Galantamine hydrobromide is an active pharmaceutical ingredient and an alkaloid with an acute oral toxicity hazard classification (UN 2811, Class 6.1, Packing Group II). NutraBiotech supplies it strictly as a laboratory reference material, analytical standard and formulation-development raw material. It is not supplied for human or veterinary consumption, and nothing on this page is a dosing recommendation, a clinical guideline or a therapeutic claim. Galantamine is a prescription-only medicine in the United States, the European Union, the United Kingdom, Australia and China; it is not a dietary supplement in those jurisdictions.
1. What Is Galantamine Hydrobromide?
Galantamine is a tertiary alkaloid of the benzazepine type, built on a tetracyclic framework that fuses a methoxy-substituted benzene ring, a hydroxylated benzofuran and a methylated azepine ring. The molecule carries three defined stereocentres, and only the (−)-enantiomer is pharmacologically active. It was characterised in the early 1950s by Soviet pharmacologists working on Galanthus species, entered clinical use in Eastern Europe for myasthenia and post-polio paralysis long before it reached Western markets, and was approved by the US FDA in 2001 for mild to moderate dementia of the Alzheimer’s type.
Two CAS numbers define the material, and the distinction between them drives every calculation made from a weighed quantity. The salt carries nearly all commercial galantamine — the pharmacopoeial article, the Razadyne legacy, and every bulk API shipment — while the free base is the neutral alkaloid handled in mechanistic work.
The neutral tertiary alkaloid, three defined stereocentres with activity confined to the (−)-enantiomer. Handled as the reference species for mechanistic acetylcholinesterase and nicotinic receptor work, where the counter-ion would contribute mass without contributing activity.
One mole of hydrobromic acid per mole of galantamine, and the form in which bulk API ships. The single protonation step accounts for the entire 80.92 g/mol mass difference between the two forms, and both the European and the United States Pharmacopoeia monograph this salt rather than the base.
1.1 Chemical Profile & Basic Specs
- IUPAC name: (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef]benzazepin-6-ol hydrobromide.
- Synonyms: galanthamine hydrobromide, Nivalin, Lycoremine; marketed historically as Reminyl and later Razadyne.
- Counter-ion: one mole of hydrobromic acid per mole of galantamine. This single protonation step accounts for the entire 80.92 g/mol mass difference between the two forms.
- Physical form: white to off-white crystalline powder, odourless, bitter taste, melting point 256 °C.
- Hazard class: acute oral toxicity Category 3 (H301, toxic if swallowed); UN 2811, Class 6.1, Packing Group II. Mouse intravenous LD50 is reported at approximately 5.2 mg/kg.
1.2 Origin, Biosynthesis & Supply Reality
Galantamine is an Amaryllidaceae alkaloid. It occurs in the bulbs and flowers of snowdrops (Galanthus nivalis, G. caucasicus, G. woronowii), daffodils (Narcissus pseudonarcissus, cultivar Carlton), snowflakes (Leucojum aestivum) and red spider lily (Lycoris radiata). Typical alkaloid content in bulbs runs from 0.05% to 0.2%.
Biosynthesis follows the norbelladine route: phenylalanine and tyrosine condense to 4′-O-methylnorbelladine, which cyclises through a para–ortho phenol coupling, and the resulting dienone is closed into the benzofuran ether by intramolecular nucleophilic addition before reduction and methylation complete the skeleton. Commercial production does not rely on the plant pathway for bulk volume. Total synthesis proceeds through narwedine with a stereoselective reduction step, and the vast majority of pharmaceutical-grade material is semi-synthetic.
A single Welsh hill farm at 1,200 feet in the Black Mountains was reported to produce roughly 20 kg of galantamine per year — enough for about 9,000 patients — after researchers found that altitude stress raises alkaloid yield in daffodils. That figure illustrates the scale gap: botanical sourcing cannot meet global demand, which is why semi-synthetic narwedine chemistry governs the API market and why extract-derived material has a measurably different impurity profile from the synthetic route.
