No

Item 项目

Standard 标准

1

Properties 外观

White crystalpowder,odorless,sweet

2

Melting point 熔点,℃

166--170

3

Identification 鉴别

Correspond to USP24,BP98

4

Acidity 酸度

Correspond to USP24,BP98

5

Clarity and color of a 10%(m/v) solution in water 溶液澄清度及色泽

Correspond to USP24,BP98

6

Chloride 氯化物,%

≤ 0.003

7

Sulphate 硫酸盐,%

≤ 0.010

8

Sulphated ash 灼烧残渣,%

≤ 0.1

9

Loss on dry 干燥失重,%

≤ 0.1

10

Arsenic 砷盐,PPm

≤ 1

11

Heavy Metal(as Pb) 重金属,PPm

≤ 0.5

12

Nickel 镍,PPm

≤ 1

13

Specific rotation 旋光度

+4.0°-- +7.0°(BP98)

14

Reducing Sugars 还原糖

Correspond to USP24,BP98

15

Assay (dried) 含量,%

98.0--101.5

16

Sorbitol 山梨醇,%

≤ 2.0

17

Microbial contamination       微生物

-Aerobic bacteria             需氧菌

-Yeasts and moulds       霉菌和酵母菌

-Enterobaceria                肠道菌

〈 10 CFU/g             

〈 10 CFU/g             

   negative in 1 g

18

Bacterial endotoxins 细菌内毒素

〈100g/l of Mannitol,Bacterial endotoxins

≥100g/l of Mannitol,Bacterial endotoxins

≤4 I.U./g

≤2.5 I.U./g

No

Item 项目

Standard 标准

1

Identification 鉴别

Correspond to USP24

2

Properties 外观

White crystal powder,odorless,sweet

3

Clarity and colour of a 10%(m/v) solution inwater 溶液澄清度及色泽

Correspond to USP24

4

Sulphated ash 灼烧残渣,%

≤ 0.1

5

Chloride 氯化物,%

≤ 0.0050

6

Sulphate 硫酸盐,%

≤ 0.010

7

Arsenic 砷盐,%

≤ 0.0003

8

Heavy Metal(as Pb) 重金属,%

≤ 0.001

9

Nickel 镍,PPm

≤ 1

10

Reducing Sugars 还原糖,mg

≤ 50

11

Total Sugars 总糖,mg

≤ 50

12

Acidity 酸度

Correspond to USP24

13

Assay as D-glucitol(anhydrous) 含量,%

98.0--100.5

14

Melting point 熔点,℃

99--101

15

Specific rotation(anhydrous) 旋光度

+4.0°-- +7.0°

16

Water 水份,%

〈 1

17

Powder fineness 粒度   

Through sieve No.40 ASTM 通过40 目,%

Through sieve No.200 ASTM 通过200目,%

              97       

              20

18

Microbial contamination 微生物            

  -Aerobic bacteria 需氧菌         

-Yeasts and moulds 霉菌和酵母菌

-Enterobaceria 肠道菌

〈 10 CFU/g      

〈 10 CFU/g        

negative in 1 g

No

Item 项目

Standard 标准

1

Properties 外观

White crystal powder,odorless,sweet

2

Specific rotation 旋光度

+4.0°-- +7.0°

3

Identification 鉴别

Correspond to CP2000

4

Acidity 酸度

Correspond to CP2000

5

Clarity and colour of a 10%(m/v) solution inwater 溶液澄清度及色泽

Correspond to CP2000

6

Chloride 氯化物,%

≤ 0.005

7

Sulphate 硫酸盐,%

≤ 0.01

8

Reducing Sugars 还原糖,mg

≤ 67

9

Total Sugars 总糖,mg

≤ 50

10

Loss on dry 干燥失重,%

≤ 1.0

11

Sulphated ash 灼烧残渣,%

≤ 0.1

