SHANGYU JINGXIN PHARMACEUTICAL CO., LTD.

MSDS for Simvastatin

Material Safety Data Sheet

Revision Date: 10 September 2016

1 - PRODUCT AND COMPANY IDENTIFICATION

Common Name: Simvastatin

Use: Active Pharmaceutical Ingredient

Company identification: SHANGYU JINGXIN PHARMACEUTICAL CO., LTD.

NO. 31 WEISAN ROAD, HANGZHOU BAY
SHANGYU ECONOMIC AND
TECHNOLOGICAL DEVELOPMENT AREA,
SHANGYU, ZHEJIANG PROVINCE, CHINA-312369
Phone: +86-575-82728326 Fax: +86-575-82728551

2 - HAZARD IDENTIFICATION

2.1 Classification of the substance or mixture

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.

This substance is not classified as dangerous according to Directive 67/548/EEC.

2.2 Label elements

The product does not need to be labelled in accordance with EC directives or respective national
laws.

2.3 Other hazards – none

3 - COMPOSITION/INFORMATION ON INGREDIENTS
Common Name: Simvastatin
Formula C25H38O5
Synonym: Synvinolin
Chemical Name: Butanoic acid, 2,2-dimethyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-
(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester, [1S-
[1alpha, 3alpha, 7beta, 8beta-(2S*, 4S*), 8a beta]]-
CAS: 79902-63-9
RTECS Number: EK7798000
Chemical Family: Lactone
Therapeutic Category: Antihyperlipidemic (HMG-CoA reductase inhibitor)
Composition: Pure Material

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

4 - FIRST AID MEASURES

4.1 Description of 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

Flush eyes with water as a precaution.

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

4.2 Most important symptoms and effects, both acute and delayed
The most important known symptoms and effects are described in the labelling (see section 2.2)
and/or in section 11.

4.3 Indication of any immediate medical attention and special treatment needed
no data available

4.4 Overdose Treatment

For current information about the treatment of overdose, consult a certified Regional Poison Control
Center by calling the number listed in your local telephone directory.

5 - FIREFIGHTING MEASURES

5.1 Extinguisher Media:

Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and
materials.

5.2 Fire and Explosion Hazards:

This material is assumed to be combustible. As with all dry powders, it is advisable to ground
mechanical equipment in contact with dry material to dissipate the potential buildup of static
electricity.

5.3 Firefighting Procedures:

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

equipment and protective clothing.

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.
Avoid breathing dust. For personal protection see section 8.

6.2 Environmental precautions

Do not let product enter drains.

6.3 Methods and materials for containment and cleaning up

Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed
containers for disposal.

6.4 Reference to other sections

For disposal see section 13.

7 - HANDLING AND STORAGE

7.1 Precautions for safe handling

Avoid formation of dust and aerosols.

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.

7.3 Recommended storage temperature:

NMT 30 °C

74 Specific end use(s)

Apart from the uses mentioned in section 1.2 no other specific uses are stipulated

8 - EXPOSURE CONTROL / PERSONAL PROTECTION

8.1 Engineering Controls:

Engineering controls such as exhaust ventilation are recommended.

8.2 Respiratory Protection:

Use a NIOSH-approved respirator, if it is determined to be necessary by an industrial hygiene
survey involving air monitoring. In the event that a respirator is not required, an approved dust mask
should be used.

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

8.3 Gloves
Chemically compatible

8.4 Eye Protection

Safety goggles or glasses

8.5 Protective Clothing

Protect exposed skin.

8.6 Exposure Limits

TWA (industry): 0.025 mg/m3

9 - PHYSICAL AND CHEMICAL PROPERTIES

Properties as indicated on the MSDS are general and not necessarily specific to the simvastatin Lot
provided.

Appearance and Odor: White to off-white crystalline powder.

