Performance Products. EMPILAN DPHS Water-in-Oil emulsifier for Beauty & Personal Care

Transcription

1 Performance Products EMPILAN DPHS Water-in-Oil emulsifier for Beauty & Personal Care

2 EMPILAN DPHS is a non-ionic emulsifier and dispersing agent. Its polymeric nature can provide excellent long term stability performances and a soft and light touch to personal care water in oil formulations. On the basis of our test results, EMPILAN DPHS is also a very efficient emulsifier that allows high levels of water to be incorporated in formulations even at very low concentrations.ilglycerine carbonate is not classified as hazardous under EU CLP and combines low toxicity with low potential to cause skin and eye irritation, particularly when compared to other commonly used solvents. Applications Skin Care Baby Care Sun Care Lip Care Lipstick Foundation Creams Antiperspirants Benefits High sensory skin feel benefits Provides excellent long term stability Compatible with a wide range of oils, from non-polar to high polarity Compatible with a wide range of skin care actives and additives Alternative to silicone based emulsifiers Creates a light skin feel for W/O emulsions Inner water phase up to 85% Allows the formulation of low viscosity W/O emulsions Provides stable moisturized W/O emulsions in colour cosmetics, such as lip care and foundation creams Typically used at low concentrations (1-3%) Improves texture at higher concentrations Additional information EMPILAN DPHS INCI name PEG-30 Dipolyhydroxystearate Function Emulsifying Appearance at 25 C Paste HLB Typically 5-6 Range OF application Typically 1-3% 1

3 EMPILAN DPHS molecule at the water/oil interface Unlike typical water in oil emulsifiers, EMPILAN DPHS contains two extended lipophilic chains attached to either end of a large hydrophilic group. This specific structure provides a strong, irreversible anchoring of the polar back bone to the water droplet surface. At the same time, the dual extended lipophilic chains efficiently prevent coalescence of the droplets giving increased stability to the emulsion. The highly efficient nature of this structure allows the inner water phase to be up to 85% on the total formulation composition with excellent long term emulsion stability. A flexible level of use to meet all expectations The concentration of an emulsifier can play an important role in the properties of an emulsion, not only in terms of stability but it can also change other factors such as viscosity and the sensorial characteristics based on the exact amount used. An emulsifier that provides good emulsion stability over a wide range of concentrations offers a useful extra tool in helping to create the desired effect. The performance of EMPILAN DPHS in a simple emulsion was compared to two other emulsifiers with similar HLB values. Variation of emulsifier content from 1 to 5% Ingredient % w/w EMPILAN DPHS Glyceryl Oleate Sorbitan Oleate Ethylhexyl Palmitate q.s* to 100 q.s to 100 q.s to 100 Magnesium Stearate Aqua Glycerin Magnesium Sulphate Heptahydrate Preservative

4 The information in the table below summarises the stability data obtained at RT, 4 C and 40 C for the formulations with 1 to 5% emulsifier content. The stability tests for both glyceryl oleate and sorbitan sleate failed in general after 2 weeks at RT,4 C or 40 C. Indeed, formulations unstable with sorbitan sleate or glyceryl oleate have presented agglomerates or phase separation at different storage temperature. In this particular formulation EMPILAN DPHS has proved more versatile, being able to provide excellent stability over a wide concentration range. Meanwhile sorbitan oleate and glyceryl oleate would require the addition of a co-emulsifier to achieve the same benefits. Emulsion stability at RT, 4 C and 40 C Stability (Room temperature/4 C/40 C) Emulsifier concentration 1% 2% 3% 4% 5% EMPILAN DPHS > 3 months > 3 months > 3 months > 3 months > 3 months Glyceryl Oleate < 2 weeks < 2 weeks < 2 weeks < 2 weeks < 1 week Sorbitan Oleate < 2 weeks < 1 month < 2 weeks < 2 weeks < 2 weeks The following micrographs, resulting on the basis of Huntsman tests, were obtained from previous emulsifiers formulations to compare the droplet size and distribution using 1% emulsifier. EMPILAN DPHS emulsifier provides smaller and a more homogeneous droplet size distribution, compared to Sorbitan Oleate or Glyceryl Oleate which demonstrate larger droplet sizes and a more heterogeneous distribution (Figure below). The small droplet size obtained with EMPILAN DPHS helps to explain the better long-term stability compared to other emulsifiers and the possibility to act on the sensory feeling and texture depending on the desired concentration of the emulsifier. Difference in droplet size distribution with 1% emulsifier (40X) 1% EMPILAN DPHS 1% Sorbitan oleate 1% Glyceryl oleate

