Sds 1236

SAFETY DATA SHEET
This safety data sheet was created pursuant to the requirements of:
Regulation (EC) No. 1907/2006 and Regulation (EC) No. 1272/2008
Revision date 05-May-2023 Revision Number 3
SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
Product Code(s) CAT 1236
Product Name Moxonidine Impurity Standard
Form Not applicable
Pure substance/mixture Mixture
1.2. Relevant identified uses of the substance or mixture and uses advised against
Recommended use Laboratory use
Uses advised against No information available
1.3. Details of the supplier of the safety data sheet
Supplier
British Pharmacopoeia Commission

MHRA
10 South Colonnade
Canary Wharf
London E14 4PU
United Kingdom
Tel : +44 (0)20 3080 6561

eMail: bpcrs@mhra.gov.uk
For further information, please contact
E-mail address bpcrs@mhra.gov.uk
1.4. Emergency telephone number
Emergency Telephone +44 (0)20 3080 6561 (Monday - Friday: 8am - 5pm)
Emergency Telephone - §45 - (EC)1272/2008

Europe 112
Austria No information available
Bulgaria
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EGHS / EN Page 1 / 16
SAFETY DATA SHEET
CAT 1236 - Moxonidine Impurity Standard

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Croatia
Cyprus
Czech Republic
Denmark
France
Hungary
Ireland
Italy
Lithuania
Luxembourg
Netherlands
Norway
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
SECTION 2: Hazards identification

2.1. Classification of the substance or mixture
Regulation (EC) No 1272/2008
Acute toxicity - Oral Category 3 - (H301)
Specific target organ toxicity — single exposure Category 3 - (H336)
Chronic aquatic toxicity Category 2 - (H411)
2.2. Label elements
Contains Moxonidine
Signal word
Danger
Hazard statements
H301 - Toxic if swallowed
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H336 - May cause drowsiness or dizziness
H411 - Toxic to aquatic life with long lasting effects
Precautionary Statements - EU (§28, 1272/2008)

P264 - Wash face, hands and any exposed skin thoroughly after handling
P273 - Avoid release to the environment
P301 + P310 - IF SWALLOWED: Immediately call a POISON CENTER or doctor
P391 - Collect spillage
P501 - Dispose of contents/ container to an approved waste disposal plant
2.3. Other hazards
Toxic to aquatic life.
This mixture contains no substance considered to be persistent, bioaccumulating or toxic (PBT). This mixture contains no
substance considered to be very persistent nor very bioaccumulating (vPvB).
Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors.
Chemical name EU - REACH (1907/2006) - Article 59(1) EU - REACH (1907/2006) - Endocrine
- Candidate List of Substances of Very Disruptor Assessment List of
High Concern (SVHC) for Authorisation Substances
Moxonidine - -
6-Chloromoxonidine - -
6-O-Desmethyl Moxonidine - -
4-Hydroxy Moxonidine - -
4-Methoxymoxonidine - -
SECTION 3: Composition/information on ingredients

3.1 Substances
Not applicable
3.2 Mixtures
Chemical name Weight-% REACH registration EC No (EU Classification according Specific M-Factor M-Factor
number Index No) to Regulation (EC) No. concentration (long-term)
1272/2008 [CLP] limit (SCL)
Moxonidine 90 - - 629-833-3 Acute Tox. 3 (H301)
75438-57-2 100% STOT SE 3 (H336)
Aquatic Chronic 2
(H411)
6-Chloromoxonidine 0 - 10% - - Acute Tox. 3 (H301)

SAFETY DATA SHEET

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352457-35-3
6-O-Desmethyl 0 - 10% - - Acute Tox. 3 (H301)
Moxonidine STOT SE 3 (H336)
352457-33-1 Aquatic Chronic 2
(H411)
4-Hydroxy 0 - 10% - - Acute Tox. 3 (H301)

Moxonidine STOT SE 3 (H336)
352457-34-2 Aquatic Chronic 2
(H411)
4-Methoxymoxonidi 0 - 10% - 75439-01-9 Acute Tox. 3 (H301)

ne Aquatic Chronic 2
75439-01-9 (H411)
Full text of H- and EUH-phrases: see section 16
Acute Toxicity Estimate

No information available
This product does not contain candidate substances of very high concern at a concentration >=0.1% (Regulation (EC) No.
1907/2006 (REACH), Article 59)
SECTION 4: First aid measures

