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Injection grade Hydroxypropyl betadex hydroxypropyl-beta-cyc
Wed Dec 6, 2017 03:36

Product name:Hydroxypropyl betadex
Synonyms: Hydroxypropyl-beta-cyclodextrin
CAS No.:128446-35-5
DMF No.:030168
Grade: Injection grade

Injection grade Hydroxypropyl betadex have been approved record by US FDA , DMF No.: 030168.
product features:
1.Content of betadex is very lower, almost absent.
2. Bacterial endotoxins<20EU/g
Main Application:
1. Increase the solubility
2. Cover up bad smells
3. Control the release rate of drugs
Test Standard USP39-NF34
Molar Substitution 0.40-1.50
Clarity of solution 50%(w/v) water solution is clear
Identification(IR) same absorption bands as USP Hydroxypropyl Betadex RS
Loss on Drying ≤10.0%
Conductivity 10%(w/v)
water solution ≤200µS/cm
Propylene oxide ≤1ppm
Propylene glycol  ≤2.5%
Sum of Other Impurities ≤1%
Betadex ≤1.5%
Any other single impurity ≤0.25%
Heavy Metal ≤20μg/g
TAMC(cfu/g) ≤1000cfu/g
TYMC(cfu/g) ≤100cfu/g
Bacterial endotoxins ≤20EU/g
(EU/g) url:

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