Odor Threshold: n/f

pH: n/f

Melting Range: 135 - 138° C

Boiling Point: n/f

Flash Point: n/f

Autoignition Temperature: 755° F

Evaporation Rate: n/f

Upper Flammability Limit: n/f

Lower Flammability Limit: n/f

Vapor Pressure: n/f

Vapor Density: n/f

Specific Gravity: n/f

Solubility in Water: Practically insoluble

Fat Solubility: n/f

Other Solubility: Freely soluble in alcohol, in chloroform, in methyl alcohol; sparingly soluble in
propylene glycol; very slightly soluble in petroleum spirit.

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

Partition Coefficient: n-octanol/water: 4.68

Percent Volatile: n/f

Reactivity in Water: n/f

Explosive Properties: n/f

Oxidizing Properties: n/f

Formula: C25H38O5

Molecular Weight: 418.6

10 - STABILITY AND REACTIVITY

1.0 Conditions to Avoid

Avoid exposure to heat and light.

10.2 Incompatibilities
Oxidizing agents.

10.3 Decomposition Products

Emits toxic fumes under fire conditions.

10.4 Stable?
Yes

10.5 Hazardous Polymerization?

No

11 - TOXICOLOGICAL PROPERTIES

Oral Rat: LD50: 4438 mg/kg

Oral Mouse: LD50: 3 grams/kg

Other Toxicity Data: Oral Dog LD50: >5 grams/kg

Irritancy Data: Skin/Rabbit: slight to moderate; Eye/Rabbit: slight

Corrosivity: n/f

Sensitization Data: n/f

Listed as a Carcinogen by: NTP: No IARC: No OSHA: No

Other Carcinogenicity Data:

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

Studies in mice at doses 3.5 and 33 times the maximum recommended human dose found an
increased incidence of liver carcinomas and lung adenomas in the mid- and high-dose groups of
both sexes. Eye adenomas were increased in the high-dose group of both sexes. A two-year study in
rats exposed to simvastatin concentrations 45 times hugher than those in humans given 40 mg
revealed an increased incidence of thyroid follicular adenomas.

Mutagenicity Data:
No evidence of mutagenicity was noted by a microbial mutagen test using mutant strains of S.
typhimurium with or without rat or mouse liver metabolic activation. No evidence of mutagenicity
was seen in an in vitro chromosomal aberration assay in mouse bone marrow. There was also no
evidence of damage to genetic material in in vitro alkaline elution assays using rat or mouse
hepatocytes, a V-79 mammalian cell forward mutation study, or an in vitro chromosome aberration
study in CHO cells.

Reproductive and Developmental Effects:

Decreased fertility was noted in rat and dog studies with simvastatin. There have been reports of
congenital anomalies in children born to women taking simvastatin early in the first trimester. There
is concern that the cholesterol-lowering effect of HGM-CoA reductase inhibitors can have an
adverse effect on development of the embryo.

12 - ECOLOGICAL INFORMATION

Ecological Information:
Toxic to aquatic species. May cause long-term adverse effects in the aquatic environment. LC50
Daphnia Magna: 5.9 mg/L

13 - DISPOSAL CONSIDERATIONS

Waste treatment methods

Product
Offer surplus and non-recyclable solutions to a licensed disposal company. Dissolve or mix the
material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner
and scrubber.

Contaminated packaging
Dispose of as unused product.

14 -TRANSPORT INFORMATION

14.1 UN number
ADR/RID: - IMDG: - IATA: -

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SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. MSDS for Simvastatin

14.2 UN proper shipping name

ADR/RID: Not dangerous goods

IMDG: Not dangerous goods

IATA: Not dangerous goods

14.3 Transport hazard class(es)

ADR/RID: - IMDG: - IATA: -

14.4 Packaging group

ADR/RID: - IMDG: - IATA: -

14.5 Environmental hazards

ADR/RID: no IMDG Marine pollutant: no IATA: no

14.6 Special precautions for user

no data available

15 - REGULATORY INFORMATION

Chinese Regulatory Information: n/f

International Regulatory Information: EINECS#: 404-520-2

16 - OTHER INFORMATION

Prepared by: Shangyu Jingxin Pharmaceutical Co., Ltd.

Further information: None

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

n/f=not found

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