MedPath

Soybean oil

Generic Name
Soybean oil
Brand Names
Clinoleic, Clinolipid, Intralipid, Nutrilipid, Olimel, Periolimel
Drug Type
Biotech
CAS Number
8001-22-7
Unique Ingredient Identifier
241ATL177A

Overview

Derived from soybeans, soybean oil is a common vegetable oil and a source of polyunsaturated and saturated fatty acids. It is a complex mixture of triglycerides where per 100 g, soybean oil has 16 g of saturated fat, 23 g of monounsaturated fat, and 58 g of polyunsaturated fat. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). It is used as a cooking oil and lipid emulsion for parenteral nutrition in clinical settings. Soybean oil-based lipid emulsion is the only FDA-approved lipid formulation for clinical use.

Background

Derived from soybeans, soybean oil is a common vegetable oil and a source of polyunsaturated and saturated fatty acids. It is a complex mixture of triglycerides where per 100 g, soybean oil has 16 g of saturated fat, 23 g of monounsaturated fat, and 58 g of polyunsaturated fat. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). It is used as a cooking oil and lipid emulsion for parenteral nutrition in clinical settings. Soybean oil-based lipid emulsion is the only FDA-approved lipid formulation for clinical use.

Indication

Indicated for parenteral nutrition as a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Associated Conditions

  • Essential Fatty Acid Deficiency (EFAD)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
INTRAVENOUS
10 g in 100 mL
2022/07/25
0338-0518
INTRAVENOUS
20 g in 100 mL
2023/10/13
65219-535
INTRAVENOUS
20 g in 100 mL
2022/07/21
0338-0519
INTRAVENOUS
20 g in 100 mL
2023/05/17
0264-4460
INTRAVENOUS
30 g in 100 mL
2023/02/15
65219-537
INTRAVENOUS
3.5 g in 100 mL
2023/08/07
63323-714
INTRAVENOUS
6 g in 100 mL
2019/08/30
63323-820
INTRAVENOUS
20 g in 100 mL
2022/07/21
0338-0519
INTRAVENOUS
20 g in 100 mL
2023/10/13
65219-531
INTRAVENOUS
20 g in 100 mL
2019/01/09
0338-0519

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
INJECTION
200 mg/ml
1990/12/15
SIN05269P
INJECTION, EMULSION
8.7g/1000ml
2021/03/24
SIN16136P
EMULSION
80.00g/1000ml
2009/03/16
SIN13614P
INJECTION, EMULSION
60g per 1000ml
2007/04/12
SIN13246P
INJECTION
100.0g/1000ml
1991/04/08
SIN05658P
INJECTION, EMULSION
8.7g/1000ml
2021/03/24
SIN16135P
INJECTION, EMULSION
16.00g/1000ml
2018/04/23
SIN15468P
INJECTION, EMULSION
16.00g/1000ml
2023/03/07
SIN16734P
INJECTION
35.0 g/l
2001/11/16
SIN11718P
INJECTION, EMULSION
16.00g/1000ml
2018/04/23
SIN15469P

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date
HK-62246
Part 1, Schedule 1 & Schedule 3 Poison
POM
2013/10/24
HK-60999
b. braun medical (hk) ltd
Part 1, Schedule 1 & Schedule 3 Poison
POM
2012/01/11
HK-61000
b. braun medical (hk) ltd
Part 1, Schedule 1 & Schedule 3 Poison
POM
2012/01/11

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
180546
Active
2012/01/09
Soya Oil
136599
Active
2007/09/04
Soya Oil
141396
Active
2007/09/04
Soya Oil
197417
Active
2013/08/09
Soya Oil
303755
Active
2019/07/01
Soya Oil
329619
Active
2020/08/27
Soya Oil
77745
Active
2001/12/11
Soya Oil
180550
Active
2012/01/09
Soya Oil
173891
Active
2012/01/09
Soya Oil
329617
Active
2020/08/27
Soya Oil
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