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NIPASOL M

CAS Number: 94-13-3
EC Number: 202-307-7
Molecular Formula: C10H12O3
Molecular Weight: 180.201

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.

Nipasol M, the n-propyl ester of p-hydroxybenzoic acid, occurs as a natural substance found in many plants and some insects, although Nipasol M 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, Nipasol M 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. 
Nipasol M's E number is E217.

In 2010 the European Union Scientific Committee on Consumer Safety stated that Nipasol M 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%.

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.

Nipasol M 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 Nipasol Mn is used as a food additive. 
Nipasol M has a role as an antifungal agent and an antimicrobial agent. 

Nipasol M is a benzoate ester, a member of phenols and a paraben. 
Nipasol M derives from a propan-1-ol and a 4-hydroxybenzoic acid.

Nipasol M appears as colorless crystals or white powder or chunky white solid. 

Nipasol M has a melting point 95-98°C. 
Nipasol M has hdorless or faint aromatic odor. 
Nipasol M has low toxicity and tasteless. 

Nipasol M 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.

Uses of Nipasol M:
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.

Nipasol M is used as preservatives and antioxidants, and also used in the pharmaceutical industry
Nipasol M is used as the antimicrobial preservative in pharmaceuticals and cosmetics

According to ethyl p-hydroxybenzoate (17007)
Nipasol M is used as antiseptic and antimicrobial.
Nipasol M is used as the preservatives of food, cosmetics and medicines.

Applications of Nipasol M:
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.

Dissolving in water of Nipasol M:
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 Nipasol M 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, Nipasol M 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 Nipasol M maximum solubility and any further quantities may be dissolved in the oil phase, or solvent, as appropriate.

pH Stability of Nipasol M:
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 of Nipasol M:
Nipasol M is stable up to 80 °C.

Solubility of Nipasol M:
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 of Nipasol M:
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 (%)
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 (%)
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 of Nipasol M:
Nipasol M 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.

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).

Safety of Nipasol M:
Nipasol M and other parabens are widely used as antimicrobial preservatives in cosmetics, food products, and oral and topical pharmaceutical formulations.
Nipasol M 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. 
The WHO has set an estimated acceptable total daily intake for methyl, ethyl, and propyl parabens at up to 10 mg/kg body-weight.

Chemical properties of Nipasol M:
Nipasol M is a colorless and fine crystalline or white crystalline powder, almost odorless and with slightly astringent.
Nipasol M is soluble in ethanol, ethyl ether, acetone and other organic solvents
Nipasol M is slightly soluble in water.

Properties of Nipasol M:
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 %

Names of Nipasol M:

IUPAC name of Nipasol M:
Propyl 4-hydroxybenzoate

Trade names of Nipasol M:
Faracide P
Microcare OHB
Paratexin P
Solbrol P

Other names of Nipasol M:
4-Hydroxybenzoesäurepropylester
Propyl paraben
Propyl p-hydroxybenzoate
Propyl parahydroxybenzoate
Nipasol
E216

Synonyms of Nipasol M:
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
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
NSC23515
p-Hydroxybenzoic acid n-propyl ester
NCGC00090965-03
NCGC00090965-04
SMR000112070
DSSTox_CID_2527
WLN: QR DVO3
DSSTox_RID_76614
DSSTox_GSID_22527
Propyl parahydroxybenzoate;Propyl 4-hydroxybenzoate
Caswell No. 714
Propyl 4-hydroxybenzoate, 99+%
Propyl 4-hydroxybenzoate, >=99%
Bayer D 206
FEMA Number 2951
Pulvis conservans
CAS-94-13-3
FEMA No. 2951
HSDB 203
p-Oxybenzoesaurepropylester
EINECS 202-307-7
NSC 23515
p-Oxybenzoesaurepropylester
Propylparaben
EPA Pesticide Chemical Code 061203
BRN 1103245
AI3-01341
Propylester kyseliny p-hydroxybenzoove
4-Hydroxybenzoic acid propylester
36M
Propylparaben (NF)
Propylester kyseliny p-hydroxybenzoove
Propylparaben, USAN
ACMC-209rqc
85403-59-4
Propylis parahydroxybenzoas
propyl para-hydroxybenzoate
SCHEMBL977
p-Oxybenzoesaeurepropylester
EC 202-307-7
cid_7175
n-propyl-p-hydroxy-benzoate
4-10-00-00374
KSC489Q5P
MLS002222346
MLS006011654
BIDD:ER0229
Propyl-4-Hydroxybenzoate,(S)
CHEMBL194014
Propyl parahydroxybenzoate (TN)
DTXSID4022527
BDBM70190
CTK3I9857
KS-00000GZK
NSC8511
4-Hydroxybenzoic acid-propyl ester
HMS2268K21
Propyl 4-hydroxybenzoate, BioXtra
Propyl parahydroxybenzoate (JP17)
HY-N2026
NSC-8511
PROPYL PARA HYDROXY BENZOATE
ZINC1586788
Tox21_111048
Tox21_400012
4-hydroxybenzoic acid n-propyl ester
ANW-40210
BBL023754
NSC-23515
s5405
SBB015060
STL294815
4-Hydroxybenzoic acid, n-propyl ester
AKOS008948099
component of Heb-Cort MC (Salt/Mix)
CCG-266432
DB14177
DS-3427
MCULE-6661199693
NCGC00090965-01
NCGC00090965-02
NCGC00090965-05
NCGC00090965-06
NCGC00090965-07
AK106260
E216
K713
ST075003
CS-0018518
FT-0618698
P1955
T8305
D01422
A844839
Propyl 4-hydroxybenzoate, p.a., 99.0-100.5%
Propyl Parahydroxybenzoate 0.01 mg/ml in Methanol
Propyl Parahydroxybenzoate 1.0 mg/ml in Methanol
Q511627
4-Arm PEG-OMs, 95%, average M.W. 20,000
Q-201635
Propyl 4-hydroxybenzoate, SAJ first grade, >=98.0%
Propyl 4-hydroxybenzoate, tested according to Ph.Eur.
Propyl 4-hydroxybenzoate, Vetec(TM) reagent grade, 98%
Propylparaben, certified reference material, TraceCERT(R)
UNII-AZF98361GV component QELSKZZBTMNZEB-UHFFFAOYSA-N
4-Hydroxybenzoic acid-propyl ester 1000 microg/mL in Acetonitrile
Propylparaben, United States Pharmacopeia (USP) Reference Standard
Propyl parahydroxybenzoate, European Pharmacopoeia (EP) Reference Standard
Propylparaben, Pharmaceutical Secondary Standard; Certified Reference Material
4-Hydroxybenzoic acid propyl ester
Propyl chemsept
protaben p
pulvis conservans
Solbrol P
tegosept p
4-hydroxybenzoic propyl ester
p-hydroxy propyl benzoate
aseptoform p
betacide p
bonomold op
Chemacide PK
Chemocide PK
Chemoside PK
nipagin p
Nipasol
nipasol m
nipasol p
nipazol
n-Propyl paraben
n-propyl p-hydroxybenzoate
paseptol
preserval p
propagin
Propyl paraben
Propyl Parasept
propyl aseptoform
propyl butex
Propyl Chemosept
Propyl-P-Hydroxybenzoate
Propyl-P-Hydroxy Benzoate
Propyl Nipasol
Propyl Hydroxybenzoate
Propyl p-hydroxybenzoate
 

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