alendronate sodium trihydrate|121268-17-5

Alendronic acid (INN) or alendronate sodium (USAN) — sold as Fosamax by Merck — is a bisphosphonate drug used for osteoporosis, osteogenesis imperfecta, and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 IU and 5,600 IU, under the name Fosamax+D). Merck's U.S. patent on alendronate expired in 2008 and the drug is now available as a generic. This is the most widely prescribed bisphosphonate medicine in the United States .

Alendronic Acid Monosodium Salt Trihydrate

(4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt Trihydrate

Alendronate sodium

4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid,monosodium,Alendronate sodium trihydrate

Alendronate SodiuM Trihydrate

4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid,monosodium MK-217

Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate Trihydrate

Alendronate monosodium trihydrate

Sodium alendronate

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1.Identification

1.1 GHS Product identifier

Product name	alendronate sodium trihydrate

1.2 Other means of identification

Product number	-
Other names	(4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt Trihydrate

1.3 Recommended use of the chemical and restrictions on use

Identified uses	For industry use only.
Uses advised against	no data available

1.4 Supplier's details

Company	MOLBASE (Shanghai) Biotechnology Co., Ltd.
Address	Floor 4 & 5, Building 12, No. 1001 North Qinzhou Road, Xuhui District, Shanghai, China
Telephone	+86(21)64956998
Fax	+86(21)54365166

1.5 Emergency phone number

Emergency phone number	+86-400-6021-666
Service hours	Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours).

2.Hazard identification

2.1 Classification of the substance or mixture

Acute toxicity - Oral, Category 4

Skin irritation, Category 2

Serious eye damage, Category 1

Specific target organ toxicity – single exposure, Category 3

Reproductive toxicity, Category 2

Specific target organ toxicity – repeated exposure, Category 2

Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 3

2.2 GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H302 Harmful if swallowed H315 Causes skin irritation H318 Causes serious eye damage H335 May cause respiratory irritation H361 Suspected of damaging fertility or the unborn child H373 May cause damage to organs through prolonged or repeated exposure H412 Harmful to aquatic life with long lasting effects
Precautionary statement(s)
Prevention	P264 Wash ... thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/protective clothing/eye protection/face protection. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P271 Use only outdoors or in a well-ventilated area. P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P273 Avoid release to the environment.
Response	P301+P312 IF SWALLOWED: Call a POISON CENTER/doctor/…if you feel unwell. P330 Rinse mouth. P302+P352 IF ON SKIN: Wash with plenty of water/... P321 Specific treatment (see ... on this label). P332+P313 If skin irritation occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before reuse. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER/doctor/… P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312 Call a POISON CENTER/doctor/…if you feel unwell. P308+P313 IF exposed or concerned: Get medical advice/ attention. P314 Get medical advice/attention if you feel unwell.
Storage	P403+P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up.
Disposal	P501 Dispose of contents/container to ...

2.3 Other hazards which do not result in classification

none

3.Composition/information on ingredients

3.1 Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
alendronate sodium trihydrate	alendronate sodium trihydrate	121268-17-5	none	100%

4.First-aid measures

4.1 Description of necessary first-aid measures

General advice

Consult a physician. Show this safety data sheet to the doctor in attendance.

If inhaled

If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

In case of skin contact

Wash off with soap and plenty of water. Consult a physician.

In case of eye contact

Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.

If swallowed

Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

4.2 Most important symptoms/effects, acute and delayed

no data available

4.3 Indication of immediate medical attention and special treatment needed, if necessary

no data available

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

5.2 Specific hazards arising from the chemical

no data available

5.3 Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

6.Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.

6.2 Environmental precautions

Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.

6.3 Methods and materials for containment and cleaning up

Pick up and arrange disposal. Sweep up and shovel. Keep in suitable, closed containers for disposal.

7.Handling and storage

7.1 Precautions for safe handling

Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Avoid exposure - obtain special instructions before use.Provide appropriate exhaust ventilation at places where dust is formed. For precautions see section 2.2.

7.2 Conditions for safe storage, including any incompatibilities

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.

8.Exposure controls/personal protection

8.1 Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2 Appropriate engineering controls

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

8.3 Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Safety glasses with side-shields conforming to EN166. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

Skin protection

Wear impervious clothing. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique(without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

Respiratory protection

Wear dust mask when handling large quantities.

