SAFETY DATA SHEET

1. Identification
Product identifier Azelastine Hydrochloride
Other means of identification
Catalog number 1046158
CAS number 79307-93-0
Chemical name 4-(p-Chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-phthalazinone
monohydrochloride
Recommended use Specified quality tests and assay use only.
Recommended restrictions Not for use as a drug. Not for administration to humans or animals.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
Company name U. S. Pharmacopeia
Address 12601 Twinbrook Parkway
Rockville
MD
20852-1790
United States
Telephone RS Technical Services 301-816-8129
Website www.usp.org
E-mail RSTECH@usp.org
Emergency phone number CHEMTREC within US & 1-800-424-9300
Canada
CHEMTREC outside US & +1 703-527-3887
Canada

2. Hazard(s) identification
Physical hazards Not classified.
Health hazards Acute toxicity, oral Category 4
Reproductive toxicity Category 2
Environmental hazards Not classified.
OSHA defined hazards Not classified.

Label elements

Signal word Warning

Hazard statement Harmful if swallowed. Suspected of damaging fertility or the unborn child.
Precautionary statement
Prevention Obtain special instructions before use. Do not handle until all safety precautions have been read
and understood. Wash thoroughly after handling. Wear protective gloves/protective clothing/eye
protection/face protection.
Response If swallowed: Call a poison center/doctor if you feel unwell. Rinse mouth. If exposed or concerned:
Get medical advice/attention.
Storage Store locked up.
Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.
Hazard(s) not otherwise None known.
classified (HNOC)
Supplemental information Potent pharmacologically active material.

Material name: Azelastine Hydrochloride USP SDS US

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3. Composition/information on ingredients
Substance
Chemical name Common name and synonyms CAS number %
Azelastine Hydrochloride 79307-93-0 100

4. First-aid measures
Inhalation Move to fresh air. Call a physician if symptoms develop or persist.
Skin contact Wash off with soap and water. Get medical attention if irritation develops and persists.
Eye contact Rinse with water. Get medical attention if irritation develops and persists.
Ingestion Rinse mouth. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs.
Get medical advice/attention if you feel unwell.
Most important Potent pharmacologically active material. Occupational exposure to small amounts may cause
symptoms/effects, acute and physiological effects.
delayed
Indication of immediate Provide general supportive measures and treat symptomatically.
medical attention and special
treatment needed
General information Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from
an occupational health physician or other licensed health-care provider familiar with workplace
chemical exposures. In the United States, the national poison control center phone number is
1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give
oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must
receive immediate medical attention.

5. Fire-fighting measures
Suitable extinguishing media Water. Foam. Dry chemical or CO2. Use fire-extinguishing media appropriate for surrounding
materials.
Unsuitable extinguishing None known.
media
Specific hazards arising from No unusual fire or explosion hazards noted.
the chemical
Special protective equipment Wear suitable protective equipment.
and precautions for firefighters
Fire fighting Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area.
equipment/instructions Firefighters should use self-contained breathing equipment and protective clothing.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
General fire hazards No unusual fire or explosion hazards noted.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Wear appropriate personal protective equipment. Avoid
protective equipment and inhalation of dust from the spilled material. Do not touch damaged containers or spilled material
emergency procedures unless wearing appropriate protective clothing. Ensure adequate ventilation. For personal
protection, see section 8 of the SDS.
Methods and materials for Avoid the generation of dusts during clean-up. Sweep up or vacuum up spillage and collect in
containment and cleaning up suitable container for disposal. Clean surface thoroughly to remove residual contamination. For
waste disposal, see section 13 of the SDS.
Environmental precautions Avoid discharge into drains, water courses or onto the ground.

7. Handling and storage

Precautions for safe handling As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of
dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with
suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin
thoroughly. Select and use containment devices and personal protective equipment based on a
risk assessment of material potency and exposure potential.
Conditions for safe storage, Store in tight container as defined in the USP-NF. This material should be handled and stored per
including any incompatibilities label instructions to ensure product integrity.

