熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号U202302006对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.115492454704548985502254708548510.26
2 11.155502655320551730.38
单位质量响应值RSD%判断
4937.084948.250.16数据可信
高温30天-供试品溶液-25101501批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111569-1156921.04518.317.9421.0418.307.93
210246-1024618.63818.64
39364-936417.03417.03
49601-960117.46517.46
59945-994518.09118.09
69652-965217.55817.56
10min117746-1774632.28129.924.9132.3229.954.92
216644-1664430.27630.31
315910-1591028.94128.97
415977-1597729.06329.09
516885-1688530.71530.74
615537-1553728.26328.29
15min123345-2334542.46640.144.0642.5540.224.06
222376-2237640.70340.78
321521-2152139.14839.22
421531-2153139.16639.24
522690-2269041.27441.36
620929-2092938.07138.15
20min127683-2768350.35748.563.1550.5248.713.16
226937-2693749.00049.15
326152-2615247.57247.71
426190-2619047.64147.78
527594-2759450.19550.35
625630-2563046.62346.76
30min134196-3419662.20560.471.9262.4560.701.93
233546-3354661.02261.25
332930-3293059.90260.12
432852-3285259.76059.98
533535-3353561.00261.24
632410-3241058.95659.17
45min142294-4229476.93573.242.7177.2873.572.71
239843-3984372.47772.81
339290-3929071.47171.79
439932-3993272.63972.96
540610-4061073.87274.21
639605-3960572.04472.36
60min145169-4516982.16581.491.1782.6481.941.17
244697-4469781.30781.76
344048-4404880.12680.57
444850-4485081.58582.03
545538-4553882.83683.29
644494-4449480.93781.37
极限152127-5212794.82297.242.1795.4397.822.15
252395-5239595.31095.90
352904-5290496.23696.81
454161-5416198.52299.10
555079-55079100.192100.79
654054-5405498.32898.90
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号U202302006对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.115499354845546835488054886548570.21
2 11.155564455031553380.79
单位质量响应值RSD%判断
4937.624963.050.37数据可信
高温30天-供试品溶液-25101501批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111962-1196221.72621.262.7321.7321.262.74
211269-1126920.46720.47
311691-1169121.23421.23
411592-1159221.05421.05
512171-1217122.10622.11
611555-1155520.98720.99
10min118564-1856433.71732.972.7533.7533.002.75
217391-1739131.58631.62
317771-1777132.27732.31
418173-1817333.00733.04
518724-1872434.00834.04
618301-1830133.23933.27
15min124271-2427144.08243.433.0044.1743.512.99
222709-2270941.24541.33
323970-2397043.53643.62
423593-2359342.85142.94
524832-2483245.10145.19
624085-2408543.74443.83
20min128354-2835451.49852.042.5851.6652.212.58
227552-2755250.04150.20
328748-2874852.21452.38
428430-2843051.63651.80
529728-2972853.99454.16
629116-2911652.88253.05
30min134398-3439862.47564.283.4662.7364.533.45
234370-3437062.42562.66
335522-3552264.51764.77
434767-3476763.14663.39
537616-3761668.32068.58
635675-3567564.79565.05
45min141043-4104374.54476.523.2374.9076.883.23
241454-4145475.29175.63
341766-4176675.85876.21
441816-4181675.94876.30
544835-4483581.43281.80
641885-4188576.07476.43
60min145747-4574783.08885.312.7683.5785.802.76
246090-4609083.71184.18
347375-4737586.04586.53
446968-4696885.30685.79
549320-4932089.57890.09
646318-4631884.12584.61
极限152785-5278595.87196.260.8396.4996.880.81
253829-5382997.76798.37
352997-5299796.25696.88
452985-5298596.23496.86
552809-5280995.91496.57
652579-5257995.49796.12
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号U202302006对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.115519055603555445512755278553480.39
2 11.155539955040552200.46
单位质量响应值RSD%判断
4981.824952.470.42数据可信
高湿30天-供试品溶液-25101501批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116076-1607629.09932.9818.0129.1032.9818.01
215277-1527727.65327.65
318719-1871933.88333.88
418939-1893934.28234.28
524179-2417943.76743.77
616146-1614629.22629.23
10min122230-2223040.23945.9616.8740.2946.0116.87
222172-2217240.13440.18
325429-2542946.02946.09
426767-2676748.45148.51
533213-3321360.11960.19
622520-2252040.76440.81
15min127428-2742849.64856.4314.0649.7656.5614.07
229673-2967353.71153.82
331177-3117756.43456.57
431733-3173357.44057.58
539372-3937271.26871.44
627674-2767450.09350.21
20min131582-3158257.16764.8111.9557.3765.0311.96
236308-3630865.72265.92
335857-3585764.90565.13
435926-3592665.03065.26
543363-4336378.49278.78
631777-3177757.52057.72
30min137595-3759568.05175.609.5868.3475.949.60
243458-4345878.66478.98
341355-4135574.85775.19
442241-4224176.46176.80
548288-4828887.40787.83
637668-3766868.18368.48
45min144111-4411179.84685.355.7780.2585.815.80
248340-4834087.50187.94
347634-4763486.22386.68
446582-4658284.31984.79
551574-5157493.35593.92
644677-4467780.87081.28
60min148281-4828187.39491.023.4487.9391.623.48
251534-5153493.28293.87
350544-5054491.49092.09
449213-4921389.08189.69
552917-5291795.78696.51
649206-4920689.06889.61
极限153484-5348496.81298.041.2997.5098.791.29
253852-5385297.47898.22
355410-55410100.298101.05
453655-5365597.12297.88
554197-5419798.10398.99
654367-5436798.41099.10
熊去氧胆酸颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号U202302006对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.115541855344557055527355365554210.31
2 11.155510154553548270.71
单位质量响应值RSD%判断
4988.394917.221.02数据可信
高湿30天-供试品溶液-25101501批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145001-4500181.69668.7617.2481.7068.7617.24
243346-4334678.69278.69
342147-4214776.51576.51
435424-3542464.31064.31
532138-3213858.34458.34
629204-2920453.01853.02
10min152121-5212194.62286.3411.4494.7686.4511.45
252044-5204494.48294.61
351959-5195994.32894.46
447034-4703485.38785.49
542468-4246877.09877.19
639729-3972972.12572.21
15min157244-57244103.92293.318.86104.2293.578.87
253279-5327996.72497.01
354349-5434998.66798.95
451371-5137193.26093.51
546538-4653884.48684.71
645610-4561082.80283.01
20min153945-5394597.93394.705.5998.4095.115.61
253549-5354997.21497.66
354974-5497499.801100.25
453564-5356497.24297.65
548779-4877988.55588.92
648166-4816687.44287.79
30min153747-5374797.57496.382.9198.2096.952.94
253697-5369797.48398.09
354767-5476799.426100.04
453886-5388697.82698.39
550650-5065091.95192.47
651795-5179594.03094.52
45min153692-5369297.47497.911.5998.2798.641.62
253724-5372497.53298.31
355208-55208100.226101.01
454669-5466999.24899.98
552861-5286195.96596.63
653445-5344597.02697.67
60min154073-5407398.16698.431.0899.1299.321.12
254335-5433598.64199.58
355066-5506699.968100.92
454559-5455999.04899.94
553902-5390297.85598.68
653371-5337196.89197.70
极限154011-5401198.05398.021.2199.1799.081.23
253318-5331896.79597.90
355101-55101100.032101.15
454316-5431698.60799.67
553743-5374397.56798.56
653478-5347897.08698.06
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