9003-22-9 Purity
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Specification
There was a multicenter, randomized, double-blind, parallel-group preliminary evaluation of the efficacy and safety of intravesical chondroitin sulfate sodium salt versus vehicle control in patients with interstitial cystitis/bladder pain syndrome. This was a prospective, randomized, double-blind, inactive vehicle-controlled, 12-week study (6-week treatment period followed by a 6-week follow-up period) in patients with IC/PBS. Secondary endpoints included questionnaires for symptoms and quality of life. Although twice as many patients reported clinically significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment. This trial provides the data needed to design a powerful randomized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy.
Sixty-five evaluable patients were randomized. Patients were randomized to receive once-weekly intravesical treatment with either 2.0% Chondroitin sulfate sodium salt in phosphate-buffered saline or intravesical vehicle control. The primary efficacy analysis compared responders (moderate or marked improvement) based on a 7-point global response assessment. At the time of the primary endpoint analysis (week 7), 22.6% of patients in the vehicle control group had a response, compared with 39.4% of patients in the active treatment group (P < .15). There were no statistically significant differences in any of the secondary endpoints. Overall, 76.9% of patients in the study reported at least 1 adverse event; most were mild or moderate, and most were related to vehicle control treatment. Nine non-serious intervention-related adverse events were reported in three patients in the vehicle control group, compared with two adverse events reported in one patient in the active treatment group.
Chondroitin sulfate sodium salt is a homopolymeric glycosaminoglycan with disaccharide repeating units formed by hexuronic acid and hexosamine residues, and has been used as a therapeutic drug for chronic inflammatory diseases, such as rheumatoid arthritis, liver cirrhosis, and chronic inflammatory diseases. A size exclusion HPLC method for the determination of Chondroitin sulfate sodium salt in pharmaceutical preparations has been developed and validated. The most important feature of this method is the improved economy and deterministic application by directly analyzing Chondroitin sulfate sodium salt in pharmaceutical preparations compared with previously reported determination methods. The linearity, precision, specificity, and accuracy of the method were established and validated. The intra-day and inter-day precisions were satisfactory, with relative standard deviations less than 1.0%. The recoveries of Chondroitin sulfate sodium salt in multicomponent pharmaceutical preparations were 93.38%~100.46%. The developed method was fairly easy, simple, and reproducible when the HPLC determination results were compared with the classical spectrophotometric method. Therefore, this method is expected to be successfully applied to the determination of Chondroitin sulfate sodium salt for routine quality control of pharmaceutical preparations.
A standard stock solution of Chondroitin sulfate sodium salt raw material was prepared in water at a concentration of 1.0 mg/ml. Further dilutions were made in water to provide concentrations in the range of 0.05 - 0.5 mg/ml for standard calibration. More than 20 tablets or capsules were weighed individually, the average weight was recorded, and ground into a fine powder. Accurately weighed the powder equivalent to 100 mg Chondroitin sulfate sodium salt, transferred to a 100 ml volumetric flask, and aliquoted and dissolved in 100 ml of water. After extraction by shaking, a portion of the solution was filtered with a filter membrane (pore size 0.45 mm) and diluted with water to a concentration of 0.1 mg/ml Chondroitin sulfate sodium salt. HPLC method validation was established according to the International Conference on Harmonization guidelines and included specificity, linearity, limits of detection and quantification (LOQ), precision, accuracy, recovery, and robustness tests. The specificity of the HPLC method was evaluated by measuring precision analysis using peak retention time (RT) and peak area (PA). A calibration curve was constructed based on PA versus Chondroitin sulfate sodium salt concentration.
The molecular formula of chondroitin sulfate sodium salt is C14H22NNaO16S.
The molecular weight of chondroitin sulfate sodium salt is 515.4 g/mol.
The IUPAC name of chondroitin sulfate sodium salt is sodium;(2R,3R,4R,5S,6S)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2-hydroxy-6-(hydroxymethyl)-5-oxidooxysulfonyloxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid.
The InChI of chondroitin sulfate sodium salt is InChI=1S/C14H23NO16S.Na/c1-3(17)15-5-10(9(30-32(25,26)31-24)4(2-16)27-13(5)23)28-14-8(20)6(18)7(19)11(29-14)12(21)22;/h4-11,13-14,16,18-20,23-24H,2H2,1H3,(H,15,17)(H,21,22);/q;+1/p-1/t4-,5-,6-,7-,8+,9+,10-,11-,13-,14+;/m1./s1.
The synonyms of chondroitin sulfate sodium salt include MFCD01779745 and AKOS015961482.
The hydrogen bond donor count of chondroitin sulfate sodium salt is 7.
The hydrogen bond acceptor count of chondroitin sulfate sodium salt is 16.
There are 8 rotatable bonds in chondroitin sulfate sodium salt.
The topological polar surface area of chondroitin sulfate sodium salt is 279 Ų.
There are 33 heavy atoms in chondroitin sulfate sodium salt.