| CAS No.: | 128446-35-5 or 94035-02-6 |
| Molecular Weight: | 1134.98+58n g/mol |
| Chemical Formula | C42H70O35-(C3H6O)n |
Hydroxypropyl-beta-cyclodextrin in pharmaceuticals industry, can increase solubility and bioavailability of insoluble drugs, so that the efficacy of drugs can last longer with less ingestion of drugs. It is generally used in medicine, food, cosmetics.
General Properties and Specifications of Hydroxypropyl beta cyclodextrin or Hydroxypropylbetadex or Hydroxypropyl Betadex or Hydroxy propyl betacyclodextrine or 2-Hydroxypropyl-β-cyclodextrin:
Appearance (Color): White Powder
Assay (HPLC): 99% minimum on drybasis.
Moisture content: As agreed.
Residue on ignition: 2% maximum.
Heavy metal (Pb): 0.0025% maximum.
Arsenic (As): 0.0002% maximum.
Solubility: ≥ 100 g/100ml @25.
Specifications of Hydroxypropyl Betadex USP NF Grade:
C42H70O35 (C3H6O)x where x = 7 × MS, MS being molar substitution
Beta cyclodextrin, 2-hydroxypropyl ether --- [CAS 94035-02-6].
DEFINITION
Hydroxypropyl Betadex is a partially substituted poly(hydroxypropyl) ether of Betadex. The number of hydroxypropyl groups per anhydroglucose unit expressed as molar substitution (MS) is NLT 0.40 and NMT 1.50 and is within 10% of the value stated on the label.
IDENTIFICATION
A. Infrared Absorption: The spectrum obtained with Hydroxypropyl Betadex shows the same absorption bands as the spectrum acquired with USP Hydroxypropyl Betadex RS. Due to the difference in the substitution of the substance, the intensity of some absorption bands may vary.
B. It meets the requirements of the test for Clarity of Solution.
ASSAY
To pass the test.
Acceptance criteria: 0.40–1.50 and within 10% of the value stated on the label
Limit of Betadex, Propylene Glycol, and Other Related Substances:
To pass the test by Chromatography.
Limit of Propylene Oxide:
To pass the test by Chromatography.
Acceptance criteria: NMT 0.0001%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.
Loss on Drying:
Sample: 1 g
Analysis: Dry the Sample at 20C for 2 h.
Acceptance criteria: NMT 10.0%
Clarity of Solution:
Sample: 1.0 g
Analysis: Dissolve the Sample in 2.0 mL of water, and heat.
Acceptance criteria: The resulting solution is clear and remains transparent after cooling to room temperature.
Bacterial Endotoxins Test: The level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used can be met. Where the label states that Hydroxypropyl Betadex must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used can be met.
Sterility Tests: Where the label states that Hydroxypropyl Betadex is sterile, it meets the requirements for Sterility Tests in the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used.
Conductivity:
Acceptance criteria: NMT 200 microS/cm
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.
Labeling: Label it to indicate the molar substitution (MS). Where Hydroxypropyl Betadex is intended for use in the manufacture of injectable dosage forms, it is so labeled. Where Hydroxypropyl Betadex must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled. Where Hydroxypropyl Betadex is sterile, it is so labeled.
Specifications of Hydroxypropylbetadex BP Ph Eur grade:
C42H70O35(C3H6O) with x = 7 MS
Action and use: Excipient.
DEFINITION
Hydroxypropylbetadex (β-cyclodextrin, 2-hydroxypropyl ether) is a partially substituted poly(hydroxypropyl) ether of betadex.
Content: Hydroxypropyl groups per anhydroglucose unit, expressed as molar substitution (MS): 0.40 to 1.50 and content within 10 per cent of the value stated on the label.
CHARACTERS
Appearance: White or almost white, amorphous or crystalline powder.
Solubility: Freely soluble in water and in propylene glycol.
IDENTIFICATION
A. Infrared absorption spectrophotometry.
Comparison hydroxypropylbetadex CRS.
Results The spectrum obtained with the substance to be examined shows the same absorption bands as the spectrum obtained with hydroxypropylbetadex CRS. Due to differences in the substitution of the substance, the intensity of some absorption bands can vary.
B. Appearance of solution (see Tests).
TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water prepared from distilled water and dilute to 50.0 mL with the same solvent.
Appearance of solution: The solution is clear and colourless, and remains so after cooling to room temperature.
Dissolve 5.0 g in 10.0 mL of water, with heating.
Conductivity: Maximum 200 microS/cm.
Measure the conductivity of solution S, while gently stirring with a magnetic stirrer.
Related substances:
To pass the test by liquid chromatography.
Limits:
-impurity A: maximum 1.5 per cent;
-sum of impurities other than A: maximum 1.0 per cent;
-reporting threshold: 0.05 per cent; disregard any peak eluting after impurity A.
Impurity B
To pass the test by gas chromatography.
Limit:
-impurity B: maximum 2.5 per cent.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 120 °C for 2 h.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 1000 CFU/g;
-TYMC: acceptance criterion 1002 CFU/g;
-absence of Escherichia coli;
-absence of Salmonella.
Bacterial endotoxins: Less than 10 IU/g, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins.
LABELLING
The label states:
-the molar substitution (MS);
-where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.
