依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061826801827491827621825631825641826640.06
211.081853781857901855840.16
单位质量响应值RSD%判断
16515.7316749.461.00数据可信
供试品溶液-25080102批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181162-8116243.81048.6816.6943.8148.6816.69
285643-8564346.22846.23
3120113-12011364.83564.83
481641-8164144.06844.07
590209-9020948.69348.69
682323-8232344.43644.44
10min1144246-14424677.86180.144.3678.1080.414.40
2146841-14684179.26279.52
3159521-15952186.10686.47
4144166-14416677.81878.06
5152907-15290782.53682.81
6143152-14315277.27177.52
15min1165420-16542089.29090.852.8589.9791.572.86
2166303-16630389.76790.46
3173320-17332093.55594.39
4163223-16322388.10588.78
5166404-16640489.82290.55
6175219-17521994.58095.26
20min1174070-17407093.96094.961.8295.1396.181.83
2178188-17818896.18297.38
3178086-17808696.12797.49
4171423-17142392.53193.70
5174109-17410993.98195.21
6179692-17969296.99498.20
30min1173990-17399093.91695.011.5295.6196.751.48
2176642-17664295.34897.08
3173205-17320593.49395.38
4174418-17441894.14795.83
5177458-17745895.78897.54
6180341-18034197.34499.08
45min1179825-17982597.06696.581.7499.2898.861.69
2180472-18047297.41599.68
3175339-17533994.64497.06
4174958-17495894.43996.64
5180209-18020997.27399.56
6182773-18277398.657100.94
60min1175144-17514494.53995.992.0997.2998.802.02
2179461-17946196.86999.67
3172685-17268593.21296.15
4176479-17647995.26097.99
5180534-18053497.449100.27
6182683-18268398.609101.44
极限1174797-17479794.35296.321.7297.6399.661.66
2179273-17927396.768100.11
3175678-17567894.82798.28
4178834-17883496.53199.79
5178611-17861196.41199.77
6183421-18342199.007102.38
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.914068914066214065514067704064154066500.05
211.004128614132784130700.08
单位质量响应值RSD%判断
37273.1437551.820.53数据可信
供试品溶液-25080102批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206426-20642649.41154.6315.2849.4154.6315.28
2218328-21832852.25952.26
3297193-29719371.13771.14
4207518-20751849.67249.67
5229544-22954454.94454.94
6210461-21046150.37650.38
10min1339041-33904181.15483.363.9881.4383.664.01
2346978-34697883.05383.34
3370906-37090688.78189.18
4338189-33818980.95081.23
5358469-35846985.80486.11
6335981-33598180.42180.70
15min1378110-37811090.50592.302.6991.2393.072.70
2383276-38327691.74292.49
3397672-39767295.18896.08
4373741-37374189.45990.19
5382136-38213691.46992.25
6398797-39879795.45796.18
20min1394614-39461494.45695.791.8495.6897.061.86
2407718-40771897.59298.85
3406253-40625397.24298.66
4389540-38954093.24194.46
5397721-39772195.19996.49
6405231-40523196.99798.25
30min1391204-39120493.63995.161.6295.3996.971.58
2402483-40248396.33998.14
3391643-39164393.74495.70
4392565-39256593.96595.71
5402076-40207696.24298.06
6405359-40535997.02898.82
45min1403328-40332896.54196.401.5798.8198.741.52
2407937-40793797.64599.98
3395538-39553894.67797.16
4394336-39433694.38996.65
5407472-40747297.53399.89
6407807-40780797.61399.95
60min1391560-39156093.72595.531.9396.5398.401.87
2405009-40500996.94499.83
3389399-38939993.20796.21
4396247-39624794.84697.63
5405719-40571997.114100.01
6406632-40663297.332100.21
极限1389336-38933693.19295.521.7796.5298.921.72
2405102-40510296.966100.39
3393309-39330994.14397.67
4399247-39924795.56598.88
5399054-39905495.51898.95
6408261-40826197.722101.14
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061837911836671837181834451838041836850.08
211.081863971867001865480.12
单位质量响应值RSD%判断
16608.0516836.460.97数据可信
供试品溶液-25080102批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17240-72403.8873.669.293.893.669.26
26205-62053.3313.33
35822-58223.1263.13
47142-71423.8343.83
57268-72683.9023.90
67207-72073.8693.87
10min110121-101215.4345.575.325.465.595.30
210622-106225.7035.72
39427-94275.0615.08
410578-105785.6795.70
510463-104635.6175.64
611043-110435.9295.95
15min111215-112156.0216.264.676.076.314.68
211296-112966.0656.11
311085-110855.9516.00
411743-117436.3056.36
512346-123466.6286.68
612243-122436.5736.63
20min112110-121106.5026.722.856.596.802.86
