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 “ac WEGELE Wavsrbarg Grit Ga KE Hsp. 0-72 -B3512 Waser, Garang Tophone +9 (007 TSS sr (]O0T1 To-do coer orageers HEGGLE Wasser Verwabigy Oma, pect ty ‘of snr sence Pry (020) doe Deck Fans Mayr” gr’ Peer ores er 65312 Wemsrurg Dating nde Rete Taso WA TERE VATJGN: DEBISG72E2Areas oo 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. Toes MEGLE Wenerburg Gn 8 Go KO Ngan 6-12-8512 Wane, GaonyTaephone 9607 TOO Toe t0{0}00"" Ta-4e4. nQinagge dete lhnenmeagacr nwa anagurert HEGOLE Wissroog Vewatnge Gna reported by ‘om salt van e Peg (EO): Joe eck Fare Mayr Egront ler gered Ofer 8312 Waeetug Daun Trae Rage Train HRA T826-VATGN- DEBIETSS2 Page 2 trom 3MEeLES 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 Tere NEGELE Wassrbarg Gai 8 Gos NG Nagle, 692-835: Waren, Gsrany Tape 5) 87 TD oe 9 0}007 odes. begs teal reagan nar agua MEGGLE Waaeasarg Voss net repress i gat ven Peg (CO) Joa as Fan Maer Egor ter Aegis oe 02 Wants tetan Trae Reger Tunstnn HRA 782 VATIGNG: CESTEO7SB2