Note: Ingredients listed on restricted chemical lists
EC/CAS
200-334-9/57-50-1
Name of the chemical
Sucrose, pure C12H22O11
Concentration
N/A
EC/CAS
500-019-9/9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
0.3-0.7
General Information
Version
4.01
Revision date
2025-07-21
Product name
Xyntha (Moroctocog alfa; Antihemophilic Factor VIII)
Product name
Xyntha (Moroctocog alfa; Antihemophilic Factor VIII)
Identification on the label/Trade name
XYNTHA
Product Synonyms
ReFacto AF
Chemical name
Not determined
1.2.1 Relevant identified uses
Pharmaceutical product used as coagulant
Icons in SDS
Company Information
company name
Pfizer Inc
e-mail address of the competent person responsible for the Safety Data Sheet
pfizer-MSDS@pfizer.com
GHS Information
Signal word
Not classified
Section 2
SECTION 2: Hazards identification
OSHA Classification of the substance or mixture
2.3 Other hazards
Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).
Signal word
Not classified
Hazard statements
Not classified in accordance with international standards for workplace safety. Unknown acute toxicity 0.3 - 0.7 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 0.3 - 0.7 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 0.3 - 0.7 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). Unknown aquatic toxicity Contains 0.3 - 0.7 % of components with unknown hazards to the aquatic environment.
PBT Substances
& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.
2.1 Classification of the substance or mixture
GHS - Classification: This mixture is classified as not hazardous according to regulation (EC) 1272/2008 [CLP]. OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable
