Product Name: Ixazomib Citrate
Chemical Family: Peptide-based boronic acid
Synonyms: MLN9708; Ninlaro
CAS Number: 1239908-20-9 (Ixazomib); 5-(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-3-yl)-1-[(2S)-1-oxo-3,4-dihydro-2H-1,4-benzoxazine-2-carbonyl]pyrrolidine-2-carboxamide citrate
Application: Pharmaceutical active substance, proteasome inhibitor for multiple myeloma treatment
Manufacturer: Commercially produced by various pharmaceutical manufacturers
Emergency Contact: Refer to local guidelines for emergency poisoning services and corporate safety programs
Classification (GHS): Health hazard; toxicity to reproduction, specific organ toxicity, suspected carcinogen, acute toxicity
Signal Word: Danger
Hazard Statements: Harmful if swallowed; may damage fertility or the unborn child; causes serious eye irritation; causes skin irritation; suspected of causing cancer; may cause damage to organs through prolonged exposure
Pictograms: Health hazard, exclamation mark
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Target Organs: Blood, immune system, kidneys, liver
Precautionary Statements: Avoid contact with eyes, skin, and clothing; prevent inhalation of dust; always use protective equipment in laboratory or production settings; restrict handling to trained professionals
Chemical Name: Ixazomib Citrate
Purity: 97-99% (as typically supplied)
Molecular Formula: C20H23B N2 O9
Impurities: Includes minor synthetic route intermediates; these are proprietary to manufacturer and found at trace levels only
Component Breakdown: Active pharmaceutical ingredient only, non-formulated bulk substance
Appearance: White to off-white powder
Other Ingredients: Contains variable amounts of water by weight depending on storage; residual solvent levels fall under ICH Q3C Class 2 limits
Inhalation: Remove exposed individual to fresh air immediately; restrict further exposure; medical evaluation recommended due to potential for immune and respiratory system effects
Skin Contact: Remove contaminated clothing without delay; wash affected area thoroughly with soap and water, paying close attention to broken skin and exposure duration; seek medical attention if irritation persists
Eye Contact: Rinse eyes under gentle running water for a minimum of 15 minutes; keep eyelids open throughout flushing; remove contact lenses if present; follow up with specialized healthcare if symptoms appear
Ingestion: Do not induce vomiting; wash mouth with large volumes of water; seek prompt medical attention regardless of apparent symptom severity, as systemic absorption requires monitoring
Delayed Effects: Risk for immune suppression, nausea, or neurological symptoms—ongoing observation post-exposure considered essential especially for occupational incidents
Special Advice to Healthcare Personnel: Treat symptomatically, monitor organ functions especially renal and hepatic; report severe adverse effects to pharmacovigilance service
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, foam, or water spray in fine mist; avoid high-pressure streams
Unsuitable Media: Do not use direct water jet as powder can spread
Unusual Hazards: Combustion can form hazardous fumes including nitrogen oxides, carbon monoxide, and boron compounds
Firefighters’ Protection: Wear self-contained breathing apparatus and full protective suit; ventilate enclosed spaces after fire
Additional Information: Prevent firewater from entering surface or ground water systems as pharmaceutical dust may contaminate water sources
Personal Precautions: Wear protective clothing, nitrile gloves, safety goggles, and NIOSH-approved dust mask; restrict unprotected personnel from site; isolate spill area
Environmental Precautions: Prevent release to drains and water sources; collect contaminated soil/sorbent for hazardous waste disposal
Methods of Cleaning Up: Use inert absorbent such as sand or universal binder; sweep up material with minimal dust generation and place in sealed, labeled containers; decontaminate area with detergent solution
Notification: Inform relevant local authorities if contamination risk or personnel exposure occurs; document all exposures for follow-up and regulatory compliance
Handling: Handle under local exhaust ventilation or biological safety cabinet; avoid inhalation of dust and direct skin or eye contact; strict laboratory hygiene and hand washing protocol
Storage Conditions: Store in tightly closed container in a cool, dry, well-ventilated place; avoid humidity and incompatible chemicals such as oxidizers; maintain in dark storage to prevent photodegradation
Special Storage Requirements: Label all containers with hazard statements and access controls; refrigeration not mandatory unless specified by product stability data
Incompatibilities: Strong oxidizers, acids, bases increase decomposition or fire risk
