Prednisone

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Prednisone
Posting date : Aug 23, 2011
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Prednisone Product Name: prednisone English Name: Prednisone CAS number: 53-03-2 Packaging specifications: 1kg Specifications : 97% ~ 102%, pharmaceutical grade Product description: Prednisone Pinyin names: Ponisong English Name: Prednisone Page number: 2000 edition two 436 C21H26O5 358.43 This product is 17 alpha, 21 - two hydroxy progesterone steroid - 1, 4 - diene - 3, 11, three 20 ketone. According to the calculation of dry goods, including C21H26O5 should be 97% ~ 102%. [ character ] this product is white or almost white crystalline powder; odorless. This product is slightly soluble in ethanol or chloroform, almost insoluble in water. The melting point of the product melting point ( Annex VI C ) ranged from 225 to 231 degrees C ( - 220 DEG C in a capillary to ), When melting and decomposition. The specific rotation of the product, precision that will add two oxygen, six ring dissolved and diluted into quantitative 1ml each containing about 5mg The solution, according to the determination of ( Annex VI E ), specific rotation should be + 167 degrees to + 175 degrees Discrimination [ ] (1 ) the product of about 5mg, plus 2ml sulfate dissolved, placed 5 minutes show orange; the liquid Pour water 10ml, solution that turns yellow, fade to blue green. ( 2) take the goods, accurately weighed, plus ethanol dissolved and diluted into quantitative 1ml each containing about 15 u g solution, According to spectrophotometry ( Appendix A ), the 240nm wavelength determination of absorption, the absorption coefficient ( E1% For 1cm ) 405 to 435. ( 3) the goods should be infrared light absorption pattern contrast pattern ( spectral set 612) consistent. [ check ] other steroidal take the goods, chlorination imitation of methanol ( 9: 1) each made of 1ml in 3mg containing solution, As for the sample solution; precision measuring amount, chlorine imitation of methanol ( 9: 1) diluted into 1ml each containing 60 g solution, As a control solution. According to thin layer chromatography ( Appendix V B ) test, absorb the solution 5 U L, respectively, in the same Silica gel G thin-layer plate, with methylene chloride and diethyl ether methanol - water ( 77 : 15: 8: 1.2) as developing solvent, after expansion, clothes Stem, at 105 degrees 10 minutes to dry, cool, sprayed with an alkaline tetrazolium solution, the immediate view, for the sample solution. The impurity spot shall not be more than 3, its color and the control solution in the main spot, shall not be deeper. Loss on drying takes this approximately 0.5g, at a temperature of 105 DEG C dried for 3 hours, loss weight shall not exceed 1% ( Appendix VIII L ). [ ] according to content determination by high-performance liquid chromatography ( Appendix V D ) determination. Chromatographic condition and system suitability test with eighteen alkyl silane bonded silica as filler; water - four tetrahydrofuran - Methanol ( 688 : 250: 62) as mobile phase; the detection wavelength was 254nm. Number of theoretical plates by prednisone peak calculation should not be less than 3000, prednisone and the peak internal standard substance peak separation shall comply with the requirements. Internal standard solution preparation and acetanilide, adding dilute methanol ( 1, 2) each made of 1ml containing 0.11mg solution, i.e. Have to. Determination and prednisone controlled amount of goods, accurately weighed, adding dilute methanol ( 1, 2) each made of dissolved and quantitative dilution 1ml about 0.2mg containing solution. Precision measuring the solution with internal standard solution of the 5ml, the 50ml flask, the thin armor Alcohol ( 1, 2) dilute to the mark, shake, 10 u l injected into the liquid chromatograph, recording chromatogram; other take this amount of goods, According to the determination of. According to the internal standard method calculated by peak area, namely. [ category ] adrenal cortex hormones drug. [ storage ] shading, seal preservation

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