"Type: Food Additives
Origin: China
CAS No.: 63-42-3
AUCO No.: 919
Packing: 25kg bag"
Items Standard
Identification A The infrared absorption spectrum of the sample is concordant with that of the standard.
Identification B The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A
The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots, disregarding any spots at the origin.
Identification C A red color develops.
Specific optical rotation +54.4~+55.9, calculate on the anhydrous basis
Acidity or alkalinity Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a red color.
Water Not more than 1.0%
Residue on ignition Not more than 0.1%
Heavy metals The limit is 5�µg per g.
Protein and light-absorbing impurities The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220nm and is not more than 0.07 in the range of 270 to 300nm.
TPC <100cfu/g
Yeast & Mould <50cfu/g
Escherichia coli (/10g) absence
Conclusion : The Quality of lactose product has the achieved scandard of USP40 after examination standard examination, and consequently meet the provision.
Color Take an appropriate amount of sample in the white shallow dish on the natural light line, observe, white to light yellow.
Taste smell Take an appropriate amount of sample in the white shallow dish in natural light, observe, slightly sweet and odorless.
State of organization Take an appropriate amount of the sample in the white shallow disk in natural light, observe, crystal or powder crystal.
Lactose a (In the dry basis)/(g/100g) A lactose content according to (100- water-ash)/(100-water) calculation. 99.0
Water/(g/100g) 6.0 (GB 5009.3-2010 Karl fisher method)
Ash/(g/100g) 0.3 (GB 5009.4)
PH/(10% aqueous solution) Take 10g of lactose in 100ml beaker, add distilled water into 10% water solution,with a pH measuring the value of pH. 4.5-7.0.
Conclusion : The quality standard test of this food lactose is in accordance with the regulations.
Color Take an appropriate amount of sample in the white shallow dish on the natural light line, observe, white to light yellow.
Taste smell Take an appropriate amount of sample in the white shallow dish in natural light, observe, slightly sweet and odorless.
State of organization Take an appropriate amount of the sample in the white shallow disk in natural light, observe, crystal or powder crystal.
Lactose a (In the dry basis)/(g/100g) A lactose content according to (100- water-ash)/(100-water) calculation. 99.0
Water/(g/100g) 6.0 (GB 5009.3-2010 Karl fisher method)
Ash/(g/100g) 0.3 (GB 5009.4)
PH/(10% aqueous solution) Take 10g of lactose in 100ml beaker, add distilled water into 10% water solution,with a pH measuring the value of pH. 4.5-7.0.
Conclusion : The quality standard test of this food lactose is in accordance with the regulations.
Items Standard
Color Take an appropriate amount of sample in the white shallow dish on the natural light line, observe, white to light yellow.
Taste smell Take an appropriate amount of sample in the white shallow dish in natural light, observe, slightly sweet and odorless.
State of organization Take an appropriate amount of the sample in the white shallow disk in natural light, observe, crystal or powder crystal.
Lactose a (In the dry basis)/(g/100g) A lactose content according to (100- water-ash)/(100-water) calculation. 9.0
Water/(g/100g) 6.0 (GB 5009.3-2010 Karl fisher method)
Ash/(g/100g) 0.3 (GB 5009.4)
PH/(10% aqueous solution) Take 10g of lactose in 100ml beaker, add distilled water into 10% water solution,with a pH measuring the value of pH. 4.5-7.0.
Conclusion : The quality standard test of this food lactose is in accordance with the regulations.
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Appearance White Fine Powder
Assay 99.0%
Mesh Through 300 Mesh
Arsenic(As) 3PPM
Heavy Metals(Pb) 10PPM
Residue On Ignition 0.1%
Water 0.3%
Maleic Acid 0.1%
Colour(Pt-Co) 15HAZEN
Dss 0.3%
Melting Point 286~289
Solubility(25 ) 1.00g/100ml water
"Type: Food Additives
Origin: China
CAS No.: 59-30-3
AUCO No.: 886
Packing: 25kg drum"
Items Standard
Appearance Yellow or orange crystalline powder
Ultraviolet absorption A256/A365=2.8-3.0
Assay 97.0%-102.0%
Water Not more than 8.5%
Residue on ignition Not more than 0.3%
Related substances Not more than 2.0%
Residual solvents Meet the requirements
"Type: Food Additives
Origin: China
CAS No.: 89-65-6
AUCO No.: 233
Packing: 25kg carton"
