MEGGLE USA Inc. CERTIFICATE OF ANALYSIS (Spec. 30420-£/02) Order No: 2011-1 Product: GRANULAC 200 DEFINITION GGranuLac 200 Is the MEGGLE brend name for fine milled lactose. GGrenuLac 200 complies with the menagraph "Lactose Monohydrate" in the USP/NF. This monograph Ig harmonized between the Ph.Eur. and 3P. Lactose Monohydrate is a natural disaccharide, obtained fram milk, which consists of one glucose and one galactose moiety. (CHARACTERISTICS GranuLac 200 is white or almost white, odorless powder. It is freely but siowly soluble in weter, practically insoluble in alcohol Lot Number: 1c 023-1-801 Sublot (Bags): 1,501 to 3,200 Production Date: Week 25, 2011 Expiry Date: Week 23, 2014 TRENTIETCATION —USENE ot conform Infrared Absorption a Identinestion 8 USPINE <200> Conform Conform ‘Thin Layer (Chromatographic Identiication Test) Ieentifcation C USP/NF Lactose Monohydrate Conform Conform Test Clarity and Color ef ——=—USP/NF Lactose Monohydrate Clear, nearly colorless Conform solution ‘Absofbance at 400nr nical NMT 0,08 Speaitic Rotation USP/NF <781S> 454,40 - 455.99 55.0 ‘Acidity or Alkalinity —_-USP/NF Lactose Monohydrate NMT 0.4 mi 03 of 0.1N NaOH Loss on Drying USP/NF <731> NMT 0.5% ot ‘water USP/NF <921> Method 1 45% ~ 5.5% 52 Residue on Ignition ——_USP/NF <281> NMT 0.196 0.9 Heavy Metals USP/NF <231> NMT 5 u9/9) <5 Protein and Light USP/NF <851> 240-220nm: NMT 0.25 0.03 Absorbing Impurities 270-300nm: NMT 0.07 oot Partice Size Air Jet Sieve = “<32 jm: 45 ~ 7596 Conform Distribution 40 for 2 minutes +<100 pm: NLT 90% Conform Working Pressure: 1500-2500pa Page 1 of 2 ‘rane even ax fi) Seas atone taweimegge or mn magi shana enMEGGLE USA Inc, Lot Number: uc 023-2-801 ‘Sublot (Bags): 1,501 to 3,200, Production Date: Week 23, 2011, Expiry Date: Week 23, 2014 MICROBIALLIMITS — Method specification Result Total Aerobie Microbial sp <61> wr 300 NNT 50 fu 1 {ane Mod Count CIYMC) Bo Escherichia coll Use <62> Negative / 109 Negatve Salmonela spp. Usp <62> Negative / 109 Negative ‘STORAGE In tight containers, under dry and odor-free conditions, ‘MANUFACTURE SITE: DDavisco Foods International, Inc. 719 North Main Street. Le Sueur, MN 56058, USA ‘RELEASE SITE: Davisco Foods International, Inc. 719 North Main Street. Le Sueur, MN 56058, USA Validation Run #2 ‘APPROVED: quality Assurance (Davisco) ‘Adrian Bahr “The above data does not release purchaser from performing an Incoming control A legally binding assurance forthe ‘Tltablity ofthe product fr a defined application cannot be derived from the sbove Page 2 of 2 rane: @epea‘eer Pax fe) 622.8006: uncner srwceG@mnmh con wm eae Ae