1.3 Mechanism: AChE Inhibition Plus Nicotinic Allosteric Potentiation
Galantamine is a reversible, competitive inhibitor of acetylcholinesterase, and the only marketed cholinesterase inhibitor that additionally acts as a positive allosteric potentiating ligand at nicotinic acetylcholine receptors. Reported IC50 values are 410 nM at AChE and 8,404 nM at BChE, an approximately 50-fold selectivity for the acetyl- over the butyryl-cholinesterase.
The allosteric action binds a site distinct from the acetylcholine-binding site on α4β2, α3β4, α6β4 and α7 nicotinic receptors, shifting the receptor into a state that responds more strongly to the acetylcholine that the enzyme inhibition has preserved. The two mechanisms therefore act on the same synapse from opposite ends: one raises transmitter concentration, the other raises receptor responsiveness.
2. Free Base vs Hydrobromide Salt: The Conversion That Changes Every Calculation
The two forms are the same active moiety with different masses. A stock solution weighed against the wrong molecular weight produces a 28% molarity error before any assay begins.
Free base MW = 287.35 g/mol. Hydrobromide salt MW = 368.27 g/mol. Salt to free base: 287.35 ÷ 368.27 = 0.7803. Free base to salt: 368.27 ÷ 287.35 = 1.2815. One gram of galantamine hydrobromide contains 780.3 mg of galantamine; one gram of galantamine free base is equivalent to 1.2815 g of the hydrobromide salt.
| Hydrobromide salt quantity | Free base equivalent (× 0.7803) | Typical lab context |
|---|---|---|
| 5 mg | 3.90 mg | Reference-standard vial |
| 10 mg | 7.80 mg | In vitro IC50 stock |
| 25 mg | 19.51 mg | Method-development stock |
| 100 mg | 78.03 mg | Analytical batch |
| 1 G | 780.3 mg | Formulation development |
| 10 G | 7.803 G | Pilot batch |
| 100 G | 78.03 G | Scale-up |
| 1 KG | 780.3 G | Commercial API |
| 10 KG | 7.803 KG | Bulk drum export grade |
An assay or dosing table built on a COA that reports purity as “galantamine hydrobromide 99.5%” but a stock solution weighed as though the material were galantamine produces a systematic error. The counter-ion is not inert filler — it is 22% of the mass. A 1 mM nominal solution prepared this way is actually 0.78 mM. Reverse the error and the solution is 1.28 mM, which matters in a system with a narrow therapeutic window and a cholinergic ceiling effect.
2.1 Why the Hydrobromide Salt Dominates the Market
Three practical properties pushed the hydrobromide salt into the pharmacopoeia and kept the free base as a research intermediate:
- Crystallinity and melting point. The salt melts at 256 °C against 126.5 °C for the free base — a 130-degree gap that translates into a far more robust solid-state profile, easier filtration and a longer shelf life.
- Aqueous solubility. The protonated salt dissolves freely in water, whereas the free base is only sparingly soluble. Oral solution and immediate-release tablet formulations depend on that solubility.
- Pharmacopoeial lock-in. Both the European Pharmacopoeia and the United States Pharmacopoeia monograph the hydrobromide salt, and the Chinese Pharmacopoeia has listed galantamine hydrobromide raw material and injection since 1977. Reference standards, pharmacopoeial assays and compendial specifications are all written against the salt.
Neutral Alkaloid
MW 287.35 g/mol, melting point 126.5 °C, sparingly soluble in water. Molarity follows directly from the weighed mass with no counter-ion correction. The species that binds the enzyme.
Pharmacopoeial Salt
MW 368.27 g/mol, melting point 256 °C, freely soluble in water. Ph.Eur., USP and China Pharmacopoeia monographs are written against this form, and bulk API ships as this salt.
3. Physicochemical Properties
The free base is normally encountered as the neutral alkaloid for mechanistic work — the species that binds the enzyme. The hydrobromide salt is the handled, weighed, formulated article. The two are differentiated below on the properties that decide an experiment.
