PHR3790

Polysorbate 80

certified reference material, pharmaceutical secondary standard

• Synonym(s): TWEEN^® 80, POE (20) sorbitan monooleate, Polyethylene glycol sorbitan monooleate, Polyoxyethylenesorbitan monooleate, Polysorbate 80
• CAS Number: 9005-65-6
• MDL number: MFCD00082107
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1547969
• CofA: current certificate can be downloaded
• packaging: pkg of (5x1G)
• application(s): pharmaceutical
• SMILES string: CCCCCCCC/C=C/CCCCCCCC(=O)OCCOCC(C1C(CC(O1)OCCO)OCCO)OCCO
• InChI: 1S/C32H60O10/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-30(36)40-25-24-37-27-29(39-22-19-34)32-28(38-21-18-33)26-31(42-32)41-23-20-35/h9-10,28-29,31-35H,2-8,11-27H2,1H3/b10-9+
• InChI key: RGPBUVUVZKQNHD-MDZDMXLPSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Polysorbate 80 can be used as an internal standard in the determination of Polysorbate 80 in liquid formulations, parenteral formulations and pharmaceutical suspensions using high-performance liquid chromatography.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

To see an example of a Certificate of Analysis for this material enter LRAA6959(changes by product) in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Legal Information

TWEEN is a registered trademark of Croda International PLC

Safety Information

• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable