SAFETY DATA SHEET

Page : 1 Revised edition no : 3 Date : 10 / 12 / 2009 Supersedes : 1 / 8 / 2008

MOXIFLOXACIN HYDROCHLORIDE CRS

Y0000703

X
Xn : Harmful

9 : Miscellaneous dangerous substances and articles.

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1 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

Trade name Use Directions for use Company identification : MOXIFLOXACIN HYDROCHLORIDE CRS : For laboratory tests and assays only, as described in the European Pharmacopoeia. : For any questions: www.edqm.eu/hd (HelpDesk) : EDQM 7, Alle Kastner CS 30026 F-67081 Strasbourg FRANCE Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71

2 HAZARDS IDENTIFICATION
Risk Phrases Adverse human health effects : Harmful if swallowed. - Irritating to eyes. - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. : May produce irregular heart beat. Exposure may produce an allergic reaction. This material may induce blood disorders and/or aggravate pre-existing blood disorders. Gastrointestinal disorders.

3 COMPOSITION/INFORMATION ON INGREDIENTS
Components
Substance name

: This product is hazardous.

Contents

Moxifloxacin hydrochloride

CAS No 186826-86-8

EC No -----

Annex No -----

Classification ----Xn; R22 Xi; R36 R52-53

4 FIRST AID MEASURES

First aid measures - Inhalation - Skin contact - Eye contact - Ingestion : Assure fresh air breathing. Rest. If you feel unwell, seek medical advice. : Remove affected clothing and wash all exposed skin area with mild soap and water, followed by warm water rinse. : Rinse immediately with plenty of water. Obtain medical attention if pain, blinking, tears or redness persist. : Rinse mouth. If swallowed, seek medical advice immediately and show this container or label.

In case of reactions described in hazards identification or other severe, immediate or persisting symptoms seek medical advice and call the nearest poison centre. Show the label and this safety data sheet.

5 FIRE-FIGHTING MEASURES
Extinguishing media

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7, Alle Kastner CS 30026 F-67081 Strasbourg FRANCE Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71

SAFETY DATA SHEET

Page : 2 Revised edition no : 3 Date : 10 / 12 / 2009 Supersedes : 1 / 8 / 2008

MOXIFLOXACIN HYDROCHLORIDE CRS

Y0000703

5 FIRE-FIGHTING MEASURES (continued)

- Suitable extinguishing media - Unsuitable extinguishing media Surrounding fires Protection against fire Hazardous combustion products : : : : Water spray. Carbon dioxide. Dry powder. Do not use a heavy water stream. Use water spray or fog for cooling exposed containers. Do not enter fire area without proper protective equipment, including respiratory protection. : Incomplete combustion will generate poisonous carbon monoxide, carbon dioxide and other toxic gases.

6 ACCIDENTAL RELEASE MEASURES

General precautions Personal precautions Clean up methods : Remove ignition sources. Evacuate area. : Spill should be handled by trained cleaning personnel properly equipped with respiratory and eye protection. : To clean the floor and all objects contaminated by this material, use : Water. / Detergent. Avoid dust production. Ensure adequate ventilation.

7 HANDLING AND STORAGE

Personal protection Technical protective measures Handling Storage Storage - away from : Avoid all unnecessary exposure. Ensure prompt removal from eyes, skin and clothing. : Material should be handled in a laboratory hood whenever possible. : Handle in accordance with good industrial hygiene and safety procedures. : MOXIFLOXACIN HYDROCHLORIDE CRS is not intended for long-term storage. Keep container tightly closed in a cool, well ventilated place. : All heat sources, including direct sunlight. Open flame. Sources of ignition. Sparks. Incompatible materials, see 10

8 EXPOSURE CONTROLS/PERSONAL PROTECTION

Personal protection

- Respiratory protection - Hand protection - Skin protection - Eye protection Industrial hygiene

: Wear approved mask. (P2) In case of insufficient ventilation, wear suitable respiratory equipment. : Wear suitable gloves resistant to chemical penetration. : Wear suitable protective clothing. : Chemical goggles or safety glasses. : Provide local exhaust or general room ventilation.

