Pantoprazole sodium sesquihydrate

Safety Data Sheet

according to Regulation (EC) No. 453/2010
Revision date: 19/08/2015 : Version: 1.0

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
Product form : Substance
Substance name : Pantoprazole sodium sesquihydrate
Chemical name : 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]-sulfinyl]-, sodium
salt, hydrate (2:3)
CAS No. : 164579-32-2
Product code : PP
Formula : C16H14N3NaO4S.1.5H2O
Synonyms : 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl] sulfinyl]benzimidazole, sodium salt,
sesquihydrate
Product group : Pharmaceutical product
1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Main use category : Industrial use,Professional use
Industrial/Professional use spec. : Isolated intermediate
Function or use category : Antiulcerative

1.2.2. Uses advised against

No additional information available
1.3. Details of the supplier of the safety data sheet
Hetero drugs Ltd
7-2-A2, Hetero Corporate, Industrial Estate
500082 Hyderabad - INDIA
T 04023774009
[email protected] - www.heterodrugs.com
1.4. Emergency telephone number
No additional information available

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP]
Not classified
Classification according to Directive 67/548/EEC or 1999/45/EC
Carc.Cat.3; R40
Full text of R-phrases: see section 16.

Adverse physicochemical, human health and environmental effects

No additional information available
2.2. Label elements
Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Hazard pictograms (CLP) :

None
CLP Signal word : Warning
Hazard statements (CLP) : H335 - May cause respiratory irritation
H332 - Harmful if inhaled
H315 - Causes skin irritation
H312 - Harmful in contact with skin
H302 - Harmful if swallowed
Precautionary statements (CLP) : P102 - Keep out of reach of children
P103 - Read label before use
P201 - Obtain special instructions before use
P202 - Do not handle until all safety precautions have been read and understood
P232 - Protect from moisture
P233 - Keep container tightly closed
P234 - Keep only in original container
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Pantoprazole sodium sesquihydrate
Safety Data Sheet
according to Regulation (EC) No. 453/2010

P235+P410 - Keep cool. Protect from sunlight

EUH phrases : EUH210 - Safety data sheet available on request

2.3. Other hazards

No additional information available

SECTION 3: Composition/information on ingredients

3.1. Substances
Substance type : Multi-constituent
Name : Pantoprazole sodium sesquihydrate
CAS No. : 164579-32-2
EC no :
EC index no :
Name Product identifier % Classification according to
Directive 67/548/EEC
Acetone (CAS No.) 67-64-1 F; R11
(EC no) 200-662-2 Xi; R36
(EC index no) 606-001-00-8 R66
R67
Ethanol (CAS No.) 64-17-5 F; R11
(EC no) 200-578-6
(EC index no) 603-002-00-5
Methanol (CAS No.) 67-56-1 F; R11
(EC no) 200-659-6 T; R23/24/25-39/23/24/25
(EC index no) 603-001-00-X
Diisopropyl ether (CAS No.) 108-20-3 F; R11
(EC no) 203-560-6 R19
(EC index no) 603-045-00-X R66
R67
Dichloromethane (CAS No.) 75-09-2 Carc.Cat.3; R40
(EC no) 200-838-9
(EC index no) 602-004-00-3
5-(Difluoromethoxy)-1H-benzimidazole-2-thiol (CAS No.) 97963-62-7 Not classified

5-(Difluoromethoxy)-2-[(RS)-[3,4-dimethoxypyridin- (CAS No.) 624742-53-6 Not classified

