Top quality Hydroxypropyl Beta cyclodextrin(HPBCD)/128446 35 5

SPECIFICATION(USP38)

RESULTS

Appearance

white powder, insipid, innocent

Qualify

Assay

≥98%

99.5%

 Degree of Substitution

2.8-10.5

5.5

Clarity of solution

50%(w/v) water solution is clear

clear

Identification(IR)

 same absorption bands with USP Hydroxypropyl Betadex RS

Qualify

Loss on Drying

≤10%

4.5%

Conductivity

10%(w/v) water solution ≤200µS/cm

70

Propylene oxide

≤1ppm

<0.18ppm

Propylene glycol

≤2.5%

0.05%

Sum of Other Impurities

≤1%

0.51%

Betadex

≤1.5%

0.39%

Residue on Ignition

≤0.2%

0.09%

Heavy Metal

≤20ppm

<10ppm

chloride

≤0.05%

<0.05%

Bacterial endotoxins

≤25EU/g

<20EU/g

TAMC(cfu/g)

≤1000

80

TYMC(cfu/g)

≤100

30

Salmonella/E. Coli (cfu/g)

Absent

Absent