3.1 Solubility & Stock Solution Preparation
| Property | Galantamine free base | Galantamine hydrobromide |
|---|---|---|
| Water | Sparingly soluble (~14–57 mg/mL, batch-dependent) | Freely soluble |
| DMSO | ≥50 mg/mL | Soluble |
| Ethanol | 15–100 mg/mL (with warming) | Very slightly soluble in anhydrous ethanol |
| Chloroform / acetone / ether | Practically insoluble | Insoluble |
| Dilute alkali hydroxide | — | Dissolves |
| Recommended stock | 10 mM in DMSO | 10 mM in water or DMSO |
The hydrobromide salt is the easier of the two to put into aqueous buffer, which makes it the default for in vitro AChE and nAChR assays run in physiological media. The free base is preferred where the counter-ion itself could interfere — for example in ion-channel electrophysiology or in assays read on a bromide-sensitive detector. In both cases a 10 mM stock is the usual starting point, with DMSO used for the free base and either water or DMSO for the salt.
Hydrobromide stock solutions diluted into unheated aqueous media can supersaturate, and the alkaloid drops out as a fine suspension that reads as a false-negative in turbidimetric or fluorescence assays. Pre-warming the receiving buffer to 37 °C, adding the organic stock last, and keeping the final solvent content below 1% (v/v) resolves the majority of cases. Residual precipitate after a 37 °C water bath with brief sonication indicates a stock that was made above its true solubility limit.
3.2 Stability, Light Sensitivity & Degradation Pathways
Galantamine hydrobromide has been characterised under forced-degradation conditions, and the results define how the material is stored and shipped.
| Stress condition | Outcome | Degradation kinetics |
|---|---|---|
| Acidic | Degrades | First order |
| Photolytic (light) | Degrades | First order |
| Oxidative (peroxide) | Degrades | Two-phase |
| Alkaline | Stable | — |
| Elevated temperature | Stable | — |
Three degradation processes account for the products observed: dehydration, epimerisation at the stereocentres, and N-oxidation of the tertiary amine. Epimerisation is the most consequential for research use because the biological activity resides in a single enantiomer — a racemising stock solution loses potency without any change in the HPLC total-purity figure.
Practical storage derived from the same data and vendor specifications:
- Solid: store at −20 °C under inert gas (argon or nitrogen), protected from light. The material is hygroscopic, so containers are kept tightly sealed and desiccated.
- Solutions: aliquot and hold at −20 °C. Working solutions are typically used within two weeks to one month.
- Packaging: amber or opaque vials with a plastic insert; clear glass is a photolytic risk in transit.
- Handling: equilibrate the sealed vial to room temperature before opening to avoid condensation on the hygroscopic solid.
3.3 Purity & Impurity Profile
Galantamine hydrobromide is controlled by a compendial specification, and the individual limits are what a COA review is measured against.
| Test | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (HPLC, on galantamine basis) | 98.0–102.0% |
| Assay (non-aqueous titration) | ≥98.0% |
| Melting point | 256 °C |
| pH (aqueous solution) | 4.5–6.5 |
| Specific rotation [α]20D | −90° to −100° (2% in water) |
| UV absorption | 79.6–86.2 (289 nm, 50 µg/mL in water) |
| Loss on drying | ≤1.0% |
| Heavy metals | ≤10 ppm |
| Arsenic | ≤2 ppm |
| Sulfated ash | ≤1.0% |
| Dihydrogalanthamine | ≤0.1% |
| Single specified impurity | ≤0.1% |
| Total impurities | ≤1.0% |
A COA that lists an HPLC purity figure but omits the dihydrogalanthamine limit and the specific rotation leaves the two most informative identity and potency checks unreported. Dihydrogalanthamine is the hydrogenation impurity formed when the C=C double bond in the cyclohexene ring is reduced; it co-elutes closely with galantamine on many generic HPLC methods and depresses potency without affecting the total-purity number. Specific rotation is the only practical check that the material has not partially racemised, since the enantiomers share the same mass and the same UV chromophore.
