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Nipasol™ M is a broad spectrum antimicrobial agent designed for preservation of a wide range of cosmetics, toiletries and topical pharmaceuticals.
CAS: 94-13-3
EC: 202-307-7
Synonyms:
PROPYLPARABEN; Propyl 4-hydroxybenzoate; 94-13-3; Propyl paraben; 4-Hydroxybenzoic acid propyl ester; Propyl p-hydroxybenzoate; n-Propyl 4-hydroxybenzoate; Nipasol; Nipazol; Propyl parahydroxybenzoate; Propyl Butex; Betacide P; Propylparasept; Propagin; Chemacide pk; Chemocide pk; N-Propyl p-hydroxybenzoate; Propyl Parasept; Aseptoform P; p-Hydroxypropyl benzoate; Propyl Chemosept; Protaben P; Tegosept P; Propyl aseptoform; Nipagin P; Nipasol P; Solbrol P; Paseptol; 4-Hydroxybenzoic acid, propyl ester; Preserval P; Betacine P; Bonomold OP; Nipasol M; p-Hydroxybenzoic acid propyl ester; p-Hydroxybenzoic propyl ester; Propyl-4-hydroxybenzoate; Parasept; N-Propylparaben; Propyl chemsept; Propyl-paraben; Benzoic acid, 4-hydroxy-, propyl ester; n-propyl paraben; Benzoic acid, p-hydroxy-, propyl ester; UNII-Z8IX2SC1OH; Chemoside PK; Lexgard P; Pulvis conservans; p-Hydroxybenzoic acid, propyl ester; MFCD00002354; n-PROPYL-p-HYDROXYBENZOATE; propyl 4-oxidanylbenzoate; Z8IX2SC1OH; MLS002152934; CHEBI:32063
Nipasol™ M is a broad spectrum antimicrobial agent designed for preservation of a wide range of cosmetics, toiletries and topical pharmaceuticals. It is suitable for both rinse-off and leave-on formulations. This product is freely soluble in most oils, waxes, fatty alcohols, but has relatively low solubility in water.Propylparaben. Nipasol® M is a propyl 4-hydroxybenzoate. Acts as a preservative. It is a long-chain Paraben for higher efficacy and less water solubility. Nipasol® M is used in shampoos, shower products, liquid soap, decorative cosmetics, syndet, bar soaps, wet wipes, hair conditioners, hair styling products, creams, lotions, antiperspirants and deodorants.Nipasol M is a broad spectrum antimicrobial agent designed for preservation of a wide range of cosmetics, toiletries and topical pharmaceuticals. Nipasol M is suitable to preserve both rinse- off and leave- on formulations. Europe: maximum concentration 0.4 % (acid) for 1 ester, and 0.8 % (acid) for mixtures of esters, no restrictions, Annex VI, 76/768/EEC. Japan: maximum concentration 1 % in cosmetic product, no restrictions. USA: considered safe as used by Cosmetic Ingredient
Review (1984). Nipasol M is freely soluble in most oils, waxes, fatty alcohols, but have relatively low solubility in water. The low aqueous solubility does not affect the microbiological efficacy of the esters. Most formulations requiring preservation contain a significant amount of water. This may mean that Nipasol M cannot readily be added directly to the formulation. Other methods of incorporation are quite straightforward however, and are listed below. The solubility of Nipasol M increases greatly as the temperature of the water rises. Therefore a concentrate may be made up by heating an appropriate quantity of water to 60- 100 °C prior to addition of Nipasol M. This concentrate may then be added to the formulation, provided that the ester concentration does not exceed its solubility in the formulation at normal ambient temperatures. Nipasol M is readily soluble in polar organic solvents. Where such a solvent is already part of a formulation an Nipasol M concentrate may be made up prior to addition. If a suitable solvent is not already part of the formulation, a highly concentrated solution may be made up e.g. 32 % in Ethanol, which would give insignificant residual levels of ethanol in the end product. Nipasol M is readily soluble in lipophilic ingredients and may be introduced to a formulation by adding to the oil phase with some warming before any emulsification stage. In multiphase systems, such as emulsions, it is often advisable to use a combination of aqueous dissolution with either of the other methods to ensure adequate preservation. The ester may be incorporated in the water to its maximum solubility and any further quantities may be dissolved in the oil phase, or solvent, as
appropriate.Nipasol M remains fully stable over a wide pH range from 4- 8. In general the lower the pH of the formulation, the more active is Nipasol M. That can result in a lower use concentration when the pH of the formulation is more acidic. Nipasol M is stable up to 80 °C. The product must be stored in tighly closed container in a cool, well- ventilated, dry place. Typical use concentrations of Nipasol M is 0.1 – 0.3 %.Combinations of p- Hydroxybenzoic acid esters, e.g. with Nipagin M, Nipagin A or Nipabutyl exhibit increased activity compared with individual esters
Nipasol M is a single long-chain paraben preservative for personal care products.
