Sucralfate

Sucralfate	Last updated: 12/09/2025
(Also known as: sulfated disaccharide, aluminium salt)

GENERAL INFORMATION

Description

A sucrose aluminum hydroxide compound used to treat various gastrointestinal and oral issues

Examples of veterinary uses

Used for the prevention and treatment of ulcers in the mouth, esophagous, stomach, and intestines

Examples of species treated

Cats; Dogs; Ferrets; Chinchillas; Reptiles; Birds

Approval status

VMR 2013/2033 approval status (GB/UK)

Not approved

EU Regulatory approval status

Not approved

Chemical structure

Isomerism

Sucralfate does not exhibit classical isomerism in the way small organic molecules like levothyroxine do. Instead, its complexity arises from being a polymeric aluminum salt of sucrose octasulphate, which is a large, amorphous molecule with variable hydration and structural conformations. Rather than existing as distinct stereoisomers or geometric isomers, sucralfate can form different structural forms (or polymorphs) depending on how the aluminum ions coordinate with the sulphate groups and water molecules. Recent studies have revealed that at least two structural forms of sucralfate exist, differing in their aluminum environments and hydration levels, which can influence their stability and rate of acid-induced breakdown. These variations are more akin to conformational or supramolecular isomerism, rather than traditional stereoisomerism, and they reflect the compound’s semi-crystalline, gel-forming nature rather than a rigid molecular structure.

Chemical formula

C₁₂H₅₄Al₁₆O₇₅S₈

Canonical SMILES

C(C1C(C(C(C(O1)OC2(C(C(C(O2)OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])COS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al].O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O

Isomeric SMILES

C([C@@H]1[C@H]([C@@H]([C@H]([C@@H](O1)O[C@]2([C@H]([C@@H]([C@H](O2)OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])COS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al])OS(=O)(=O)O[Al].O.O.O.O.O.O.O.O.O.O.O.O.O.O.O.O

International Chemical Identifier key (InChIKey)

MNQYNQBOVCBZIQ-JQOFMKNESA-A

International Chemical Identifier (InChI)

2D structure diagram/image available?

Yes

General status

Veterinary substance type

Medicinal drug: anti-ulcer

Substance groups

Disaccharides

Minimum active substance purity

Known relevant impurities

Substance origin

Synthetic

Mode of action

Acts as a stomach acid buffer

Molecular targets

[Pepsin, Inhibitor], [Fibroblast growth factor 2, Agonist], [Pro-epidermal growth factor, Inducer], [Fibrinogen alpha chain, Antagonist], [Fibrinogen beta chain, Antagonist], [Fibrinogen gamma chain, Antagonist]

CAS RN

54182-58-0

EC number

259-018-4

CIPAC number

US EPA chemical code

PubChem CID

Therapeutic Class

Drugs for peptic ulcers and gastro-oesophageal reflux disease

ATCvet Code

QA02BX02

Controlled Drug?

Regulation 37/2010 MRL Classification

Molecular mass

974.74

PIN (Preferred Identification Name)

hexadeca-µ-hydroxytetracosahydroxy(µ8-91,3,4,6-tetra-O-sulfo-β-Dfructofuranosyl-a-D-glucopyranoside tetrakis(hydrogen sulfato)8-)))hexadecaaluminum

IUPAC name

hexadeca-µ-hydroxytetracosahydroxy(µ8-91,3,4,6-tetra-O-sulfo-β-Dfructofuranosyl-a-D-glucopyranoside tetrakis(hydrogen sulfato)8-)))hexadecaaluminum

CAS name

aluminium sucrose octasulphate

Forever chemical

Other status information

Relevant Environmental Water Quality Standards

Physical state

White to yellow coloured amorphous powder

Commercial

Property

Value

Availability status

Current

Introduction & key dates

1932, first developed as an antipeptic agent

Example manufacturers & suppliers of products using this active now or historically

Idis pharma

Example products using this active

Antepsin
Carafate
Sulcrate

Formulation and application details

Typically formulated as an oral medication, in tablet and liquid suspension forms. Often human drugs are adapted for animal use and used off-label

Commercial production

The production of sucralfate involves a multi-step chemical synthesis starting with sucrose, which is first sulphated to form sucrose polysulfate. This intermediate is then neutralised with an alkali metal solution, typically sodium hydroxide, to produce a sucrose polysulphate alkali metal salt. In the next step, the alkali metal ions are exchanged for aluminium ions, typically using an aluminium salt, resulting in the formation of sucrose polysulphate aluminium salt. Finally, this compound is neutralised and purified to yield sucralfate.

