Lactulose FOS

bH
Revision Status
Page
Specification / Certificate of Analysis
04
1 of 3
Specification
Version
released QA
0001
Date
Lactulose
Quality
EP, crystals
Name
Sign
Eiken Cramer
hm
id
25.11.2011
tG
m
Document
Product Code
Chemical Data
Batch-No.
10615
en
sc
Synonyma
Definition
nn
4-O-(-D-Galactopyranosyl)-D-arabino-hex-2-ulofuranose with a content of 95.0 - 102.0 %
.P
fa
Origin/Synthesis (short description)
Reference
Characters
Appearance
Assay / Ratio
K.
-W
Colour
Lactulose, anhydr. subst. (LC, 2.2.29)
Identification
by
TLC (2.2.27, Test A)
LC (2.2.29, Test B)
Requirements
EP
Crystalline powder
EP
White or almost white
Reference
EP
Observations
Requirements
Observations
95.0 - 102.0 %
Reference
EP
Requirements
Observations
Corresponds with reference

chromatogram
EP
Retention time and size of principal

peak correspond to reference
EP
A red precipitate is formed
Typical reaction with ammonia R (Test D)
EP
A red colour develops
Specific optical rotation, anhydr. subst.
EP
-46.0 to -50.0
ed
Cupri-tartrate method (Test C)
id
(2.2.7, Test E)
ov
Tests
EP
pr
Appearance of solution (2.2.1/2.2.2,II)
Reference
Certificate of Analysis
Requirements
Observations
Clear and not more intensely coloured

than reference solution BY5
Date
Name
Sign
released QA
Dieses Dokument ist keine Freigabeanalyse und entbindet den Empfnger nicht von einer unverzglichen und
vollstndigen Wareneingangskontrolle und eigenverantwortlichen Freigabe. Dieses Dokument gibt keinen
Hinweis auf zulssige oder intendierte Verwendungszwecke der Ware. Der Empfnger ist dafr verantwortlich,
die Gesetze und Vorschriften je nach gewhltem Verwendungszweck in eigener Verantwortung zu beachten.
Alle Angaben haben wir laut vorliegendem Analysenzertikat unseres Vorlieferanten oder Auftragslaboratoriums
gemacht, weshalb wir fr die Richtigkeit der uns vorliegenden Angaben keine Haftung bernehmen.
With this certificate of analysis we do not release products. It is in the customer's sole responsibility to test
goods immediately and fully upon receipt and release products for further use. This document does not
give any indication of admissable or intended uses of products. The recipient is solely responsible to secure
that all laws and regulations are duly regarded which are applicable due to the use intended by him. As all
data are taken from the certificate of analysis of our supplier or contract laboratory, we do not accept any
liability for above data.
K.-W. Pfannenschmidt GmbH Habichthorst 34-36 D-22459 Hamburg EN ISO 9001 Tel. +49-40-555 866-0 Fax +49-40-555 38 98 www.pfannenschmidt.de
bH
Revision Status
Page
04
2 of 3
Specification
Version
released QA
0001
Date
Lactulose
Quality
EP, crystals
Product Code
Chemical Data
Batch-No.
Requirements
pH (2.2.3)
EP
Specific optical rotation, anhydr. subst. (2.2.7)
EP
Related substances ( LC, 2.2.29):
EP
Sum of impurities A, B, C, D and E
EP
Epilactose (A)
Internal
Max. 0.5 %
Galactose (B)
Internal
Max. 0.5 %
Internal
Max. 0.5 %
Internal
Max. 0.5 %
Internal
Max. 0.5 %
EP
Max. 50 ppm
EP
Max. 9 ppm
EP
Max. 0.5 ppm
EP
Max. 2.5 %
Fructose (D)
Tagatose (E)
Boron
Lead (2.4.10)
Water (2.5.12)
nn
-46.0 to -50.0
Max. 3 %
EP
Max. 0.1 %
Total aerobic microbial count (2.6.12)
EP
Max. 100 cfu/g
E. coli (2.6.13)
EP
Negative /g
Internal
Negative /10 g
Internal
Min. 0.68 g/ml
Internal
Max. 40 % < 100 microns
Internal
< 30 sec.
Salmonella
Bulk density
Particle size
by
Sulfated ash (2.4.14)
K.
-W
Methanol, GC (2.2.28)
Observations
3.0 - 7.0
.P
fa
Lactose (C)
10615
en
Reference
ed
Flowability
Sign
Eiken Cramer
sc
Synonyma
Tests
Name
hm
id
25.11.2011
tG
m
Document
Requirements
Manufacturing and Release Data
Observations
id
Manufacturing date
Analysis date
ov
Retest Schedule
Reference
pr
Storage
Min. 36 months
Requirements
Date
Name
Sign
released QA
bH
Revision Status
Page
04
3 of 3
Specification
Version
released QA
0001
Date
Lactulose
Quality
EP, crystals
Product Code
Chemical Data
Batch-No.
Reference
Sign
Eiken Cramer
10615
sc
Synonyma
Requirements
en
Storage
Name
hm
id
25.11.2011
tG
m
Document
Containers
Tightly closed, cool, dark and dry
nn
Further remarks
Omitted as neither substance is used in the production process.