4.1. Description of first aid measures
General advice Show this safety data sheet to the doctor in attendance.
Inhalation Remove to fresh air. IF exposed or concerned: Get medical advice/attention.
Eye contact Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids.
Consult a doctor.
Skin contact Wash skin with soap and water. In the case of skin irritation or allergic reactions see a
doctor.
Ingestion Do NOT induce vomiting. Rinse mouth. Never give anything by mouth to an unconscious
person. Get medical attention.
4.2. Most important symptoms and effects, both acute and delayed
Symptoms Inhalation of high vapour concentrations may cause symptoms like headache, dizziness,
SAFETY DATA SHEET

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tiredness, nausea and vomiting.
4.3. Indication of any immediate medical attention and special treatment needed
Note to doctors Treat symptomatically.
SECTION 5: Firefighting measures

5.1. Extinguishing media
Suitable Extinguishing Media Use extinguishing measures that are appropriate to local circumstances and the
surrounding environment.
Large Fire CAUTION: Use of water spray when fighting fire may be inefficient.
Unsuitable extinguishing media Do not scatter spilled material with high pressure water streams.
5.2. Special hazards arising from the substance or mixture
Specific hazards arising from the No information available.

chemical
5.3. Advice for firefighters
Special protective equipment and Firefighters should wear self-contained breathing apparatus and full firefighting turnout gear.
precautions for fire-fighters Use personal protection equipment.
SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
Personal precautions Ensure adequate ventilation. Use personal protective equipment as required. Evacuate
personnel to safe areas.
Other information Refer to protective measures listed in Sections 7 and 8.
For emergency responders Use personal protection recommended in Section 8.
6.2. Environmental precautions
Environmental precautions See Section 12 for additional Ecological Information.
6.3. Methods and material for containment and cleaning up
Methods for containment Prevent further leakage or spillage if safe to do so.

SAFETY DATA SHEET

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Methods for cleaning up Take up mechanically, placing in appropriate containers for disposal.
Prevention of secondary hazards Clean contaminated objects and areas thoroughly observing environmental regulations.
6.4. Reference to other sections
Reference to other sections See section 8 for more information. See section 13 for more information.
SECTION 7: Handling and storage

7.1. Precautions for safe handling
Advice on safe handling Handle in accordance with good industrial hygiene and safety practice. Ensure adequate
ventilation. Avoid breathing vapours or mists. In case of insufficient ventilation, wear suitable
respiratory equipment.
General hygiene considerations Avoid contact with skin, eyes or clothing. Do not eat, drink or smoke when using this
product. Wash hands before breaks and after work. Wear suitable gloves and eye/face
protection.
7.2. Conditions for safe storage, including any incompatibilities
Storage Conditions Please refer to the manufacturer's certificate for specific storage and transport temperature
conditions. Store only in the original receptacle unless other advice is given on the CoA.
Keep containers tightly closed in a dry, cool and well-ventilated place. Keep out of the reach
of children.
7.3. Specific end use(s)
Risk Management Methods (RMM) The information required is contained in this Safety Data Sheet.
SECTION 8: Exposure controls/personal protection

8.1. Control parameters
Exposure Limits This product, as supplied, does not contain any hazardous materials with occupational
exposure limits established by the region specific regulatory bodies.
Biological occupational exposure limits

This product, as supplied, does not contain any hazardous materials with biological limits established by the region specific
SAFETY DATA SHEET

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regulatory bodies
Derived No Effect Level (DNEL) No information available.

Predicted No Effect Concentration No information available.
(PNEC)
8.2. Exposure controls
Personal protective equipment
Eye/face protection Avoid contact with eyes. Wear safety glasses with side shields (or goggles).
Hand protection The protective gloves to be used must comply with the specifications of EC Directive
89/686/EEC and the related standard EN374. Wear protective nitrile rubber gloves.
Skin and body protection Wear suitable protective clothing.
Respiratory protection No protective equipment is needed under normal use conditions. If exposure limits are
exceeded or irritation is experienced, ventilation and evacuation may be required.
General hygiene considerations Avoid contact with skin, eyes or clothing. Do not eat, drink or smoke when using this
product. Wash hands before breaks and after work. Wear suitable gloves and eye/face
protection.
Environmental exposure controls Do not allow into any sewer, on the ground or into any body of water.
SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties
Physical state Solid
Appearance Solid
Colour white
Odour Odourless.
Odour threshold No information available
Property Values Remarks • Method

Melting point / freezing point No data available None known
Initial boiling point and boiling rangeNo data available None known
Flammability No data available None known
Flammability Limit in Air None known
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Upper flammability or explosive No data available
limits
Lower flammability or explosive No data available
limits
Flash point No data available None known
Autoignition temperature No data available None known
Decomposition temperature None known
pH No data available None known
pH (as aqueous solution) No data available No information available
Kinematic viscosity No data available None known
Dynamic viscosity No data available None known
Water solubility No data available None known
Solubility(ies) No data available None known
Partition coefficient No data available None known
Vapour pressure No data available None known
Relative density No data available None known
Bulk density No data available
Liquid Density No data available
Relative vapour density No data available None known
Particle characteristics
Particle Size No information available
Particle Size Distribution No information available
9.2. Other information
9.2.1. Information with regards to physical hazard classes

