Claris Limited Material Safety Data Sheet Injectables Limited · 2015. 2. 4. · Ciprofloxacin 0.2...

Material Safety Data Sheet

1. PRODUCT IDENTIFICATION

2. COMPOSITION INFORMATION

Component Weight% CAS# OSHA PELACGIH TLV

Ciprofloxacin 0.2 85721-33-1 NONE NONE

Dextrose Monohydrate 5.0 5996-10-1 NONE NONE

Lactic Acid

Material Safety Data Sheet >94.0

7732-18-5

NONE

NONE.

3. HAZARD IDENTIFICATION

Routes of Entry: Ciprofloxacin Injection may be absorbed via contact with skin or

eyes; inhalation of aerosols or accidentally ingested. Under normal use with

supervision of a physician, Ciprofloxacin Injection presents little hazard.

Health Hazard (Acute & Chronic): Ciprofloxacin is used as a gram-negative and

gram-positive antibiotic and may affect the digestive, central nervous system and

kidneys. Minimal health hazard is expected upon occupational exposure.

General Effects of Exposure: .

Acute Effects of Exposure: Acute overexposure to this product may cause nausea,

diarrhea, vomiting, headache, rash, phototoxicity, and abdominal pain /discomfort.

Due to the packaging of this product worker exposure is not expected to occur,

however, if accidental release of the product does occur, contact with this product

may cause slight eye and skin irritation based on the pH of this product

Chronic Effects of Exposure:

Chronic overexposure to this product may cause tremor, restlessness, and

lightheadedness

Carcinogenicity:

NTP? None

IARC Monographs? None

OSHA Regulated? None

Page 2 of 11

EMERGENCY OVERVIEW: Material is clear to yellow liquid. Avoid

contact with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly. after handling.

Claris Injectables Limited Corporate Headquarters, Ellisbridge

Ahmedabad – 380006, Indiawww.clarislifesciences.com

Water for Injection

Injectables Limited

http://www.clarislifesciences.com/


Signs & Symptoms of Exposure: Acute signs and symptoms of exposure may

include eye, skin, and respiratory irritation. May cause nausea, vomiting, abdominal

pain, headache, nervousness, restlessness, or skin rash.

Medical Conditions Generally Aggravated by Exposure: Hypersensitivity to any

component of the preparation.

4. FIRST AID MEASURES

Eye Exposure: Flush eyes with large volumes of water for 15 minutes or more.

Seek treatment from a physician.

Skin Exposure: Wash skin with cool, soapy water. Remove contaminated clothing.

Contact a physician if irritation develops.

Ingestion: If ingestion occurs, flush mouth with water and seek medical attention

immediately. If person in conscious, induce vomiting; never induce vomiting on in

unconscious person. Contact poison control center.

Inhalation: If difficulty breathing, administer oxygen. Seek medical attention

immediately. If necessary, provide artificial respiration. Overdose should be treated

symptomatically

NOTES TO HEALTH PROFESSIONALS:See patient package insert in case pack/carton for complete information.

Page 3 of 11



Injectables Limited



5. FIRE AND EXPLOSION HAZARD DATA

Flash Point (Method Used): Not applicable

Lower Explosion Limit: Not Established (LEL%)

Upper Explosion Limit: Not Established (UEL %)

Flammable Limits: Not applicable

Extinguishing Media: Use water or multi-purpose ABC extinguisher

Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe

area. Fire fighters must wear self-contained breathing apparatus to avoid inhalation

of smoke. Product is not expected to present a fire hazard concern.

Unusual Fire/Explosion Hazards: None known

6. ACCIDENTAL RELEASE INFORMATION

Release to Land: Absorb Ciprofloxacin with absorbent materials and dispose

according to local, state, and federal guidelines. Prevent contact with sewers and

waterways. Wash area with soap and water. Wear personal protective equipment.

Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill

immediately to prevent evaporation. Wear respiratory protection as necessary.

Page 4 of 11



Injectables Limited



7. PRECAUTION FOR SAFE HANDLING AND USE

Steps to be taken in case material is released or spilled: See Section 6 above.

Wear all necessary protective equipment including nitrile or latex gloves, protective

clothing, safety glasses. A dust/mist respirator (N95) may be necessary if excessive

aerosols are generated. Large spills may require the use of protective coveralls,

boots, double gloves and SCBAs.

Waste Disposal Method: Dispose of according to local, state, and federal

guidelines. Incineration at a licensed facility is recommended.

Precautions to be taken in handling and storing: Store between 5º to 25°C (41º

to 77°F). Protect from light, avoid excessive heat, protect from freezing.

Keep this and all drugs out of the reach of children. Store in a dry place away from

excessive hear. Containers should be kept tightly closed to prevent contamination.

Use normal precaution for storage of a drug. Avoid contact with eyes. Avoid

contact with skin or clothing. Wash thoroughly after handling.

Storage Temperature:

Minimum: 5°C (41°F)

Maximum: 25°C (77°F)

Shelf Life: Do not use after expiration date.

Other Precautions: None identified.

8. CONTROL MEASURES AND PERSONAL PROTECTIVE

EQUIPMENT

Page 5 of 11



Injectables Limited

Release to Water: Refer to the local water authority; drain disposal is not recommended. Refer to local, state, and federal guidelines.



