Melphalan Hydrochloride for Injection 50 mg/vial

SECTION 2: Hazards identification

OSHA Hazards Classification of the substance and mixture:

2.1 Classification of the substance or mixture

This product is classified as hazardous according to the OSHA Hazard Communication Standard. However, products that is subject to the labeling requirements of the Food and Drug Administration are exempt from the labeling provisions of the standard.

Signal word

Class 6.1

Hazard statements

Symbol(s), and/or

Precautionary statements

c) Description of Hazards: May cause local tissue damage should extravasation occur, as well as bone marrow suppression, possible bleeding, possible anaphylaxis, is potentially mutagenic. May cause cancer, mutagenic effects, fetal harm in pregnancy, and may also produce allergic skin reactions. (d) Unknown Acute Toxicity N/A SECTION 3 – COMPOSITION AND INGRIDIENTS Melphalan Hydrochloride for Injection Impurities / Common Stabilizing Chemical Name Name / Synonym Qty/unit CAS No. Additives Melphalan 55.95 mg Hydrochloride N/A 3223-07-2 N/A Povidone k12 N/A 20 mg 9003-39-8 N/A Hydrochloric Acid N/A q.s to pH 7647-01-0 N/A Water for Injection Water q.s. to 2.5 mL 7732-18-5 N/A Nitrogen N/A q.s 7727-37-9 N/A q.s quantity sufficient, N/A Not Applicable Sterile Diluent for Melphalan Hydrochloride for Injection Common Impurities / Chemical Name Name / Qty/unit % CAS No. Stabilizing Synonym Additives Ethanol (96%) N/A 0.52 mL 5.2 64-17-5 N/A Propylene Glycol N/A 6.0 mL 60 57-55-6 N/A Sodium Citrate N/A 0.20 g 2 6132-04-3 N/A Water for Injection Water q.s. to 10 mL 32.8 7732-18-5 N/A Nitrogen N/A q.s N/A 7727-37-9 N/A q.s quantity sufficient, N/A Not Applicable