212191-121916.5456.63
312472-124726.6966.77
412617-126176.7746.86
512587-125876.7586.85
613103-131037.0357.13
30min113198-131987.0867.182.797.217.312.75
212914-129146.9337.05
313755-137557.3857.50
413561-135617.2817.41
513791-137917.4047.53
613063-130637.0137.14
45min113721-137217.3677.541.887.537.701.81
214192-141927.6197.78
314127-141277.5857.74
414048-140487.5427.71
514409-144097.7367.90
613761-137617.3887.56
60min115090-150908.1027.922.208.308.132.12
214306-143067.6817.88
315126-151268.1218.32
414795-147957.9438.15
514487-144877.7787.99
614740-147407.9148.12
极限113963-139637.4977.984.017.748.233.92
214988-149888.0478.29
314832-148327.9638.21
415810-158108.4888.74
514962-149628.0338.29
614656-146567.8698.12
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.914085594087684090114089524087814088140.05
211.004145804154334150060.15
单位质量响应值RSD%判断
37471.4937727.820.49数据可信
供试品溶液-25080102批-辛伐他汀-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112545-125452.9882.6913.302.992.7013.25
210209-102092.4312.43
38881-88812.1152.12
411920-119202.8392.84
512811-128113.0513.05
611492-114922.7372.74
10min118077-180774.3054.318.074.324.328.02
219187-191874.5704.58
315259-152593.6343.65
418219-182194.3394.35
518659-186594.4444.46
619128-191284.5564.57
15min124167-241675.7565.678.745.805.718.70
221403-214035.0985.14
321645-216455.1555.19
423393-233935.5725.61
526620-266206.3406.38
625524-255246.0796.12
20min126703-267036.3606.695.666.436.765.63
226742-267426.3696.44
327399-273996.5266.59
427973-279736.6626.73
528668-286686.8286.90
630929-309297.3667.44
30min134655-346558.2548.336.888.368.446.80
231196-311967.4307.53
336467-364678.6858.78
436155-361558.6118.72
537904-379049.0289.14
633463-334637.9708.09
45min139403-394039.3859.753.009.549.902.96
242161-4216110.04110.19
340614-406149.6739.82
440581-405819.6659.82
542653-4265310.15910.32
640240-402409.5849.74
60min150909-5090912.12511.485.2212.3311.695.12
243992-4399210.47810.68
349844-4984411.87112.07
448734-4873411.60711.82
546606-4660611.10011.32
649207-4920711.72011.93
极限147227-4722711.24812.224.1111.5212.494.02
252526-5252612.51012.77
352046-5204612.39612.66
452074-5207412.40212.68
552977-5297712.61812.90
651031-5103112.15412.43
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061825901826611825481823091822441824700.11
211.081845881850731848300.19
单位质量响应值RSD%判断
16498.1916681.410.79数据可信
供试品溶液-25080102批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16833-68333.6983.858.873.703.858.90
27468-74684.0414.04
36364-63643.4443.44
46631-66313.5883.59
58086-80864.3764.38
67322-73223.9623.96
10min110390-103905.6235.813.025.645.833.02
210680-106805.7805.80
310456-104565.6585.68
410751-107515.8185.84
511291-112916.1106.13
610862-108625.8785.90
15min112158-121586.5796.712.426.636.762.42
212205-122056.6056.66
312262-122626.6366.69
412212-122126.6096.66
512849-128496.9537.01
612711-127116.8796.93
20min112652-126526.8477.253.916.947.343.88
213028-130287.0507.14
313417-134177.2617.35
413379-133797.2407.33
513871-138717.5067.60
614072-140727.6157.71
30min113925-139257.5367.672.987.667.802.91
214844-148448.0338.16
314510-145107.8527.98
414048-140487.6027.73
514071-140717.6157.75
613681-136817.4047.54
45min114981-149818.1077.941.918.288.121.87
214396-143967.7917.97
314463-144637.8278.00
414666-146667.9378.11
515062-150628.1518.33
614515-145157.8558.03
60min114020-140207.5877.983.707.808.203.63
215149-151498.1988.42
315062-150628.1518.37
415238-152388.2468.46
514955-149558.0938.32
614105-141057.6337.85
极限114796-147968.0078.131.128.268.391.14
214932-149328.0818.34
315035-150358.1368.40
414943-149438.0878.35
515131-151318.1888.46
615273-152738.2658.53
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.914063054062634060434061004053004060020.11
211.004104494114994109740.19
单位质量响应值RSD%判断
37213.7537361.270.28数据可信
供试品溶液-25080102批-辛伐他汀-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116082-160823.8624.3113.343.864.3013.35
218911-189114.5424.54
315834-158343.8033.80
415906-159063.8203.82
521698-216985.2115.21