5 A powerful emulsifier to stabilize water-in-oil emulsions with different internal water phase volume In water in oil emulsions a high concentration of water can sometimes provide the formulation with a lighter, more desirable feel. The structure of EMPILAN DPHS allows this to be achieved while maintaining excellent long term emulsion stability. To demonstrate this, a basic formulation was prepared using different emulsifiers to compare the performance of EMPILAN DPHS with the traditional W/O emulsifiers, Glyceryl Oleate and Sorbitan Oleate and the water content was varied for each emulsifier as shown in table below. Variation of water content from 55 to 95 % Ingredient % w/w EMPILAN DPHS Glyceryl Oleate Sorbitan Oleate Ethylhexyl Palmitate q.s* to 100 q.s to 100 q.s to 100 Magnesium Stearate Water phase Preservative The information in the table below summarises the stability data obtained at RT, 4 C and 40 C for all the formulations. From 55% to 65% water, none of the three emulsifiers tested gave satisfactory results. The formulations prepared with Sorbitan Oleate and Glyceryl Oleate proved to be highly unstable at these water levels. The formulations prepared with EMPILAN DPHS demonstrated a better stability compared to the other emulsifiers giving up to 1 month stability at 65% water content. At water phase concentrations of 75 85% both Sorbitan Oleate and Glyceryl Oleate failed to give stable emulsions, although the stability was seen to be slightly better at 85%. EMPILAN DPHS was the only emulsifier capable of giving highly stable formulations with this high level of water, which should help to create cosmetic water in oil emulsions with better sensory properties. Emulsion stability at RT, 4 C and 40 C Stability (Room temperature/4 C/40 C) Water phase concentration 55% 65% 75% 85% 95% EMPILAN DPHS <1 week <1 month >3 months >3 months Failed Glyceryl Oleate Failed Failed Failed <2 weeks Failed Sorbitan Oleate Failed Failed Failed <2 weeks Failed In this test, none of the emulsifiers gave stable formulations with water contents greater than 85%.

6 In addition to evaluating the stability of the emulsifier, the viscosity profile depending on internal phase content was also determined for the formulations using EMPILAN DPHS and the results are shown in the graph below. EMPILAN DPHS stabilizes the water oil interface allowing the formation of finely dispersed water droplets at all ranges of water content up to 85%. However, it is clear from the graph that the viscosity of the formulation was very low at lower water contents (55-65%) and this was probably the main reason for the reduced stability. In this case, the lower water content formulas could have been further stabilized with the addition of a suitable viscosity modifier which would have resolved the issue but this was not studied. Viscosity profile of emulsions with different water content 2,5 Viscosity (Pa.s) 2 1,5 1 0,5 A rheometer with a cone plate 40mm, 2 allowed the analysis of flow behavior by measuring the viscosity at a shear rate of 100s % water 65 % water 75 % water 85 % water % water phase

7 High compatibility with all emollient types The use of emollients with different polarities and chemical characteristics plays a vital role in creating the desired sensory characteristics of a formulation. Consequently, it is important that an emulsifier functions with a wide range of emollients. To demonstrate this, a basic formulation was prepared using different emollients to compare the performance of EMPILAN DPHS with the traditional W/O emulsifiers, Glyceryl Oleate and Sorbitan Oleate. The ingredients used were selected to cover a broad range of polarities: isohexadecane, a commonly used non-polar emollient and caprylic / capric triglycerides, a commonly used polar emollient. The formulations are described in the following table. Variation of oil phase ingredients Ingredient % w/w EMPILAN DPHS Glyceryl Oleate Sorbitan Oleate Isohexadecane Caprylic/Capric Triglycerides Magnesium Stearate Aqua Glycerin Magnesium Sulphate Heptahydrate Preservative The information in table below summarises the stability data obtained at RT, 4 C and 40 C. Neither Glyceryl Oleate or Sorbitan Oleate produced stable emulsions with these emollients, although Sorbitan Oleate gave better results with Isohexadecane. The formulations with EMPILAN DPHS have demonstrated a high long-term stability regardless of the emollient type or polarity compared to the other emulsifiers. The product is also compatible with silicone oils (see example formulation guideline) and this makes it a highly versatile ingredient, allowing the formulation of emulsions with different sensory properties. Emulsion stability at RT, 4 C and 40 C Stability (Room temperature/4 C/40 C) Emollient type Isohexadecane Caprylic/Capric Triglycerides EMPILAN DPHS > 2 months > 2 months Glyceryl Oleate < 1 week Failed Sorbitan Oleate < 1 month Failed

