盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312166762174112173612177622174032173230.19
216.352187832178662183240.30
单位质量响应值RSD%判断
13324.5213353.150.16数据可信
供试品溶液-2024042521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%
5min129013-2901314.54512.4033.2614.5412.4033.28
230605-3060515.34315.34
329138-2913814.60814.61
414232-142327.1357.13
514132-141327.0857.08
631339-3133915.71115.71
10min191101-9110145.67146.295.6245.7546.365.65
295024-9502447.63847.72
393553-9355346.90146.98
488215-8821544.22444.26
585769-8576942.99843.04
6100329-10032950.29850.38
15min1117842-11784259.07759.961.1659.4160.281.18
2120585-12058560.45260.80
3119958-11995860.13860.48
4118270-11827059.29259.58
5119472-11947259.89460.17
6121471-12147160.89761.26
20min1125838-12583863.08663.811.3263.7564.471.30
2129174-12917464.75865.44
3128123-12812364.23164.91
4125962-12596263.14863.76
5128992-12899264.66765.28
6125585-12558562.95963.66
30min1128573-12857364.45765.921.5165.4766.931.47
2131528-13152865.93866.98
3131766-13176666.05867.09
4131363-13136365.85666.82
5134767-13476767.56268.53
6130899-13089965.62366.68
45min1133107-13310766.73066.741.2368.1068.121.20
2132776-13277666.56467.98
3132671-13267166.51167.91
4131118-13111865.73367.06
5136100-13610068.23069.58
6132965-13296566.65968.08
极限1127484-12748463.91168.894.1865.6570.644.07
2137782-13778269.07470.86
3135021-13502167.69069.46
4139407-13940769.88871.58
5144141-14414172.26273.99
6140691-14069170.53272.32
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312188352191252186622180862182532185920.20
216.352206472206322206400.01
单位质量响应值RSD%判断
13402.3313494.800.49数据可信
供试品溶液-2024042521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%
5min124050-2405011.95914.9618.0911.9614.9618.08
227220-2722013.53513.53
331803-3180315.81415.81
428901-2890114.37114.37
539928-3992819.85419.85
628619-2861914.23114.23
10min181692-8169240.62143.768.7540.6943.858.76
280192-8019239.87539.95
383948-8394841.74241.83
496167-9616747.81847.90
598576-9857649.01649.13
687507-8750743.51243.59
15min1119465-11946559.40359.362.7459.7059.692.78
2114386-11438656.87757.17
3118029-11802958.68959.01
4120846-12084660.09060.44
5124314-12431461.81462.20
6119217-11921759.28059.60
20min1128455-12845563.87363.692.2564.5064.352.27
2125385-12538562.34762.96
3127027-12702763.16363.81
4125478-12547862.39363.07
5133056-13305666.16166.89
6129147-12914764.21764.87
30min1128205-12820563.74964.132.5264.7365.142.52
2126148-12614862.72663.69
3128919-12891964.10465.10
4125046-12504662.17863.20
5132591-13259165.93067.02
6132929-13292966.09867.10
45min1130763-13076365.02165.351.8066.3566.721.80
2128328-12832863.81065.12
3132763-13276366.01567.37
4129710-12971064.49765.87
5132019-13201965.64567.11
6134992-13499267.12468.50
极限1139732-13973269.48069.772.8171.1771.502.80
2135177-13517767.21668.88
3141874-14187470.54672.27
4136336-13633667.79269.52
5144233-14423371.71973.54
6144477-14447771.84073.59
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312164722171182171782166992169582168850.14
216.352204242201842203040.08
单位质量响应值RSD%判断
13297.6713474.250.94数据可信
供试品溶液-2024042621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%
5min122098-2209811.04012.3624.2911.0412.3624.30
217351-173518.6688.67
322144-2214411.06311.06
433699-3369916.83516.84
523060-2306011.52011.52
630150-3015015.06215.06
10min192111-9211146.01746.122.6946.0846.192.66
295695-9569547.80847.86
391050-9105045.48745.55
489220-8922044.57344.67
591007-9100745.46545.53
694819-9481947.37047.45
15min1114954-11495457.42959.112.5157.7559.442.50
2120911-12091160.40560.72
3119831-11983159.86560.18
4117174-11717458.53858.88
5115219-11521957.56157.88
6121855-12185560.87761.22
20min1125653-12565362.77463.281.6363.4163.931.64
2125525-12552562.71063.36
3126695-12669563.29563.94
4126366-12636663.13063.80
5125038-12503862.46763.10
6130671-13067165.28165.97
30min1130412-13041265.15266.001.5666.1467.011.57
2131544-13154465.71766.71
3132268-13226866.07967.08
4134938-13493867.41368.43
5129556-12955664.72465.71
6133974-13397466.93167.98
45min1130489-13048965.19066.382.0066.5467.752.00
2131567-13156765.72967.09
3133153-13315366.52167.89
4137003-13700368.44469.84
5130216-13021665.05466.40
6134780-13478067.33468.75
极限1138186-13818669.03570.012.5570.7471.752.51
2145812-14581272.84574.57
3137920-13792068.90270.64
4142207-14220771.04472.82
5135876-13587667.88169.59
6140773-14077370.32872.12
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.312253122249132251332253452247702250950.12
216.352235662236332236000.03
单位质量响应值RSD%判断
13801.0413675.840.65数据可信
供试品溶液-2024042621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%
5min118965-189659.23112.3216.899.2312.3216.89
223909-2390911.63811.64
325516-2551612.42012.42
425034-2503412.18512.19
526215-2621512.76012.76
632252-3225215.69915.70
10min176085-7608537.03543.419.6437.0943.489.64
291669-9166944.62044.68
386633-8663342.16942.24
484800-8480041.27741.34
595641-9564146.55446.62
6100315-10031548.82948.92
15min1112565-11256554.79157.284.3255.0557.594.35
2119203-11920358.02358.34
3113564-11356455.27855.58
4114526-11452655.74656.04
5120474-12047458.64158.97
6125775-12577561.22161.58
20min1123344-12334460.03861.994.8160.6062.624.83
2130285-13028563.41764.05
3121147-12114758.96959.58
4122678-12267859.71460.32
5129397-12939762.98463.64
6137273-13727366.81867.52
30min1125688-12568861.17962.814.5962.0763.784.61
2130506-13050663.52464.51
3122575-12257559.66460.60
4123933-12393360.32561.26
5134415-13441565.42766.43
6137111-13711166.73967.81
45min1129915-12991563.23764.163.4964.4765.483.53
2131399-13139963.95965.30
3125858-12585861.26262.53
4129959-12995963.25864.53
5134499-13449965.46866.84
6139267-13926767.78969.23
极限1137877-13787767.11268.152.5668.7069.822.60
2138634-13863467.48169.18
3136852-13685266.61368.22
4137949-13794967.14768.77
5146018-14601871.07572.81
6142680-14268069.45071.27
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