依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851295061292851295971296911297601295680.15
210.881302171301461301820.04
单位质量响应值RSD%判断
11941.7511965.260.14数据可信
供试品溶液-24020201批-匹伐他汀钙-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%
5min1135827-13582798.48396.592.2498.4896.602.24
2135446-13544698.20698.21
3135751-13575198.42898.43
4132495-13249596.06796.07
5128511-12851193.17893.18
6131309-13130995.20795.21
10min1140279-140279101.711101.991.99101.87102.151.99
2141804-141804102.816102.98
3145120-145120105.221105.38
4137737-13773799.868100.03
5137705-13770599.844100.00
6141355-141355102.491102.65
15min1140553-140553101.909101.881.92102.24102.211.92
2141212-141212102.387102.72
3144663-144663104.889105.23
4137308-13730899.55799.88
5137842-13784299.944100.27
6141515-141515102.607102.94
20min1139767-139767101.339101.571.91101.84102.071.91
2141452-141452102.561103.07
3144010-144010104.416104.93
4136814-13681499.19899.69
5137485-13748599.685100.17
6140998-140998102.232102.73
30min1139173-139173100.909101.201.90101.58101.871.90
2140859-140859102.131102.81
3143563-143563104.092104.78
4136366-13636698.87499.53
5137078-13707899.390100.04
6140389-140389101.790102.46
45min1139207-139207100.933101.091.89101.77101.931.89
2140656-140656101.984102.83
3143322-143322103.917104.78
4136167-13616798.72999.55
5136898-13689899.259100.08
6140318-140318101.739102.58
60min1138886-138886100.701100.831.94101.71101.841.94
2140237-140237101.680102.70
3143225-143225103.847104.88
4135721-13572198.40699.39
5136604-13660499.046100.03
6139702-139702101.292102.30
极限1138528-138528100.441100.602.03101.62101.782.03
2140075-140075101.563102.75
3142803-142803103.541104.75
4135486-13548698.23599.39
5135682-13568298.37899.53
6139896-139896101.433102.61
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.003792993795493794873794593792623794110.04
210.933793323794363793840.02
单位质量响应值RSD%判断
34491.9134710.340.45数据可信
供试品溶液-24020201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%
5min119645-196455.1104.5712.635.114.5712.59
220614-206145.3625.36
316830-168304.3784.38
417328-173284.5074.51
516408-164084.2684.27
614558-145583.7873.79
10min134315-343158.9268.663.708.938.673.70
234946-349469.0909.10
333369-333698.6808.69
433266-332668.6538.66
532209-322098.3788.38
631677-316778.2398.25
15min135292-352929.1809.012.069.209.032.07
235342-353429.1939.22
334973-349739.0979.12
434539-345398.9849.01
533957-339578.8338.85
633628-336288.7478.77
20min135100-351009.1308.882.489.178.922.50
234874-348749.0719.11
333994-339948.8428.88
434583-345838.9959.03
533094-330948.6088.64
633253-332538.6498.68
30min133328-333288.6698.711.328.728.761.35
233661-336618.7568.81
334117-341178.8748.93
433726-337268.7728.82
532845-328458.5438.59
633261-332618.6528.70
45min133714-337148.7698.621.518.848.691.52
233574-335748.7338.80
333385-333858.6848.75
433110-331108.6128.68
532498-324988.4538.52
632629-326298.4878.55
60min133214-332148.6398.571.138.728.651.16
233188-331888.6338.72
333394-333948.6868.77
432781-327818.5278.61
532430-324308.4358.51
632706-327068.5078.58
极限133086-330868.6068.621.288.708.721.31
233671-336718.7588.86
333540-335408.7248.82
433100-331008.6108.70
532483-324838.4498.54
632995-329958.5828.67
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851300881302061303621301001302361301980.09
210.881308691307211307950.09
单位质量响应值RSD%判断
11999.8212021.600.13数据可信
供试品溶液-24020201批-匹伐他汀钙-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%
5min1129461-12946193.42092.955.8293.4292.955.82
2127111-12711191.72491.72
3137707-13770799.37099.37
4136235-13623598.30898.31
5117546-11754684.82284.82
6124775-12477590.03890.04
10min1139072-139072100.355101.551.19100.51101.711.20
2139017-139017100.316100.47
3143241-143241103.364103.53
4141894-141894102.392102.56
5140028-140028101.045101.19
6141146-141146101.852102.00
15min1139461-139461100.636101.641.00100.96101.961.00
2139157-139157100.417100.74
3142872-142872103.097103.44
4141740-141740102.281102.62
5140747-140747101.564101.87
6141123-141123101.835102.16
20min1138740-138740100.116101.351.09100.61101.851.09
2138876-138876100.214100.70
3142699-142699102.973103.48
4141385-141385102.024102.53
5140172-140172101.149101.63
6140865-140865101.649102.14
30min1138408-13840899.876101.181.08100.53101.841.09
2138548-13854899.977100.63
