Norfloxacin

TEST SPECIFICATION RESULT
Description White to pale yellow crystalline powder Complies
Identification Shall comply with USP24 test A and B Complies
Loss on drying ≤1.0% 0.2%
Residue on ignition ≤0.1% 0.05%
Heavy metals ≤0.0015% Complies
Purity The sum of all impurities’ peaks isn’t more than 0.5% Complies
Assay 99.0-101.0% 99.6%


Glycine

Item Medical grade Food grade Feed grade Industrial grade
Appearance White crystal powder White crystal powder White crystal powder White crystal powder
Assay % 99.0-101.0 98.5-101.5 98.5-101.0 ≥97.5
Ph value 5.6-6.4 5.6-6.4 5.6-6.4 5.6-6.4
Transmittance % 98.0 98.0 95.0 ---
Heavy metals % 0.001 0.002 0.002 ---
Arsenic % 0.0001 0.0002 0.0003 ---
Loss on drying % 0.2 0.2 0.2 1.0
Residue on ignition % 0.1 0.1 0.5 0.5
Chloride % 0.007 0.007 0.007 0.70
Sulphate % 0.006 0.006 0.006 ---
Ammonium salt % --- --- --- ---
Iron % 0.001 0.001 0.002 0.003

 

Taurine
Item GB-14759-93 JP8
Assay ≥98.5% ≥98.5%
Clarity of solution ≤0.5 creation clear
Readily carbonizable substances colorless colorless
Sulplate ≤ 0.014% ≤ 0.014%
Chloride ≤ 0.011% ≤ 0.011%
Heavy metals ≤ 0.002% ≤20ppm
Ammonium ≤ 0.02% ≤200ppm
Arsenic 0.0002% 2ppm
Loss in drying 0.2% 0.2%



L -Phenylalanine
Item                                                Specification                     Result
Specific rotation                               -33.0 ° to –35.0°                -33.2°
Transmittance Clear and colorless     ≥98.0%                            99.0%
Chloride                                           ≤0.02%                           Conform    
Ammonium                                      ≤0.02%                            Conform
Sulfate                                             ≤0.02%                            Conform
Iron                                                  ≤10ppm                           Conform
Heavy metals                                    ≤10ppm                           Conform
Arsenic                                            ≤1.5ppm                          Conform
Other amino acids                            Chromatographically Not detectable    Conform
Loss on drying                                  ≤0.20%                            0.17%
Residue on ignition                            ≤0.10%                           0.05%
Assay                                              ≥98.5%                            98.87%
PH                                                   5.4 - 6.0                           5.87

L-Alanine
Item                                                Specification                            Result
Specific rotation                               +14.3 °to +15.2°                       +14.5°
Transmittance                                  ≥98.0%                                   98.6%
Chloride                                           ≤0.02%                                   <0.02%
Ammonium                                      ≤0.02%                                   <0.02%
Sulfate                                             ≤0.02%                                  <0.02%
Iron                                                 ≤0.001%                                 <0.001%
Heavy metals                                  ≤0.001%                                  <0.001%
Arsenic                                          ≤0.0001%                                 <0.0001%
Other amino acids                          Chromatographically Not detectable      Conform
Loss on drying                                ≤0.20%                                      0.12%
Residue on ignition                          ≤0.10%                                      0.07%
Assay                                            99.0-101.0%                               99.1%
PH                                                 5.7-6.7                                       6.1

L-Aspartic Acid
Item Specification Result
Specific rotation +24.8 °to +25.8° +25.1°
Transmittance ≥98.0% 98.6%
Chloride ≤0.02% <0.02%
Ammonium ≤0.05% /
Sulfate ≤0.03% <0.03%
Iron ≤10ppm <10ppm
Heavy metals ≤10ppm <10ppm
Arsenic ≤1ppm <1ppm
Other amino acids Chromatographically Not detectable Conform
Loss on drying ≤0.2% 0.11%
Residue on ignition ≤0.1% 0.07%
Assay 98.5-100.0% 99.1%
PH 2.5-3.5 2.9


L-Lysine Monohydrochloride
Item Fodder grade Medicine grade
Appearance A white or nearly white free-flowing crystalline A white or nearly white free-flowing crystalline
Assay 98.5-101.5 % 99.0~100.5%
Arsenic 0.0002% 0.0001%
Heavy metals 0.001% 0.001%
Transmittance 95.0% 98.0%
Loss on drying 0.6 0.4
Residue on ignition 0.2% 0.1%
Chloride 0.02% 0.02%
Sulfate 0.02% 0.028%
Ammonium 0.02% 0.02%
Other amino acids Not detectable Not detectable
PH value(10% in water) 5.0-6.0 5.0-6.0