4. Side-by-Side Comparison Table
| Property | Galantamine free base | Galantamine hydrobromide | Donepezil hydrochloride |
|---|---|---|---|
| CAS number | 357-70-0 | 1953-04-4 | 120011-70-3 |
| Molecular formula | C17H21NO3 | C17H21NO3·HBr | C24H29NO3·HCl |
| Molecular weight (g/mol) | 287.35 | 368.27 | 415.95 |
| Counter-ion | None | Hydrobromic acid | Hydrochloric acid |
| Chemical class | Benzazepine alkaloid (tertiary amine) | Same active moiety, protonated | Piperidine / indanone |
| Melting point | 126.5 °C | 256 °C | 220–222 °C |
| Water solubility | Sparingly soluble | Freely soluble | ≥20 mg/mL |
| Specific rotation | — | −90° to −100° (2% in water) | — |
| Mechanism | Reversible competitive AChE inhibitor + nicotinic allosteric potentiating ligand | Same active moiety as free base | Non-competitive AChE inhibitor; no nicotinic modulation |
| Pharmacopoeial monograph | Reference standard only | Ph.Eur. + USP + China Pharmacopoeia | Ph.Eur. + USP |
| Primary lab use | Mechanistic and electrophysiology work | Compendial assay, formulation, bulk API | Comparator cholinesterase inhibitor |
| Bulk pack sizes | 1 G / 10 G / 100 G / 1 KG / 10 KG | 1 G / 10 G / 100 G / 1 KG / 10 KG | 1 G / 10 G / 100 G / 1 KG / 10 KG |
5. Galantamine vs Donepezil and Rivastigmine
The three marketed cholinesterase inhibitors are not interchangeable, and the difference is not potency but mechanism breadth.
| Attribute | Galantamine | Donepezil | Rivastigmine |
|---|---|---|---|
| Enzyme target | AChE, reversible and competitive | AChE, non-competitive | AChE and BChE, carbamate (pseudo-irreversible) |
| Nicotinic allosteric modulation | Yes — positive allosteric potentiating ligand | No | No |
| Selectivity profile | ~50-fold AChE over BChE | Predominantly AChE | Dual, with meaningful BChE activity |
| Origin | Amaryllidaceae alkaloid (semi-synthetic) | Fully synthetic | Fully synthetic |
| Counter-ion in the commercial salt | Hydrobromide | Hydrochloride | Tartrate |
The allosteric action is the distinguishing property. Galantamine binds a site distinct from the acetylcholine-binding site on α4β2, α3β4, α6β4 and α7 nicotinic receptors, shifting the receptor into a state that responds more strongly to the acetylcholine that the enzyme inhibition has preserved. Donepezil and rivastigmine raise acetylcholine concentration alone. Memantine, frequently discussed alongside these compounds, is not a cholinesterase inhibitor at all — it is an NMDA receptor antagonist that acts on a different system and is studied in combination rather than in substitution.
A study that replaces galantamine with donepezil on a molar basis tests only the cholinergic half of the mechanism and silently drops the nicotinic allosteric component. Where a protocol depends on the allosteric potentiation — receptor-desensitisation work, α7-mediated neuroprotection models, or long-term potentiation experiments — donepezil is not a valid substitute at any dose.
5.1 Galantamine Hydrobromide and Benzgalantamine
Benzgalantamine, also called galantamine benzoate and marketed as Zunveyl, is a benzoate ester prodrug of galantamine developed as a delayed-release tablet. It is metabolised to release galantamine and was developed to reduce the gastrointestinal side effects associated with the parent drug. Galantamine hydrobromide is the immediate pharmacologically active salt form, not a prodrug, and remains the standard commercial and pharmacopoeial article. The two are separate materials with separate CAS numbers and separate dossiers, and a quotation issued against one is not valid for the other.
6. Application Matching: Which Form Fits Which Experiment
The choice between the two forms follows from the experiment rather than from preference. Each row below states the laboratory question and the form that answers it.
AChE Inhibition Assay, In Vitro
No counter-ion mass in the calculation, so the molarity follows directly from the weighed quantity against MW 287.35.
nAChR Allosteric Potentiation, Electrophysiology
No bromide present in solution to interfere with ion-channel recordings read on a halide-sensitive detector.
Compendial Assay or Reference Standard
The Ph.Eur. and USP monographs, the reference standards and the compendial methods are all written against the salt.