Periodically tested
pr
ov
id
ed
by
K.
-W
.P
fa
Appended information without quality change / EC 14.02.2012
Date
Name
Sign
released QA
bH
Revision Status
Page
04
1 of 3
Specification
Version
released QA
0003
Date
Fructo-Oligosaccharide
Quality
min. 93.2 % Oligofructose
Synonyma
Inulin
Product Code
Batch-No.
Sign
Ilka Ivens
11782
en
sc
Chemical Data
Name
hm
id
25.06.2015
tG
m
Document
Definition
nn
Fructo-Oligosaccharide is a mixture of oligosaccharides which are composed of fructose units linked together by
(2-1)linkages. Part of these molecules are terminated by a glucose unit (=Degree of Polymerisation or DP) of
Origin/Synthesis (short description)
.P
fa
oligofructose ranges mainly between 2 and 8.
Cichorium intybus var. foliosum; plant part used: root
Reference
Appearance
Colour
Taste
Solubility in water
Wettability in water
Assay / Ratio
by
Dispersability in water
K.
-W
Characters
Requirements
Organolept. Hygroscopic powder

Organolept. White
Organolept. Slightly sweet, no aftertaste
Min. 750 g/l
Good
Good, may require stirring
Reference
Requirements
Internal
Min. 93.2 %
Glucose + fructose + sucrose (as dry matter)
Internal
Max. 6.8 %
ed
Oligofructose (as dry matter)
id
Identification
ov
Tests
Observations
Observations
Reference
Requirements
Observations
Reference
Requirements
Observations
Internal
95 - 99 %
pH (30- 50 Brix)
Internal
5.0 - 7.0
pr
Dry matter
Date
Name
Sign
released QA
bH
Revision Status
Page
04
2 of 3
Specification
Version
released QA
0003
Date
Quality
Synonyma
Inulin
Product Code
Batch-No.
11782
Requirements
Observations
en
Reference
Tests
Sign
Ilka Ivens
sc
Chemical Data
Name
hm
id
25.06.2015
tG
m
Document
Conductivity (28 Brix)
Internal
Total mesophilic bacteria count
Internal
Max. 250 S/cm
Yeasts
Internal
Moulds
Internal
Max. 20 cfu/g
E. coli
Internal
Negative / g
Salmonella
Internal
Negative / 250 g
Max. 1,000 cfu/g
Manufacturing and Release Data

Manufacturing date
Retest Schedule
Storage
Container
Further remarks
K.
-W
Analysis date
.P
fa
nn
Max. 20 cfu/g
Reference
Requirements
Observations
Min. 36 months
Requirements
Tightly closed, cool, dark and dry
by
Heavy metals: Pb: max. 0.02 ppm, As: max. 0.03 ppm, Cd, Hg: max. 0.01 ppm
Appended information without quality change; 18.11.15 Varga
(acc. to supplier information and sampling/testing plans within scope of due care)
ed
Regulatory Data
Not a hazardous substance acc. to EC reg. 1272/2008 and 1907/2006. MSDS not required.
Product has not been subjected to irradiation.
id
Free of BSE/TSE (Bovine/Transmissible Spongiforme Encephalopathy).

No obligation of GMO labelling as defined in EC reg. 1829/2003 / 1830/2003.
ov
Free of allergens subject to labelling acc. to EU reg. 1169/2011.

No obligation of nano material labelling as defined in EU reg. 1169/2011
pr
Conforms EC reg. 178/2002 for food raw materials conc. food safety, traceability, hygiene management.
Date
Name
Sign
released QA
bH
Revision Status
Page
04
3 of 3
Specification
Version
released QA
0003
Date
Quality
Synonyma
Inulin
Product Code
Batch-No.
Sign
Ilka Ivens
11782
en
sc
Chemical Data
Name
hm
id
25.06.2015
tG
m
Document
Nutritional Data (typ. in 100 g or ml)
204 kcal / 821 kJ
nn
Energy value
Observations
Protein
Carbohydrates
5g
5g
.P
fa
thereof sugars
not detectable
Fat
not detectable
92 g
pr
ov
id
ed
by
K.
-W
Fibre
Date
Name
Sign
released QA

Lactulose FOS

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bH

Specification / Certificate of Analysis

4-O-(-D-Galactopyranosyl)-D-arabino-hex-2-ulofuranose with a content of 95.0 - 102.0 %

Origin/Synthesis (short description)

Lactulose, anhydr. subst. (LC, 2.2.29)

TLC (2.2.27, Test A)

White or almost white

Corresponds with reference

Retention time and size of principal

A red precipitate is formed

Typical reaction with ammonia R (Test D)

A red colour develops

Specific optical rotation, anhydr. subst.

Cupri-tartrate method (Test C)

Appearance of solution (2.2.1/2.2.2,II)

Clear and not more intensely coloured

Specification / Certificate of Analysis

Specific optical rotation, anhydr. subst. (2.2.7)

Related substances ( LC, 2.2.29):

Sum of impurities A, B, C, D and E

Max. 0.5 ppm

Total aerobic microbial count (2.6.12)

Max. 100 cfu/g

Min. 0.68 g/ml

Max. 40 % < 100 microns

Sulfated ash (2.4.14)

Manufacturing and Release Data

Specification / Certificate of Analysis

Tightly closed, cool, dark and dry

Omitted as neither substance is used in the production process.

Appended information without quality change / EC 14.02.2012

Specification / Certificate of Analysis

min. 93.2 % Oligofructose

Origin/Synthesis (short description)

oligofructose ranges mainly between 2 and 8.

Cichorium intybus var. foliosum; plant part used: root

Organolept. Hygroscopic powder

Glucose + fructose + sucrose (as dry matter)

Oligofructose (as dry matter)

Specification / Certificate of Analysis

min. 93.2 % Oligofructose

Conductivity (28 Brix)

Total mesophilic bacteria count

Max. 250 S/cm

Max. 1,000 cfu/g

Manufacturing and Release Data

Free of BSE/TSE (Bovine/Transmissible Spongiforme Encephalopathy).

Free of allergens subject to labelling acc. to EU reg. 1169/2011.

Specification / Certificate of Analysis

min. 93.2 % Oligofructose

Nutritional Data (typ. in 100 g or ml)

204 kcal / 821 kJ

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