3142385-142385102.746103.43
4140897-140897101.672102.35
5140458-140458101.355102.00
6140555-140555101.425102.08
45min1138693-138693100.082101.121.05100.91101.961.05
2138604-138604100.018100.84
3142410-142410102.764103.62
4141048-141048101.781102.63
5139677-139677100.792101.61
6140381-140381101.300102.13
60min1138855-138855100.199100.950.92101.19101.940.92
2138343-13834399.829100.82
3141912-141912102.405103.43
4140517-140517101.398102.41
5139536-139536100.690101.67
6140183-140183101.157102.15
极限1138537-13853799.969100.791.02101.13101.961.03
2137950-13795099.546100.70
3141964-141964102.442103.64
4140269-140269101.219102.40
5139288-139288100.511101.66
6140013-140013101.034102.20
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.003822583825083825943823393825453824490.04
210.933806723811643809180.10
单位质量响应值RSD%判断
34768.0934850.690.17数据可信
供试品溶液-24020201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%
5min119638-196385.0774.9014.365.084.9114.38
218430-184304.7654.77
322343-223435.7775.78
421408-214085.5355.54
515193-151933.9283.93
616799-167994.3434.34
10min132928-329288.5148.564.248.528.574.23
232364-323648.3688.38
335201-352019.1019.11
433758-337588.7288.74
531023-310238.0218.03
633437-334378.6458.65
15min134223-342238.8488.912.718.878.942.71
232947-329478.5188.54
335642-356429.2159.24
434236-342368.8528.88
534652-346528.9598.98
635173-351739.0949.12
20min133934-339348.7748.751.758.818.791.77
233490-334908.6598.69
334756-347568.9869.03
433661-336618.7038.74
533038-330388.5428.58
634165-341658.8338.87
30min133558-335588.6768.721.648.738.771.67
233158-331588.5738.62
334696-346968.9719.03
433726-337268.7208.77
533303-333038.6118.66
633922-339228.7718.82
45min133304-333048.6118.611.238.688.681.24
233132-331328.5668.63
334005-340058.7928.86
432748-327488.4678.53
533299-332998.6098.67
633374-333748.6298.70
60min133263-332638.6008.501.768.688.581.71
233223-332238.5908.67
331732-317328.2048.29
433068-330688.5508.63
532976-329768.5268.60
633084-330848.5548.63
极限133379-333798.6308.610.608.738.710.61
233249-332498.5978.69
333669-336698.7058.80
433085-330858.5548.65
533227-332278.5918.68
633255-332558.5988.69
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851308541308921310641310121310771309800.08
210.881320071319651319860.03
单位质量响应值RSD%判断
12071.8912131.070.35数据可信
供试品溶液-24021801批-匹伐他汀钙-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%
5min1127385-12738591.23395.712.5391.2395.702.53
2135436-13543696.99997.00
3135039-13503996.71596.71
4134816-13481696.55596.55
5132389-13238994.81794.82
6136718-13671897.91797.92
10min1142097-142097101.770101.121.16101.92101.281.16
2141016-141016100.995101.16
3142243-142243101.874102.04
4140502-140502100.627100.79
5138359-13835999.09299.25
6142898-142898102.343102.51
15min1142468-142468102.035101.121.20102.36101.451.20
2140741-140741100.798101.13
3142262-142262101.888102.22
4140661-140661100.741101.07
5138262-13826299.02399.35
6142753-142753102.239102.57
20min1141871-141871101.608100.671.14102.10101.161.14
2140492-140492100.620101.12
3141740-141740101.514102.01
4139775-139775100.107100.60
5137791-13779198.68699.17
6141703-141703101.487101.99
30min1141181-141181101.114100.341.06101.77101.011.06
2139891-139891100.190100.86
3141143-141143101.086101.76
4139480-13948099.895100.56
5137549-13754998.51299.16
6141402-141402101.272101.95
45min1140835-140835100.866100.251.09101.70101.081.09
2140154-140154100.378101.21
3141037-141037101.010101.85
4139381-13938199.824100.65
5137209-13720998.26999.09
6141229-141229101.148101.99
60min1141087-141087101.046100.051.19102.04101.051.18
2139686-139686100.043101.04
3140657-140657100.738101.75
4138723-13872399.353100.35
5136909-13690998.05499.03
6141116-141116101.067102.08
极限1140493-140493100.62199.791.23101.79100.961.23
2139126-13912699.642100.81
3140472-140472100.606101.78
4138622-13862299.281100.44
5136372-13637297.66998.81
6140952-140952100.950102.13
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.003809843815443820403823863822493818410.16
210.933809423819253814340.19
单位质量响应值RSD%判断
34712.8234897.900.38数据可信
供试品溶液-24021801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%
5min113418-134183.4704.0710.803.474.0710.83
218318-183184.7374.74
315206-152063.9323.93
416714-167144.3224.32
515998-159984.1374.14
614699-146993.8013.80