Formulation Development, Oral Solid or Solution
Freely water-soluble and crystalline, with a 256 °C melting point that supports filtration and downstream processing.
Long-Term Stability Stock
A 130-degree melting-point advantage over the free base gives a more robust solid state across long storage intervals.
Bulk API Export and Commercial Supply
The standard commercial salt form, with the compendial dossier and the pharmacopoeial references already aligned to it.
Chiral and racemisation studies sit outside this split: either form can be used, provided the specific rotation is recorded on the batch. The free base simplifies the mass balance, while the rotation value confirms that the material has not lost enantiopurity.
7. Regulatory & Export Risk
- Medicine status. Galantamine hydrobromide is a prescription-only medicine in the US, EU, UK, Australia and China. It holds no OTC or supplement status in those jurisdictions, and export documentation for the API carries a pharmaceutical, not a supplement, classification.
- HS classification. Galantamine, as a vegetable alkaloid, falls under HS heading 2939 (vegetable alkaloids, natural or reproduced by synthesis) and specifically 2939.79 (other alkaloids) — China declarations use 2939799090; the US HTS entry is 29397900. Finished dosage forms move to Chapter 30 (HS 3003 / 3004).
- Transport classification. Solid galantamine hydrobromide is regulated as UN 2811, Class 6.1, Packing Group II, consistent with an oral toxicity Category 3 hazard. Air freight requires the corresponding dangerous-goods documentation.
- Controlled-substance status. Galantamine is not a controlled substance under the US Controlled Substances Act, the UK Misuse of Drugs Act or the UN conventions. It is also not on the WADA Prohibited List — it is a prescription therapeutic agent, not a doping-class substance.
- Pharmacopoeial documentation. A complete dossier for a regulated market pairs the batch COA with the compendial specification, residual-solvent data and, where the route is semi-synthetic, the narwedine route description.
- Botanical-versus-synthetic disclosure. Extract-derived and semi-synthetic galantamine have different impurity fingerprints. The COA states which route produced the batch, because a downstream customer’s impurity method may be validated for only one of them.
The Class 6.1 classification adds dangerous-goods handling cost to every air shipment, which favours larger consolidated orders over frequent small ones on this molecule. Sea freight moves the same material under the same UN number with a longer lead time and a lower per-kilogram cost.
8. Export Volume Ranking
The cholinesterase-inhibitor API group trades on a well-established demand hierarchy. The ordering below is a qualitative, directional market view, not a published statistic, and reflects general enquiry and shipment patterns rather than audited trade data.
- Donepezil hydrochloride — first-line by prescription volume; the largest single API in the group and the most requested comparator standard.
- Galantamine hydrobromide — a durable second, supported by its distinct dual mechanism, a stable generic base and a semi-synthetic route that makes bulk supply predictable.
- Rivastigmine tartrate — steady demand, with a notable transdermal-patch share that pulls API into a smaller number of specialised buyers.
- Memantine hydrochloride — a different target class (NMDA), frequently co-sourced with a cholinesterase inhibitor and tracked in the same cholinergic-dementia portfolio.
Two structural features shape galantamine’s export profile: the semi-synthetic narwedine route concentrates API manufacturing among a small number of capable sites, and the alkaloid’s hazard classification adds dangerous-goods cost to every air shipment, which favours larger consolidated orders over frequent small ones.
9. Supplier Red Flags When Buying Galantamine Hydrobromide
- Salt-versus-base ambiguity on the COA. A document that reports “galantamine 99%” without stating the salt form and the calculation basis cannot be reconciled against a molarity calculation. Every stock solution depends on knowing whether the 99% refers to the salt or the free base.
- Missing dihydrogalanthamine limit. The single impurity specific to galantamine is omitted from many generic COAs, removing the only check on the hydrogenation impurity that depresses potency while co-eluting with the main peak.
- No specific rotation. An HPLC-only COA cannot detect racemisation. With three stereocentres and one active enantiomer, a rotation value in the −90° to −100° range is the minimum identity evidence.
- Clear-glass packaging. Galantamine hydrobromide degrades photolytically. Material shipped in transparent vials has an unquantified light-exposure history.