8 EMPILAN DPHS, an essential ingredient for a unique texture The sensory evaluation is an important criteria because it helps to define the real benefits of an end-finished product and to control if the formulation of the ingredients selected provides the required expectations. As an essential part of the formulation, the emulsifier plays an important role into the definition of sensory attributes of an end-finished product. To illustrate this, a formulation was prepared using different emulsifiers to compare the benefits of EMPILAN DPHS with two standard W/O emulsifiers like a polyglyceryl ester and a silicone based emulsifier with an oil phase containing emollients with different polarity. Formulation of end-finished product with different emulsifiers to compare performances Ingredient % w/w EMPILAN DPHS Polyglyceryl esters Silicone based emulsifier Isohexadecane Ethylhexyl Palmitate Caprylic/Capric Triglycerides Magnesium Stearate Aqua Glycerin Magnesium Sulphate Heptahydrate Preservative The graphics below demonstrate the possibility to preserve similar and even higher sensory benefits with EMPILAN DPHS compared to standard polyglyceryl esters or silicone based emulsifiers. The evaluation highlights higher spreadability and less tackiness compared to a silicone based emulsifier and higher absorbency and less greasiness compared to a polyglyceryl ester type emulsifier. Sensory evaluation with different emulsifiers EMPILAN DPHS vs. silicone based emulsifier High Film- Forming High spreadability High Absorbency High Film- Forming EMPILAN DPHS vs. Polyglyceryl Esters High spreadability High Absorbency Less Tackiness Less greasy Less Tackiness Less greasy EMPILAN DPHS EMPILAN DPHS Silicone based Polyglyceryl esters

9 High consistency at low concentration The evaluation of an emulsion consistency is essential to determine the product performances. A cream and a lotion have different consistencies and this is linked to the ingredients used in order to obtain the required consistency. For example, the emulsifier concentration in the formulation of a cream or a lotion is one parameter that can influence the properties of the end product. A texture analyzer has been used to measure the firmness, the consistency, the cohesiveness and the index of viscosity of two formulations with 1% or 5% of the w/o emulsifier EMPILAN DPHS. There is a correlation between this measurement and the pick-up when performing a sensory evaluation. Ingredient % w/w EMPILAN DPHS Isohexadecane Caprylic/Capric Triglycerides Ethyhexyl Palmitate Magnesium Stearate Glycerin Magnesium Sulphate Heptahydrate Aqua Up to 100 Up to 100 Phenoxyethanol (and) Caprylyl Glycol q.s q.s* Fragrance q.s q.s Texture analyzer with Back Extrusion Rig (TA.XTPlus Stable Micro Systems) The texture analyzer enables to highlight different profiles when playing with the emulsifier content. The formulation with 1% EMPILAN DPHS has highlighted a higher firmness, consistency, cohesiveness and index of viscosity than with 5% of EMPILAN DPHS. This behaviour has also been confirmed by sensory evaluation (pick-up). This evaluation has shown the possibility to create different textures with different concentration of EMPILAN DPHS. Firmness (g) Consistency (g.sec) % EMPILAN DPHS 5% EMPILAN DPHS 0 1% EMPILAN DPHS5% EMPILAN DPHS Index of viscosity (g.sec) Cohesiveness (g) % EMPILAN DPHS 5% EMPILAN DPHS % EMPILAN DPHS5% EMPILAN DPHS

