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Product Name: Acarbose
Chemical Name: O-4,6-dideoxy-4-[[{(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-en-1-yl}amino]-alpha-D-glucopyranosyl]-alpha-D-glucopyranose
Synonyms: Bay G 5421, Glucobay
CAS Number: 56180-94-0
Manufacturer: Refer to packaging or supplier information sheet
Recommended Use: Pharmaceutical agent, antidiabetic drug
Restrictions on Use: For prescription use only, not suitable for non-therapeutic applications
Emergency Contact: Refer to local or national chemical safety authority
Classification: Not classified as hazardous according to GHS criteria
Label Elements: No pictogram or hazard statement required for bulk material
Signal Word: None
Health Hazards: May cause mild irritation in eyes, nose, throat, or skin upon contact; ingestion leads to gastrointestinal effects (flatulence, diarrhea)
Environmental Hazards: Low toxicity to aquatic life; persistence in environment low due to rapid breakdown
Other Hazards: Dust generation could cause mild respiratory irritation; not combustible
Chemical Identity: Acarbose
Purity: >98% (commercial pharmaceutical grade)
Impurities: Minor related substances below 1% including deoxy-analogues and residual solvents
Excipient Content: Dependent on finished pharmaceutical formulation; tablets may carry starch, cellulose, magnesium stearate, etc.
Ingredient Listing: There are no hazardous constituents present above listed regulatory thresholds except the active ingredient
Molecular Formula: C25H43NO18
Molecular Weight: 645.6 g/mol
Inhalation: Move subject to fresh air; seek medical attention if symptoms persist such as coughing, wheezing, or shortness of breath
Skin Contact: Remove contaminated clothing; wash affected area with soap and water; consult healthcare professional if eruption or irritation develops
Eye Contact: Flush thoroughly with water for several minutes; remove contact lenses if present and easy to do; seek advice if redness or discomfort continues
Ingestion: Rinse mouth; drink water cautiously, do not induce vomiting unless directed by medical personnel; consult doctor immediately especially if large amounts are swallowed
Most Important Symptoms: Gastrointestinal discomfort, flatulence, diarrhea, possible allergic reactions in susceptible individuals
Note to Physician: Treat symptomatically, monitor for allergic response and severe dehydration if gastrointestinal side effects occur
Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or CO2 for burning packaging or other combustibles nearby
Specific Hazards: Non-flammable powder; combustion of surrounding materials may generate carbon oxides, nitrogen oxides, or toxic fumes
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing to prevent exposure
Advice for Firefighters: Apply cooling water to unaffected containers in the vicinity; keep unnecessary personnel away
Combustion Products: Decomposition may release carbon monoxide, carbon dioxide, nitrogen oxides
Special Hazards: Avoid dust inhalation, avoid contact with skin and eyes during fire and clean-up
Personal Precautions: Avoid dust formation; use personal protective equipment such as gloves, protective goggles, lab coat; ensure adequate ventilation in area
Environmental Precautions: Prevent entry into sewers or waterways; alert local authorities if spill contaminates large environment
Spill Clean-Up Methods: Sweep up material using tools to avoid dust generation; collect in suitable containers for disposal; wash spill site with water after material pick-up
Reference to Other Sections: Refer to personal protection (Section 8) and disposal information (Section 13) when handling spill clean-up
Safe Handling: Use procedures to avoid direct contact and inhalation; minimize dust generation; handle in well-ventilated area; avoid eating, drinking, or smoking during handling of bulk powder
Storage Conditions: Store in tightly closed original container, in a dry, cool, well-ventilated place; optimize storage away from heat, moisture, light, and incompatible substances such as strong oxidizers
Packaging Materials: Use moisture-proof, tamper-proof containers provided by manufacturer
Incompatibilities: Keep away from acidic and oxidizing agents to protect from decomposition
Specific Storage Requirements: Storage temperature recommended at or below 25°C; keep out of reach of unauthorized personnel
Exposure Limit Values: No established occupational exposure limits for bulk product; standard nuisance dust level (10 mg/m³ for total dust, 5 mg/m³ for respirable fraction) applies
Engineering Controls: Local exhaust ventilation or fume hood for handling powders; eye-wash stations and safety showers recommended
Respiratory Protection: NIOSH-approved respirators for dust if engineering controls do not maintain airborne levels below safe threshold