Not applicable
9.2.2. Other safety characteristics

SECTION 10: Stability and reactivity

10.1. Reactivity
Reactivity No information available.
10.2. Chemical stability
Stability Stable under normal conditions.
Explosion data
Sensitivity to mechanical impact None.
Sensitivity to static discharge None.
10.3. Possibility of hazardous reactions

SAFETY DATA SHEET

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Possibility of hazardous reactions None under normal processing.
10.4. Conditions to avoid
Conditions to avoid None known based on information supplied.
10.5. Incompatible materials
Incompatible materials None known based on information supplied.
Hazardous decomposition products None known based on information supplied.
SECTION 11: Toxicological information

11.1. Information on hazard classes as defined in Regulation (EC) No 1272/2008
Information on likely routes of exposure
Product Information
Inhalation May cause drowsiness or dizziness.
Eye contact Specific test data for the substance or mixture is not available.
Skin contact Specific test data for the substance or mixture is not available.
Ingestion Specific test data for the substance or mixture is not available. Toxic if swallowed. (based on
components).
Symptoms related to the physical, chemical and toxicological characteristics
Symptoms Inhalation of high vapour concentrations may cause symptoms like headache, dizziness,
tiredness, nausea and vomiting.
Numerical measures of toxicity

Acute toxicity
The following values are calculated based on chapter 3.1 of the GHS document
ATEmix (oral) 100.00 mg/kg
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Component Information
Chemical name Oral LD50 Dermal LD50 Inhalation LC50

Moxonidine = 100 mg/kg ( Rat )
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Skin corrosion/irritation Based on available data, the classification criteria are not met.
Serious eye damage/eye irritation No information available.
Respiratory or skin sensitisation No information available.
Germ cell mutagenicity No information available.
Carcinogenicity No information available.
Reproductive toxicity No information available.
STOT - single exposure May cause drowsiness or dizziness.
STOT - repeated exposure No information available.
Aspiration hazard No information available.
11.2. Information on other hazards
11.2.1. Endocrine disrupting properties
Endocrine disrupting properties No information available.
11.2.2. Other information
Other adverse effects No information available.

SAFETY DATA SHEET

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SECTION 12: Ecological information
12.1. Toxicity
Ecotoxicity Toxic to aquatic life. Toxic to aquatic life with long lasting effects.
Unknown aquatic toxicity Contains 0 % of components with unknown hazards to the aquatic environment.
12.2. Persistence and degradability
Persistence and degradability No information available.
12.3. Bioaccumulative potential
Bioaccumulation No information available.
Component Information
Chemical name Partition coefficient
Moxonidine 0.9
12.4. Mobility in soil
Mobility in soil No information available.
12.5. Results of PBT and vPvB assessment
PBT and vPvB assessment No information available.
12.6. Endocrine disrupting properties
Endocrine disrupting properties No information available.
12.7. Other adverse effects

No information available.
SECTION 13: Disposal considerations

13.1. Waste treatment methods
Waste from residues/unused Dispose of in accordance with local regulations. Dispose of waste in accordance with
products environmental legislation.
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Contaminated packaging Do not reuse empty containers.
SECTION 14: Transport information

IATA
14.1 UN number or ID number UN2811
14.2 UN proper shipping name Toxic solid, organic, n.o.s. (Moxonidine)
14.3 Transport hazard class(es) 6.1
14.4 Packing group III
Description UN2811, Toxic solid, organic, n.o.s. (Moxonidine), 6.1, III
14.5 Environmental hazards Yes
14.6 Special precautions for user
Special Provisions A3, A5
ERG Code 6L
IMDG
Description UN2811, Toxic solid, organic, n.o.s., 6.1, III, Marine pollutant
14.5 Marine pollutant P
Environmental hazards Yes
Special Provisions 223, 274
EmS-No F-A, S-A No information available
14.7 Maritime transport in bulk No information available
according to IMO instruments
RID
Description UN2811, Toxic solid, organic, n.o.s. (Moxonidine), 6.1, III, Environmentally Hazardous
Classification code T2
ADR
SAFETY DATA SHEET

