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Active Pharmaceuticals

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  • Specifications
  • Product Description
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  • COA
Product Name Hydroxypropyl Beta Cyclodextrin (HPBCD)
CAS NO. 94035-02-6
MF C54H102O39
MW 1375.36
EINECS 618-994-5
Melting point 267 °C

Hydroxypropyl beta-cyclodextrin are purified polydisperse products resulting from the controlled reaction of propylen oxide and native beta-cyclodextrin. Hydroxypropyl beta-cyclodextrin is itself very soluble in water (greater than 500 mg/ml at room temperature compared to 18 mg/ml for beta-cyclodextrin), and is used for molecular encapsulation of a variety of sparingly water compounds to enhance the aqueous solubility of the encapsulated compound.

In Pharmaceuticals:

Hydroxypropyl beta cyclodextrin is a solution to insoluble or low solubility drugs (including plant extracts). Through molecular encapsulation,it could increase the drug solubility and control the release rate of the drug,increase the drug's bioavailability and reduce the toxic side-effets.

1. Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of in-situ encapsulation).

2. To increase water solubility of poorly soluble drugs.

3. To increase bioavailability.

4. To improve organoleptic properties of bitter or unpleasant actives.

In Food:

Hydroxypropyl beta cyclodextrin could increase the stability of molecular nutrition and long-time effect,cover up or adjust bad smell and tastes of food nutrition molecular, improve production process and product quality and extend the shelf-life.

In Cosmetics

Hydroxypropyl beta cyclodextrin used as stabilizer,emulsifier and odor absorber.It could reduce organic molecules stimulation to skin mucosal and enhance the stability of the effective components.Prevent volatile, oxidation of nutrient composition ,increase the solubility of insoluble flavours and fragrances and keep the fragrance slow releasing and lasting.

1. Suitable for encapsulation of volatile compounds.

2. To increase shelf life of expensive flavours.

Item Specifications Results
Appearance white powder, insipid, innocent Conforms
Degree of Substitution 2.8-10.5 5.3
Clarity of solution 50%(w/v) water solution is clear clear
Identification(IR) same absorption bands with USP Hydroxypropyl Betadex RS Conforms
Loss on Drying ≤10% 3.5%
Conductivity 10%(w/v) water solution ≤200µS/cm 154µS/cm
Propylene oxide ≤1ppm <0.18ppm
Propylene glycol ≤2.5% 0.29%
Sum of Other Impurities ≤1% 0.51%
Betadex ≤1.5% 0.12%
Residue on Ignition ≤0.2% 0.07%
Heavy Metal ≤20ppm <20ppm
chloride ≤0.05% <0.05%
TAMC(cfu/g) ≤1000 cfu/g 30 cfu/g
TYMC(cfu/g) ≤100 cfu/g 10 cfu/g
Salmonella/E. Coli (cfu/g) Absent Absent
Conclusion According to standards of USP35-NF30, the product is Qualified.

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