10 Moisturising foundation cream This foundation combines a pleasant and non-oily skin feel with a creamy texture that spreads easily on the skin thanks to the versatile W/O emulsifier EMPILAN DPHS. Part D INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 3.00 Caprylic/Capric Triglycerides Tegosoft CT Evonik 3.00 Paraffinum Liquidum C12-15 Alkyl Benzoate Tegosoft TN Evonik 4.00 Cyclopentasiloxane Xiameter PMX-0245 Dow Corning 7.00 Dimethicone Xiameter PMX 200 silicone fluid 350 CS FG Dow Corning 1.00 Magnesium Sulphate Heptahydrate Propylene Glycol Aqua - - q.s* to 100 Titanium Dioxide SWD 7556 Sun Chemical 5.52 Yellow Iron Oxides C.I YLW FE OX SYN WAX Synthetic wax dispersion SWD 5073 Sun Chemical 1.73 Red Iron Oxides C.I RED FE OX SYN WAX Synthetic wax dispersion SWD 7575 Sun Chemical 0.55 Black Iron Oxides C.I BLACK FE OX SYN WAX Synthetic wax dispersion SWD 7550 Sun Chemical 0.20 Methylisothiazolinone, Phenoxyethanol Neolone PE Dow q.s Ethanol Alcohol Processing Instructions Prepare part A and B separately and heat both to 75 C Add phase C to phase A, stir and heat up again Slowly add part B to part A-C and homogenize At circa 35 C, add the individual ingredients of part D in order Allow to cool while stirring Technical Data Appearance Viscosity (Brookfield Spindle LV 64, 6 RPM, 20 C after 1 min) Stability RT, 4 C, 40 C Ref: cream ca mpa.s Stable at least 3 months EV/MG/219-03/13

11 Moisturizing milk This W/O emulsion combines skin protection with easy spreading and light skin feel while EMPILAN DPHS releases a refreshing moisturisation. INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 3.00 Paraffinum Liquidum Caprylic/Capric Triglycerides Tegosoft CT Evonik 4.00 Isohexadecane Purolan IHD Lanxess 6.00 Aqua - - q.s* to 100 Glycerin Magnesium Sulphate Heptahydrate Methylisothiazolinone, Phenoxyethanol Neolone PE Dow 0.05 Processing Instructions Prepare part A and B separately and heat both to 75 C Slowly add part B to part A and homogenize At circa 35 C, add phase C Allow to cool while stirring Technical Data Appearance Viscosity (Brookfield Spindle LV 63, 6 RPM,, 20 C after 1 min) Stability RT, 4 C, 40 C white cream ca mpa.s Stable at least 3 months Ref: EV/MG/219-02/13

12 Cleansing milk This cleansing milk has been formulated with EMPILAN DPHS, a light W/O emulsifier providing soft and smooth skin feel during application and also delivers a moisturising effect with non-greasy after feel. INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 3.00 C12-13 Alkyl Lactate Cosmacol ELI Sasol 7.00 Cetearyl Ethylhexanoate Lanol 1688 Seppic 7.00 Aqua - - q.s* to 100 Glycerin Magnesium Sulphate Ethanol Methylisothiazolinone, Phenoxyethanol Neolone PE Dow 0.05 Processing Instructions Prepare part A and B separately and heat both to 75 C Slowly add part B to part A and homogenize At circa 35 C, add phase C Allow to cool while stirring Technical Data Appearance Viscosity (Brookfield Spindle LV 64, 6 RPM, 20 C after 1 min) Stability RT, 4 C, 40 C white cream ca mpa.s Stable at least 3 months Ref: EV/MG/219-01/13

13 Soothing hand cream EMPILAN DPHS delivers a light and stable W/O hand cream utilising allantoin to moisturize and sooth the skin from external stress and a UV filter to help protect the skin against sun damage. Part D INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 2.00 Cera Alba White Bees Wax Seatons 3.00 Ethylhexyl Palmitate Tegosoft OP Evonik 5.00 Ethylhexyl Methoxycinnamate Uvinul MC 80 BASF 5.00 Isohexadecane Purolan IHD Lanxess 5.00 Magnesium Stearate - Mosselman 0.70 Aqua - - q.s* to 100 Glycerin Allantoin Methylisothiazolinone, Phenoxyethanol Neolone PE Dow q.s Fragrance Orchid APF Aromes et Parfums q.s Processing Instructions Prepare part A and B separately and heat both to 75 C Slowly add part B to part A and homogenize At circa 35 C, add parts C and D in order Allow to cool while stirring Technical Data Appearance Viscosity (Brookfield Spindle LV 64, 6 RPM, 20 C after 1 min) Stability RT, 4 C, 40 C white cream ca mpa.s Stable at least 3 months Ref: EV/MG/219-04/13