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Description UN2811, Toxic solid, organic, n.o.s. (Moxonidine), 6.1, III, (E), Environmentally Hazardous
Classification code T2
Tunnel restriction code (E)
SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
National regulations
Germany
Water hazard class (WGK) non-hazardous to water (nwg)
Poland SDS created according to the following Polish regulation: Act of February 25, 2011 on
chemical substances and their mixtures (Journal of Laws of 2018, item 143, as
amended). Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH), establishing the European Chemicals Agency (EC) as amended. Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on classification, labeling and packaging of substances and mixtures, as
amended. Regulation of the Minister of Health of 10 August 2012 on the criteria and
method of classifying chemical substances and their mixtures (Journal of Laws of
2012, item 1018). Regulation of the Minister of Health of 20 April 2012 on labeling
packaging of hazardous substances and mixtures and some mixtures (Journal of
Laws of 2012, item 445). Regulation of the Minister of Family, Labor and Social Policy
of 12 June 2018 on the maximum allowable concentrations and intensities of factors
harmful to health in the work environment (Journal of Laws of 2018, item 1286).
Announcement of the Minister of Economy, Labor and Social Policy of August 28,
2003 on the publication of the unified text of the Ordinance of the Minister of Labor
and Social Policy on general health and safety at work regulations (Journal of Laws
of 2003, No. 169, item 1650) . Regulation of the Minister of Health of 30 December
2004 on occupational safety and health related to the presence of chemical agents in
the workplace (Journal of Laws of 2005, No. 11, item 86). Act of December 14, 2012 on
waste (Journal of Laws of 2013, item 21) Regulation of the Minister of Health of
December 30, 2004 on occupational health and safety related to the presence of
chemical agents in the workplace (Journal U. of 2005, No. 11, item 86). Waste Act of
December 14, 2012 (Journal of Laws of 2013, item 21). Act of 13 June 2013 on the
management of packaging and packaging waste, Journal of Laws 2013, item 888).
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Government statement of September 24, 2002 - European Agreement on the
International Carriage of Dangerous Goods by Road (ADR) (Journal of Laws No. 194,
item 1629 and Journal of Laws of 2003, No. 207, item 2013 and 2014).
European Union
Take note of Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents
at work.
Authorisations and/or restrictions on use:

This product does not contain substances subject to authorisation (Regulation (EC) No. 1907/2006 (REACH), Annex XIV) This
product does not contain substances subject to restriction (Regulation (EC) No. 1907/2006 (REACH), Annex XVII)
DIRECTIVE (EU) 2021/1187 on the marketing and use of explosives precursors

Not applicable
Persistent Organic Pollutants

Not applicable
Dangerous substance category per Seveso Directive (2012/18/EU)

E2 - Hazardous to the Aquatic Environment in Category Chronic 2
Ozone-depleting substances (ODS) regulation (EC) 1005/2009

Not applicable
International Inventories
TSCA Contact supplier for inventory compliance status
DSL/NDSL Contact supplier for inventory compliance status
EINECS/ELINCS Contact supplier for inventory compliance status
ENCS Contact supplier for inventory compliance status
IECSC Contact supplier for inventory compliance status
KECL Contact supplier for inventory compliance status
PICCS Contact supplier for inventory compliance status
AIIC Contact supplier for inventory compliance status
Legend:
TSCA - United States Toxic Substances Control Act Section 8(b) Inventory
DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List
EINECS/ELINCS - European Inventory of Existing Chemical Substances/European List of Notified Chemical Substances
ENCS - Japan Existing and New Chemical Substances
IECSC - China Inventory of Existing Chemical Substances
KECL - Korean Existing and Evaluated Chemical Substances
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PICCS - Philippines Inventory of Chemicals and Chemical Substances
AICS - Australian Inventory of Chemical Substances
15.2. Chemical safety assessment
Chemical Safety Report A Chemical Safety Assessment is not required for this substance
SECTION 16: Other information

Key or legend to abbreviations and acronyms used in the safety data sheet
Full text of H-Statements referred to under section 3

H301 - Toxic if swallowed
H336 - May cause drowsiness or dizziness
H411 - Toxic to aquatic life with long lasting effects
Legend
SVHC: Substances of Very High Concern for Authorisation:
Legend Section 8: Exposure controls/personal protection

