Polysorbat 80 NF, Multi-Compendial, J.T.Baker®
Glass bottle, amber, narrow mouth, 1 L
: Avantor
- GMP manufactured product
- Vegetable based
Suitable for use in the manufacture of parenteral dosage forms.
: Sorbitanmono(cis-9-octadecenoat), ethoxyliert
- :9005-65-6
- :MFCD00082107
- :–21 °C
- :1,062 g/cm³
- :Management of Change (MOC) category = R
- :113 °C (closed cup)
- :Stue temperatur
- :500-019-9
Documents
sds_BAKR4117
SDS
spec_BAKR4117-02 spec_BAKR4117-03 spec_BAKR4117-04 spec_BAKR4117-04 spec_BAKR4117-06
Product specification
- Meets E.P. Chemical Specifications:≤2.0
- Meets B.P. Chemical Specifications:65 - 80
- Meets N.F. Requirements:Passes Test
- Meets J.P. Chemical Specifications:Passes Test
- GMP Manufactured Product:≤0.25%
- CAUTION: For Manufacturing, processing or repackaging:45 - 55
- Bulk Pharmaceutical Chemical:1.06 - 1.09
- NF - Acid Value:≤ 2.0
- NF - Hydroxyl Value:65 - 80
- NF - Identification A:Passes Test
- NF - Identification B:Passes Test
- NF - Residue on Ignition:≤ 0.25 %
- NF - Saponification Value:45 - 55
- NF - Specific Gravity at 25°C:1.06 - 1.09
- NF - Viscosity at 25°C, cSt:300 - 500
- NF - Water (H₂O):≤ 3.0 %
- NF - Peroxide Value:≤ 10.0
- NF - Ethylene Oxide:≤ 1 ppm
- NF - Dioxane:≤ 10 ppm
- NF - Composition of Fatty Acids - Myristic Acid:≤ 5.0 %
- NF - Composition of Fatty Acids - Palmitic Acid:≤ 16.0 %
- NF - Composition of Fatty Acids - Palmitoleic Acid:≤ 8.0 %
- NF - Composition of Fatty Acids - Stearic Acid:≤ 6.0 %
- NF - Composition of Fatty Acids - Oleic Acid:≥ 58.0 %
- NF - Composition of Fatty Acids - Linoleic Acid:≤ 18.0 %
- NF - Composition of Fatty Acids - Linolenic Acid:≤ 4.0 %
- EP - Acid Value:≤ 2.0
- EP - Total Ash:≤ 0.25 %
- EP - Hydroxyl Value:65 - 80
- EP - Identification A:Passes Test
- EP - Identification D:Passes Test
- EP - Peroxide Value:≤ 10.0
- EP - Ethylene Oxide:≤ 1 ppm
- EP - Dioxan:≤ 10 ppm
- EP - Saponification Value:45 - 55
- EP - Water (H₂O):≤ 3.0 %
- EP/BP - Composition of Fatty Acids - Myristic Acid:≤ 5.0 %
- EP/BP - Composition of Fatty Acids - Palmitic Acid:≤ 16.0 %
- EP/BP - Composition of Fatty Acids - Palmitoleic Acid:≤ 8.0 %
- EP/BP - Composition of Fatty Acids - Stearic Acid:≤ 6.0 %
- EP/BP - Composition of Fatty Acids - Oleic Acid:≥ 58.0 %
- EP/BP - Composition of Fatty Acids - Linoleic Acid:≤ 18.0 %
- EP/BP - Composition of Fatty Acids - Linolenic Acid:≤ 4.0 %
- Appearance:Passes Test
- JP - Acid Value:≤ 2.0
- JP - Composition of Fatty Acids - Myristic Acid:≤ 5.0 %
- JP - Composition of Fatty Acids - Palmitic Acid:≤ 16.0 %
- JP - Composition of Fatty Acids - Palmitoleic Acid:≤ 8.0 %
- JP - Composition of Fatty Acids - Stearic Acid:≤ 6.0 %
- JP - Composition of Fatty Acids - Oleic Acid:≥ 58.0 %
- JP - Composition of Fatty Acids - Linoleic Acid:≤ 18.0 %
- JP - Composition of Fatty Acids - Linolenic Acid:≤ 4.0 %
- JP - Dioxane:≤ 10 ppm
- JP - Ethylene Oxide:≤ 1 ppm
- JP - Heavy Metals (as Pb):≤ 20 ppm
- JP - Hydroxyl Value, meq KOH/g:65 - 80
- JP - Identification:Passes Test
- JP - Peroxide Value:≤ 10.0
- JP - Residue on Ignition:≤ 0.25 %
- JP - Water (H₂O):≤ 3.0 %
- JP - Saponification Value:45 - 55
- Additional Tests - Color (Gardner):≤ 7
- Additional Tests - Odor (Faint):Passes Test
- Additional Tests - Peroxide Value, meqO₂/kg:≤ 2.0
- Additional Tests - Endotoxin Concentration (EU/mL):≤ 10
- Free Ethylene Oxide:≤ 1 ppm
- 1,4-Dioxane:≤ 5 ppm
- Microbiological - Total Aerobic Microbial Count (cfu/g):≤ 100
- Microbiological - Escherichia Coli:Passes Test
- Microbiological - Pseudomonas aeruginosa:Passes Test
- Microbiological - Salmonella:Passes Test
- Microbiological - Staphylococcus aureus:Passes Test
- Microbiological - Total Yeast and Mold Count (cfu/g):≤ 50
- Ethylene glycol:≤ 0.10 %
- Diethylene glycol :≤ 0.10 %
- Pakning:Glass bottle, amber, narrow mouth
- Pakn:1 L
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