10min131173-311738.0618.251.528.078.261.52
232131-321318.3098.32
332478-324788.3988.40
432036-320368.2848.29
532138-321388.3108.32
631471-314718.1388.14
15min133162-331628.5758.611.688.598.631.67
234380-343808.8908.91
332915-329158.5118.53
432933-329338.5168.54
533409-334098.6398.66
633033-330338.5428.56
20min133370-333708.6298.601.098.668.641.10
233112-331128.5628.60
333620-336208.6948.73
432946-329468.5198.55
533704-337048.7158.75
632824-328248.4888.52
30min132881-328818.5028.500.998.558.550.99
233401-334018.6378.69
332944-329448.5198.57
432440-324408.3888.44
532898-328988.5078.56
632655-326558.4448.49
45min132769-327698.4738.411.778.548.481.76
233364-333648.6278.69
332669-326698.4488.51
431623-316238.1778.24
532489-324898.4018.46
632316-323168.3568.42
60min133712-337128.7178.363.418.798.443.38
232609-326098.4328.51
332640-326408.4408.52
430340-303407.8457.92
532471-324718.3968.47
632246-322468.3388.41
极限131015-310158.0208.332.108.118.422.07
232122-321228.3068.40
332583-325838.4258.52
432326-323268.3598.45
532251-322518.3408.43
633043-330438.5448.63
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851322861321791320891322101321721321870.06
210.881314001313501313750.03
单位质量响应值RSD%判断
12183.1312074.910.64数据可信
供试品溶液-24021801批-匹伐他汀钙-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%
5min1126927-12692790.70093.273.0390.7093.273.03
2135915-13591597.12297.12
3132123-13212394.41394.41
4133623-13362395.48595.48
5126068-12606890.08690.09
6128488-12848891.81591.82
10min1142365-142365101.731100.352.95101.88100.502.94
2143934-143934102.853103.01
3143140-143140102.285102.44
4141955-141955101.438101.60
5133069-13306995.08995.24
6138099-13809998.68398.84
15min1142425-142425101.77499.933.05102.09100.263.05
2143438-143438102.498102.83
3143058-143058102.227102.55
4140751-140751100.578100.91
5132817-13281794.90995.22
6136596-13659697.60997.93
20min1142138-142138101.56999.703.01102.06100.193.01
2142702-142702101.972102.48
3142605-142605101.903102.40
4140879-140879100.670101.17
5132474-13247494.66395.13
6136353-13635397.43597.92
30min1141705-141705101.26099.533.01101.92100.193.01
2142764-142764102.016102.69
3142309-142309101.691102.36
4140568-140568100.447101.11
5132325-13232594.55795.18
6136050-13605097.21997.86
45min1141831-141831101.35099.213.04102.18100.033.04
2141973-141973101.451102.30
3141599-141599101.184102.02
4140310-140310100.263101.09
5131865-13186594.22895.01
6135453-13545396.79297.60
60min1140577-140577100.45498.982.94101.4599.972.94
2141578-141578101.169102.18
3141376-141376101.025102.03
4140215-140215100.195101.19
5131303-13130393.82794.77
6136069-13606997.23298.20
极限1140446-140446100.36098.672.89101.5299.822.89
2141283-141283100.958102.14
3140684-140684100.530101.70
4139616-13961699.767100.93
5131332-13133293.84794.94
6135116-13511696.55197.68
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.003814433822633826823824063822253822040.13
210.933743693749093746390.11
单位质量响应值RSD%判断
34745.8234276.210.97数据可信
供试品溶液-24021801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%
5min113907-139073.6273.398.363.633.398.40
213664-136643.5643.56
312666-126663.3033.30
411284-112842.9432.94
514060-140603.6673.67
612330-123303.2163.22
10min133147-331478.6458.223.958.658.233.97
232794-327948.5538.56
331422-314228.1958.20
431376-313768.1838.19
530208-302087.8787.88
630211-302117.8797.88
15min133393-333938.7098.374.288.738.384.28
230237-302377.8867.91
333653-336538.7778.80
432385-323858.4468.46
532007-320078.3478.37
630774-307748.0268.04
20min134353-343538.9598.434.278.998.464.25
232990-329908.6048.64
332852-328528.5688.60
431753-317538.2818.31
531539-315398.2258.26
630390-303907.9267.96
30min133098-330988.6328.493.588.688.533.57
234415-344158.9759.02
331652-316528.2558.30
432349-323498.4378.48
532644-326448.5148.56
631087-310878.1078.15
45min134775-347759.0698.345.449.138.415.40
232953-329538.5948.66
332213-322138.4018.46
431362-313628.1798.24
530853-308538.0468.11
629826-298267.7797.84
60min132895-328958.5798.263.218.668.333.23
232572-325728.4958.57
331811-318118.2968.37
431701-317018.2688.34
530523-305237.9608.03
630444-304447.9408.01
极限131540-315408.2268.193.048.328.283.03
232858-328588.5698.66
332064-320648.3628.45
430952-309528.0728.16
530850-308508.0468.13
630197-301977.8757.96
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