Technical Information
EUDRAGIT® L 100-55
EIP / Product Regulatory Datasheet
…………………………………………………………………………...
This Product Regulatory Data Sheet is built up following the standardized Excipient Information
Package (EIP) format published by IPEC (International Pharmaceutical Excipients Council).
Table of Contents
1
General Product Information
2
Manufacturing, Packaging and Release Site Information
3
Physico-Chemical Information
4
Regulatory Information
5
Miscellaneous Product Information
6
Revisions
7
Contact Information
1
General Product Information
Product: EUDRAGIT® L 100-55.
Scope: This datasheet pertains only to the product listed above.
Specification and testing methods: see product specification INFO 7.4/E.
Storage conditions: see product specification INFO 7.4/E and product label.
Minimum stability date: see certificate of analysis and product label.
EIP - L 100-55
Evonik Operations GmbH
EUDRAGIT® L 100-55
July 2020
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2
Manufacturing, Packaging and Release Site Information
EUDRAGIT® L 100-55 is manufactured, tested for release, packaged, labeled and stored under
the responsibility of the following company:
Evonik Operations GmbH
Kirschenallee
64293 Darmstadt (Germany)
Telephone:
Fax:
Homepage:
+49 (0) 6151 18 01
+49 (0) 6151 18 02
http://www.eudragit.com
Interim Storage
Qualified third party logistic specialists in Germany may be used for the interim storage of this
product.
This product is manufactured in conformance with:
GMP standard:
Management
system:
ESHQ policy:
EXCIPACT™
certification
3
The Joint IPEC – PQG Good Manufacturing Practice
Guide for Pharmaceutical Excipients 2017 and
USP-NF General Chapter <1078>
Quality: ISO 9001
Environment: ISO 14001
see ESHQ values: http://www.evonik.com
(Responsibility)
Evonik Pharma Polymers & Services is certified
since January 2014
Physico-Chemical Information
CAS number
25212-88-8
FDA UNII
NX76LV5T8J
Chemical/IUPAC Name
Poly(methacrylic acid-co-ethyl acrylate) 1:1.
INCI Name
Acrylates Copolymer.
FDA-SRS Preferred Substance Term
Methacrylic acid - ethyl acrylate copolymer (1:1) type A.
EIP - L 100-55
Evonik Operations GmbH
EUDRAGIT® L 100-55
July 2020
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Physical Properties
EUDRAGIT® L 100-55 is a solid substance in form of a white powder with a faint characteristic
odor.
Molar Mass Information
MW approx. 320,000 g/mol.
In previous publication the approximate weight average molar mass was indicated to be
250,000. This was determined by viscometry in the 1960ies and had never been re-evaluated
since then. The determination of the weight average molar mass of acrylic copolymer by size
exclusion chromatography (SEC) or gel permeation chromatography (GPC), respectively, is
difficult due to adsorptive and associative phenomena of these polymers. In 2004 a robust SEC
method was developed for this polymer. Based on this method the weight average molar mass
is approximately MW 320,000 g/mol.
Chemical Properties
EUDRAGIT® L 100-55 contains an anionic copolymer based on methacrylic acid and ethyl
acrylate. The ratio of the free carboxyl groups to the ester groups is approximately 1:1.
The product contains 0.7 % Sodium Laurylsulfate Ph. Eur. / NF and 2.3 % Polysorbate 80 Ph.
Eur. / NF on solid substance. EUDRAGIT® L 100-55 is the dry substance obtained from
EUDRAGIT® L 30 D-55 by spray drying.
Chemical Structure
The monomers are statistically ordered in the copolymer chain.
Production Process
Emulsion polymerization and subsequent spray drying.
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Evonik Operations GmbH
EUDRAGIT® L 100-55
July 2020
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Product Flow
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July 2020
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4
Regulatory Information
Compendial Compliance
EUDRAGIT® L 100-55 meets the specifications of the following pharmacopoeias:
Ph. Eur.
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A
USP-NF
Methacrylic Acid and Ethyl Acrylate Copolymer
JPE
Dried Methacrylic Acid Copolymer LD
Drug Master File
EUDRAGIT® L 100-55 is described in US Drug Master File:
# 002584.
A Letter of Authorization is issued upon written request.
Food Label
USA:
not approved as direct or as indirect food additive (21 CFR 172 to 177 and 180
to 186)
EU:
not listed (Council Directive 89/107/EEC and amendments)
Production Related Substances
Sulfur dioxide and sulphites
Disinfectant additives
Preservatives
Plasticizers (e.g. phthalates)
Emulsifiers
Simethicone
Antioxidants
Sodium chloride
Iodine and iodine salts
EIP - L 100-55
Not anticipated to be more than 10 mg/kg
No
No
No
0.7 % sodium laurylsulfate and 2.3 % polysorbate 80
with ref. to dry subst.
