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DSZJ-4057-240226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(%)100.0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%
115.992110462108932113792111122116072112070.14
216.032116892111592114240.18
单位质量响应值RSD%判断
13208.6913189.270.11数据可信
供试品溶液-2024042221批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111829-118296.0058.81104.556.018.81104.56
212187-121876.1876.19
32036-20361.0341.03
4-0.0000.00
531487-3148715.98415.98
646540-4654023.62623.63
10min181347-8134741.29662.3418.7441.3362.4018.76
2121005-12100561.42961.46
3137842-13784269.97669.98
4115269-11526958.51758.52
5139657-13965770.89770.99
6141740-14174071.95572.09
15min1155128-15512878.75183.905.4679.0184.305.54
2168853-16885385.71986.09
3172365-17236587.50287.90
4152500-15250077.41777.74
5170340-17034086.47486.96
6172491-17249187.56688.10
20min1169014-16901485.80087.292.9186.5088.152.98
2173233-17323387.94288.79
3175943-17594389.31890.20
4163170-16317082.83483.59
5174824-17482488.75089.71
6175528-17552889.10790.12
30min1169886-16988686.24388.383.1187.4289.723.16
2177948-17794890.33691.68
3179458-17945891.10292.48
4167381-16738184.97186.19
5170542-17054286.57688.03
6179322-17932291.03392.55
45min1175660-17566089.17490.052.9190.8391.882.96
2175475-17547589.08090.92
3184684-18468493.75595.64
4170092-17009286.34888.04
5176628-17662889.66691.60
6181742-18174292.26294.28
60min1164589-16458983.55487.844.1085.7190.184.10
2180478-18047891.62093.96
3180246-18024691.50293.91
4168180-16818085.37787.54
5167428-16742884.99587.43
6177231-17723189.97292.50
极限1182221-18222192.50593.030.7595.1295.850.82
2184353-18435393.58796.43
3184705-18470593.76696.68
4182678-18267892.73795.38
5181336-18133692.05694.96
6184184-18418493.50296.53
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DSZJ-4057-240226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(%)100.0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%
115.992111642109862114002112962112382112170.08
216.032106822103932105380.10
单位质量响应值RSD%判断
13209.3213134.000.41数据可信
供试品溶液-2024042321批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13343-33431.7011.9423.401.701.9423.38
23530-35301.7961.80
33425-34251.7421.74
43479-34791.7701.77
55641-56412.8702.87
63511-35111.7861.79
10min1123030-12303062.58761.306.2262.6061.316.22
2122160-12216062.14462.15
3108696-10869655.29555.30
4116522-11652259.27659.29
5121295-12129561.70461.72
6131258-13125866.77266.78
15min1152099-15209977.37479.325.2477.7379.675.24
2156599-15659979.66380.02
3148355-14835575.47075.79
4151632-15163277.13777.48
5155378-15537879.04279.40
6171479-17147987.23387.61
20min1164062-16406283.46084.084.9584.2584.874.94
2169790-16979086.37487.17
3162174-16217482.50083.24
4153087-15308777.87778.64
5164913-16491383.89384.69
6177670-17767090.38391.25
30min1170794-17079486.88586.114.2988.1487.374.29
2173145-17314588.08189.36
3160104-16010481.44782.64
4166958-16695884.93386.13
5164036-16403683.44784.71
6180601-18060191.87493.24
45min1165499-16549984.19186.973.6985.9288.703.70
2175681-17568189.37191.14
3166275-16627584.58686.23
4168955-16895585.94987.62
5167855-16785585.39087.12
6181476-18147692.31994.20
60min1172771-17277187.89086.734.1790.0988.954.15
2176005-17600589.53691.80
3166655-16665584.77986.90
4166670-16667084.78786.94
5160763-16076381.78283.98
6180110-18011091.62494.01
极限1176861-17686189.97189.254.6192.6691.954.59
2172406-17240687.70590.47
3168750-16875085.84588.43
4168745-16874585.84288.46
5175394-17539489.22591.88
6190480-19048096.89999.80
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DSZJ-4057-240226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(%)100.0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%
115.992110882104442104092102922098962104260.21
216.032098232091592094910.23
单位质量响应值RSD%判断
13159.8513068.680.50数据可信
供试品溶液-2024042421批-pH6.8(内含0.02%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13790-37901.9362.8448.281.942.8448.27
23531-35311.8041.80
33526-35261.8021.80
48128-81284.1534.15
54639-46392.3702.37
69692-96924.9524.95
10min1114915-11491558.71460.1611.9258.7360.1811.92
2100750-10075051.47751.49
3114777-11477758.64458.65
4109443-10944355.91955.94
5125361-12536164.05264.06
6141225-14122572.15772.18
15min1151730-15173077.52581.293.7977.8681.643.82
2151761-15176177.54177.84
3161588-16158882.56182.90
4161054-16105482.28982.62
5161963-16196382.75383.12
6166519-16651985.08185.51
20min1161969-16196982.75686.382.8383.5287.182.86
2167243-16724385.45186.18
3167550-16755085.60886.40
4169733-16973386.72387.51
5171608-17160887.68188.51
6176211-17621190.03390.93
30min1167693-16769385.68188.912.6186.9190.192.64
2170141-17014186.93288.13
3177378-17737890.62991.90
4175694-17569489.76991.04
5173394-17339488.59489.91
6179785-17978591.85993.26
45min1165864-16586484.74689.082.6086.4590.852.61
2173963-17396388.88490.57
3177012-17701290.44292.22
4174040-17404088.92490.70
5176562-17656290.21292.02
6178599-17859991.25393.16
60min1167592-16759285.62989.432.5587.8091.702.57
2174112-17411288.96091.14
3176900-17690090.38592.66
4173105-17310588.44690.71
5178669-17866991.28993.60
6179756-17975691.84494.26
极限1171802-17180287.78092.652.8890.4395.412.87
2181874-18187492.92695.60
3179368-17936891.64694.42
4186001-18600195.03597.79
5184512-18451294.27497.09
6184400-18440094.21797.15
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