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8. Exposure controls/personal protection
Exposure limit values
Industrial Use
Material Type Value
Azelastine Hydrochloride TWA 50 micrograms/m3
(CAS 79307-93-0)
Biological limit values No biological exposure limits noted for the ingredient(s).
Appropriate engineering No open handling. For laboratory operations, use approved ventilation or containment system
controls (biological safety cabinet, ventilated balance enclosure, glovebox). Control exposures to below the
occupational exposure level (if available). Select and use containment devices and personal
protective equipment based on a risk assessment of exposure potential. Cover all containers for
solutions and slurries while being transferred.
Individual protection measures, such as personal protective equipment
Eye/face protection Wear safety glasses with side shields, chemical splash goggles, or full face shield, if necessary.
Base the choice of protection on the job activity and potential for contact with eyes or face. An
emergency eye wash station should be available.
Skin protection
Hand protection Consider double gloves. Wear nitrile or other impervious gloves if skin contact is possible. When
the material is dissolved or suspended in an organic solvent, wear gloves that provide protection
against the solvent.
Other Train employees in proper gowning and degowning practices. Wear disposable lab coat,
disposable sleeve covers and two pair of gloves as appropriate for the task. Base the choice of
skin protection on the job activity, potential for skin contact and solvents and reagents in use. Do
not wear protective garments in common areas (e.g., cafeterias) or out-of-doors.
Respiratory protection Use a powered air-purifying respirator (PAPR) with HEPA filters, disposable outerware and head
cover for spill cleanup. Choose respiratory protection appropriate to the task and the level of
existing engineering controls.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.

General hygiene Pharmacological effects may be seen with occupational exposure. Handling practices in this SDS
considerations are recommendations for laboratory use of reference standards. Procedures for any other uses or
quantities should be determined after an appropriate assessment.

9. Physical and chemical properties

Appearance Appearance descriptions are general information and not specific to any USP lot.
Physical state Solid.
Form Crystalline powder.
Color White.
Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point 437 - 444.2 °F (225 - 229 °C)
Initial boiling point and boiling Not available.
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density Not available.
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Solubility(ies)
Solubility (water) Sparingly soluble.
Solubility (other) Dichloromethane: Soluble.
Methanol: Sparingly soluble.
Propylene glycol: Sparingly soluble.
Ethanol: Slightly soluble.
Octanol: Slightly soluble.
Glycerine: Slightly soluble.
Partition coefficient 0.169
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Other information
Molecular formula C22H24ClN3O . HCl
Molecular weight 418.36
pH in aqueous solution 5 - 5.4

10. Stability and reactivity

Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Stable at normal conditions.
Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid Contact with incompatible materials.
Incompatible materials Strong oxidizing agents.
Hazardous decomposition Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. NOx. Cl-.
products

11. Toxicological information

Information on likely routes of exposure
Inhalation Knowledge about health hazard is incomplete.
Skin contact Knowledge about health hazard is incomplete.
Eye contact Knowledge about health hazard is incomplete.
Ingestion Harmful if swallowed.
Symptoms related to the Bitter or metallic taste. Drowsiness. Headache. Dry mouth. Fatigue.
physical, chemical and
toxicological characteristics
Information on toxicological effects
Acute toxicity Harmful if swallowed.
Product Species Test Results
Azelastine Hydrochloride (CAS 79307-93-0)
Acute
Oral
LD50 Dog 107 mg/kg
Guinea pig 126 mg/kg
Mouse 143 mg/kg
Rat 580 mg/kg
410 mg/kg
Skin corrosion/irritation Knowledge about health hazard is incomplete.
Serious eye damage/eye Based on available data, the classification criteria are not met.
irritation

