Product Fact Sheet

NIPAGIN® M

Preservative for the cosmetic industry

Chemical Name Methyl 4-Hydroxybenzoate CLARIANT INTERNATIONAL LTD

INCI designation Methylparaben Rothausstrasse 61

4132 Muttenz
Chemical structure
Switzerland

BUSINESS UNIT INDUSTRIAL &

CONSUMER SPECIALTIES

www.ics.clariant.com
www.clariant.com

1
PRODUCT PROPERTIES

Appearance (20 °C) White, crystalline powder.

Chemical and physical data

o
Melting point 125 - 128 C

Assayacc. BP/PH.Eur 98.0 - 102.0 %

Uses
Nipagin® M is a broad spectrum antimicrobial agent designed for preservation of
a wide range of cosmetics, toiletries and topical pharmaceuticals. Nipagin® M is
suitable to preserve both rinse- off and leave- on formulations.

Applications
Typical use concentrations of Nipagin® M is 0.1 – 0.3 %.

Combinations of p- Hydroxybenzoic acid esters, e.g. with Nipasol® M, Nipagin®

A or Nipabutyl® exhibit increased activity compared with individual esters.
Regulatory Status
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.

1
These characteristics are for guidance only and not to be taken as product specifications. The tolerances are
given in the product specification sheet. For further product properties, specifications, safety and ecological
data, please refer to the MSDS.

Page 1 of 4 NIPAGIN® M May 2013

USA: considered safe as used by Cosmetic Ingredient Review (2006),
Methylparaben up to 0.4 % if used alone (paraben mixes up to 0.8 %).

Incorporation
Nipagin® 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. CLARIANT INTERNATIONAL LTD

Most formulations requiring preservation contain a significant amount of water. Rothausstrasse 61

4132 Muttenz
This may mean that Nipagin® M cannot readily be added directly to the Switzerland
formulation. BUSINESS UNIT INDUSTRIAL &
CONSUMER SPECIALTIES
Other methods of incorporation are quite straightforward however, and are
www.ics.clariant.com
listed below www.clariant.com
Dissolving in water
The solubility of Nipagin® 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 Nipagin® 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

Nipagin® M is readily soluble in polar organic solvents. Where such a solvent is
already part of a formulation, a Nipagin® 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.

Nipagin® 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
Nipagin® 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 Nipagin® M. That can result
in a lower use concentration when the pH of the formulation is more acidic.

Temperature stability
Nipagin® M is stable up to 80 °C.

Page 2 of 4 NIPAGIN® M May 2013

Solubility
The solubility of Nipagin® M in different solvents is illustrated in the following
table:

Solvent % (w/w)
Water 10 °C 0.13
Water 25 °C 0.25
Water 80 °C 3.1
CLARIANT INTERNATIONAL LTD
Water 100 °C 6.2
Acetone 39 Rothausstrasse 61
Methanol 37 4132 Muttenz
Switzerland
Ethanol 32
Propylene Glycol 26 BUSINESS UNIT INDUSTRIAL &
Glycerol 3.3 CONSUMER SPECIALTIES
Vegetable oils (arachis) 2.4 www.ics.clariant.com
Liquid paraffin 0.02 www.clariant.com

Microbial Activity
Nipagin® 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 Nipagin® M against examples of
different groups of microorganisms.

Microorganisms MIC level (%)

Gram Negative Bacteria
Pseudomonas aeruginosa 0.20
Escherichia coli 0.10
Klebsiella aerogenes 0.075
Klebsiella pneumoniae 0.10
Serratia marcescens 0.075
Proteus vulgaris 0.10
Salmonella enteritidis 0.15
Salmonella typhi 0.15
Gram Positive Bacteria
Stpahylococcus aureus 0.15
Streptococcus haemolyticus 0.10
Bacillus cereus 0.075
Bacillus subtilis 0.10
Lactobacillus buchneri 0.10
Yeasts
Candida albicans 0.10
Saccharomyces cerevisiae 0.10
Moulds
Aspergillus brasiliensis 0.10
Penicillium digitatum 0.05
Rhizopus nigricans 0.05

Page 3 of 4 NIPAGIN® M May 2013

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.

CLARIANT INTERNATIONAL LTD

Rothausstrasse 61
4132 Muttenz
Switzerland

BUSINESS UNIT INDUSTRIAL &

CONSUMER SPECIALTIES

www.ics.clariant.com
www.clariant.com

This information corresponds to the present state of our knowledge For sales to customers located within the United States and Canada
and is intended as a general description of our products and their the following applies in addition:
possible applications. Clariant makes no warranties, express or NO EXPRESS OR IMPLIED WARRANTY IS MADE OF THE
implied, as to the information’s accuracy, adequacy, sufficiency or MERCHANTABILITY, SUITABILITY, FITNESS FOR A PARTICULAR
freedom from defect and assumes no liability in connection with any PURPOSE OR OTHERWISE OF ANY PRODUCT OR SERVICE.
use of this information. Any user of this product is responsible for
determining the suitability of Clariant’s products for its particula
application. * Nothing included in this information waives any of ® Trademark of Clariant registered in many countries
Clariant’s General Terms and Conditions of Sale, which control © 2012 Clariant International Ltd
unless it agrees otherwise in writing. Any existing
intellectual/industrial property rights must be observed. Due to
possible changes in our products and applicable national and
international regulations and laws, the status of our products could
change. Material Safety Data Sheets providing safety precautions,
that should be observed when handling or storing Clariant products,
are available upon request and are provided in compliance with
applicable law. You should obtain and review the applicable Material
Safety Data Sheet information before handling any of these products.
For additional information, please contact Clariant.

Page 4 of 4 NIPAGIN® M May 2013