Microsoft word - msds_loratadine impurity standard_cat875.doc
BRITISH PHARMACOPOEIA CHEMICAL REFERENCE SUBSTANCE MATERIAL SAFETY DATA SHEET
The substance to which this Safety Data Sheet relates is supplied exclusively as a British Pharmacopoeia Chemical Reference Substance (BPCRS) for chemical test and assay purposes. It is not intended to be used for any other purpose and is not for human consumption. The BPCRS is supplied in accordance with the Terms of Trade and Supply as set out in the catalogue. The information set out in this sheet is applicable solely to the substance when used as a BPCRS and is not intended to apply to any other use or preparation of the substance (e.g. at different concentrations, in drug dosage form or in bulk quantities). The information which follows has been assembled from sources considered reliable, in particular from material provided in the ordinary way by the manufacturer or supplier. It has not been independently verified by the British Pharmacopoeia. The accuracy of the information cannot therefore be guaranteed, nor does it constitute any expression of opinion by the British Pharmacopoeia concerning the substance. This information is not to be regarded as a representation or statement concerning the quality or safety of the substance except that of use as a BPCRS by professional persons having technical skill and at their own discretion and risk. All persons using BPCRS materials must determine the risks associated with the substance depending on the actual conditions of use and should take appropriate measures. Information given in sections 2, 3, 4, 5, 6, 9, 10, 11, 12 and 13 relates to the bulk substance and is not necessarily relevant to the BPCRS regarding the small quantities contained in vials. Information in sections 1, 7, 8 and 14 applies only to the BPCRS. 1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY
LORATADINE IMPURITY STANDARD BPCRS Caution! This substance is a mixture. It’s properties have not been fully investigated. Information given in this MSDS refers to the main component; loratadine.
British Pharmacopoeia Commission Secretariat
Telephone: +44 (0)20 3080 6561 (office hours) Email: [email protected] Emergency telephone: +44 (0)20 3080 6561 (office hours) Reference standard for laboratory use 2. HAZARDS IDENTIFICATION May cause skin, eyes and respiratory tract irritation. Symbol: Xi R-phrases: None 3. COMPOSITION/INFORMATION ON INGREDIENTS
Loratadine containing a small quantity (< 1 %) of impurity E C22H23ClN2O2 (loratadine) 4. FIRST AID MEASURES
Inhalation: Remove to fresh air. If breathing becomes difficult, call a physician. Skin contact: Flush with copious amounts of water and soap for at least 15 minutes. Remove contaminated clothing and shoes. Eye contact: Assure adequate flushing by separating the eyelids with fingers. Flush with copious amounts of water for at least 15 minutes. Ingestion: Wash out mouth with water and administer fresh water provided person is conscious. In any case seek medical advice and call the nearest poison centre. Show the label and this safety data sheet. 5. FIRE FIGHTING MEASURES
Extinguishing media: Water spray. Carbon dioxide, dry chemical powder or appropriate foam. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 6. ACCIDENTAL RELEASE MEASURES
Wear self-contained breathing apparatus, rubber boots and heavy rubber gloves. Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pick up is complete. 7. HANDLING AND STORAGE
Handling: Avoid inhalation. Avoid contact with eyes, skin and clothing. Avoid prolonged or repeated exposure. Storage: Keep unopened in the original container at about 2-8 °C. Protect from heat. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Respiratory protection: Protecting mask (filter P1). Hand protection: Compatible chemical-resistant gloves. Eye protection: Wear protective chemical safety goggles. 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: White or almost white, crystalline powder. Solubility: Prac
BRITISH PHARMACOPOEIA CHEMICAL REFERENCE SUBSTANCE 