Benefits
Water-soluble
High efficacy
Nipasol M is a long chain paraben preservative for higher efficacy in personal care products.
It is suitable for the following products:
Antiperspirants & Deodorants
Wet Wipes
Decorative Cosmetics
Creams, Lotions
Shampoos, Shower Gels, Liquid Soap
Hair Conditioner
Hair Styling
Syndet, Bar Soap
Chemical name: Propyl 4-Hydroxybenzoate
INCI designation: Propylparaben
Product properties *)
Appearance (20°C)
White, almost white crystalline powder.
Chemical and physical data
Melting point: 96 - 98 oC
Assayacc. BP/PH.Eur: 98.0 - 102.0 %
nipasol m
Name: Propyl 4-hydroxybenzoate
CAS: 94-13-3
Molecular Formula: C10H12O3
Molecular Weight: 180.201
EC / List no.: 202-307-7
CAS no.: 94-13-3
Nipasol M is a broad spectrum antimicrobial agent designed for preservation of a wide range of cosmetics, toiletries and topical pharmaceuticals.
Nipasol M is suitable for both rinse-off and leave-on formulations.
Nipasol M is freely soluble in most oils, waxes, fatty alcohols, but has relatively low solubility in water.
Propylparaben, the n-propyl ester of p-hydroxybenzoic acid, occurs as a natural substance found in many plants and some insects, although it is manufactured synthetically for use in cosmetics, pharmaceuticals, and foods.
Nipasol M is a member of the class of parabens.
Nipasol M is a preservative typically found in many water-based cosmetics, such as creams, lotions, shampoos, and bath products.
Nipasol M is a a food additive, it has the E number E216.
Sodium propyl p-hydroxybenzoate, the sodium salt of propylparaben, a compound with formula Na(C3H7(C6H4COO)O), is also used similarly as a food additive and as an anti-fungal preservation agent.
Its E number is E217.
In 2010 the European Union Scientific Committee on Consumer Safety stated that it considered the use of butylparaben and propylparaben as preservatives in finished cosmetic products as safe to the consumer, as long as the sum of their individual concentrations does not exceed 0.19%.
Uses
Nipasol M is a broad spectrum antimicrobial agent designedfor preservation of a wide range of cosmetics,toiletries and topical pharmaceuticals.
Nipasol M is suitable to preserve both rinse- off and leave- on formulations.
Applications
Typical use concentrations of Nipasol M is 0.1 – 0.3 %.
Combinations of p- Hydroxybenzoic acid esters, e.g.with Nipagin M, Nipagin A or Nipabutyl exhibit increased activity compared with individual esters.
Incorporation
Nipasol M is freely soluble in most oils, waxes, fatty alcohols, but have relatively low solubility in water.
The low aqueous solubility does not affect the microbiological efficacy of the esters.
Most formulations requiring preservation contain a significant amount of water.
This may mean that Nipasol M cannot readily be added directly to the formulation.
Other methods of incorporation are quite straightforward however, and are listed below.
Dissolving in water
The solubility of Nipasol M increases greatly as the temperature of the water rises.
Therefore a concentrate may be made up by heating an appropriate quantity of water to 60- 100 °C prior to addition of Nipasol M.
This concentrate may then be added to the formulation, provided that the ester concentration does not exceed its solubility in the formulation at normal ambient temperatures.
Dissolving in organic solvents Nipasol M is readily soluble in polar organic solvents.
Where such a solvent is already part of a formulation an Nipasol M concentrate may be made up prior to addition.
If a suitable solvent is not already part of the formulation, a highly concentrated solution may be made up e.g. 32 % in Ethanol, which would give insignificant residual levels of ethanol in the end product.
Solubilisation in oils, emulsifiers etc.
Nipasol M is readily soluble in lipophilic ingredients and may be introduced to a formulation by adding to the oil phase with some warming before any emulsification stage.
In multiphase systems, such as emulsions, it is often advisable to use a combination of aqueous dissolution with either of the other methods to ensure adequate preservation.
The ester may be incorporated in the water to its maximum solubility and any further quantities may be dissolved in the oil phase, or solvent, as appropriate.
pH stability
Nipasol M remains fully stable over a wide pH range from 4- 8.
In general the lower the pH of the formulation, the more active is Nipasol M.
That can result in a lower use concentration when the pH of the formulation is more acidic.
Temperature stability
Nipasol M is stable up to 80 °C.
Solubility
The solubility of Nipasol M in different solvents is illustrated in the following table.