14 Creamy Sun Protection Milk The following sunscreen milk water in oil emulsion combines the emolliency effect of isohexadecane with the hydration properties of glycerine. This rich and fresh combination leaves on the skin a long lasting hydration and softening effect protecting the epidermis by dryness. Part D INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 2.00 Isohexadecane Purolan IHD Lanxess 8.00 Chamomilla Recutita Flower Extract Ethylhexyl Methoxycinnamate Uvinul MC 80 BASF 5.00 Buthyl Methoxybenzoylmethane Eusolex 9020 Merck 1.50 Disodium EDTA Magnesium Sulfate Heptahydrate Glycerin Methylisothiazolinone, Phenoxyethanol Neolone PE Dow 0.01 Aqua - - q.s* to 100 Phenylbenzimidazole Sulfonic Acid Parsol HS DSM 1.50 Aqua Silica Dimethyl Silylate AEROSIL R972 Evonik 0.30 Processing Instructions Prepare phase A by incorporating all the ingredients, heat up to 75 C while stirring at moderate speed Prepare phase B by incorporating all the ingredients, heat up to 75 C while stirring at moderate speed Prepare phase C by neutralization of Phenylbenzimidazole sulphonic acid to ph 7 Incorporate phase C into phase B and check ph to avoid re-crystallization of Phenylbenzimidazole sulphonic acid Pour phase B into phase A+C under increased speed to allow the emulsion formation and homogenize Let cool down to 50 C and incorporate phase D under moderate stirring Let the formulation cool down under moderate stirring Technical Data Appearance Stability RT, 4 C, 40 C cream stable at least 3 months Ref. EV/MG/

15 Sun Protection Lotion The following sunscreen lotion water in oil emulsion combines the emolliency effect of hexyl laurate with the hydration properties of glycerine. This light and fresh combination leaves on the skin a long lasting hydration and softening effect protecting the epidermis from dryness. INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 2.00 Hexyl laurate Cetiol A BASF PPG-15 Stearyl Ether TEGOSOFT E Evonik 2.00 Cyclopentasiloxane Xiameter PMX 0245 Dow corning 4.00 Titanium Dioxide (and) Alumina (and) Stearic Acid Eusolex T-S Merck Aqua - - q.s* to 100 Magnesium Sulfate Heptahydrate Glycerin Methylisothiazolinone, Phenoxyethanol Neolone PE Dow 0.01 Ethylhexyl Methoxycinnamate Uvinul MC 80 BASF Prepare phase A by incorporating all the ingredients, heat up to 75 C while stirring at moderate speed Prepare phase B by incorporating all the ingredients, heat up to 75 C while stirring at moderate speed Pour phase B into phase A and homogenize Let cool down to 50 C and incorporate phase C under moderate stirring Let the formulation cool down under moderate stirring Technical Data Appearance Stability RT, 4 C, 40 C lotion Stable at least 3 months Ref. EV/MG/

16 Rich moisturizing lipstick Part D INCI name Trade name Supplier % w/w Jojoba oil - Mosselman Soybean Glycerides (and) ButyrospermumPparkii Butter Lipex L sens AAK 6.40 Unsaponifiables Candelilla Cera Candelilla wax Seatons 8.40 Copernicia Cerifera Cera Kahlwax 2442 Kahlwax 8.40 Cera Alba Yellow beeswax Seatons 3.90 Caprylic/Capric Triglycerides Ester 610 Mosselman PEG-30 Dipolyhydroxystearate EMPILAN DPHS Huntsman 3.00 D&C Red 6 BALK SYN WAX Synthetic wax dispersion Sun Chemical 6.00 SWD4512 Hexyldecanol Eutanol G16 BASF 8.00 Aqua Glycerin Propylparaben Microcare OHB Thor 0.10 Tocopheryl Acetate Vitamin E acetate BASF 0.30 Processing Instructions Heat A, B and C up to 90 C Add B to A when is melted and stir Add to A-B and homogenize Let cool the formulation to 70 C and add D while stirring Pour into a lipstick mould at around 70 C Let cool the mould at RT 10 min and at 0 C 10min Put into appropriate lipstick case Technical Data Appearance Stability RT, 4 C, 40 C solid Stable at least 3 months Ref: EV/MG/2605/022 F