=8:

9 PHYSICAL AND CHEMICAL PROPERTIES

Chemical formula Molecular weight Physical state at 20 C Colour pH value Melting point [C] : : : : : : C21H25ClFN3O4 437.9 Powder. Yellow. No data available. No data available.

EDQM

7, Alle Kastner CS 30026 F-67081 Strasbourg FRANCE Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71

SAFETY DATA SHEET

Page : 3 Revised edition no : 3 Date : 10 / 12 / 2009 Supersedes : 1 / 8 / 2008

MOXIFLOXACIN HYDROCHLORIDE CRS

Y0000703

9 PHYSICAL AND CHEMICAL PROPERTIES (continued)

Boiling point [C] Solubility in water Flash point [C] Log P octanol / water at 20C : : : : No data available. Partially soluble. No data available. -1.87

10 STABILITY AND REACTIVITY

Stability and reactivity Materials to avoid Conditions to avoid Hazardous decomposition products Hazardous reactions Hazardous polymerization : : : : Stable under normal conditions. Strong oxidizers. Heat. Light. Moisture. Carbon monoxide. Carbon dioxide. Hydrogen fluoride. Chlorides. Nitrogen oxides. When heated to decomposition, emits dangerous fumes. : None under normal conditions. : Will not occur.

11 TOXICOLOGICAL INFORMATION
RTECS nr Rat oral LD50 [mg/kg] Rabbit dermal LD50 [mg/kg] Rat inhalation LC50 [mg/L/4h] Acute toxicity Chronic toxicity Sensitization : : : : : VB1983750 ( See actual entry in RTECS for complete information. ) 1320 No data available. No data available. May produce irregular heart beat. This material may induce blood disorders and/or aggravate pre-existing blood disorders. Gastrointestinal disorders. : No data available. : No data available.

12 ECOLOGICAL INFORMATION
Ecological effects information : Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. : No data available. LC50-96 Hour - fish [mg/L] EC50-48 Hour-Daphnia magna [mg/L] : No data available. : > 25 IC50-72h-Algae [mg/L] : No data available. Biodegradation [%] : No data available. Persistence - degradability : -1.87 Log P octanol / water at 20C : No data available. Bioaccumulative potential

13 DISPOSAL CONSIDERATIONS
General : Dispose of this material and its container at hazardous or special waste collection point. Dispose in a safe manner in accordance with local/national regulations.

EDQM

7, Alle Kastner CS 30026 F-67081 Strasbourg FRANCE Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71

SAFETY DATA SHEET

Page : 4 Revised edition no : 3 Date : 10 / 12 / 2009 Supersedes : 1 / 8 / 2008

MOXIFLOXACIN HYDROCHLORIDE CRS

Y0000703

14 TRANSPORT INFORMATION
Land transport - Proper shipping name - UN No. - ADR Class - ADR Packing group - Labelling ADR : ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Moxifloxacin hydrochloride) : 3077 : 9 : III

Air transport - Proper shipping name - UN No. - IATA - Class or division - IATA Packing group - IATA-Label

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: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Moxifloxacin hydrochloride) : 3077 : 9 : III

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: Xn : Harmful : R22 : Harmful if swallowed. R36 : Irritating to eyes. R52/53 : Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. : S36/37 : Wear suitable protective clothing and gloves. S61 : Avoid release to the environment. Refer to special instructions/Safety data sheets.

15 REGULATORY INFORMATION
Symbol(s) R Phrase(s)

S Phrase(s)

16 OTHER INFORMATION
Further information List of relevant R phrases : Revision - See : * : R22 : Harmful if swallowed. R36 : Irritating to eyes. R52/53 : Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

The contents and format of this SDS are in accordance with REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, as amended. DISCLAIMER OF LIABILITY The information in this SDS was obtained from sources which we believe are reliable. However, the information is provided without any warranty, express or implied, regarding its correctness. The conditions or methods of handling, storage, use or disposal of the product are beyond our control and may be beyond our knowledge. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of the product. This MSDS was prepared and is to be used only for this product. If the product is used as a component in another product, this MSDS information may not be applicable.
End of document

EDQM

7, Alle Kastner CS 30026 F-67081 Strasbourg FRANCE Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71