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DMV-Fonterra Excipients
The Ingredients of success
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Certificate of analysis
Issue date Page 1/2
11.03.2008
Purchase o.der Kawarlal & Company
INDT/025/08 27 Raghunayakulu Street
Delivery item 600003 CHENNAI
80368793 900003 India
Order item
301430 000020
Total Quantity Item
15.380 KG
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Material:
Pharmatose 450 M
Lactose USP/NF.Ph.Eur .• JP
Multi layer paper bag with a polythene
innerbag; contents 20 kg net.
Manufacturing site: DMV International B.V., Veghel, The Netherlands
Product name Pharmatose 450M
Product description: A white or almost white, crystalline powder freely but slowly
soluble in water, practically insoluble in ethanol
Residual solvents
(CPMP/ICH/283/95): No class 1,2,3 solvents are used during production
Identification Complies with Pharmacopoeia when tested
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Lot: 10377117 Quantity: 15.380 KG
Manufacture date: 01.2008 3Xp1ry date: 12.2010
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SPBCInCA'l'lON
Characteristic unit Lower Upper value
\ Limit Limit.
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Water ( KF) \ 4,5 5,5 4,8
Loss on drying \ 0.0 0,5 0,2
Specific rotation 20 °C anhydr NON 54,4 55,9 55,2
\ Residue on ignition/Sulph.Ash \ 0,00 0,10 0,09
Absorb.l% , 1cm at 270-300 nm NON 0,00 C.07 0,01
\ Absorb.l\ . lcm at 210-220 nm NON 0,00 0,25 0,03
AbRorb.10% , lcm at 400 nm NON 0,00 0,04 0,02
Appearance of solution (Ph.Eur Passes test
Clear and not more
I, coloured than ref.BY"
i - Clarity and Colour of Solution Passes test

or nearly colourless
Acidity (ml O.lN NaOH/6 g) ml/6g 0,0 0,4 0,2
Heavy Metals (max. 5 ppm) Passes test
Particle size (PSD) t­ <45 J.lffi % 90,0 100,0 94,3

(This is an electronic document valid without signature)

o e-.")pyrighr_~ DHV-Fonterra Sxcipip.Ilts GmbH & Co. KG

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Frleslandfoods

net Chemical
B-30S Neelam Centre
400030 Mumbai
INDIA

CERTIFICATE OF ANALYSIS
PrOduct : Lactopres$@ Spray-dried 250
Product code : 585241
Order no : 1232683
Customer's ref. no. : SCCPLj609/6110
Batchnumber : 634074
Date of production : 27-05-2009
Retest date : 27-11-2010

DesqiDtjon : s~~ lactose pharmaceutical

irare~iilrm USP/ NF, EP, JP
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Physi@I-Chemicill data C) 5pegfiS;i1tipn Resylti
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Identification
Appearance in solution
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.. conform USP/NF,EP, JP
clear and nearly colourless
conform
conform
Residue on ignition Max. 0.1 % 0.05 %
Total Water 4.5 - 5.5 % 4.95 %
Loss on drying Max. 1.0 % 0.16 %
Acidity (0.1 N NaOH) Max. 0.4 ml 0.32 ml
Specific Optical Rotation (on anhydrous basis) +54.4° to +55.9° 55.1 °
Absorbance between 210-220 nm( 1 % , 1 cm ) Max. 0.25 < 0.25
Absorbance between 270-300 nm( 1 % , 1 cm ) Max. 0.07 < 0.07
Absorbance at 400 nm (10 %, 1 cm) Max. 0.04 0.001
Heavy metals Max. 5 ppm < 5 ppm

Mlc;;rpbiologlcal data Specification

Total plate count Max. 100 / 9 < 1/ 9

Enterobacteriaceae absent in 1 9 absent
Escherichia coli absent in 10 g absent
Salmonellae absent in 5 x 25 g absent
Yeasts & moulds Max. 10/ 9 < 1/ g

Particle size distribution (Aitjet sieve analysis, Alpine)

< 250 micron > 98 % 100 %

< 100 micron 30 - 60 % 53 %
< 75 micron < 50 % 33 %
< 45 micron < 15 % 12 %

Borculo. 16-07-2009

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