619168-191684.6034.60
10min129477-294777.0797.648.037.107.668.03
231428-314287.5487.57
330205-302057.2547.28
430237-302377.2627.28
536249-362498.7068.73
633317-333178.0018.03
15min139952-399529.5959.744.659.669.804.68
238774-387749.3129.38
339694-396949.5339.59
439071-390719.3839.44
542346-4234610.17010.25
643388-4338810.42010.49
20min141384-413849.93911.079.9410.0511.199.88
240835-408359.8079.93
346346-4634611.13111.24
445991-4599111.04511.16
549147-4914711.80311.94
652848-5284812.69212.82
30min148114-4811411.55511.954.2711.7212.134.19
253530-5353012.85613.03
350280-5028012.07512.25
449160-4916011.80611.98
549838-4983811.96912.17
647530-4753011.41511.61
45min156639-5663913.60312.813.8413.8413.063.75
250663-5066312.16712.41
353448-5344812.83613.08
453624-5362412.87813.12
553891-5389112.94313.21
651765-5176512.43212.69
60min146782-4678211.23512.628.3211.5412.948.10
254005-5400512.97013.28
352790-5279012.67812.99
459959-5995914.40014.71
550901-5090112.22412.56
650957-5095712.23812.57
极限155132-5513213.24113.334.4413.6113.724.35
252037-5203712.49712.88
355883-5588313.42113.81
455051-5505113.22113.61
555268-5526813.27313.68
659715-5971514.34114.74
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.061854561857561860331860351857261858010.14
211.081862331862991862660.03
单位质量响应值RSD%判断
16799.3716811.010.05数据可信
供试品溶液-25080102批-依折麦布-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%
5min15792-57923.0943.447.423.093.447.43
26879-68793.6753.67
36612-66123.5323.53
47015-70153.7473.75
56081-60813.2493.25
66244-62443.3363.34
10min18962-89624.7885.146.004.805.166.05
210660-106605.6955.72
39452-94525.0495.07
49708-97085.1865.21
59622-96225.1405.16
69287-92874.9614.98
15min110512-105125.6165.983.945.666.033.90
211209-112095.9886.04
311008-110085.8815.93
411244-112446.0076.06
511864-118646.3386.38
611335-113356.0556.10
20min111852-118526.3316.331.586.416.411.58
211819-118196.3146.40
311855-118556.3336.41
412175-121756.5046.59
511602-116026.1986.28
611779-117796.2926.37
30min112030-120306.4276.693.496.546.813.47
212896-128966.8897.01
312686-126866.7776.89
413119-131197.0087.13
512320-123206.5816.70
612134-121346.4826.60
45min112482-124826.6686.802.976.816.952.94
213298-132987.1047.26
312380-123806.6146.77
412529-125296.6936.85
513109-131097.0037.16
612586-125866.7246.87
60min112227-122276.5326.843.706.717.033.63
212322-123226.5836.78
313477-134777.2007.39
412876-128766.8787.07
513115-131157.0067.20
612830-128306.8547.04
极限113694-136947.3157.005.617.537.225.37
212883-128836.8827.12
311803-118036.3056.54
413774-137747.3587.59
512955-129556.9217.15
613464-134647.1937.42
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.914124904133034133434134914126764130610.11
211.004140074137434138750.05
单位质量响应值RSD%判断
37860.7737625.000.45数据可信
供试品溶液-25080102批-辛伐他汀-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%
5min13467-34670.8230.9711.630.820.9711.64
24584-45841.0881.09
33527-35270.8370.84
44385-43851.0401.04
54276-42761.0151.01
64345-43451.0311.03
10min13596-35960.8530.946.400.860.946.32
24187-41870.9931.00
34126-41260.9790.98
43726-37260.8840.89
54187-41870.9931.00
63904-39040.9260.93
15min14454-44541.0571.189.431.071.209.40
24595-45951.0901.10
34839-48391.1481.16
44956-49561.1761.19
55479-54791.3001.31
65624-56241.3341.35
20min15155-51551.2231.335.741.241.355.74
25606-56061.3301.35
35346-53461.2681.28
45846-58461.3871.40
55689-56891.3501.37
66032-60321.4311.45
30min16258-62581.4851.573.771.511.603.70
26711-67111.5921.62
36399-63991.5181.54
46946-69461.6481.67
56670-66701.5831.61
66737-67371.5981.62
45min17201-72011.7091.695.631.741.735.50
27684-76841.8231.86
36863-68631.6281.66
46545-65451.5531.59
57412-74121.7591.79
67135-71351.6931.73
60min16982-69821.6571.818.101.701.857.96
26784-67841.6101.65
38177-81771.9401.98
47574-75741.7971.84
57929-79291.8811.93
68250-82501.9572.00
极限18979-89792.1302.027.272.182.087.02
27766-77661.8431.90
37919-79191.8791.93
49233-92332.1912.24
58274-82741.9632.02
68983-89832.1312.19
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