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 Local effects
0.1 % Single dose irritation test
Result: Irritant.
Species: Rabbit
Organ: Eye
Severity: Slight.
0.2 % Repeated dose irritation test
Result: Non-irritant.
Species: Rabbit
Organ: Eye
Irritation test
Result: Negative.
Species: Rabbit
Organ: Eye
Respiratory or skin sensitization
Respiratory sensitization Knowledge about sensitization hazard is incomplete.
Skin sensitization Based on available data, the classification criteria are not met.
0.2 % Sensitization test
Result: Non-sensitizing.
Species: Guinea pig
Organ: Skin
Germ cell mutagenicity Knowledge about mutagenicity is incomplete.
Carcinogenicity Based on available data, the classification criteria are not met.
Two year rat and mice oral study, (30 mg/kg and 25 mg/kg,
respectively)
Result: No evidence of carcinogenicity. This is approximately
240 and 100 time the max recommended daily intranasal dose
in adults.
IARC Monographs. Overall Evaluation of Carcinogenicity
Not listed.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
US. National Toxicology Program (NTP) Report on Carcinogens
Not listed.
Reproductive toxicity Suspected of damaging fertility or the unborn child.
This material has been shown to cause developmental toxicity in animal studies. No fertility
impairing effects were seen in animal studies.
Reproductivity
Embryo-fetal development study
Result: Caused structural abnormalities (oligo-and
brachydactylia), delayed ossification, and skeletal variations,
in the absence of maternal toxicity.
Species: Rat
Specific target organ toxicity - Knowledge about health hazard is incomplete.
single exposure
Specific target organ toxicity - Knowledge about health hazard is incomplete.
repeated exposure
Aspiration hazard Based on available data, the classification criteria are not met.
Further information Potent pharmacologically active material. Occupational exposure to small amounts may cause
physiological effects.

12. Ecological information

Ecotoxicity The product is not classified as environmentally hazardous. However, this does not exclude the
possibility that large or frequent spills can have a harmful or damaging effect on the environment.
Persistence and degradability No data is available on the degradability of this substance.
Bioaccumulative potential
Octanol/water partition coefficient log Kow
0.169
Mobility in soil No data available.

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Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.

13. Disposal considerations

Disposal instructions Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the
user of the product to determine, at the time of disposal, whether the product meets RCRA criteria
for hazardous waste.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused Empty containers or liners may retain some product residues. This material and its container must
products be disposed of in a safe manner (see: Disposal instructions).
Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied.

14. Transport information

DOT
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
Transport in bulk according to Not applicable.
Annex II of MARPOL 73/78 and
the IBC Code
General information It is the shipper's responsibility to determine the correct transport classification at the time of
shipment.

15. Regulatory information

US federal regulations This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication
Standard, 29 CFR 1910.1200.
Toxic Substances Control Act (TSCA)
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous Yes
chemical
Classified hazard Acute toxicity (any route of exposure)
categories Reproductive toxicity
SARA 313 (TRI reporting)
Not regulated.

Other federal regulations

Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act Not regulated.
(SDWA)

Material name: Azelastine Hydrochloride USP SDS US

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US state regulations
California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material
is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. For
more information go to www.P65Warnings.ca.gov.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) No
Canada Domestic Substances List (DSL) No
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical No
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory No
Philippines Philippine Inventory of Chemicals and Chemical Substances No
(PICCS)
Taiwan Taiwan Chemical Substance Inventory (TCSI) Yes
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).

16. Other information, including date of preparation or last revision

Issue date 11-06-2012
Revision date 11-23-2020
Version # 03
Disclaimer USP Reference Standards are sold for chemical test and assay purposes only, and NOT for
human consumption. The information contained herein is applicable solely to the chemical
substance when used as a USP Reference Standard and does not necessarily relate to any other
use of the substance described, (i.e. at different concentrations, in drug dosage forms, or in bulk
quantities). USP Reference Standards are intended for use by persons having technical skill and
at their own discretion and risk. This information has been developed by USP staff from sources
considered reliable but has not been independently verified by the USP. Therefore, the USP
Convention cannot guarantee the accuracy of the information in these sources nor should the
statements contained herein be considered an official expression. NO REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information contained
herein.

Material name: Azelastine Hydrochloride USP SDS US

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