Thermal hazards

no data available

9.Physical and chemical properties

Physical state	White Crystalline Solid
Colour	no data available
Odour	no data available
Melting point/ freezing point	208°C(lit.)
Boiling point or initial boiling point and boiling range	170°C(lit.)
Flammability	no data available
Lower and upper explosion limit / flammability limit	no data available
Flash point	63°C(lit.)
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	no data available
Partition coefficient n-octanol/water (log value)	no data available
Vapour pressure	no data available
Density and/or relative density	1.857g/cm3
Relative vapour density	no data available
Particle characteristics	no data available

10.Stability and reactivity

10.1 Reactivity

no data available

10.2 Chemical stability

Stable under recommended storage conditions.

10.3 Possibility of hazardous reactions

no data available

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

no data available

10.6 Hazardous decomposition products

no data available

11.Toxicological information

Acute toxicity

Oral: no data available
Inhalation: no data available
Dermal: no data available

Skin corrosion/irritation

no data available

Serious eye damage/irritation

no data available

Respiratory or skin sensitization

no data available

Germ cell mutagenicity

no data available

Carcinogenicity

no data available

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

12.Ecological information

12.1 Toxicity

Toxicity to fish: no data available
Toxicity to daphnia and other aquatic invertebrates: no data available
Toxicity to algae: no data available
Toxicity to microorganisms: no data available

12.2 Persistence and degradability

no data available

12.3 Bioaccumulative potential

no data available

12.4 Mobility in soil

no data available

12.5 Other adverse effects

no data available

13.Disposal considerations

13.1 Disposal methods

Product

The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.

Contaminated packaging

Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.

14.Transport information

14.1 UN Number

ADR/RID: Not dangerous goods.

IMDG: Not dangerous goods.

IATA: Not dangerous goods.

14.2 UN Proper Shipping Name

ADR/RID: unknown

IMDG: unknown

IATA: unknown

14.3 Transport hazard class(es)

ADR/RID: Not dangerous goods.

IMDG: Not dangerous goods.

IATA: Not dangerous goods.

14.4 Packing group, if applicable

ADR/RID: Not dangerous goods.

IMDG: Not dangerous goods.

IATA: Not dangerous goods.

14.5 Environmental hazards

ADR/RID: no

IMDG: no

IATA: no

14.6 Special precautions for user

no data available

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

no data available

15.Regulatory information

15.1 Safety, health and environmental regulations specific for the product in question

Chemical name	Common names and synonyms	CAS number	EC number
alendronate sodium trihydrate	alendronate sodium trihydrate	121268-17-5	none
European Inventory of Existing Commercial Chemical Substances (EINECS)			Not Listed.
EC Inventory			Not Listed.
United States Toxic Substances Control Act (TSCA) Inventory			Not Listed.
China Catalog of Hazardous chemicals 2015			Not Listed.
New Zealand Inventory of Chemicals (NZIoC)			Not Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS)			Not Listed.
Vietnam National Chemical Inventory			Not Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Not Listed.

16.Other information

Information on revision

Creation Date	Aug 10, 2017
Revision Date	Aug 10, 2017

Abbreviations and acronyms

CAS: Chemical Abstracts Service
ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
IMDG: International Maritime Dangerous Goods
IATA: International Air Transportation Association
TWA: Time Weighted Average
STEL: Short term exposure limit
LC50: Lethal Concentration 50%
LD50: Lethal Dose 50%
EC50: Effective Concentration 50%

References

IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
ECHA - European Chemicals Agency, website: https://echa.europa.eu/

Disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product.

Section 1. Chemical Product and Company Identification
    Sodium Alendronate        Catalog
    A1368, YY835
    Common Name/
    Number(s).
    Trade Name
    CAS#        121268-17-5
    Manufacturer
    Commercial Name(s)
    Sodium Alendronate

Section 4. First Aid Measures
    Eye Contact        Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at
    least 15 minutes. Cold water may be used. Get medical attention if irritation occurs.
    Skin Contact        Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
    Cold water may be used.
    Serious Skin Contact        Not available.
    Inhalation        If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
    medical attention.
    Serious Inhalation        Not available.
    Ingestion        Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
    unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight
    clothing such as a collar, tie, belt or waistband.
    Serious Ingestion        Not available.

