培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244452454433494446914448864451074446560.18
210.184466744456164461450.17
单位质量响应值RSD%判断
43423.4443825.640.66数据可信
供试品溶液-2023090912批-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%
5min1182246-18224693.81093.511.0793.8193.511.07
2181149-18114993.24593.25
3178082-17808291.66791.67
4182217-18221793.79593.80
5183669-18366994.54394.54
6182609-18260993.99794.00
10min1187287-18728796.40595.690.9596.5695.850.95
2184784-18478495.11695.27
3182949-18294994.17294.32
4186313-18631395.90496.06
5186421-18642195.95996.12
6187662-18766296.59896.75
15min1187189-18718996.35495.791.0096.6796.101.00
2184880-18488095.16695.48
3183148-18314894.27494.58
4185939-18593995.71196.03
5187093-18709396.30596.62
6188282-18828296.91797.23
20min1185944-18594495.71495.510.7896.1995.990.78
2184660-18466095.05395.53
3183180-18318094.29194.76
4185936-18593695.70996.19
5186322-18632295.90896.39
6187264-18726496.39396.87
30min1185969-18596995.72695.390.9096.3696.020.90
2184034-18403494.73095.36
3182742-18274294.06594.69
4185689-18568995.58296.22
5185957-18595795.72096.36
6187467-18746796.49897.14
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244441444442284424384440664450594439870.22
210.184412774420454416610.13
单位质量响应值RSD%判断
43358.1143385.170.05数据可信
供试品溶液-2023090912批-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%
5min1187727-18772797.19396.451.4297.1996.451.43
2185232-18523295.90195.90
3186519-18651996.56796.57
4189994-18999498.36698.37
5186266-18626696.43696.44
6182043-18204394.25094.25
10min1192118-19211899.46698.641.6799.6398.801.67
2188498-18849897.59297.75
3191473-19147399.13299.29
4193667-193667100.268100.43
5192261-19226199.54099.70
6185078-18507895.82195.98
15min1191952-19195299.38098.571.3899.7198.891.38
2188564-18856497.62697.95
3191292-19129299.03999.36
4193015-19301599.931100.26
5191511-19151199.15299.48
6185959-18595996.27796.59
20min1191522-19152299.15898.531.4999.6599.021.49
2188957-18895797.83098.31
3191000-19100098.88799.38
4193389-193389100.124100.62
5191646-19164699.22299.71
6185328-18532895.95196.43
30min1191172-19117298.97698.181.5599.6498.841.54
2188131-18813197.40298.05
3190772-19077298.76999.43
4192603-19260399.717100.38
5190711-19071198.73899.39
6184460-18446095.50196.14
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244459064443634433824430454431034439600.28
210.184441304449434445360.13
单位质量响应值RSD%判断
43355.4743667.580.51数据可信
供试品溶液-2023091111批-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%
5min1156863-15686380.95376.0213.6980.9576.0213.70
2167139-16713986.25786.26
3143860-14386074.24374.24
4167244-16724486.31186.31
5117801-11780160.79460.79
6130931-13093167.57067.57
10min1186943-18694396.47797.360.9296.6197.480.93
2188834-18883497.45397.60
3188727-18872797.39897.52
4191862-19186299.01699.16
5187689-18768996.86296.96
6187854-18785496.94797.06
15min1188326-18832697.19197.990.7197.4998.280.72
2189888-18988897.99798.30
3189722-18972297.91198.20
4192375-19237599.28099.59
5189471-18947197.78298.04
6189483-18948397.78898.06
20min1188521-18852197.29197.980.6997.7598.430.70
2189864-18986497.98498.45
3190143-19014398.12898.58
4192225-19222599.20399.68
5189079-18907997.57998.01
6189281-18928197.68498.12
30min1188832-18883297.45297.840.6698.0798.460.67
2189310-18931097.69898.33
3189130-18913097.60698.22
4192073-19207399.12499.76
5188713-18871397.39097.98
6189444-18944497.76898.37
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244410444415304424024425924418414418820.15
210.184431824443584437700.19
单位质量响应值RSD%判断
43152.5443592.340.72数据可信
供试品溶液-2023091111批-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%
5min1130590-13059067.61175.8310.1267.6175.8310.12
2152855-15285579.13979.14
3148988-14898877.13777.14
4149752-14975277.53277.53
5128546-12854666.55366.55
6168035-16803586.99887.00
10min1190615-19061598.68997.971.4398.8098.101.44
2192152-19215299.48499.62
3189616-18961698.17198.30
4186346-18634696.47896.61
5185482-18548296.03196.14
6191122-19112298.95199.10
15min1191594-19159499.19698.431.4599.4798.721.46
2192827-19282799.834100.13
3189454-18945498.08898.38
4188100-18810097.38797.68
5185980-18598096.28996.56
6192724-19272499.781100.09
20min1191785-19178599.29498.441.3599.7498.901.36
2192319-19231999.571100.04
3189420-18942098.07098.53
4188431-18843197.55898.01
5186201-18620196.40396.83
6192648-19264899.741100.22
30min1191213-19121398.99898.461.2799.6199.081.28
2192179-19217999.498100.13
3188954-18895497.82998.45
4189100-18910097.90498.52
5186570-18657096.59497.19
6193043-19304399.946100.59
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