2yl]methyl]sulfinyl]-1-methyl-1H-benzimidazole
6-(Difluoromethoxy)-2-[(RS)-[3,4-dimethoxypyridin-2- (CAS No.) 624742-53-6 Not classified
yl]methyl]sulfinyl]-1-methyl-1H-benzimidazole
5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2- Not classified
pyridyl)methyl]sulfonyl]-1H-benzimidazole
5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl]thio]- Not classified
1H-benzimidazole
Mixture of the stereo isomers of 6,6'-bis(difluoromethoxy)-2,2'- Not classified
bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1’H-5,5'-
bibenzimidazolyl
Name Product identifier % Classification according to
Regulation (EC) No.
1272/2008 [CLP]
Acetone (CAS No.) 67-64-1 Flam. Liq. 2, H225
(EC no) 200-662-2 Eye Irrit. 2, H319
(EC index no) 606-001-00-8 STOT SE 3, H336
Ethanol (CAS No.) 64-17-5 Flam. Liq. 2, H225
(EC no) 200-578-6
(EC index no) 603-002-00-5
Methanol (CAS No.) 67-56-1 Flam. Liq. 2, H225
(EC no) 200-659-6 Acute Tox. 3 (Dermal), H311
(EC index no) 603-001-00-X Acute Tox. 3 (Inhalation), H331
Acute Tox. 3 (Oral), H301
STOT SE 1, H370
Diisopropyl ether (CAS No.) 108-20-3 Flam. Liq. 2, H225
(EC no) 203-560-6 STOT SE 3, H336
(EC index no) 603-045-00-X
Dichloromethane (CAS No.) 75-09-2 Carc. 2, H351
(EC no) 200-838-9
(EC index no) 602-004-00-3
5-(Difluoromethoxy)-1H-benzimidazole-2-thiol (CAS No.) 97963-62-7 Not classified

5-(Difluoromethoxy)-2-[(RS)-[3,4-dimethoxypyridine- (CAS No.) 624742-53-6 Not classified

2yl]methyl]sulphinyl]-1-methyl-1H-benzimidazole
6-(Difluoromethoxy)-2-[(RS)-[3,4-dimethoxypyridine-2- (CAS No.) 624742-53-6 Not classified
yl]methyl]sulphinyl]-1-methyl-1H-benzimidazole
5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2- Not classified
yl)methyl]sulphonyl]-1H-benzimidazole
5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2- Not classified
yl)methyl]sulphanyl]-1H-benzimidazole

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Pantoprazole sodium sesquihydrate
Safety Data Sheet
according to Regulation (EC) No. 453/2010

Name Product identifier % Classification according to

Regulation (EC) No.
1272/2008 [CLP]
Mixture of the stereo isomers of 6,6'-bis(difluoromethoxy)-2,2'- Not classified
bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulphinyl]-1H,1H'-5,5'-
bibenzimidazolyl
Full text of R-, H- and EUH-phrases: see section 16.
3.2. Mixtures
Not applicable

SECTION 4: First aid measures

4.1. Description of first aid measures
First-aid measures general : Allow the victim to rest in a well ventilated area. Seek immediate Medical attention. check the
vital fuctions-Unconscious:maintain adequate airway andrespiration. Flush with water while
holding eyelids open for at least 15 minutes. Seek medical attention immediately.
First-aid measures after inhalation : Immediately wash skin with soap and copious Amounts of waterfor at least 15 minutes. If
Irritation persists seek medical attention . Remove the victim into fresh air-Respiratory
problems:consult a doctor/medical service. Remove to fresh air and keep patient at rest. Seek
medical attention immediately. Rewmove contaminated clothing. Flush arera with large amount
of water. USE SOAP. seek medical attention.
First-aid measures after skin contact : Rewmove contaminated clothing. Flush arera with large amount of water. USE SOAP. seek
medical attention. Wash immediately with lots of water-Sope may be used-Do not
apply(chemical)neutralizing agents-Take victim to a doctor if irritation persists.
First-aid measures after eye contact : Immediately flush eyes with running water for at least 15 minutesSeek medical attention. Rinse
immediately with lots of water-Do not apply neutralizing agents-Take victim to an
ophthalmoglogist if irritation persists. Flush with water while holding eyelids open for at least 15
minutes. Seek medical attention immediately.
First-aid measures after ingestion : If swallowed, wash out mouth with water, provided Person is conscious. Seek medical advice.
Rinse mouth with water-Immediately after ingestion:give lots of water to drink. Never give
anything by mouth to an unconscious person.Wash out mouth with water.Do not induce vomiting
unless directed by medical personnel. Seek medical attention immediately.
4.2. Most important symptoms and effects, both acute and delayed
No additional information available
4.3. Indication of any immediate medical attention and special treatment needed
No additional information available