Section 5. Fire and Explosion Data
    Flammability of the Product May be combustible at high temperature.
    Auto-Ignition Temperature Not available.
    Flash Points        Not available.
    Flammable Limits        Not available.
    These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), phosphates. Some metallic oxides.
    Products of Combustion
    Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
    Various Substances
    Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
    of Various Substances        Risks of explosion of the product in presence of static discharge: Not available.
    Fire Fighting Media        SMALL FIRE: Use DRY chemical powder.
    and Instructions        LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
    Special Remarks on        As with most organic solids, fire is possible at elevated temperatures Material in powder form, capable of creating
    Fire Hazards        a dust explosion.
    Special Remarks on Explosion Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust
    Hazards        explosion hazard.

Section 6. Accidental Release Measures
    Small Spill        Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
    spreading water on the contaminated surface and dispose of according to local and regional authority
    requirements.
    Large Spill
    Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water
    on the contaminated surface and allow to evacuate through the sanitary system.
    Sodium Alendronate

Section 7. Handling and Storage
    Precautions        Keep away from heat. Keep away from sources of ignition.
    Ground all equipment containing material. Do not breathe dust.
    Storage        Keep container tightly closed. Keep container in a cool, well-ventilated area.

Section 8. Exposure Controls/Personal Protection
    Engineering Controls        Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
    recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
    airborne contaminants below the exposure limit.
    Personal Protection
    Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
    Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
    a Large Spill        to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
    BEFORE handling this product.
    Exposure Limits        Not available.

Section 9. Physical and Chemical Properties
    Physical state and appearance Solid. (Crystalline powder.)        Odor        Not available.
    Taste        Not available.
    Molecular Weight        325.1 g/mole
    Color        White. Off-white.
    pH (1% soln/water)        Not available.
    Boiling Point        Not available.
    Melting Point        Not available.
    Critical Temperature        Not available.
    Not available.
    Specific Gravity
    Vapor Pressure        Not applicable.
    Vapor Density        Not available.
    Volatility        Not available.
    Odor Threshold        Not available.
    Not available.
    Water/Oil Dist. Coeff.
    Ionicity (in Water)        Not available.
    See solubility in water.
    Dispersion Properties
    Solubility        Soluble in cold water.
    Very slightly soluble in methanol.

Section 10. Stability and Reactivity Data
    Stability        The product is stable.
    Instability Temperature        Not available.
    Conditions of Instability        Exess heat
    Incompatibility with various        Not available.
    substances
    Corrosivity        Not available.
    Sodium Alendronate
    Not available.
    Special Remarks on
    Reactivity
    Not available.
    Special Remarks on
    Corrosivity
    Polymerization        Will not occur.

Section 11. Toxicological Information
    Routes of Entry        Inhalation. Ingestion.
    Toxicity to Animals        LD50: Not available.
    LC50: Not available.
    Chronic Effects on Humans Not available.
    Other Toxic Effects on
    Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
    Humans
    Special Remarks on        Not available.
    Toxicity to Animals
    Special Remarks on        May cause adverse reproductive effects.
    Chronic Effects on Humans
    Special Remarks on other        Potential Health Effects:
    Toxic Effects on Humans        Skin: May cause skin irritation.
    Eyes: Dust may cause eye irritation.
    Inhalation: Dust may cause respiratory tract irritation.
    Ingestion: May cause headache, dizziness, stomach/abdominal pain, abdominal distension, gas or fullness,
    nausea, vomiting, diarrhea or constipation, heartburn, irritation of the esophagus, acid reflux, dyspepsia, pain or
    difficulty swallowing, changes in taste, black or tarry stools, gastric ulcer. Other rare side effects may include
    bone, muscle or joint pain, duodenal ulcer, esophageal erosions, esophagitis, esophageal stricture, hypocalcemia,
    oropharyngeal ulceration, osteonecrosis, photosensitivity. It may rarely cause allergic reaction with skin rash,
    itiching (hives) and facial swelling.
    Medical Conditions Aggravated by Exposure: Hypersensitivity to material; kidney disease; esophageal
    abnormalities; hypocalcemia

Section 12. Ecological Information
    Ecotoxicity        Not available.
    BOD5 and COD        Not available.
    Products of Biodegradation        Possibly hazardous short term degradation products are not likely. However, long term degradation products may
    arise.
    The product itself and its products of degradation are not toxic.
    Toxicity of the Products
    of Biodegradation
    Special Remarks on the        Not available.
    Products of Biodegradation