Respiratory Protection: Under normal use, respirators should not be required if

adequate ventilation is available. A dust/mist respirator (N95) may be necessary if

excessive aerosols are generated.

For large spill emergencies, self-contained breathing apparatus (SCBA) may be

required.

Personnel wearing respirators should be fit tested and approved for respirator use

under the OSHA Respiratory Protection Standard, 29 CFR 1910.134.

Ventilation: Handle product in a well-ventilated area.

Protective Gloves: Nitrile or latex

Eye Protection: Safety glasses or goggles

Other Protective Clothing or Equipment: Lab coat

Work/Hygienic Practices: Wash hands following use. No eating, drinking, or

smoking when handling this product.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Liquid

Specific Gravity: Approx. to water

Appearance: A clear colorless to pale yellow solution

Melting Point/Range: Not applicable

Boiling Point/Range: Approximate to water

Evaporation Rate: Approx. to water

Vapor Pressure: Approximate to water

Page 6 of 11



Injectables Limited



10. STABILITY AND REACTIVITY DATA

Stability: Stable

Incompatibility (Materials to Avoid): Oxidizing agents. See product insert and

the physicians’ Desk Reference (PDR) for Drug Interaction.

Hazardous Decomposition or Byproducts: Decomposition products of this

compound may include potentially hazardous byproducts of nitrogen oxides, carbon

monoxide, carbon dioxide, and hydrogen fluoride.

Hazardous Polymerization: Will not occur.

Conditions to Avoid: None identified

11. TOXICOLOGICAL INFORMATION

Carcinogenicity: After daily dosing to mice and rats for upto 2 years, there is no

evidence that Ciprofloxacin has any carcinogenic or tumorigenic effects in these

species.

Mutogenicity: 2 of the 8 invitro mutogenicity tests conducted with Ciprofloxacin

were positive, but 3 in vivo test systems gave negative results.

Page 7 of 11



Injectables Limited

Solubility in Water: Soluble

Vapor Density: Approximate to water

pH: 3.5-4.6



Page 8 of 11



Injectables Limited

evidence of impaired fertility or harm to the fetus due to ciprofloxacin.

Reproductive Toxicity: Reproduction studies have been performed in rats and mice at doses upto 6 times the usual daily human dose and have revealed no



For Ciprofloxacin: RTECS # VB1993800

LD50, oral, mouse = 5 mg/kg

LD50, subcutaneous, mouse ≥ 1 gm/kg

LD50, oral, rat ≥ 2 gm/kg

LD50, subcutaneous, rat ≥ 1 gm/kg

LD50, intravenous, mouse = 122 mg/kg

LD50, intraperitoneal, mouse = 1165 mg/kg

LD50, intravenous, rat = 207 mg/kg

12. ENVIRONMENTAL IMPACT INFORMATION

Information is currently not available on the environmental impact of

Ciprofloxacin. Handle in a manner that prevents spills or releases to the

environment

13. DISPOSAL INFORMATION

Ciprofloxacin should be disposed of in accordance with national, state, local, or

applicable regulations. Incineration at an approved, permitted facility is

recommended.

14. TRANSPORTATION INFORMATION

Ciprofloxacin is not a DOT Hazardous Material. Ciprofloxacin is not a Marine

Pollutant.

Page 9 of 11



Injectables Limited



15. REGULATORY INFORMATION

United States Federal Regulations

OSHA Hazcom Standard Rating: Non-Hazardous

TSCA Inventory List: This product is exempt from TSCA Regulation under

Section 3(2)(B)(vi) when used for pharmaceutical

application.

CERCLA Hazardous Substance: None

SARA Title III

SARA Section 302 Extremely Hazardous Substances: Exempt

SARA Section 311/312 Hazard Categories: Exempt from SARA Section 311/312

SARA Section 313 Toxic Chemicals: Exempt

RCRA Status: If discarded in its

purchased form, this product would not be a hazardous

waste either by listing or by characteristic. However,

under RCRA, it is the responsibility of the product user to

determine at the time of disposal, whether a material

containing the product or derived from the product should

be classified as a hazardous waste. (40 CFR 261.20-

24)

The following chemicals are specifically listed by individual states; other product

specific health and safety data in other sections of the MSDS may also be

applicable for state requirements. For details on your regulatory requirements you

should contact the appropriate agency in your state.

Page 10 of 11



Injectables Limited



16. OTHER DATA

The information in this document is believed to be correct as of the date issued.

HOWEVER, NO WARRANTY OF MERCHANTABILITY, FITNESS FOR

ANY PARTICULAR PURPOSE, OR ANY OTHER WARRANTY IS

EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY OR

COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE

OBTAINED FROM THE USE OF THIS INFORMATION OR THE

PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE HAZARDS

RELATED TO ITS USE. This information and product are furnished on the

condition that the person receiving them shall make his own determination as to the

suitability of the product for his particular purpose and on the condition that he

assumes the risk of his use thereof.

Page 11 of 11



Injectables Limited

Claris Limited Material Safety Data Sheet Injectables Limited · 2015. 2. 4. · Ciprofloxacin 0.2...

Documents

Transcript of Claris Limited Material Safety Data Sheet Injectables Limited · 2015. 2. 4. · Ciprofloxacin 0.2...