β-Cyclodextrin (β-CD) CAS 7585-39-9 Assay 98.0%~102.0% Factory

Specific rotation
Take this product, weigh it precisely, add water to dissolve and quantitatively dilute it into a solution containing about 10 mg per 1 ml, and determine it according to law (General rule 0621), the specific rotation was 159°to 164°.
Differential diagnosis
Take about 0.2g of this product, add 2ml of Iodine test solution, heat it in a water bath to dissolve it, and let it cool to produce yellow-brown precipitate.
In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution. 6
The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
Absorbance of impurities
Take this product about 1 g, precision weighing, add water 100ml to dissolve, according to UV-visible spectrophotometry (General rule 0401) determination, the absorbance in the wavelength range of 230~350nm should not exceed 0.10, the absorbance in the wavelength range of 350~750nm should not exceed 0.05.
pH
take 0.20g of this product, add 20ml of water to dissolve, add 0.2ml of saturated potassium chloride solution, and determine according to law (General rule 0631), pH value should be 5.0~8.0.
Clarity and color of solution
Take this product 0. 50g, add 50ml of water to dissolve, check according to law (General rule 0901 and general rule 0902), the solution should be clear and colorless; In case of turbidity, compare with No. 2 Turbidity standard solution (General rule 0902, first method), not more concentrated.
Chloride
Take this product 0.39G, checked according to law (General rule 0801), and standard sodium chloride solution 7.0ml should not be more concentrated than the control solution (0.018%).
Reducing sugar
Take this product 1.0 g, precision weighing, add water 25ml to dissolve, Add alkaline copper tartrate test solution 40tnl, slowly boil for 3 minutes, place at room temperature overnight, filter with 4# vertical melting funnel, the precipitate was washed with warm water until the washing solution was neutral. The filtrate and washing solution were discarded, while hot with potassium permanganate titration solution (0 .0M o l/L) titration. According to the dry product, the consumption of potassium permanganate titrant (0.02 Mol/l) per L g should not exceed 3.2ml(1.0%).
Cyclohexane
Take about 0.2g of this product, precision weighing, in the top empty bottle, add the internal standard solution (take the right amount of dichloroethylene, add 20% dimethyl sulfoxide solution to make the solution containing about 0.04 in each lm l, (Ready) 10.0ml, as the test solution; Another precision weighing cyclohexane, plus internal standard solution to make about 1 l/l containing cyclohexane 0.078mg of solution, measure 10.0ml in a top empty bottle as a control solution. According to the test of residual solvent determination (General rule 0861), the capillary column with 100% dimethylpolysiloxane as stationary liquid is used as the chromatographic column; The column temperature is 90℃; The inlet temperature is 200℃; The detector temperature is 250℃; the Headspace bottle equilibration temperature was 70℃ and the equilibration time was 20 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component should be in accordance with the provisions. The test solution and the reference solution are respectively injected in the headspace, the chromatogram is recorded, and the peak area is calculated according to the internal standard method.
Loss on drying
Take this product, dry to constant weight at 105℃, weight loss shall not exceed 14.0% (General rule 0831).
Ignition residue
The 1.0 g of this product shall be taken for inspection according to law (General rule 0841), and the remaining residue shall not exceed.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Microbial limit
This product shall be taken and inspected according to law (General Principles 1105 and 1106). The total number of aerobic bacteria per l g of test product shall not exceed 100cfu, the total number of molds and yeasts shall not exceed 100cfu, E. Coli should not be detected.
Content determination
Measured by high performance liquid chromatography (General 0512).
Chromatographic conditions and system suitability test a Eighteen alkyl silane-bonded silica gel was used as a filler; Water-methanol (85 : 15) was used as a mobile phase; And the measurement was performed with a differential refractive index detector. The theoretical plate number is not less than 1500 calculated as the betal cyclodextrin peak.
determination method: take about 50mg of this product, weigh it accurately, put it in a 10ml measuring flask, add an appropriate amount of water to dissolve and dilute to the scale, shake well, and use it as a test solution, 10/xl was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Another 50mg of the reference substance of betaloc cyclodextrin was measured accurately, and the same method was used for determination. According to the external standard method to calculate the peak area, that is.