Minute amounts of a silicone antifoaming emulsion are
used in the production process
No
No
No
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July 2020
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Allergen and Compound Ingredient Disclosure Statement
The allergens named in EU Directive 1169/2011 and relevant amendments are not used in the
manufacture of EUDRAGIT® L 100-55.
The product does not contain any of the sensitizing fragrances listed in Annex III of EU
Regulation 1223/2009 entries 67 to 92, in the Appendix of the Annex to the EC Guideline
"Excipients in the labelling and package leaflet of medicinal products for human use" and in
Australian TGO 91/92.
EUDRAGIT® products are synthetic acrylic copolymers. The following substances are neither
used nor intentionally added in the manufacture and packaging of EUDRAGIT® products.
Therefore, more than omnipresent traces are not anticipated in the product. In addition, none of
the potent substances indicated with an asterisk (*) are produced or handled in the same
production site either.
Abalone
Grapes & grapevine derivatives
Amino acids (e.g. glutamate, LHerbicides (*)
phenylalanine)
Animal Coal
Honey
Animal derived products and animal-byHormones (*)
products
Antibiotics (e.g. penicillin) (*)
Human derived products
Artificial colours
Lactose
Artificial flavors
Latex and latex derivatives
Artificial sweetener
Lupine
Aristolochic acid
Malt dextrin
Asbestos
Mesylate ester
Beef and beef derivatives
Milk
Bisphenol (A-Z)
Molluscs
Bovine and bovine products
Mustard
Caffeine
Nuts (almonds, hazelnuts, walnuts,
cashews, pecan nuts, Brazil nuts, pistachio
nuts, macadamia nuts, Queensland nuts)
Carbohydrates
Peanuts and peanut products
Carbomer homopolymer
Pesticides (*)
Casein
Pork and pork products
Celery and celery products
Proteins
Cellulose
Radioactive substances (*)
Cereals (corn, buckwheat, wheat, rye,
barley, oats spelt, kamut or other hybridized Rice and rice products
strains)
Chicken and chicken products
Rosin
Cochineal extract
Sesame seeds
Collagen
Sorbitol
Crustaceans
Soy and soy products (soybeans)
Cytotoxics (*)
Squid
Dairy products and derivatives
Starch
Eggs and egg products
Stem cells or eukaryotic cells
Fish and fish products
Steroids (*)
Flaxseed
Sugar
Fragrances
Sugar alcohol (e.g. xylitol, maltitol)
Fructose
Sulphonic acid ester
Gelatin
Table salt
Gluten (corn, wheat, oat, rye)
Wool derivatives
Glycerin
Yeast / autolyzed yeast
EIP - L 100-55
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EUDRAGIT® L 100-55
July 2020
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Residual Solvents
Organic solvents are not used in the manufacture, packing and storage of this product. Small
amounts of ethanol may be detectable within the minimum stability period. The concentration
remains below 0.5 %.
Source:
The ethyl acrylate integrated in polymer chain may hydrolyze chemically at a very low level to
acrylic acid and ethanol. The acrylic acid remains in the polymer chain but ethanol is released.
This hydrolysis starts with manufacturing and is ongoing during storage.
A Residual Solvents Statement is given on every Certificate of Analysis on page 2.
BSE/TSE Status
The product covered by this document is synthetically manufactured in equipment restricted to
the production of chemical products in facilities where no animal derived materials are used.
Based on the manufacturing and processing methods used there is no potential for TSE/BSE
agent to be present in the product.
A TSE/BSE Confirmation/Statement is given on every Certificate of Analysis on page 2.
Genetically Modified Material (GMM) / Genetically Modified Organism (GMO) Information
This product is manufactured by chemical process. Certain ingredients, specifically, Sodium
Laurylsulfate Ph. Eur. / NF and Polysorbate 80 Ph. Eur. / NF are of natural origin. Our suppliers
confirmed that genetically modified materials are not used in the manufacturing of these
ingredients.
A GMM/GMO statement is given on every Certificate of Analysis on page 2.
Melamine Information
Animal derived products or nitrogen-containing raw materials including melamine are neither
used in the manufacture nor packaging of EUDRAGIT® products. Consequently EUDRAGIT®
products are not tested for melamine content. More than omnipresent traces are not anticipated
in the product.
Nitrosamine Information
Nitrosamine information is available upon request.
Sodium/Potassium/Calcium/Magnesium
Not more than 0.2 % each in the product calculated from the limit for sulphated ash
(max. 0.4 %).
Elemental Impurities and Heavy Metals
Elemental Impurities and Heavy Metals information is provided in the specification. Background
information is available upon request.
Kosher/Halal Status
Neither Kosher nor Halal certificates are available. The product is manufactured by chemical
synthesis. No animal derived raw materials are used.
Halal: poly acrylic acid and its salts are considered as Halal according to Indonesian authority
LPPOM MUI (document# SK07.I.2013).