SECTION 5: Firefighting measures

5.1. Extinguishing media
Suitable extinguishing media : Use carbon dioxide, dry chemical.
5.2. Special hazards arising from the substance or mixture
Fire hazard : Flammable with air within explosin lomits Indirect fire hazard may be ignited by sparks
Gas/vapour spreads at floor level:ignition hazard.
Explosion hazard : Not expected for the product, although the packaging is combustible.
Reactivity : Reacts slowly with air-Upon combustion CO and CO2 are formed-And formation of metallic
fumes-Reacts with (some)-metals.
5.3. Advice for firefighters
Precautionary measures fire : Fight fire from a safe distance. Wear full protective clothing. Use water spray to keep exposed
containers and equipment cool. Toxic, corrosive of flammable thermal decomposition products
are expected when the product is exposed to fire. Self-contained breathing apparatus and full
protective equipment is recommended for firefighters.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
General measures : Keep upwind-Mark the danger area-Consider evacuation-Seal off low-liing area-Close doors and
windows of adjecent premiss.

6.1.1. For non-emergency personnel

No additional information available
6.1.2. For emergency responders
No additional information available
6.2. Environmental precautions
For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage systems.

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Pantoprazole sodium sesquihydrate
Safety Data Sheet
according to Regulation (EC) No. 453/2010

6.3. Methods and material for containment and cleaning up

For containment : Absorb material with suitable materials such as clay absorbent or absorbent pads for aqueous
solutions.
Methods for cleaning up : Wipe up with a damp cloth and place in container for disposal. Clean spill area thoroughly.
Other information : Wash clothing and equipment after handling.
6.4. Reference to other sections
No additional information available

SECTION 7: Handling and storage

7.1. Precautions for safe handling
Precautions for safe handling : Gloves.
Handling temperature : 25 °C
7.2. Conditions for safe storage, including any incompatibilities
Storage conditions : Preserve in tight cotainer at 2-8ºC.
Storage temperature : 2-8 °C
Storage area : Store away from heat.
Special rules on packaging : Triple laminated aluminium package.
7.3. Specific end use(s)
No additional information available

SECTION 8: Exposure controls/personal protection

8.1. Control parameters
No additional information available

8.2. Exposure controls

Appropriate engineering controls : Engineering controls should be usd as the primary means to control exposures. General room
ventilation is adequate unless the process generates dust, mist or fumes. Kepp airborne
contamination levels below the exposure limites listed above in this section.
Personal protective equipment : Gloves. Dust production: dust mask with filter type P2. Protective clothing. Protective goggles.

Materials for protective clothing : Chloroprene rubber nitrile rubber.

Hand protection : Gloves.
Eye protection : Protective goggles.
Skin and body protection : Protective clothing.
Respiratory protection : Gas mask with filter type A.

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties
Physical state : Solid
Appearance : White to off-white powder.
Molecular mass : 432.4
Colour : White.
Odour : None.
Odour threshold : No data available
pH : No data available
Melting point : No data available
Solidification point : No data available
Boiling point : No data available
Flash point : No data available
Relative evaporation rate (butylacetate=1) : No data available
Flammability (solid, gas) : No data available
Explosive limits : No data available
Vapour pressure : No data available
Relative vapour density at 20 °C : No data available
Relative density : No data available

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Pantoprazole sodium sesquihydrate
Safety Data Sheet
according to Regulation (EC) No. 453/2010

Solubility : Freely soluble in water, in methanol and dehydrate alcohol ,Practically insolublein hexane and in
dichhlomethane.
Log Pow : No data available
Log Kow : No data available
Self ignition temperature : No data available
Decomposition temperature : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
Explosive properties : No data available
Oxidising properties : No data available
9.2. Other information
No additional information available

