Hydroxypropyl-Beta-Cyclodextrin (HP-BCD)
羟丙基倍他环糊精
Enterprise Standard 企业标准
Items
|
Standard
|
Appreance外观 |
White powder |
Specific Rotation比旋度 |
+125° - +145 ° |
PH Value 酸碱度 |
5.0-8.0 |
Chloride 氯化物 |
0.018 pct Max |
Residue on Ignition 灼烧残渣 |
0.5 pct Max |
Average Degree of
Substitution平均取代度 |
4-9 |
Hydroxy propyl 羟丙基 |
22-41 pct |
Heavy Metals 重金属 |
5 ppm Max |
Lead 铅 |
1 ppm Max |
Arsenic砷 |
1 ppm max |
Total Bacteria Count (cfu/g) 细菌总数
|
300 Max
|
Yeast and Mould (cfu/g) 霉菌和酵母菌
|
50 max for each
|
Colon Coli (cfu/g) 大肠杆菌
|
Negative/阴性
|
Samonella (Cfu/g) 沙门氏菌
|
Negative/阴性
|
|
Packing:
10kgs per carton per carton with PE bag inner.
Alpha+Beta+Gama Mixed Cyclodextrins
α+β+γ混合环糊精
Enterprise Standard 企业标准
Name of
Product 品名
|
α+β+γ 混合环糊精
|
α- Cyclodextrin α－环糊精
|
30 pct Min.
|
β- Cyclodextrin β－环糊精
|
Between
20-25 pct
|
γ-Cyclodextrin γ－环糊精
|
Between 5-7
pct
|
Total Cyclodextrin 总环糊精
|
55 pct Min
|
Glucose +
Maltose 其他糖
|
45 pct max
|
Moisture 水份
|
8 pct Max
|
Residue on
ignition灼烧残渣
|
0.5 Max
|
Cloride (Cl) 氯化物
|
0.018 Max
|
Heavy
metals (ppm) 重金属
|
5ppm max
|
Lead (ppm) 铅
|
1ppm Max
|
Arsenic 砷
|
1ppm Max
|
Total
Bacteria Count (cfu/g) 细菌总数
|
300
Max
|
Colon Coli
(cfu/g) 大肠杆菌
|
Negative/阴性
|
Samonella (Cfu/g) 沙门氏菌
|
Negative/阴性
|
Yeast and
Mould (cfu/g) 霉菌和酵母菌
|
50 max for
each
|
Packing:
20kgs PE bag inner, 20kgs per paper carton
Betacylcodextrin or Betadex ( BCD)
Pharmaceuticals Grade (医药级)
Items
|
EP5.0
|
USP-NF 26
|
CP2500
|
Appearance外观
|
White crystalline powder ,odorless
|
白色结晶粉末，无异味
|
Identifying 鉴别
|
Positive
|
阳性
|
Color of solution
溶液澄清度与颜色
|
Solution colorless and
clear
|
澄清无色
|
PH value PH 值
|
5.0-8.0
|
---
|
5.0-8.0
|
Specific Optical Rotation比旋度
|
+160° to 164 °
|
+159°～164 °
|
Reducing sugars
还原糖
|
0.2％ Max
|
1% Max
|
1% 以下
|
Light-absorbing impurities
光吸收杂质
|
<0.1
% (230-350nm)
|
---
|
---
|
<0.05%
(350-750nm)
|
Relative
substance
相关物质
|
Trichloroethylene
|
---
|
10 ppm max
|
80 ppm max
|
Toluene
|
10ppm
max
|
890 ppm max
|
Heavy
Metals
（As Pb）重金属
|
10 ppm max
|
5 ppm max
|
10ppm 以下
|
Loss on drying
干燥失重
|
16％ max
|
14％ max
|
14％ 以下
|
Residue on ignition (Sulphated ash)
灼烧残渣
|
0.1％ max
|
Assay（dry basis)含量
|
98.0-101.0％
|
98.0-102.0％
|
96.0-102.0％
|
Total Bacteria Count(CFU/g) 细菌总数
|
---
|
1000
|
Yeast （CFU/g）酵母菌
|
---
|
小于100
|
Colon coli(CFU/g) 大肠杆菌
|
---
|
Negative 阴性
|
Salmonella (CFU/g)
沙门氏菌
|
----
|
Negative阴性
|
Packing: 20kgs per paper carton with PE bag
inner.
Betacyclodextrin Food Grade
Japanese Food Additive Grade (日本食品添加剂公定七版)
Items 項目
|
Standard基準値
|
Apprearance 性状 |
White Crystalline Powder 白色～微黄色粉末 |
Assay 純度 |
98% Min |
Loss on drying 乾燥減量 |
14% Max |
Residue on ignition 強熱残分（%) |
＜0.1 |
Color of Solution 溶状 |
无色透明（0.5/50ml) |
Color of filter paper滤纸异物
|
<D-D
|
Specific Rotation 比旋光度(°)[α] |
＋160～+164° |
Ｐｈ Value Ｐｈ値 |
5.0～8.0 |
Cl 塩化物 |
＜ 0.018 |
Heavy Metals 重金属（ppm) |
＜5ppm |
Lead 铅 |
<1.0ug/g(ppm) |
Arsenic ヒ素 |
＜1.3ppm |
Reducing substance 還元性物質(%) |
＜１.0 |
Total Bacteria Count 一般生菌数(cfu) |
＜300ヶ/g |
Moulds, Yeasts カビ，酵母(cfu) |
<50cfu/g |
Escherichia Coli 大腸菌群 |
Negative/10g |
Salmonella サルモネラ菌 |
Negative/10g |
Betacylcodextrin European Food additive Standard
(E459 OF COMMISSION Directive 2003/95/EC)
Items
|
Standard
|
Apprearance
|
Virtually odourless, white or
almost white crystalline solid
|
Assay
|
98% Min.
|
Water
|
14% max
|
Other cyclodextrins
|
2% Max
|
Residual solvents
|
Toluene
|
1ppm max
|
Trichloroethylene
|
1ppm
max
|
Reducing substances ( as glucose)
|
1% max
|
Sulphated ash
|
0.1% max
|
Arsenic
|
1mg/kg (1 ppm) max
|
Lead
|
|