Solvent % (w/w)
Water 10 °C 0.018
Water 25 °C 0.04
Water 80 °C 0.45
Water 100 °C 0.7
Acetone 51
Methanol 50
Ethanol 50
Propylene Glycol 29
Glycerol 1.0
Vegetable oils (arachis) 1.4
Liquid paraffin 0.033
Microbial Activity
Nipasol M exhibits microbiostatic activity against a wide range of bacteria, yeast and mould.
This is illustrated by the following table which shows the minimum inhibitory concentration (MIC) of Nipasol M against examples of different groups of microorganisms.
Microorganisms MIC level (%)
Gram Negative Bacteria
Pseudomonas aeruginosa 0.08
Escherichia coli 0.04
Klebsiella aerogenes 0.04
Klebsiella pneumoniae 0.025
Serratia marcescens 0.04
Proteus vulgaris 0.025
Salmonella enteritidis 0.04
Salmonella typhi 0.06
Microorganisms MIC level (%)
Gram Positive Bacteria
Stpahylococcus aureus 0.04
Streptococcus haemolyticus 0.04
Bacillus cereus 0.025
Bacillus subtilis 0.025
Lactobacillus buchneri 0.025
Yeasts
Candida albicans 0.013
Saccharomyces cerevisiae 0.013
Molds
Aspergillus niger 0.02
Penicillium digitatum 0.006
Rhizopus nigricans 0.013
Storage instructions
The product must be stored in tighly closed container in a cool, well- ventilated, dry place.
Further information on handling, storage and dispatch is given in the EC safety data sheet.
Propylparaben is the benzoate ester that is the propyl ester of 4-hydroxybenzoic acid.
Preservative typically found in many water-based cosmetics, such as creams, lotions, shampoos and bath products.
Also Propylparaben is used as a food additive.
Propylparaben has a role as an antifungal agent and an antimicrobial agent.
Propylparaben is a benzoate ester, a member of phenols and a paraben.
Propylparaben derives from a propan-1-ol and a 4-hydroxybenzoic acid.
Propyl-4-hydroxybenzoate appears as colorless crystals or white powder or chunky white solid.
Propylparaben.
Nipasol M by Clariant is a propyl 4-hydroxybenzoate.
Nipasol M acts as a preservative.
Nipasol M is a long-chain Paraben for higher efficacy and less water solubility.
Nipasol M is used in shampoos, shower products, liquid soap, decorative cosmetics, syndet, bar soaps, wet wipes, hair conditioners, hair styling products, creams, lotions, antiperspirants and deodorants.
Chemical properties
Propylparaben is a colorless and fine crystalline or white crystalline powder, almost odorless and with slightly astringent.
Propylparaben is soluble in ethanol, ethyl ether, acetone and other organic solvents
Propylparaben is slightly soluble in water.
Uses
1. Propylparaben Used as preservatives and antioxidants, and also used in the pharmaceutical industry
2. Used as the antimicrobial preservative in pharmaceuticals and cosmetics
3. According to ethyl p-hydroxybenzoate (17007)
4. Used as antiseptic and antimicrobial.
5. Used as the preservatives of food, cosmetics and medicines.
content analysis
Same with Method 1 in "Butyl p-hydroxybenzoate (07002)".
In calculation, per mL of 1 mol/L sodium hydroxide corresponds to 180.2mg of this goods (C10Hl2O8).
Production methods
This product can be derived from the esterification of p-hydroxybenzoic acid and n-propanol.
First mix p-hydroxybenzoic acid with propanol and heat to dissolve.
Then add sulfuric acid slowly and continue to heat for 8h of refluxion.
After cooling, pour them into the 4% sodium carbonate solution for precipitation and crystallization.
Filtrate and wash to neutral to obtain the crude product.
After further ethanol recrystallization, the finished products are obtained.
In the preparation, the cation exchange resin can be used in place of the sulfuric acid catalyst.
It can be derived from the esterification of p-hydroxybenzoic acid and n-propanol in the presence of sulfuric acid.
Add p-hydroxybenzoic acid and n-propanol in turn to the esterification reactor, and heat to dissolve.
Add concentrated sulfuric acid slowly and heat for 8h of refluxion. Pour the reaction solution into 4% sodium carbonate solution before it is cooled.
Constantly stir for precipitation and crystallization.
Then the crude product can be obtained after centrifugal filtration and washed to neutral.
Finally the finished product is acquired after activated carbon decolorization and ethanol recrystallization.
The method of preparing ethyl p-hydroxybenzoate can also be used as a reference.
HOC6H4COOH + C3H7OH [H2SO4] → HOC6H4COOC3H7 + H2O
Chemical Properties
White or almost white, crystalline powder.