Occupational Exposure Limit: Employer should determine OEL based on risk assessment; typically in low microgram range due to cytotoxicity
Engineering Controls: Operate with local exhaust ventilation, preferably in negative pressure enclosure
Personal Protective Equipment: Disposable nitrile gloves, chemical splash goggles, fluid-resistant laboratory coat, closed shoes; respiratory protection (FFP2/P2 mask or air-purifying respirator in powder handling)
Hygiene Recommendations: Change gloves frequently; wash hands after removal of PPE; do not eat or drink in work areas; use dedicated cleaning tools
Environmental Protection: Prevent pharmaceutical dust or liquid from entering surface or ground water; treat effluents as hazardous chemical waste
Physical State: Solid powder
Color: White to off-white
Odor: Odorless
pH: Soluble in aqueous buffers—mildly acidic to neutral
Melting Point: Decomposition starts above 200°C
Boiling Point: Not applicable for solid
Solubility: Freely soluble in dimethyl sulfoxide (DMSO), slightly soluble in water
Partition Coefficient (Log P): Moderate (logP ~ 0.2-0.6, varies with salt form)
Vapor Pressure: Negligible at ambient conditions
Flammability: Non-flammable in finished powder, but can support combustion if involved in fire
Chemical Stability: Stable under recommended conditions of storage and handling
Instability: Prolonged exposure to light, acids, alkalis, or elevated temperature may initiate decomposition
Hazardous Decomposition Products: Combustion yields carbon oxides, boron oxides, and nitrogen oxides
Incompatibility: Oxidizing agents markedly increase decomposition
Polymerization: Does not undergo hazardous polymerization under standard handling
Acute Toxicity: LD50 values are not fully published; cytotoxic at low microgram doses
Chronic Toxicity: Animal data show systemic effects on bone marrow, GI tract, and immunological markers during repeated exposure
Mutagenicity: Positive in in-vitro micronucleus and chromosome aberration tests
Carcinogenicity: Not listed by IARC; in-vivo studies suggest potential for tumor promotion at high doses
Reproductive Toxicity: Evidence of embryo-fetal toxicity in animal studies even at low exposures; avoid handling during pregnancy
Sensitization: Prolonged or repeated contact can result in skin and respiratory sensitization
Medical Conditions Aggravated by Exposure: Pre-existing respiratory, renal, or hepatic dysfunction may worsen with accidental exposure
Toxicity to Aquatic Life: Ecotoxicological profile limited but suggests moderate risk to algae and aquatic invertebrates at low concentrations
Persistence and Degradability: Slow breakdown in soil and water; not readily biodegradable
Bioaccumulative Potential: No significant bioaccumulation expected due to low Log P
Mobility in Soil: Expected low mobility, binds to soil particulates
Other Adverse Effects: Potential for pharmaceutical pollution if released at production scale, stressing the need to prevent effluent discharge to watersheds
Waste Disposal Methods: Treat containers and waste as hazardous chemical; incinerate at licensed facility specializing in cytotoxic pharmaceutical disposal
Contaminated Packaging: Triple rinse or dispose with chemical waste; do not reuse
Sewage Disposal Restrictions: Never dispose material or waste solution in regular drain; always use designated chemical collection
Legal Compliance: Follow national and local regulations for hazardous industrial waste and cytostatic agents; keep records for all disposals
UN Number: Does not meet criteria for UN classification under current transport guidelines, but manufacturer label applies if bulk shipped
Proper Shipping Name: Ixazomib Citrate, pharmaceutical raw material
Transport Hazard Class: Not regulated by DOT/IATA/ADR in final form but use caution in bulk shipments; treat as hazardous if in powder form and in large quantities
Packing Group: Not assigned for this product; packaging must prevent dust formation and exposure
Special Precautions: Protect from light and moisture; do not ship with food or animal feeds
Labeling: Complies with GHS, OSHA Hazard Communication Standard where adopted; labeled as hazardous pharmaceutical dust in workplace
Inventory Status: Ixazomib and salts appear on international regulatory lists as pharmaceutical product; not covered by TSCA, DSL, or EINECS
OSHA Status: Subject to employer workplace controls due to cytotoxicity
SARA Title III: Not reportable
California Proposition 65: Not listed as of last review; check current listings
WHMIS (Canada): Controlled product, hazardous pharmaceutical agent
EU Regulations: Requires advanced controls in R&D and manufacturing per REACH standards
Additional Notes: Employers need to comply with all workplace control requirements regarding hazardous pharmaceutical substances, including documented training for workers