12

Heavy Metal(as Pb) 重金属,%

≤ 0.0010

13

Arsenic 砷盐,%

≤ 0.0002

14

Assay 含量,%

≥ 98.0

No

Item 项目

Standard 标准

1

Fatty acid 脂肪酸,%

71--75

2

Acidity 酸值, mg KOH/g

≤ 10

3

Alcoholy 多元醇，%

29.5--33.5

4

Saponiufication-number 皂化值, mg KOH/g

147--157

5

Hydroxy-number 羟值, mg KOH/g

235-260

6

Water 水份,%

≤ 1.5

7

Arsenic 砷,%

≤ 0.0003

8

Heavy metal (as Pb) 重金属,%

≤ 0.001

No

Item 项目

Standard 标准

1

Acidity 酸值, mg KOH/g

≤ 2.0

2

Saponification-number 皂化值, mg KOH/g

45--55

3

Hydroxy-number 羟值, mg KOH/g

81--96

4

Water 水份,%

≤ 3.0

No

Item 项目

Standard 标准

1

Fatty acid 脂肪酸,%

71--75

2

Acidity 酸值, mg KOH/g

≤ 8

3

Alcoholy 多元醇，%

29.5--33.5

4

Saponiufication-number 皂化值, mg KOH/g

147--160

5

Hydroxy-number 羟值, mg KOH/g

193-210

6

Water 水份,%

≤ 2.0

7

Arsenic 砷,%

≤ 0.0003

8

Heavy metal(as Pb) 重金属,%

≤ 0.001

No

Item 项目

Standard 标准

1

Dry Substane 干物质,%

69.5±1

2

Refractive index(20℃) 折射率

1.455--1.465

3

Specific Gravity(20℃) 密度

≥1.285

4

Water 水份,%

28.5--31.5

5

Sulphated ash 灼烧残渣,%

≤ 0.10

6

Chloride 氯化物,ppm

≤ 10

7

Sulfate 硫酸盐,ppm

≤ 10

8

Arsenic 砷,ppm

≤ 1

9

Heavy Metal(as Pb) 重金属,ppm

≤ 5

10

Reducing Sugars 还原糖,%

≤ 0.20

No

Item 项目

Standard 标准

1

Assay,含量,%

≥ 96.0

2

Reducing Sugars 还原糖,%

≤ 0.3

3

Sulphated ash 灼烧残渣,%

≤ 0.10

4

Chloride 氯化物,%

≤ 0.003

5

Sulfate 硫酸盐,%

≤ 0.003

6

Arsenic 砷,%

≤ 0.0002

7

Heavy Metal(as Pb) 重金属,%

≤ 0.001

8

Nickel 镍,ppm

≤ 0.0003

9

Water 水份,%

≤ 4.0

No

Item 项目

Standard 标准

1

Properties 外观

Clarity and colour 澄清、无色液体

2

Assay,有效物含量，%

≥ 69.5

3

Sulphated ash 1，3二氯丙醇，ppm

≤ 15

4

Chloride 环氧氯丙烷，ppm

≤ 5

5

pH值（10%水溶液）

 5--7

No

Item 项目

Standard 标准

1

Properties 外观

White crystalline powder, sweet

2

Assay,含量,%

≥ 98.0

3

Reducing Sugars 还原糖,%

≤ 0.3

4

Sulphated ash 灼烧残渣,%

≤ 0.1

5

Nickel 镍, ppm

≤ 2

6

Arsenic 砷, ppm

≤ 0.5

7

Heavy Metal (as Pb) 重金属, ppm

≤ 1

8

Copper 铜，ppm

≤ 2

9

Water 水份(含结晶水）,%

≤ 7

No

Item 项目

Standard 标准

1

Melting point 熔点

167--168 ℃

2

Assay (dried) 含量

> 99.8 %

3

Acidity 酸度 (CH₃COOH)

< 0.002 %

4

Chloride 氯化物

< 0.0001 %

5

Sulphate 硫酸盐

< 0.0005 %

6

Heavy Metal(as Pb) 重金属

< 0.0001 %

7

Iron(Fe³⁺) 铁

< 0.0002 %

No

Item 项目

Standard 标准

1

Properties 外观

achromaticity or buff 

2

Assay 果糖含量（干基）,%

≥ 40.0

3

Solid Content 固形物含量,%

≥ 70.0

4

pH 

3.5 ~ 5.0

5

Sulphate ash 硫酸盐灰份,%

≤ 0.1

6

Arsenic 砷,ppm

≤ 0.5

7

Lead (Pb) 铅,ppm

≤ 0.5