TWA TWA (time-weighted average) STEL STEL (Short Term Exposure Limit)
Ceiling Maximum limit value * Skin designation
Classification procedure
Classification according to Regulation (EC) No. 1272/2008 [CLP] Method Used
Acute oral toxicity Calculation method
Acute dermal toxicity Calculation method
Acute inhalation toxicity - gas Calculation method
Acute inhalation toxicity - Vapour Calculation method
Acute inhalation toxicity - dust/mist Calculation method
Skin corrosion/irritation Calculation method
Serious eye damage/eye irritation Calculation method
Respiratory sensitisation Calculation method
Skin sensitisation Calculation method
Mutagenicity Calculation method
Carcinogenicity Calculation method
Reproductive toxicity Calculation method
STOT - single exposure Calculation method
STOT - repeated exposure Calculation method
Acute aquatic toxicity Calculation method
Chronic aquatic toxicity Calculation method
Aspiration hazard Calculation method
Ozone Calculation method
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Key literature references and sources for data used to compile the SDS
Agency for Toxic Substances and Disease Registry (ATSDR)
U.S. Environmental Protection Agency ChemView Database
European Food Safety Authority (EFSA)
EPA (Environmental Protection Agency)
Acute Exposure Guideline Level(s) (AEGL(s))
U.S. Environmental Protection Agency Federal Insecticide, Fungicide, and Rodenticide Act
U.S. Environmental Protection Agency High Production Volume Chemicals
Food Research Journal
Hazardous Substance Database
International Uniform Chemical Information Database (IUCLID)
Japan GHS Classification
Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
NIOSH (National Institute for Occupational Safety and Health)
National Library of Medicine's ChemID Plus (NLM CIP)
National Library of Medicine’s PubMed database (NLM PUBMED)
National Toxicology Program (NTP)
New Zealand's Chemical Classification and Information Database (CCID)
Organisation for Economic Co-operation and Development Environment, Health, and Safety Publications
Organisation for Economic Co-operation and Development High Production Volume Chemicals Programme
Organisation for Economic Co-operation and Development Screening Information Data Set
World Health Organization
Revision date 05-May-2023
This material safety data sheet complies with the requirements of Regulation (EC) No. 1907/2006
Disclaimer
The information in this safety data sheet (SDS) has been prepared with due care and is true and accurate to the best of
our knowledge. The user must determine the suitability of the information for its particular purpose, ensure compliance
with existing laws and regulations, and be aware that other or additional safety or performance considerations may arise
when using, handling and/ or storing the material. The information in this SDS does not purport to be all inclusive or a
guarantee as to the properties of the material supplied, and should be used only as a guide. British Pharmacopoeia
Commission Office makes no warranties or representations as to the accuracy and completeness of the information
contained herein, shall not be heldresponsible for the suitability of this information for the user's intended purposes or
the consequences of such use, and shall not be liable for any damage or loss, howsoever arising, direct or otherwise.
End of Safety Data Sheet

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SAFETY DATA SHEET

Revision date 05-May-2023 Revision Number 3

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

Product Code(s) CAT 1236

Product Name Moxonidine Impurity Standard

Form Not applicable

Pure substance/mixture Mixture

Recommended use Laboratory use

Uses advised against No information available

1.3. Details of the supplier of the safety data sheet

British Pharmacopoeia Commission

Tel : +44 (0)20 3080 6561

For further information, please contact

E-mail address bpcrs@mhra.gov.uk

1.4. Emergency telephone number

Emergency Telephone - §45 - (EC)1272/2008

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard

SECTION 2: Hazards identification

2.2. Label elements

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard

Precautionary Statements - EU (§28, 1272/2008)

2.3. Other hazards

Toxic to aquatic life.

SECTION 3: Composition/information on ingredients

6-Chloromoxonidine 0 - 10% - - Acute Tox. 3 (H301)

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard

4-Hydroxy 0 - 10% - - Acute Tox. 3 (H301)

4-Methoxymoxonidi 0 - 10% - 75439-01-9 Acute Tox. 3 (H301)

Full text of H- and EUH-phrases: see section 16

Acute Toxicity Estimate

SECTION 4: First aid measures

Inhalation Remove to fresh air. IF exposed or concerned: Get medical advice/attention.

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard

Note to doctors Treat symptomatically.

SECTION 5: Firefighting measures

5.2. Special hazards arising from the substance or mixture

Specific hazards arising from the No information available.

5.3. Advice for firefighters

SECTION 6: Accidental release measures

Other information Refer to protective measures listed in Sections 7 and 8.

For emergency responders Use personal protection recommended in Section 8.

6.2. Environmental precautions

Environmental precautions See Section 12 for additional Ecological Information.

6.3. Methods and material for containment and cleaning up

Methods for containment Prevent further leakage or spillage if safe to do so.

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard

6.4. Reference to other sections

SECTION 7: Handling and storage

7.2. Conditions for safe storage, including any incompatibilities

7.3. Specific end use(s)

SECTION 8: Exposure controls/personal protection

Biological occupational exposure limits

Revision date 05-May-2023 Revision Number 3

CAT 1236 - Moxonidine Impurity Standard