Section 13. Disposal Considerations
    Waste Disposal        Waste must be disposed of in accordance with federal, state and local environmental
    control regulations.
    Sodium Alendronate

Section 14. Transport Information
    DOT Classification        Not a DOT controlled material (United States).
    Identification        Not applicable.
    Not applicable.
    Special Provisions for
    Transport
    DOT (Pictograms)

Section 15. Other Regulatory Information and Pictograms
    No products were found.
    Federal and State
    Regulations
    California        California prop. 65: This product contains the following ingredients for which the State of California has found
    to cause cancer which would require a warning under the statute: No products were found.
    Proposition 65
    Warnings
    California prop. 65: This product contains the following ingredients for which the State of California has found
    to cause birth defects which would require a warning under the statute: No products were found.
    Other Regulations        EINECS: This product is not on the European Inventory of Existing Commercial Chemical Substances.
    Canada: Not listed on Canadian Domestic Substance List (DSL) or Canadian Non- Domestic Substance List
    (NDSL).
    China: Not listed on National Inventory.
    Japan: Not listed on National Inventory (ENCS).
    Korea: Not listed on National Inventory (KECI).
    Philippines: Not listed on National Inventory (PICCS).
    Australia: Not listed on AICS.
    WHMIS (Canada) Not controlled under WHMIS (Canada).
    Other Classifications
    DSCL (EEC)
    This product is not classified according Not applicable.
    to the EU regulations.
    Health Hazard
    HMIS (U.S.A.)        1 National Fire Protection
    1 Flammability
    1 Association (U.S.A.)
    Fire Hazard
    1 0 Reactivity
    Health
    Reactivity
    0
    Specific hazard
    Personal Protection
    E
    WHMIS (Canada)
    (Pictograms)
    DSCL (Europe)
    (Pictograms)
    TDG (Canada)
    (Pictograms)
    Sodium Alendronate
    ADR (Europe)
    (Pictograms)
    Protective Equipment
    Gloves.
    Lab coat.
    Dust respirator. Be sure to use an
    approved/certified respirator or
    equivalent.

SECTION 16 - ADDITIONAL INFORMATION
N/A

1.Synthesis Route

1310-73-2

121268-17-5

2.Synthesis Route

66376-36-1

121268-17-5

3.Synthesis Route

56-12-2

121268-17-5

alendronate sodium trihydrate

121268-17-5

C4H18NNaO10P2

Basic Info

Properties

Safety Info

MSDS

SAFETY DATA SHEETS

According to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) - Sixth revised edition

1.Identification

1.1 GHS Product identifier

1.2 Other means of identification

1.3 Recommended use of the chemical and restrictions on use

1.4 Supplier's details

1.5 Emergency phone number

2.Hazard identification

2.1 Classification of the substance or mixture

2.2 GHS label elements, including precautionary statements

2.3 Other hazards which do not result in classification

3.Composition/information on ingredients

3.1 Substances

4.First-aid measures

4.1 Description of necessary first-aid measures

General advice

If inhaled

In case of skin contact

In case of eye contact

If swallowed

4.2 Most important symptoms/effects, acute and delayed

4.3 Indication of immediate medical attention and special treatment needed, if necessary

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

5.2 Specific hazards arising from the chemical

5.3 Special protective actions for fire-fighters

6.Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

6.2 Environmental precautions

6.3 Methods and materials for containment and cleaning up

7.Handling and storage

7.1 Precautions for safe handling

7.2 Conditions for safe storage, including any incompatibilities

8.Exposure controls/personal protection

8.1 Control parameters

Occupational Exposure limit values

Biological limit values

8.2 Appropriate engineering controls

8.3 Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

9.Physical and chemical properties

10.Stability and reactivity

10.1 Reactivity

10.2 Chemical stability

10.3 Possibility of hazardous reactions

10.4 Conditions to avoid

10.5 Incompatible materials

10.6 Hazardous decomposition products

11.Toxicological information

Acute toxicity

Skin corrosion/irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure

STOT-repeated exposure

Aspiration hazard

12.Ecological information

12.1 Toxicity

12.2 Persistence and degradability

12.3 Bioaccumulative potential

12.4 Mobility in soil

12.5 Other adverse effects

13.Disposal considerations

13.1 Disposal methods

Product