LIPOXOL 4000 MED SP

1 of 36 products in this brand
LIPOXOL 4000 MED SP is a Medical Grade Polyethylene Glycol belonging to Sasol's PEG range of products For documents specific to a region, please contact Sasol using the 'Request Document' button.

Chemical NamePEG 4000

FunctionsFluid Loss Control Additive

Chemical FamilyPolyethylene Glycols, Polyglycols, Polyols

Technical Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Industrial Additives Functions
CAS No.
25322-68-3
EC No.
500-038-2

Features & Benefits

Base Chemicals Features

Applications & Uses

Applicable Processes
Industrial Additives End Use
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.  LIPOXOL 3350 MED and LIPOXOL 4000 MED are used as active ingredients in medicinal products, i.e. laxatives.
  • 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. 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.

Properties

Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
Color Number (APHA, 25% in water)max. 15mg Pt/lDIN EN 1557
Color Number (25 % in water)min. 6BYPh. Eur.
Average molar mass3600 - 4400g/molCalc. from OH no
pH (5 % in demin. water)4.5 - 7.5-USP/NF
Dynamic Viscosity at 20°C (50% in water)110 - 170mPa.sPh. Eur.
Kinematic Viscosity at 98.9°C110 - 158mm2/sUSP/NF
Heavy Metals as Pbmax. 5mg/kgUSP/NF
Ethylene and Diethylene Glycol Contentmax. 1000mg/kgAB 039 010 (Internal Method)
Ethylene Glycol Contentmax. 620mg/kgAB 039 010 (Internal Method)
Acid/alkaline React. Substancesmax. 0.1ml 0.1 M NaOHPh. Eur.
Red. substancesmin. 3RPh. Eur.
Sulfate Ash Contentmax. 0.1%
1,4-Dioxane Contentmax. 1mg/kgPh. Eur.
Density at 20°C (50 % in water)approx. 1.08g/cm3
Solubility in water (at 20°C)approx. 500g/l
Surface Tension at 20°C (50% in water)54 - 57mN/m
Water Contentmax. 1.0%
Ignition Temperatureapprox. 420°C
Flash Pointapprox. 250°C
Ethylene Oxide Contentmax. 1mg/kgPh. Eur.
Formaldehyde Contentmax. 15mg/kgPh. Eur.
Freezing Point53 - 59°CPh. Eur.
Acid Numbermax. 0.2mg KOH/gEN ISO 2114
Assay Content90 - 110%USP/NF
Hydroxyl Number26 - 31mg KOH/gDIN EN 13296

Regulatory & Compliance

Technical Details & Test Data

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 fulfills 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 molds 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).

Packaging & Availability

Packaging Type
Packaging Information
  • Lipoxol 4000 flakes are supplied in polyethylene sacks of 25 kg palletised to 1 t or in big bags.
  • Lipoxol 4000 powder is supplied in 500 kg big bags.
  • Road tankers (Melt).

Storage & Handling

Storage and Handling

Cool and dry in original package. Stainless steel (Steel No.1.4541 or 1.4571).