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Evonik Operations GmbH
EUDRAGIT® L 100-55
July 2020
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Viral Safety
Neither animal/human cells nor human/animal derived materials are used in the manufacture of
this product. Therefore viral contaminations are not anticipated in this product.
Bioburden/Pyrogens
The product is a synthetic (meth)acrylic copolymer. Microbial purity is controlled and specified
(see specification). A bioburden or pyrogenic contamination is not anticipated in the product.
Aflatoxin
The product is a synthetic (meth)acrylic copolymer. Microbial purity is controlled and specified
(see specification). An aflatoxin contamination is not anticipated in the product.
Dioxin
Dioxin is neither used in the manufacture nor anticipated from raw materials nor from production
conditions. Therefore dioxin contaminations are not anticipated in this product.
Irradiation
Neither the product nor the raw materials are subjected to irradiation.
Proposition 65
See product US Material Safety Data Sheet.
5
Miscellaneous Product Information
Batch Definition
A batch is a quantity of homogenous product manufactured either within a manufacturing cycle
or during a defined time period.
Batch/Lot Numbering System
The lot number is composed of a letter at the first place which represents an internal production
site, followed then by nine digits representing a manufacturing order date, product code and
sequential batch number.
Packaging Material
The materials used in the manufacture of EUDRAGIT® primary packaging materials are allowed
according to EU food packaging legislation.
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July 2020
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Re-evaluation Period
EUDRAGIT® L 100-55 is stable in the original sealed and unopened container stored under
conditions as specified for at least 36 months. The minimum stability date is given on the label
of each individual container and on each Certificate of Analysis on page 1.
If the product is to be used after longer storage we recommend performing tests given in the
'EUDRAGIT® Products suggested tests for Re-examination' leaflet. Especially in case of
advanced formulations we recommend to consider if a trial production and suitability tests are
necessary.
Technically Unavoidable Particles Profile (TUPP)
TUPP information is available upon request.
History of Use
Year of introduction to the market: 1985.
EUDRAGIT® L 100-55 is the dry substance obtained from EUDRAGIT® L 30 D-55.
The polymer dispersion EUDRAGIT® L 30 D-55 is commercially available since 1972.
Common Uses
EUDRAGIT® polymers are widely used as a platform for functional oral solid dosage forms.
Macronutrient Information
The polymer is neither absorbed nor degraded in the gastro-intestinal system. It is excreted
unchanged.
Safety Information
Summary of safety data is available upon request.
Stability Information
Storage stability data is available upon request.
6
Revisions
Date of Publication
Document Version
July 2015
6.0
June 2018
July 2020
EIP - L 100-55
Revision Description
Update: Company name
change, new USP-NF
monograph name mandatory
Dec 1, 2015, minor modifications
on existing texts
7.0
Update: minor editorial
modifications, interim storage,
SRS name, Elemental
Impurities, EU food packaging
legislation, common uses
8.0
Update: Company name
change, minor editorial
modifications, Australian
TGO 91/92, Nitrosamine, TUPP
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July 2020
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7
Contact Information
Regulatory Affairs (Evonik Operations GmbH)
Dr. Johanna Eisele
Head of Regulatory Affairs
Tel: +49 6151 18-4763
E-mail: johanna.eisele@evonik.com
Quality Assurance (Evonik Operations GmbH)
Mr. Boris Glasbrenner
Head QA Operations
Tel: +49 6151 18-4879
E-mail: boris.glasbrenner@evonik.com
Sales
(Evonik Operations GmbH)
Mr. Karsten Weber
Head of Global Sales Support
Tel: +49 6151 18-3550
E-mail: karsten.weber@evonik.com
USA Contact
(Evonik Corporation)
Mr. Chris Armstrong
Director Supply / Demand Chain
Tel: +1 732 981-5339
E-mail: chris.armstrong@evonik.com
Date:
July 2020
Dr. Johanna Eisele
Boris Glasbrenner
Evonik Operations GmbH
Head of Regulatory Affairs
Pharma Polymers & Services
Evonik Operations GmbH
Head QA Operations
Darmstadt/Weiterstadt Health Care
(written by computer and therefore not signed)
'100120927 - TBBT!
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July 2020
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This information and all further technical advice are based on our present knowledge and experience. However, it implies no liability or other legal
responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty,
whether expressed or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes
according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and
testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified
experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply
that similar products could not be used.
®
= registered trademark
The name EUDRAGIT® is a protected trademark owned by Evonik Industries or one of its subsidiaries
July 2020
Evonik Operations GmbH
Kirschenallee, 64293 Darmstadt, Germany
PHONE +49 6151 18-4019, FAX +49 6151 18-3520
www.eudragit.com
EIP - L 100-55
Evonik Operations GmbH
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July 2020
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