Chemical Properties
Propylparaben occurs as a white, crystalline, odorless, and tasteless powder.
Chemical Properties
Propyl p-hydroxybenzoate is almost odorless.
Uses
propylparaben is one of the most frequently used preservatives against bacteria and mold.
It has a low sensitizing and low toxicity factor, is reputed to be very safe, and considered to be a noncomedogenic raw material.
Uses
An antimicrobial
Uses
Pharmaceutic aid (antifungal). Antimicrobial preservative in foods and cosmetics.
Definition
ChEBI: The benzoate ester that is the propyl ester of 4-hydroxybenzoic acid.
Preservative typically found in many water-based cosmetics, such as creams, lotions, shampoos and bath products.
Also used as a food additive.
Production Methods
Propylparaben is prepared by the esterification of p-hydroxybenzoic acid with n-propanol.
Preparation
Produced by esterfying p-hydroxybenzoic acid with n-propanol, using an acid catalyst such as sulfuric acid and an excess of propanol.
The materials are heated in a glass-lined reactor under reflux.
The acid is then neutralized with caustic soda and the product is crystallized by cooling.
The crystallized product is centrifuged, washed, dried under vacuum, milled and blended, all in corrosion-resistant equipment to avoid metallic contamination.
Aroma threshold values
Detection: 20 ppb
General Description
Colorless crystals or white powder or chunky white solid.
Melting point 95-98°C. Odorless or faint aromatic odor.
Low toxicity, Tasteless (numbs the tongue). pH: 6.5-7.0 (slightly acidic) in solution.
Air & Water Reactions
Water soluble [Hawley].
Reactivity Profile
Maximum stability of Propylparaben occurs at a pH of 4 to 5. Incompatible with alkalis and iron salts.
Also incompatible with strong oxidizing agents and strong acids .
Fire Hazard
Flash point data for Propylparaben are not available; however, Propylparaben is probably combustible.
Pharmaceutical Applications
Propylparaben is widely used as an antimicrobial preservative in cosmetics, food products, and pharmaceutical formulations.
It may be used alone, in combination with other paraben esters, or with other antimicrobial agents.
It is one of the most frequently used preservatives in cosmetics.
The parabens are effective over a wide pH range and have a broad spectrum of antimicrobial activity, although they are most effective against yeasts and molds.
Owing to the poor solubility of the parabens, the paraben salts, particularly the sodium salt, are frequently used in formulations.
This may cause the pH of poorly buffered formulations to become more alkaline.
Propylparaben (0.02% w/v) together with methylparaben (0.18% w/v) has been used for the preservation of various parenteral pharmaceutical formulations.
Contact allergens
This substance is one of the parabens family. Parabens are esters formed by p-hydroxybenzoic acid and an alcohol.
They are largely used as biocides in cosmetics and toiletries, medicaments, or food. They have synergistic power with other biocides.
Parabens can induce allergic contact dermatitis, mainly in chronic dermatitis and wounded skin.
Safety
Propylparaben and other parabens are widely used as antimicrobial preservatives in cosmetics, food products, and oral and topical pharmaceutical formulations.
Propylparaben and methylparaben have been used as preservatives in injections and ophthalmic preparations; however, they are now generally regarded as being unsuitable for these types of formulations owing to the irritant potential of the parabens.
Systemically, no adverse reactions to parabens have been reported, although they have been associated with hypersensitivity reactions.
storage
Aqueous propylparaben solutions at pH 3–6 can be sterilized by autoclaving, without decomposition.
At pH 3–6, aqueous solutions are stable (less than 10% decomposition) for up to about 4 years at room temperature, while solutions at pH 8 or above are subject to rapid hydrolysis (10% or more after about 60 days at room temperature).
Incompatibilities
The antimicrobial activity of propylparaben is reduced considerably in the presence of nonionic surfactants as a result of micellization.
Absorption of propylparaben by plastics has been reported, with the amount absorbed dependent upon the type of plastic and the vehicle.
Magnesium aluminum silicate, magnesium trisilicate, yellow iron oxide, and ultramarine blue have also been reported to absorb propylparaben, thereby reducing preservative efficacy.
Propylparaben is discolored in the presence of iron and is subject to hydrolysis by weak alkalis and strong acids.
Uses:
This chemical is used as a preservative in foods (salad dressings, mayonnaise, spiced sauces, mustard, frozen dairy products, baked products) and in cosmetics and pharmaceutical preparations. It is also used as an antifungal agent, and in antibacterial ointments, dermatological preparations, proprietary lotions and skin creams. Other uses are for mold control in sausage casings and as a fungicide. It is also used as a pharmaceutic aid (antifungal agent) for cats. Cross: hydroquinone monobenzyl ether, other parabens, para compounds. ICU