- Purity inflated by method selection. Non-aqueous titration and HPLC report different numbers. A supplier quoting the higher of the two without stating the method, or blending the two definitions, produces a figure that will not reproduce on release testing.
- Botanical extract represented as API. Material isolated from Lycoris or Narcissus biomass and sold as pharmaceutical-grade galantamine hydrobromide carries a different impurity profile from the semi-synthetic narwedine route, and the COA frequently does not disclose the origin.
- No residual-solvent or heavy-metal data. The semi-synthetic route uses hydrobromic acid, tetrahydrofuran, ethanol and a hydride reductant; the associated residual-solvent and inorganic-impurity data belong on a regulated-market COA.
- Absent stability data. Given that the molecule degrades under acid, light and oxidation, a supplier unable to provide batch stability data on the solid and on a standard stock solution leaves the storage claim unsupported.
10. Frequently Asked Questions
No. They share the same active moiety but differ in mass and counter-ion. Galantamine free base has CAS 357-70-0, formula C17H21NO3 and a molecular weight of 287.35 g/mol. Galantamine hydrobromide has CAS 1953-04-4, formula C17H21NO3·HBr and a molecular weight of 368.27 g/mol. The hydrobromide is the salt used in the pharmacopoeial article and in commercial formulations; the free base is the neutral alkaloid normally used for mechanistic and electrophysiology work.
Multiply the salt quantity by 0.7803, which is the ratio 287.35 ÷ 368.27. Working the other way, multiply the free base quantity by 1.2815. For example, 100 mg of galantamine hydrobromide is equivalent to 78.03 mg of galantamine, and 1 kg of the salt contains 780.3 g of galantamine. The same factor applies when a molarity is prepared from a weighed mass.
Three properties drive the choice. The salt melts at 256 °C against 126.5 °C for the free base, giving a more robust solid state and easier isolation. The protonated species is freely water-soluble while the free base is only sparingly soluble, which matters for oral solution and immediate-release formulations. Both the European Pharmacopoeia and the United States Pharmacopoeia monograph the hydrobromide salt, so reference standards and compendial methods are written against it.
No. Galantamine is not listed on the WADA Prohibited List. It is a prescription acetylcholinesterase inhibitor approved for mild to moderate Alzheimer’s dementia, not a doping-class substance. It is also not a controlled substance under the US Controlled Substances Act or the UN drug conventions, although it is prescription-only in the United States, the European Union, the United Kingdom, Australia and China.
Yes. Forced-degradation studies show first-order degradation under photolytic conditions, and vendors list the material as light-sensitive, hygroscopic and heat-sensitive. Solid material is stored at −20 °C under inert gas in light-protective containers. Solutions are aliquoted, protected from light and held at −20 °C for two weeks to one month at most.
Three processes dominate: dehydration, epimerisation and N-oxidation. Degradation is observed under acidic, photolytic and oxidative conditions, with first-order kinetics for the acidic and photolytic routes and two-phase kinetics for oxidation. The material is stable under alkaline conditions and at elevated temperature. Epimerisation is the most consequential for research, because only one enantiomer is active and racemisation reduces potency without changing the HPLC total-purity figure.
All three inhibit acetylcholinesterase, but only galantamine also acts as a positive allosteric potentiating ligand at nicotinic acetylcholine receptors, binding a site distinct from the acetylcholine-binding site on α4β2 and related receptors. Donepezil is a non-competitive AChE inhibitor without nicotinic modulation, and rivastigmine is a carbamate that inhibits both AChE and BChE with pseudo-irreversible kinetics. Reported IC50 values for galantamine are 410 nM at AChE and 8,404 nM at BChE, an approximately 50-fold selectivity.
Benzgalantamine, also called galantamine benzoate and marketed as Zunveyl, is a benzoate ester prodrug of galantamine developed as a delayed-release tablet. It is metabolised to release galantamine and was developed to reduce the gastrointestinal side effects associated with the parent drug. Galantamine hydrobromide is the immediate pharmacologically active salt form, not a prodrug, and remains the standard commercial and pharmacopoeial article.