Item Standard
Description "White or slightly yellow
crystals or powder"
Identity Positive
Assay () 99.0 - 100.5
Loss on drying () 0.4max
Specific Rotation -16.5 -18
Residue on ignition () 0.3max
Heavy Metals (as Pb) (mg/kg) 10max
Lead (mg/kg) 2max
Arsenic (mg/kg) 3max
Mercury (mg/kg) 1max
Oxalate Passes test
"Type: Food Additives
Origin: China
CAS No.: 5996-10-1
AUCO No.: 526
Packing: 25kg bag"
Items Standard
Appearance White crystal or powder,odorless and a little sweet
Specific rotation 52.0-53.5
Acidity(ml) 1.2max
De-Equivalent 99.5%Min
Chloride 0.02%max
Insoluble matter in alcohol Clear
Moisture 9.5%max
PH 4.0-6.5
Ash 0.2%max
Iron 0.002%max
Heavy metal 0.002%max
Arsenic 0.0002%max
"Type: Food/Feed Additives
Origin: China
CAS No.: 50-99-7
AUCO No.: 517
Packing: 25kg bag"
Items Standard
Appearance and solubility White or almost white,crystalline powder.It has a sweet taste.Freely soluble in water,sparingly soluble in ethanol(96%)
Identification Positive
Appearance of solution The solution is clar and not more intensely colored than reference solution BY7
Acidity or alkalinity 6.0g sample 0.1M NaOH 0.15ml
Specific optical rotation 52.5 53.3
Foreign sugars,soluble starch,dextrins Qualified
Sulphites Maximum 15ppm SO2
Chloride Maximum 125ppm
Sulphates Maximum 200ppm
Arsenic Maximum 1ppm
Barium Any opalescence in the solution is not more intense than in the standard
Calcium Maximum 200ppm
Lead Maximum 0.5ppm
Water Maximum 1.0%
Sulphated ash Maximum 0.1%
Endotoxin <1.25Eu/g
Bacilli Maximum 1000cfu/g
Mold Maximum 100cfu/g
E.coli Not available
"Type: Food/Feed Additives
Origin: China
CAS No.: 50-99-7
AUCO No.: 517
Packing: 25kg bag"
Items Standard
Appearance and solubility White or almost white,crystalline powder.It has a sweet taste.Freely soluble in water,sparingly soluble in ethanol(96%)
Identification Positive
Appearance of solution The solution is clar and not more intensely colored than reference solution BY7
Acidity or alkalinity 6.0g sample 0.1M NaOH0.15ml
Specific optical rotation 52.5 53.3
Foreign sugars,soluble starch,dextrins Qualified
Sulphites Maximum 15ppm SO2
Chloride Maximum 125ppm
Sulphates Maximum 200ppm
Arsenic Maximum 1ppm
Barium Any opalescence in the solution is not more intense than in the standard
Calcium Maximum 200ppm
Lead Maximum 0.5ppm
Water Maximum 1.0%
Sulphated ash Maximum 0.1%
Endotoxin <1.25Eu/g
Bacilli Maximum 1000cfu/g
Mold Maximum 100cfu/g
E.coli Not available
Specification:
Items Standard
Appearance Faintly yellowish to light yellow crystals.
Solubility Sparingly soluble in water; slightly soluble in acetic acid; very slightly soluble in dehydrated alcohol; practically insoluble in aceton, in ethylacetate.
A.IR IR spectrum of sample conforms to that of reference standard.
B.HPLC The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.
C.Reaction of chlorides A solution of it responds to the tests for Chloride
ASSAY (on anhydrous basis) 98.0%~102.0% of C17H18FN3O3�·HCL
Residue on ignition NMT 0.1%
Fluoroquinolonic acid (263nm) NMT 0.2%
Ciprofloxacin Analog (278nm) NMT 0.2%
Any other Individual impurity (278nm) NMT 0.2%
Total impurities (278nm) NMT 0.5%
pH� 3.0 to 4.5
Water 4.7% to 6.7%
Ethan NMT 4000ppm
"Type: Food Additives/Excipients
Origin: China
CAS No.: 1592-23-0
AUCO No.: 266
Packing: 20kg bag"
Items Standard
Appearance A fine, white or almost white, crystalline powder, Practically insoluble in water and in alcohol.
Identification A The tests for calcium
Identification B The fatty acids congealing temperature 54
Assay The content of Cao:9.0~10.5%
Loss on Drying 4.0%
Heavy Metals 10ppm
"Type: Food/Feed Additives
Origin: China
CAS No.: 7235-40-7
AUCO No.: 806
Packing: 25kg drum"
Items Standard
Description Orange-yellow to orange red free-flowing powder,no foreign matter and no odor.
Identification The retention time of the principal peak conforms to which in the reference solution.
Particle Size "100% pass through sieve 40mesh
90% pass through sieve 80mesh"
I-Carotene Assay 1.00%
Amax (1%,1cm) Colour intensity of aqu. dispersionA[1%,1cm] at maximum 25.0
Loss on drying 5.0%
Heavy Metals (as Pb) 10.00ppm
Lead (as Pb) 2.00ppm
Arsenic (as As) 2.00ppm
Cadmium (as Cd) 1.00ppm
Mercury (as Hg) 0.10ppm
Total aerobic microbial count 1000cfu/g
Total moulds and yeasts count 100cfu/g
Enterobacterial 10cfu/g
Escherichia coil n.d./10g
Salmonella n.d./25g
Staphylococcus aureus n.d./10g
