Knowde Enhanced TDS
Identification & Functionality
LIPOXOL 3350 MED flakes Features & Benefits
Applications & Uses
- 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 (Handbook of Pharmaceutical Excipients, 2nd edition, p. 355 ff.). 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. 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.
|Value||Units||Test Method / Conditions|
|Color Number (APHA, 25% in water)||max. 15||mg Pt/l||DIN EN 1557|
|Color Number (25 % in water)||min. 6||BY||Ph. Eur.|
|Molecular Weight (Average)||3015 - 3685||g/mol||USP|
|pH (5 % in demin. water)||4.5 - 7.5||-||USP/NF|
|Dynamic Viscosity at 20°C (50% in water)||83 - 120||mPa.s||Ph. Eur.|
|Heavy Metals as Pb||max. 5||mg/kg||USP/NF|
|Ethylene Glycol Content||max. 620||mg/kg||AB 039 010 (Internal Method)|
|Ethylene and Diethylene Glycol Content||max. 1000||mg/kg||AB 039 010 (Internal Method)|
|Acid/alkaline React. Substances||max. 0.1||ml 0.1 M NaOH||Ph. Eur.|
|Red. substances||min. 3||R||Ph. Eur.|
|Formaldehyde and Acetaldehyde Content||max. 200||mg/kg||USP|
|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||-|
|Average molecular mass (calc.)||3015 - 3620||g/mol||-|
|Kinematic Viscosity at 98.9°C||76 - 110||mm2/s||-|
|Density at 20°C (50 % in water)||approx. 1.08||g/cm3||-|
|Solubility in water (at 20°C)||approx. 560||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||53 - 57||°C||Ph. Eur.|
|Polydispersity Index||1.0 - 1.2||-||USP|
|Assay Content||97.0 - 103.0||% by mass||USP|
|Hydroxyl Number||31 - 37||mg KOH/g||DIN EN 13296|
Regulatory & Compliance
Technical Details & Test Data
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)
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).
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.
- 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
- 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.
- 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
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).
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
Lipoxol 3350 flakes are supplied in polyethylene sacks of 25 kg palletised to 1 t.
Storage & Handling
Precautions for safe handling
Advice on safe handling
- When processing the product, the formation and enrichment of dusts must be avoided.
- Dust can form an explosive mixture in air.
- Lipoxol grades are hygroscopic.Therefore, they should be stored in well-closed packages in a dry place.
Advice on protection against fire and explosion
- Normal measures for preventive fire protection.
- B: Fires involving liquids or liquid containing substances. Also includes substances which become liquid at elevated temperatures.
Conditions for safe storage, including any incompatibilities
Requirements for storage areas and containers
- Keep tightly closed. Keep in a dry place.
Storage class (TRGS 510)
- 10-13: German Storage Class 10 to 13
- Stable under normal conditions.
- Suitable Materials: Steel