17 Moisturising lip butter This lip balm includes water to improve the feel and limit the greasiness while helping to prevent drying of the lips. INCI name Trade name Supplier % w/w Jojoba oil - Mosselman Soybean glycerides (and) butyrospermum parkii butter Lipex L sens AAK 6.40 unsaponifiables Candelilla Cera Candelilla wax Seatons 8.40 Copernicia Cerifera Cera Kahlwax 2442 Kahlwax 8.40 Cera Alba Yellow beeswax Seatons 3.90 Caprylic/Capric Triglycerides Ester 610 Mosselman PEG-30 dipolyhydroxystearate EMPILAN DPHS Huntsman 3.00 Hexyldecanol Eutanol G16 BASF 8.00 Titanium Dioxide SWD 7556 Sun Chemical 0.22 Aqua Glycerin Magnesium Sulphate Heptahydrate Propylparaben Microcare OHB Thor 0.10 Tocopheryl Acetate Vitamin E acetate BASF 0.30 Processing Instructions Heat A and B up to 90 C Add to while stirring and homogenize Let cool the formulation to 70 C and add C while stirring Pour into appropriate container at around 70 C Technical Data Appearance Stability RT, 4 C, 40 C waxy solid Stable at least 3 months Ref: EV/MG/2605/022 B

18 Light antiperspirant cream for roll-on INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate Empilan DPHS Huntsman 1.0 PPG-14 butyl ether Tegosoft PBE Evonik 7.0 C12-15 Alkyl Benzoate Tegosoft TN Evonik 13.0 Aqua - - q.s* to 100 Aluminium chlorohydrate 50% solution Chlorhydrol 50 Summit 30.0 Methylisothiazolinone, phenoxyethanol Neolone PE Dow 0.3 Processing Instructions Prepare part A and B separately and heat both to C Slowly add part B to part A and homogenize Let cool the formulation to 50 C and add C while stirring Technical Data Appearance Viscosity (Brookfield Spindle LV 63, 6 RPM, 20 C after 1 min) Stability RT, 4 C, 40 C lotion ca mpa.s Stable at least 3 months Ref: EV/MG/2605/026 A

19 Velvety soft skin cream This formulation demonstrates the ability of Empilan DPHS to create a soft and luxurious W/O emulsion from silicone based emollients. INCI name Trade name Supplier % w/w PEG-30 Dipolyhydroxystearate Empilan DPHS Huntsman 1.00 Cetyl Dimethicone ABIL WAX 9801 Evonik 3.00 Dimethicone Xiamether PMX 200 Dow Corning 3.00 C12-15 Alkyl Benzoate Tegosoft TN Evonik 4.15 Dimethicone/Vinyl Dimethicone Dow corning 9701 cosmetic 1.00 Dow Corning Crosspolymer (and) Silica powder Bis-Hydroxyethoxypropyl Dow corning 5562 carbinol 2.00 Dow Corning Dimethicone fluid Magnesium Stearate - Mosselman 0.30 Aqua - - q.s* to 100 Glycerin Magnesium Sulphate Heptahydrate Methylisothiazolinone, phenoxyethanol Neolone PE Dow 0.05 Processing Instructions Prepare part A and B separately and heat both to 75 C Slowly add part B to part A and homogenize Cool down to 50 C and add C Technical Data Appearance Viscosity (Brookfield Spindle LV 64, 1.5 RPM, 1 min, 20 C) Stability RT, 4 C, 40 C cream ca mpa.s Stable at least 3 months Ref: EV/MG/2605/024 Q

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