Impact on climate of production and use

Published GHG data is not available for most pharmaceuticals. However, according to industry, global averages suggest producing 1 kg of a typical active pharmaceutical ingredient can range from 10 to 100 kg CO₂e for small molecule drugs and potentially up to 1000 kg CO₂e for complex biologicals such as vaccines, depending on the drug type, its formulation, complexity of synthesis, solvent recovery, and energy sources used.

ENVIRONMENTAL FATE

Property

Value

Source; quality score; and other information

Interpretation

Solubility - In water at 20 °C (mg l⁻¹)

Solubility - In organic solvents at 20 °C (mg l⁻¹)

Melting point (°C)

Boiling point (°C)

Degradation point (°C)

Flashpoint (°C)

Octanol-water partition coefficient at pH 7, 20 °C

Log P

Fat solubility of residues

Solubility

Data type

Density (g ml⁻¹)

Dissociation constant pKa) at 25 °C

Vapour pressure at 20 °C (mPa)

Henry's law constant at 25 °C (Pa m³ mol⁻¹)

Volatilisation as max % of applied dose lost

From plant surface

From soil surface

Maximum UV-vis absorption L mol⁻¹ cm⁻¹

Surface tension (mN m⁻¹)

Refractive Index

Environmental release

Degradation

Property

Value

Source; quality score; and other information

Interpretation

Soil degradation (days) (aerobic)

DT₅₀ (typical)

DT₅₀ (lab at 20 °C)

DT₅₀ (field)

DT₉₀ (lab at 20 °C)

DT₉₀ (field)

Note

Manure DT₅₀ (days)

Aqueous photolysis DT₅₀ (days) at pH 7

Value

Note

Aqueous hydrolysis DT₅₀ (days) at 20 °C and pH 7

Value

Note

Water-sediment DT₅₀ (days)

Water phase only DT₅₀ (days)

Sediment phase only DT₅₀ (days)

Air degradation

As this parameter is not normally measured directly, a surrogate measure is used: ‘Photochemical oxidative DT₅₀’. Where data is available, this can be found in the Fate Indices section below.

Decay in stored produce DT₅₀

Soil adsorption and mobility

Property

Value

Source; quality score; and other information

Interpretation

Linear

K_d (mL g⁻¹)

K_oc (mL g⁻¹)

Notes and range

Freundlich

K_f (mL g⁻¹)

K_foc (mL g⁻¹)

¹/_n

Notes and range

pH sensitivity

Fate indices

Property

Value

Source; quality score; and other information

Interpretation

GUS leaching potential index

Bio-concentration factor

BCF (l kg⁻¹)

CT₅₀ (days)

Known metabolites

None

ECOTOXICOLOGY

Terrestrial ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

V3 Rat 12000

Low

Mammals - Short term dietary NOEL

(mg kg⁻¹)

(ppm diet)

Mammals - Chronic 21d NOAEL (mg kg⁻¹ bw d⁻¹)

Birds - Acute LD₅₀ (mg kg⁻¹)

Birds - Short term dietary (LC₅₀/LD₅₀)

Birds - Chronic 21d NOEL (mg kg⁻¹ bw d⁻¹)

Earthworms - Acute 14 day LC₅₀ (mg kg⁻¹)

Earthworms - Chronic NOEC, reproduction (mg kg⁻¹)

Soil micro-organisms

Collembola

Acute LC₅₀ (mg kg⁻¹)

Chronic NOEC (mg kg⁻¹)

Non-target plants

Vegetative vigour ER₅₀ (g ha⁻¹)

Seedling emergence ER₅₀ (g ha⁻¹)

Honeybees (Apis spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Unknown mode acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Chronic

Notes

Bumblebees (Bombus spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Mason bees (Osmia spp.)

