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Sasol

LIPOXOL 8000 MED FLAKES

LIPOXOL 8000 MED FLAKES is a Medical Grade Polyethylene Glycol belonging to Sasol's PEG range of products.It is a combination with LIPOXOL 8000 MED Powder under LIPOXOL 8000 MED For documents specific to a region, please contact Sasol using the 'Request Document' button.

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Documents

Technical data sheet (TDS)
Product brochure
See all documents (3)

Properties

Features And Benefits
Ingredient Claims
Palm oil-free
Biodegradable
Non-animal origin
BSE-free
TSE-free
Porcine-free
Pesticides-free
Phthalates-free
GMO-free
NPE-free
Sugar-free
Aflatoxine-free
Alkaloids-free
Allergens-free
Antibiotics-free
Bisphenol A-free
Dioxin-free
Ethanol-free
Melamine-free
MOSH-free
MOAH-free
Nano particles-free
Carbohydrates-free
Palm kern oil-free
Biocides-free
Hormones-free
Residues-free
Preservatives-free
Radioactive-free
End Use Claims
Moisturizing
Solubilization
Plasticizing
Food Contact approved
Certifications
Kosher
Regional Availability
Latin America
North America
Europe
Asia Pacific
Middle East & Africa
Product Characteristics
Origin
Petrochemical
Synthetic
CAS No.
25322-68-3
Physical Form
Solid
Formulation Conditions
Soluble in
Water
alcohols
benzene
chloroform
glycerine glycol
Typical Properties
Value
Unit
Test Method
Color Number (APHA, 25% in water)
max. 15
mg Pt/l
DIN EN 1557
Average molar mass
7000 - 9000
g/mol
Calc. from OH no
pH (5 % in demin. water)
4.5 - 7.5
-
USP/NF
Dynamic Viscosity at 20°C (50% in water)
260 - 510
mPa.s
Ph. Eur.
Kinematic Viscosity at 98.9°C
470 - 900
mm2/s
USP/NF
Heavy Metals as Pb
max. 5
mg/kg
USP/NF
Acid/alkaline React. Substances
max. 0.1
ml 0.1 M NaOH
Ph. Eur.
Red. substances
min. 3
R
Ph. Eur.
Sulfate Ash Content
max. 0.1
%
1,4-Dioxane Content
max. 1
mg/kg
Ph. Eur.
Bulk density (flakes)
approx. 0.5
g/cm3
Bulk density (powder)
approx. 0.6
g/cm3
Density at 20°C (50 % in water)
approx. 1.08
g/cm3
Solubility in water (at 20°C)
approx. 500
g/l
Surface Tension at 20°C (50% in water)
53 - 57
mN/m
Water Content
max. 1.0
%
Ignition Temperature
approx. 420
°C
Flash Point
approx. 250
°C
Ethylene Oxide Content
max. 1
mg/kg
Ph. Eur.
Formaldehyde Content
max. 15
mg/kg
Ph. Eur.
Acid Number
max. 0.2
mg KOH/g
EN ISO 2114
Freezing Point
55 - 62
°C
Ph. Eur.
Assay Content
87.5 - 112.5
%
USP/NF
Hydroxyl Number
12.5 - 16
mg KOH/g
DIN EN 13296

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Technical product information

Recommended Uses & Known Applications
  • LIPOXOL MED grades are widely used excipients in a variety of pharmaceutical preparations. The liquid LIPOXOL MED grades are used as solvent, solubilizer and viscosity regulator in liquid pharmaceutical formulations. Mixtures of liquid and solid LIPOXOL MED grades are used as ointment bases. Solid LIPOXOL MED grades are used as suppository bases and act as binders and plasticizers for tablets.
  • The liquid LIPOXOL MED grades are readily soluble in water and miscible in all portions with other grades. With increasing molecular weight the solubility in water is slightly lowered. However, even the solubility of LIPOXOL 8000 MED in water is more than 500 g/l. The LIPOXOL MED grades are (according to their molecular weight) soluble in polar organic solvents like alcohols, benzene, glycerine glycol and chloroform. No or slight solubility is given in aliphatic hydrocarbons, ethers and fats. LIPOXOL MED grades can be used to enhance the aqueous solubility or dissolution characteristics of poorly soluble compounds.
  • Due to their hygroscopicity the LIPOXOL MED grades are used as moisturizers which provide soft and readily dispersible ointment bases causing a liquid flow opposed to the resorption. On skin they show a cleansing and drying effect. Therefore LIPOXOL MED containing ointments can be used to treat wet and inflamed wounds.
  • Liquid LIPOXOL MED grades are used as water miscible solvents dedicated for dissolution of actives in soft gelatine capsules. Aqueous solutions of LIPOXOL MED grades can be either used as suspending agents or to adjust the viscosity and consistency of pharmaceutical products. When used in combination with emulsifiers LIPOXOL MED grades can act as emulsion stabilizers.
  • In solid dosage forms LIPOXOL 3350 MED, 4000 MED, 6000 MED and 8000 MED enhance the effectiveness of tablet binders and provide plasticity to granules. There are a number of techniques producing tablets containing LIPOXOL MED grades. When used for thermoplastic granulation a mixture of powdered components with 10-15 % LIPOXOL 6000 MED is heated to 70-75°C resulting in a paste. Whilst cooling and stirring granules are formed. Solid LIPOXOL MED grades can be used for film coating of tablets or as polishing or softener materials for film tablets.
Statements and Confirmations

