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IMWITOR® 742
Product Name IMWITOR® 742
INCI Name Caprylic/ Capric Glycerides
Product Description:
IMWITOR 742 is a blend of mono-, di- and triglycerides, manly of caprylic (C8H16O2) and capric acid (C10H20O2). Glycerol and fatty acids are derived from vegetable sources.
Characteristic values
Tests Value Unit Method
Acid value 2 Max mg KOH/g Ph.Eur. 2.5.1
Saponification value 250 - 280 mg KOH/g Ph. Eur. 2.5.6
Iodine color value 6 Max g I/100 g DGF C-IV4a
Peroxide value 1 Max mequi O/kg Ph.Eur. 2.5.5
Water content 0.5 Max % Ph. Eur. 2.5.12
Monoglyceride 45.0 – 55.0 % Ph. Eur. 2.2.30
Diglycerides 20.0 – 50.0 % Ph. Eur. 2.2.30
Triglyceride 10 Max % Ph. Eur. 2.2.30
Free glycerol 2 Max. % Ph. Eur. 2.2.30
Heavy metals 10 Max ppm Ph. Eur. 2.4.8
Arsenic 3 Max ppm Ph. Eur. 2.4.2
Alkaline reacting substances 0.30 Max ml 0.01M HCl/2 g Ph. Eur. 2.4.19
Hydroxyl value 310 – 340 mg KOH/g Ph. Eur. 2.5.3
Unsaponifiable matter 0.5 Max % Ph. Eur. 2.5.7
Ash 0.1 Max % Ph. Eur. 2.4.16
Iodine value 1 Max mg I/100 mg Ph. Eur. 2.5.4
Caproic acid (C6:0) 3 Max % Ph. Eur. 2.4.22
Caprylic acid (C8:0) 50.0 – 90.0 % Ph. Eur. 2.4.22
Capric acid (C10:0) 10.0 – 50.0 % Ph. Eur. 2.4.22
Lauric acid (C12:0) 3 Max % Ph. Eur. 2.4.22
Myristic acid (C14:0) 1 Max % Ph. Eur. 2.4.22
Palmitic acid (16:0) 0.1 Max % Ph. Eur. 2.4.22
Stearic Acid (C18:0) 0.1 Max % Ph. Eur. 2.4.22
Organic Volatile Impurities meets USP
IMWITOR 742 is registered under Drug Master File no. 10508
*USP methods are validated against Ph.Eur. methods and do lead to the same results. For the following 4 parameters the USP monograph requires 90 – 110 % of the values, indicated on the labels:
Monoglyceride: 52.0 %
Saponification value: 256
Hydroxyl value: 325
Iodine value: < 1
The requirement of 90 – 110 % of label claim is fully covered by the specification ranges in absolute terms.
APPLICATIONS
Pharmaceutical IMWITOR 742 is used in used in oral, topical, rectal, vaginal und nasal preparations in the amount of 3 – 15 %, depending upon the kind and quantity of the active ingredients used.
It acts as solvent for active ingredients in oral drug forms (capsules).
IMWITOR 742 also functions as penetration enhancer. IMWITOR 742 is surface-active and works as a plasticizer in tablet coatings, as co-emulsifier in emulsions and as defoaming agent.
Cosmetic IMWITOR 742 can be used in cosmetic formulations as a co-emulsifier for O/W creams and lotions. It is also suitable as a dispersant for active ingredients in anti-acne creams. Because of its bacteriostatic properties IMWITOR 742 is able to support preservation systems.
Delivery:
HDPE plastic containers of 25 kg net.
Steel drums with an inner lacquer lining of 190 kg net.
Storage and Shelf Life:
The shelf life of IMWITOR 742 is at least 3 years, if kept in tightly closed containers protected from light and moisture and at a cool place .
* Ph.Eur = Pharmacopoeia Europe, current version * USP = United States Pharmacopeia, current version