (enantiomeric)Racemisation / synthetic routelimit
Any unspecified impurity—limit
Total related substances—limit

Impurity limits are left open deliberately. Publishing them requires method-validated data on at least three consecutive production batches; McCoy should insert its own validated limits here, or state the applicable monograph limits if release is compendial.

Tobacco-specific nitrosamines

For tobacco-derived nicotine, TSNA content is usually the deciding factor in qualification and is reported at ppb level. McCoy reports the four analytes below on every COA where the material is tobacco-derived.

TSNA panel — LC-MS/MS
AnalyteAbbrev.Limit
N-NitrosonornicotineNNNppb limit
4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanoneNNKppb limit
N-NitrosoanatabineNATppb limit
N-NitrosoanabasineNABppb limit
Total TSNA—ppb limit

Where the material is synthetic rather than tobacco-derived, TSNAs are not expected and the COA should say so explicitly with the supporting absence-of-source justification, rather than omitting the panel.

04Certificate of analysis — format

Below is the COA structure McCoy issues per batch. It is shown as a blank format, not as a specimen with results: a sample COA carrying invented batch numbers and invented results is worse than none, because buyers audit against it. A completed COA for a real batch is released with the sample shipment and again on despatch.

COA header fields issued per batch
Product name & gradeNicotine (S)-(−)-, grade
Batch / lot numberbatch no.
Batch sizekg
Date of manufacturedate
Retest / expiry datedate
Manufacturing sitesite name & address
Specification referencespec no. & version
Monograph & edition (if compendial)e.g. Ph. Eur. monograph, edition
Source of nicotineTobacco-derived / synthetic — state
Results blockEvery parameter in §02 and §03, with limit, method, and measured result
Release statement & signatoryQA authorised person, name & designation

A redacted COA from a recent commercial batch — batch number and customer references removed, results intact — is available on request once the end-use declaration is on file.

05Documentation package

These documents are issued against a signed enquiry. Items marked as pending should not be advertised until the underlying certificate exists and is current.

Safety data sheet (SDS)
16-section format to GHS / Regulation (EC) 1907/2006 Annex II. Supplied in English; other languages list.
On enquiry
Technical data sheet (TDS)
Physical constants, specification, handling summary, compatibility.
On enquiry
Certificate of analysis
Batch-specific, per §04. Issued with sample and with each despatch.
Per batch
Certificate of origin
Chamber-of-commerce attested; preferential certificates subject to destination.
Per shipment
Analytical method summaries
Method descriptions for assay, related substances and TSNA. Full validation reports under NDA.
Under NDA
Stability data
Supporting the stated retest period.
available?
Quality system certification
Insert only what McCoy or the named manufacturer currently holds, with certificate number, issuing body, scope and expiry.
pending
Regulatory support file
Drug master file, CEP, or equivalent, where the manufacturer maintains one.
pending
Declarations
Allergen, GMO, BSE/TSE, melamine, residual solvent and elemental impurity statements as applicable.
On enquiry

Certification claims on this page must map one-to-one to a certificate McCoy can produce on the day a buyer asks. If a certificate is held by the manufacturer and not by McCoy, say so and name the holder — buyers verify, and an unsupported claim ends a qualification faster than an absent one.

06Packaging

Nicotine oxidises and darkens on contact with air and light, so all pack sizes are filled under inert gas in light-excluding containers and sealed for single opening. Containers are UN-marked to the requirements of Class 6.1 Packing Group II.

Standard pack configurations
PackContainerClosure / overpack
sizeAmber glass bottleNitrogen headspace, tamper-evident seal, cushioned outer
sizeFluorinated HDPE bottleNitrogen headspace, induction seal
sizeHDPE-lined steel drumNitrogen blanket, ring closure
sizeStainless steel drumNitrogen blanket, valved closure

Every container is labelled with product name, CAS, batch number, net weight, manufacture and retest dates, GHS pictograms and signal word, UN 1654 hazard diamond and PG II marking, and the supplier emergency contact. Sample packs carry the same labelling as commercial packs.