California Prop. 65 list

LIPOXOL MED grades contains the following chemicals found on the California Proposition 65 list of chemicals published by the Governor of California:

  • 1,4-Dioxane (max. 1 mg/kg)  
  • Ethylene oxide (max. 1 mg/kg)
  • Formaldehyde (max. 30 mg/kg)
  • Ethylene glycol (max. 620 mg/kg)

Cosmetic

Assuming the use of the raw materials and manufacturing process currently employed the LIPOXOL MED grades fulfils the requirements regarding the annexes of the regulation No. (EC) 1223/2009 with the exception of very small amounts of free Ethylene oxide (≤ 1 ppm), Formaldehyde (≤ 30 ppm) and 1,4-Dioxane (≤ 1 ppm) which are characteristic for this type of product.

With regard to the Diethylene glycol content which is limited to max. 0.1% for the ready to use cosmetic product (Annex III) please consider the Diethylene glycol content of the relevant LIPOXOL MED type (exception for LIPOXOL 300 MED).

CMR

We hereby confirm that, to the best of our present knowledge, assuming the use of the raw materials and manufacturing process currently employed, LIPOXOL MED does not contain any CMR-substances classified as CMR category 1A, 1B an 2 in accordance with regulation No. (EC) 1272/2008 and its adaptations, with the exception of very small amounts of free Ethylene oxide (≤ 1 ppm), Formaldehyde (≤ 30 ppm) and 1,4-Dioxane (≤ 1 ppm) which are characteristic for this type of product.

Food additive (E 1521)

LIPOXOL 400 MED, 3000 MED, 3350 MED, 4000 MED, 6000 MED and 8000 MED are approved for the use as food additives (E 1521) acc. to regulation No. (EC) 231/2012. The confirmation for a specific batch to comply with the limits for lead (Pb: max. 1 mg/kg), ethylene oxide (EO: max. 0.2 mg/kg) and Ethylene glycol/Diethylene glycol (MEG/DEG: max. 0.25% - only for LIPOXOL 8000 MED-) can only be ensured by agreeing on a special specification.

Halal

  • LIPOXOL MED grades are not produced under muslimic supervision
  • Intermediates, starting material and LIPOXOL MED grades are of non-animal origin
  • LIPOXOL MED grades are made by a process in which only auxiliaries of non-animal origin have been used
  • Processing equipment is only used for products of non-animal origin
  • We permit in case of request a muslimic inspection of the production plant

LIPOXOL MED grades are free of Lactose, Latex, Gluten, Yeast, Maize, Wheat, Pork, Starch, Dyes and Nuts

Microbiological purity

  • The parameter given in chapter 5.1.4 (Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use) are regularly checked.
  • The determination of TAMC (total aerobic microbial count) and TYMC (total yeasts and moulds count) is done according to Ph. Eur. 2.6.12. (Microbiological examination of non-sterile products: microbial enumeration tests) and the limits of
  • TAMC ≤ 1000 cfu/g
  • TYMC ≤ 100 cfu/g  can be confirmed.

Retest date

  • LIPOXOL MED grades with an average molecular weight of < 1000 g/mol: 2 years starting with the date of production
  • LIPOXOL MED grades with an average molecular weight of ≥ 1000 g/mol: 3 years starting with the date of production

SVHC substances

Assuming the use of the raw materials and manufacturing process currently employed the LIPOXOL MED grades do not contain any substances from the SVHC list (candidate list).

WADA list

Assuming the use of the raw materials and manufacturing process currently employed the LIPOXOL MED grades do not contain any substances from the WADA list (world anti-doping association).

GMP Status

The following products are produced and filled according to Good Manufacturing Practice (GMP) standard relating to Article 47 Directive 2001/83/EC:

  • LIPOXOL 300 MED up to 8000 MED in tank cars
  • LIPOXOL 1500 MED flakes up to 8000 MED flakes in 25kg PE sacks and Big Bags (different sizes)
Storage and Handling
  • Cool and dry in original package.
  • Stainless steel (Steel No. 1.4541 or 1.4571).
Packaging Information

LIPOXOL 8000 flakes are supplied in polyethylene sacks a 25 kg palletised to 1 t.

Other Products within this Brand (31)

Complete your formula with these ingredients

Branded product

LIPOXOL 6000 MED FLAKES

INCIs: PEG-150

Branded product

LIPOXOL 400 MED

INCIs: PEG-8

Branded product

LIPOXOL 4000 MED SP

INCIs: PEG-90

Branded products
Function
Categories

LIPOXOL 200

Intermediates And Precursors
Binder , Humectant , and 5 others

LIPOXOL 3350 MED POWDER

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 6000 MED POWDER

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 3350 MED SP

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 300 MED

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 3000 FLAKES

Plasticizer , Solubilizer , and 3 others

LIPOXOL 1000 MED

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 600 MED

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 1500 MED

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 4000 MED POWDER

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 3350 MED FLAKES

Binder , Emulsion Stabilizer , and 7 others

LIPOXOL 400

Intermediates And Precursors
Binder , Humectant , and 5 others
Sasol Place, 50 Katherine Street
Sandton,  2196
South Africa