SECTION 10: Stability and reactivity

10.1. Reactivity
Reacts slowly with air-Upon combustion CO and CO2 are formed-And formation of metallic fumes-Reacts with (some)-metals.
10.2. Chemical stability
Stable under defined conditions.
10.3. Possibility of hazardous reactions
No additional information available
10.4. Conditions to avoid
Fine particles (such as dust and mists) may fuel fires/explosions.
10.5. Incompatible materials
As a precautionary measure. Keep away from strong oxidizers.
10.6. Hazardous decomposition products
No additional information available

SECTION 11: Toxicological information

11.1. Information on toxicological effects
Acute toxicity : Not classified
Skin corrosion/irritation : Not classified
Serious eye damage/irritation : Not classified
Respiratory or skin sensitisation : Not classified
Germ cell mutagenicity : Not classified
Carcinogenicity : Not classified
Reproductive toxicity : Not classified
Specific target organ toxicity (single exposure) : Not classified
Specific target organ toxicity (repeated : Not classified
exposure)
Aspiration hazard : Not classified

SECTION 12: Ecological information

12.1. Toxicity
Ecology - general : Freely soluble in water.
Ecology - air : Not dangerous for the ozone layer(1999/45/EC).

12.2. Persistence and degradability

Pantoprazole sodium sesquihydrate (164579-32-2)
Persistence and degradability % biodegradation.

12.3. Bioaccumulative potential

Pantoprazole sodium sesquihydrate (164579-32-2)
Bioaccumulative potential The substance has low potential for bioaccumulation.

12.4. Mobility in soil

Pantoprazole sodium sesquihydrate (164579-32-2)
Ecology - soil The substance has moderate mobility in groundwater. The substance has moderate mobility in
soil.

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Pantoprazole sodium sesquihydrate
Safety Data Sheet
according to Regulation (EC) No. 453/2010

12.5. Results of PBT and vPvB assessment

No additional information available
12.6. Other adverse effects
Other information : No other effects known.

SECTION 13: Disposal considerations

13.1. Waste treatment methods
Additional information : Wash clothiong and equipment after handling.
Ecology - waste materials : Take up liquid spil into absorbent material-Scoop absorbed substance into closing containers.

SECTION 14: Transport information

No dangerous good in sense of transport regulations.

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.1.1. EU-Regulations
No Annex XVII restrictions
Contains no REACH candidate substance

15.1.2. National regulations

No additional information available

15.2. Chemical safety assessment

No additional information available

SECTION 16: Other information

Training advice : Normal use of this product shall imply use in accordance with the instructions on the packaging.
Full text of R-, H- and EUH-phrases:
------ Acute Tox. 3 (Dermal) Acute toxicity (dermal) Category 3
------ Acute Tox. 3 (Inhalation) Acute toxicity (inhalation) Category 3
------ Acute Tox. 3 (Oral) Acute toxicity (oral) Category 3
------ Carc. 2 Carcinogenicity Category 2
------ Eye Irrit. 2 Serious eye damage/eye irritation Category 2
------ Flam. Liq. 2 Flammable liquids Category 2
------ STOT SE 1 Specific target organ toxicity (single exposure) Category 1
------ STOT SE 3 Specific target organ toxicity (single exposure) Category 3
------ H225 Highly flammable liquid and vapour
------ H301 Toxic if swallowed
------ H311 Toxic in contact with skin
------ H319 Causes serious eye irritation
------ H331 Toxic if inhaled
------ H336 May cause drowsiness or dizziness
------ H351 Suspected of causing cancer
------ H370 Causes damage to organs
------ R11 Highly flammable.
------ R19 May form explosive peroxides.
------ R23/24/25 Toxic by inhalation, in contact with skin and if swallowed.
------ R36 Irritating to eyes.
------ R39/23/24/25 Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.
------ R40 Limited evidence of a carcinogenic effect
------ R66 Repeated exposure may cause skin dryness or cracking.
------ R67 Vapours may cause drowsiness and dizziness.
------ F Highly flammable
------ T Toxic
------ Xi Irritant

SDS EU (REACH Annex II)

This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be
construed as guaranteeing any specific property of the product.

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