Contact acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Oral acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg bee⁻¹)

Other bee species (1)

Acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg insect⁻¹)

Mode of exposure

Other bee species (2)

Acute LD₅₀ (worst case from 24, 48 and 72 hour values - μg insect⁻¹)

Mode of exposure

Beneficial insects (Ladybirds)

Beneficial insects (Lacewings)

Beneficial insects (Parasitic wasps)

Beneficial insects (Predatory mites)

Beneficial insects (Ground beetles)

Aquatic ecotoxicology

Property

Value

Source; quality score; and other information

Interpretation

Temperate Freshwater Fish - Acute 96 hour LC₅₀ (mg l⁻¹)

Temperate Freshwater Fish - Chronic 21 day NOEC (mg l⁻¹)

Tropical Freshwater Fish - Acute 96 hour LC₅₀ (mg l⁻¹)

Temperate Freshwater Aquatic invertebrates - Acute 48 hour EC₅₀ (mg l⁻¹)

Temperate Freshwater Aquatic invertebrates - Chronic 21 day NOEC (mg l⁻¹)

Tropical Freshwater Aquatic invertebrates - Acute 48 hour EC₅₀ (mg l⁻¹)

Aquatic crustaceans - Acute 96 hour LC₅₀ (mg l⁻¹)

Sediment dwelling organisms - Acute 96 hour LC₅₀ (mg l⁻¹)

Sediment dwelling organisms - Chronic 28 day NOEC, static, water (mg l⁻¹)

Sediment dwelling organisms - Chronic 28 day NOEC, sediment (mg kg⁻¹)

Aquatic Plants (free-floating, fonds growth, fresh) - 7 day (mg l⁻¹)

Aquatic plants (rooted, growth rate, fresh) - 14 day (mg l⁻¹)

Algae - Acute (growth rate, fresh; mg l⁻¹)

Algae - Chronic (growth rate, fresh; mg l⁻¹)

Mesocosm study data

NOEAEC mg l⁻¹

Marine bivalves

HUMAN HEALTH AND PROTECTION

General

Property

Value

Source; quality score; and other information

Interpretation

Threshold of Toxicological Concern (Cramer Class)

Mammals - Acute oral LD₅₀ (mg kg⁻¹)

V3 Rat 12000

Low

Mammals - Dermal LD₅₀ (mg kg⁻¹ body weight)

Mammals - Inhalation LC₅₀ (mg l⁻¹)

Other Mammal toxicity endpoints

Intraperitoneal LD₅₀ > 4000 mg kg⁻¹

Rat

Subcutaneous LD₅₀ > 12000 mg kg⁻¹

Rat

ADI - Acceptable Daily Intake (mg kg⁻¹ bw day⁻¹)

ARfD - Acute Reference Dose (mg kg⁻¹ bw day⁻¹)

AAOEL - Acute Acceptable Operator Exposure Level (mg kg⁻¹ bw day⁻¹)

AOEL - Acceptable Operator Exposure Level - Systemic (mg kg⁻¹ bw day⁻¹)

Dermal penetration studies (%)

Dangerous Substances Directive 76/464

Exposure Routes

Public

Occupational

Mammalian dose elimination route and rate

Excreted mainly unchanged in the faeces in 24 hours

Health issues

Specific human health issues

Carcinogen

Genotoxic

Endocrine disruptor

; ; ; ;

No data found

Reproduction / development effects

Acetyl cholinesterase inhibitor

Neurotoxicant

No data found

Respiratory tract irritant

Skin irritant

Skin sensitiser

No data found

Eye irritant

Phototoxicant

No data found

General human health issues

May cause consipation
Possible kidney toxicant

Handling issues

Property

Value and interpretation

General

No information available

CLP classification 2013

WHO Classification

Not listed (Not listed)

UN Number

Waste disposal & packaging

Shelf-life, storage, stability and reactivity

TRANSLATIONS

Language

Name

English

sucralfate

French

German

Danish

Italian

sucralfato

Spanish

sucralfato

Greek

Polish

Swedish

Hungarian

Dutch

Norwegian

Record last updated:	12/09/2025
Contact:	aeru@herts.ac.uk
Please cite as:	Lewis, K.A., Tzilivakis, J., Warner, D. and Green, A. (2016) An international database for pesticide risk assessments and management. Human and Ecological Risk Assessment: An International Journal, 22(4), 1050-1064. DOI: 10.1080/10807039.2015.1133242