Skin Protection: Wear suitable gloves (latex, nitrile, or vinyl) and protective clothing
Eye Protection: Chemical safety goggles recommended especially during bulk handling
Hygiene Measures: Wash hands thoroughly after handling, remove contaminated clothing, do not eat or drink in work area
Environmental Protection: Prevent uncontrolled release to the environment, use containment where necessary
Appearance: White to off-white crystalline powder
Odor: Negligible or no characteristic odor
Odor Threshold: Data not available
pH: 5.0-7.0 in 1% aqueous suspension
Melting Point: 165-167°C (with decomposition)
Boiling Point: Not applicable – decomposes before boiling
Flash Point: Not determined – non-flammable
Evaporation Rate: Not applicable
Flammability: Non-flammable under standard conditions
Vapor Pressure: Negligible at ambient temperature
Vapor Density: Not applicable
Solubility: Freely soluble in water, practically insoluble in most organic solvents
Partition Coefficient (log Kow): -5.4 (very hydrophilic)
Decomposition Temperature: Above 165°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions under normal handling and storage
Possibility of Hazardous Reactions: May react with strong oxidizers or acids
Conditions to Avoid: Excessive heat, light, moisture; avoid mechanical shock and dust formation
Incompatible Materials: Strong acids, strong oxidizers
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, other hazardous fumes may form on decomposition
Acute Toxicity: Low oral toxicity; LD50 (rat, oral) >5000 mg/kg; may cause gastrointestinal upset
Skin Corrosion/Irritation: Not classified as a skin irritant in animal models; repeated or prolonged contact can lead to minor irritation
Serious Eye Damage/Irritation: May cause mild and transient irritation
Respiratory Sensitization: Data insufficient for classification; dust may cause mild respiratory tract irritation
Skin Sensitization: Not a known skin sensitizer, allergic reaction rare
Germ Cell Mutagenicity: No evidence for mutagenicity in standard in vitro and in vivo tests
Carcinogenicity: No evidence of carcinogenic effects from animal studies or epidemiological data
Reproductive Toxicity: Not teratogenic or toxic in reproduction studies in animals
Specific Target Organ Toxicity (Single Exposure): No targeted organ effects reported at therapeutic levels
Specific Target Organ Toxicity (Repeated Exposure): No chronic toxicity or organ effects at doses below or close to human exposure
Aspiration Hazard: Not applicable due to physical form
Toxicity (Aquatic and Terrestrial): Low toxicity to aquatic and terrestrial life; EC50 (Daphnia) >100 mg/L; minimal effect on soil organisms
Persistence and Degradability: Readily biodegradable in wastewater and soil microflora
Bioaccumulation Potential: Low potential for bioaccumulation due to high water solubility and low octanol-water partition coefficient
Mobility in Soil: Expected to be highly mobile but easily degraded
Other Adverse Effects: No known significant effects on ozone layer or atmospheric processes
Waste Treatment Methods: Collect spilled materials in suitable containers and contract licensed waste disposal company; do not dispose in household garbage
Contaminated Packaging: Rinse thoroughly before disposal; follow local, regional, national, or international regulations
Sewage Disposal: Do not flush in large quantities; small quantities from laboratory use can be treated in biological wastewater systems
Recommended Disposal: Incinerate at an approved facility or dispose of as chemical waste in accordance with local regulations
UN Number: Not classified as hazardous for transport
Proper Shipping Name: Acarbose (pharmaceutical substance, not otherwise specified)
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions: Protect from moisture and physical damage during transport; keep in original packaging; follow standard procedures for pharmaceuticals
Additional Notes: No special labeling or placarding required under ADR, IATA, IMDG, or DOT regulations
REACH Status: Exempt as medicinal product
US Regulatory Status: Regulated by Food and Drug Administration (FDA) as prescription medicine; not subject to OSHA hazardous chemicals standard
Canada DSL/NDSL: Listed as active pharmaceutical ingredient
EU Regulations: Authorized under pharmaceutical directives; not classified as dangerous under CLP regulation for bulk material
RoHS/ELV/WEEE Status: Not relevant to pharmaceuticals
Other National Laws: Observe occupational health and safety rules for pharmaceutical compounds in workplace
Safety/Health/Environmental Regulations: Follow applicable national and local workplace safety regulations for laboratory or manufacturing environments
Chemical Safety Assessment: Not required for products in regulated finished pharmaceutical form