Both routes exist. Galantamine was first isolated from Galanthus species and occurs in the bulbs and flowers of snowdrops, daffodils, snowflakes and red spider lily at 0.05% to 0.2%. Commercial pharmaceutical-grade material is predominantly semi-synthetic, produced through a narwedine intermediate with a stereoselective reduction step, because botanical yield cannot meet demand. The two routes differ in impurity profile, so a COA should state the manufacturing route.
The assay is calculated on the active moiety so that the figure is independent of the counter-ion contribution. A specification of 98.0–102.0% on a galantamine basis expresses the content of the alkaloid itself, while a figure reported on a salt basis would include the hydrobromic acid mass. The two figures differ by the 0.7803 conversion factor, and mixing them is the most common source of a stock-solution molarity error.
Dihydrogalanthamine is the hydrogenation impurity formed when the double bond in the cyclohexene ring of galantamine is reduced. The pharmacopoeial limit is ≤0.1%. It matters because it co-elutes closely with galantamine on many generic HPLC methods, so it can be under-reported in a total-purity figure while still depressing the actual potency of the material. Its absence from a COA removes one of the two most informative potency checks.
NutraBiotech supplies galantamine hydrobromide and galantamine free base in 1 G, 10 G, 100 G, 1 KG and 10 KG pack sizes. Each batch ships with a batch-specific certificate of analysis covering HPLC assay, identity, specific rotation, dihydrogalanthamine and total impurities, loss on drying, heavy metals and residual solvents, together with the safety data sheet and, on request, the regulatory documentation for the destination market.
11. Final Verdict: Galantamine Free Base vs Hydrobromide
The two forms answer different questions, and the choice is rarely a matter of preference:
| Requirement | Recommended form | Rationale |
|---|---|---|
| Mechanistic AChE or nAChR study, molar-precise | Free base — CAS 357-70-0 | Neutral alkaloid, no counter-ion mass or bromide interference |
| Compendial assay, reference standard, method validation | Hydrobromide — CAS 1953-04-4 | Ph.Eur. and USP monographs are written against the salt |
| Formulation, oral solid or solution development | Hydrobromide — CAS 1953-04-4 | Aqueous solubility plus crystalline robustness |
| Bulk API supply and commercial export | Hydrobromide — CAS 1953-04-4 | Standard commercial salt form with full dossier |
Where a project touches both worlds, the safe approach is to standardise on one form and publish the conversion factor used. Because galantamine has a narrow therapeutic window and a cholinergic ceiling effect, an unnoticed 28% mass difference between the salt and the base propagates directly into every concentration in the study. The single most useful line on any galantamine COA is the one that states, unambiguously, whether the assay is reported on a salt basis or a galantamine basis.
Galantamine hydrobromide is an active pharmaceutical ingredient and an alkaloid with an acute oral toxicity hazard classification (UN 2811, Class 6.1, Packing Group II). NutraBiotech supplies galantamine hydrobromide (CAS 1953-04-4) and galantamine free base (CAS 357-70-0) strictly as laboratory reference materials, analytical standards and formulation-development raw materials. They are not supplied for human or veterinary consumption, and the information on this page is not a clinical guideline, a dosing recommendation or a therapeutic claim. Galantamine is a prescription-only medicine in the United States, the European Union, the United Kingdom, Australia and China, and it is not a dietary supplement in those jurisdictions. Galantamine is not on the WADA Prohibited List and is not a controlled substance under the US Controlled Substances Act or the UN conventions. Statements about CAS numbers, molecular weights, specifications, degradation pathways and mechanisms describe the pharmacopoeial monographs and published literature. No therapeutic claim is made or implied.
Need Galantamine Hydrobromide With the Full COA Set on One Document?
NutraBiotech supplies galantamine hydrobromide (CAS 1953-04-4) and galantamine free base (CAS 357-70-0) in 1 G / 10 G / 100 G / 1 KG / 10 KG pack sizes. Batch documentation includes HPLC assay on a stated galantamine basis, specific rotation, the dihydrogalanthamine limit, total impurities, loss on drying, heavy metals, residual solvents and the safety data sheet. Air and sea freight are consolidated for the Class 6.1 hazard classification.
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