Sulfobutyl beta cyclodextrin Conforta con lo standard GMP

Appearance

White to off-white solid, free    from foreign matter

Qualify

           Solution Clarity             

A 30%w/v solution in water is    clear and essentially free from particles of foreign matter

Qualify

Identification (IR)

Consistent with SBECD standard

Qualify

Sodium Identification

Identify test are positive for    Sodium

+

Average Degree of Substitution

6.2-6.9

6.7

SBE 1 Content

≤0.2%

0.05%

SBE 2 Content

≤0.8%

0.15%

Water solution pH

pH of    30%w/v solution in water is 4.0-6.8

5.4

Heavy Metals

≤5ppm

<5ppm

Water

≤10%

4.0%

β-Cyclodextrin Content

≤0.1%

Absence

Sodium Chloride

≤0.2%

0.01%

1,4-butane sultone

≤0.5ppm

0.3ppm

4-Hydroxybutane-1-Sulfonic Acid

≤0.09%

0.01%

Disodium bis-(4-sulfobtyl) ether

≤0.05%

0.05%

Assay

95%-105%

99.5%

Bacterial endotoxins

≤25EU/g

≤20EU/g

Microbiology

Total viable aerobic count (mould plus yeast)

≤100CFU/g

20CFU/g

Escherichia Coli

Absence

Absence

Salmonella species

Absence

Absence

mould plus yeast

≤50CFU/g

Absence