07Minimum order, lead time and terms

Commercial terms
Sample quantityg/ml — free of charge or at cost, state; freight and hazardous-goods surcharge at buyer's account
Minimum order quantitykg
Order incrementkg
Lead time, stock materialdays from cleared documentation
Lead time, campaign materialweeks
Incoterms offerede.g. EXW / FCA / CIF — state 2020 or 2010 edition
Payment termsterms
Quotation validitydays
Annual supply capabilityMT/year — only if contractually securable

Lead time should be quoted from the date buyer-side documentation clears, not from order date. For nicotine the gating item is almost always the import permit or end-use authorisation rather than production, and a lead time quoted from order date will be missed in most destinations.

08Storage and handling

Storage

  • Store at temperature range in the original tightly closed container, protected from light.
  • Keep under inert gas. Re-blanket the headspace with nitrogen after each withdrawal.
  • Store in a locked, bunded, ventilated area reserved for Class 6.1 materials, away from oxidising agents, strong acids and foodstuffs.
  • Do not return withdrawn material to the original container.

Handling

  • Handle only in a fume hood or under local exhaust ventilation, by trained personnel, never alone.
  • Nicotine penetrates many common glove materials. Select gloves on breakthrough data for this substance, double-glove, and change on any suspected contact — do not rely on a general chemical-resistant rating.
  • Wear chemical splash goggles and impervious protective clothing; assess the need for respiratory protection against the exposure limit in force locally.
  • Have washing facilities and an emergency shower immediately accessible at the point of use, and hold a written spill and exposure procedure before the material arrives on site.
  • Skin contact is a medical emergency, not a hygiene issue. Remove contaminated clothing, wash the area immediately and seek medical attention.

The issued SDS governs in all cases, including GHS hazard and precautionary statements, exposure limits, PPE selection, first aid and disposal. This summary is for procurement planning and does not replace it. Insert the emergency response telephone number here: 24-hour emergency contact.

09Source and manufacturing information

Buyers qualifying nicotine need to know the route and the site, because both drive the impurity profile and the regulatory pathway. McCoy discloses the following on request under confidentiality, and will not substitute material from an undisclosed site against an accepted qualification.

Supply chain disclosure
RouteTobacco-derived (extraction and purification) or synthetic — state per offer
Botanical source, if derivedNicotiana species, species & growing region
Manufacturing sitename, address, country
Site regulatory registrationslist only what is held and current
McCoy's rolemanufacturer / authorised distributor / trader — state plainly
Process outlineAvailable under NDA
Change control notificationnotice period for site, route or spec change
TraceabilityBatch traceable to raw material lot / crop lot

State McCoy's own role without ambiguity. "Manufacturer and exporter" on a page for material that is bought in is the single most common finding in a supplier audit of this product, and it invalidates the qualification rather than merely embarrassing the seller.

10Export capability

Nicotine moves as a dangerous good and, in most destinations, as a controlled article as well. McCoy prepares the shipping side; the buyer holds the import side, and the order proceeds only once both are in place.

Shipping and trade data
Proper shipping nameNicotine
UN number / class / PGUN 1654 · Class 6.1 · PG II
Modes offeredsea / air / road — state, with DG-trained staff
Regulatory frameworksIMDG for sea; IATA DGR for air, subject to carrier and state variations
HS codeconfirm against destination tariff
Ports of loadingports
Countries currently servedlist only where shipments have cleared
Shipping documentsCommercial invoice, packing list, bill of lading or AWB, DG declaration, COA, certificate of origin, others

Buyer-side obligations

Requirements differ by destination and by intended use, and McCoy cannot discharge them on a buyer's behalf. Depending on the market and application these may include an import licence or precursor/poison authorisation, registration or notification of the substance, product-level authorisation for nicotine-containing goods, poison centre notification, and labelling and packaging rules for the finished article. McCoy will supply the composition and hazard documentation these filings need, on request.

Do not list a country as served until a shipment has actually cleared customs there, and do not state compliance with a destination regulation that applies to the buyer's finished product rather than to the raw material.

11Request a sample or a quote

Both routes start with the same information. Enquiries without an identified company and end use are not quoted.

Enquiry details

McCoy responds within 2 working days.

By submitting, you confirm you are enquiring on behalf of a business, that the material is for a lawful commercial or research use, and that you can receive and store an acutely toxic Packing Group II substance safely. McCoy may decline any enquiry and may require an end-use declaration, evidence of authorisation, or a site check before quoting. Nothing on this page is an offer to supply; a binding offer is the written quotation only.

Wire the form to endpoint or mailbox and confirm the privacy notice and data retention statement before publishing.