MES SLED
MEGGLE)
CERTIFICATE OF ANALYSIS ‘Spec. No 40000000047 Version 04
DeliveryNo: 80140215
Material: 13005015 SORBOLAC 400
LotNo. Lroseaza tenses
Manufact. Date Expiry Date
weay20t6 weey2019
DEFINITIONICHARAGTERS/PRODUGTION
SORBOLAG 400 is MEGGLE's brand name for a milled lactose,
SORBOLAG 400 conforms to the monograph "Lactose Monohydrate” in the European Phormacopoela (Ph. Eur.)
‘This monograph is hermonized between Ph. Eur., USP-NF and JP.
SORBOLAC 400 is a white or almost white, erysallin, odourless povider. itis freely but slowly soluble in water,
practically ingoluble in ethanol (96 par cent}
Production and release site: Molkerel MEGGLE Wasserburg GmbH & Co. KG, Megglestr. 6-12, 83512
Wasserourg, Germany
“The management system of Molkerei MEGGLE Wasserburg GmbH & Co. KG, Megolest. 6-12, 83612
Wasserburg, Germany has been certified meeting the requirements of GMP and GDP according to EXIPACT™.
[ Method [Specification ‘unit | Result}
IDENTIFICATION
Identification AIPh, Eur. 2.2.24Vinfrared absorption ‘cantons ‘conforms
spectrophotomety
Identification B/USP-NF <201>7Thin-layer chromatographic |onforms. ‘conforms"|
identification test
Identification D/Ph, Eur. 25.12/Water conforms conforms"
TESTS.
[Appearance of solution Ph. Gur 22.1 Viewal [max 3 NTU 0a]
smothod (max 3. NTU
‘equals "The solution is
clear)
"Appearance of solution Ph, Eur 2.2.2 Method Ii| The solution is not more | econforms|
intensely coloured than
reference solution BY: _|
[Aclaty oF alkalinity Ph. Eur. Lactose The soluto ‘conforms
Monohydrate lcolouriess |
Page 4 from3
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CERTIFICATE OF ANALYSIS ‘Spec. No.: 10000000047 Version 01
DeliveryNoz 80140215
Material: 13005015 SORBOLAC 400
Lot No. Lio3e42e16A545
[Method [Specification Unit Result
[Acidity or alkalinity Ph. Eur. Lactose max 0.4 mi 02!
Monohydrate/Requirem
lent of 0.1 M sodium
hydroxide to change the |
[colour of the indicator to
pink orred
[Specific optical rotation (anhydrous | Ph. Eur. 2.2.7 54.4 - 55.9 a 35.
substance)
[Absorbance at 400 nm Ph. Eur. 2.2.25 max 0.04 0.00]
[Absorbance from 210 to 2201nm [Ph Eur. 2.2.25 max 0.25 0.05;
‘Absorbance from 270 to 300.nm | Ph. Eur. 2.2.25 max 0.07 0.02|
Heavy metals Ph. Eur. 2.4.8 Method A| max 5 vaig_| conforms"
Water Ph. Eur. 2.5.12 45-55 % 5A
[Loss on drying [USP-NF <731> [max 05: % 0.31
'Sulfated ash Ph, Eur, 2.4.14 max 0.4 % conforms”
Particle size dietibution < 32 pm —_|Ph. Eur. min 90 % ‘98 - 100
2,9.38/Air-ontrainment
‘method (air-jet sieving);
10 g; +0.1 g ALOsi p=
1500 - 2500 Pa; 2 min
MICROBIAL CONTAMINATION
“Total aorobie microbial count Ph, Eur. 2.6.1210SP-NF [max 100 cfulg 1
(TAMC) <6 1>/JP 4.05
Total combined yeasts/moulds count |Ph. Eur. 2.6.12/USP-NF |max 50 fulg 4
«TYMC) <8 1>/JP 4.05
Escherichia coli Ph, Eur. 2.6.13/USP-NF | absence 1109 absence"
<62>1NP 4.05
‘Salmonelfa spp. Ph, Eur. 2.6.13/USP-NF | absence n0g ‘absence|
<62>/NP 4.05
* The conformity to specication is assured by periodical testing.
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Page 2 trom 3MEeLES
CMECGLED
CERTIFICATE OF ANALYSIS ‘Spec. No: 10000000047 Version 01
DaliveryNo: 80140215
Material: 13005015 SORBOLAC 400
Lot No. Lyoseazet6Asas
CONTAINERSTORAGE
\Wel-closed container. Storage in an unopened, originally packed MEGGLE container al room temperature under
dry and odour-free conditions.
‘This document Is valid without signature
‘Wasserburg: 12.09.2016
Quality assurance
Dr. G. Maller
CP = Consumer Products
‘The above data do not release purchaser from performing an incoming control. A legally binding assurance for the
‘sultabilty of the product fora defined application purpose cannot be derived from the above.
Page 3 from 3
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