L-Cysteine
Item Specification
Appearance White crystalline powder
Assay 98.5-102.0 %
Specific rotation +5.5°~+7.0°
Transmittance 98.0%
Heavy metals 0.001%
Arsenic 0.0001%
Loss on drying 8.5-12.0%
Residue on ignition 0.1%
Chloride 19.82-0.29%
Sulfate 0.02%
Iron 0.001%
Other amino acids 10ug


L-Cysteine HCL MONO
Item
Assay
Specific rotation
Transmittance
Heavy metals
Arsenic
Loss on drying
Residue on ignition
Chlorine content
Sulfate salt
Iron
Other amino acids
Specification
98.5-102.0 %
+5.5°~+7.0°
98.0%
0.001%
0.0001%
8.5-12.0%
0.1%
19.82-0.29%
0.02%
0.001%
10ug


L-Cysteine hydrochloride anhydrous
Item
Appearance
Assay
Specific optical rotation
Loss on drying
Transmittance
Arsenic
Residue on ignition
PH value
Specification
White crystalline powder
98.5-102.0 %
+5.6°~+8.9°
≤0.01%
98.0%
0.001%
<0.001%
0.5-2.0


DL-Alanine
Item
Appearance
Assay
Transmittance
PH value (5% in water)
Heavy metal(as Pb)
Arsenic(as As2O3)
Loss on drying
Residue on ignition
Chloride(as Cl)
Specification
White crystalline powder
98.5-101.5 %
≥95.0%
5.5-7.0
≤0.002%
≤0.0004%
≤0.2%
≤0.1%
≤ 0.02%


DL-Methionine
Item
Appearance
Assay
Transmittance(10%,in water)
Ph value
Heavy metal(as Pb)
Iron
Arsenic(as As2O3)
Loss on drying
Residue on ignition
Other Amino acids
Specification
White crystalline platelets or powder
98.5-101.5 %
98.0%
5.6~6.1
≤0.001%
≤0.001%
≤0.0001%
≤0.3%
≤0.1%
Conforms


Ascorbic Acid
TEST
Description
Identification
Melting point
PH
Clarity
Color of solution
Heavy metals
Ferrite
Copper salt
Oxalic Acid
Residue on ignition
Specific rotation
Organic volatile impurity
Assay
SPECIFICATION
White crystalline powder
Positive
Around190℃
2.1-2.6
Conforms
≤BY7
≤10ppm
≤2ppm
≤5ppm
≤0.2%
≤0.1%
+20.5°to +21.5°
Conforms
99.0-100.5%
RESULT
Conforms
Positive
191.0℃
2.2
Conforms
≤BY7
≤10ppm
≤2ppm
≤5ppm
≤0.2%
0.02%
+21.05°
Conforms
99.70%


Sulphadimidine
TEST
Characteristics

Identification Pass in Pass in positive reaction
Melting point
Acidity
Clarity and color of solution
Heavy metals
Related substances
Loss on drying
Residue on ignition
Assay
SPECIFICATION
White or almost white crystalline powder


197-200℃
≤0.1mol/L NaOH 0.2ml
≤Y5BY5GY5
≤20ppm
≤0.5%
≤0.5%
≤0.1%
99.0-101.0%
RESULT
Conforms

Positive reaction

198-199.2℃
<0.2ml
< Y5BY5GY5
<20ppm
<0.5%
0.1%
0.16%
99.78%



Paracetamol
TEST
Characteristics
Solubility


Identification
Melting range
Chloride
Sulfate
Sulfide
Readily carbonizable substances
Freeр-aminophenol
Related substances
Water
Residue on ignition
OVI
Assay
Heavy metals
STANDARD
A white crystalline powder
Sparingly soluble in water,freely soluble in alcohol,very slightly soluble
in ether and in methylene chloride
Conforms
168-172℃
≤0.014%
≤0.02%
No coloration or spelling occurs
Conforms

≤0.005%
Conforms
≤0.5%
≤0.1%
Meets the requirements
99.0-101.0%
≤0.001%
RESULT
Conforms
Conforms


Conforms
169-170℃
<0.014%
<0.02%
Conforms
Conforms

<0.005%
Conforms
0.05%
0.04%
Conforms
99.9%
<0.001%

 
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