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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792090192090672092982089372090652090770.07
215.682099002096192097600.10
单位质量响应值RSD%判断
13241.1013377.550.73数据可信
供试品溶液-2024042221批-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%
5min125374-2537412.7756.4858.2812.776.4858.31
27198-71983.6243.62
33863-38631.9451.94
411980-119806.0316.03
516174-161748.1438.14
612659-126596.3736.37
10min1133531-13353167.22747.2430.6067.3047.2830.63
268526-6852634.50034.52
356528-5652828.45928.47
487716-8771644.16144.19
5113580-11358057.18357.23
6103123-10312351.91851.95
15min1190996-19099696.15888.267.5396.6088.567.59
2153431-15343177.24677.46
3167645-16764584.40284.57
4180174-18017490.71090.99
5176508-17650888.86489.23
6183096-18309692.18192.50
20min1190637-19063795.97894.192.8996.9694.972.86
2196049-19604998.70299.34
3183677-18367792.47493.11
4182282-18228291.77192.55
5182830-18283092.04792.90
6187004-18700494.14994.98
30min1190040-19004095.67795.292.8097.1996.602.72
2199503-199503100.441101.63
3187511-18751194.40495.56
4186217-18621793.75295.04
5185012-18501293.14694.51
6187302-18730294.29995.66
45min1190126-19012695.72096.062.4597.7697.902.34
2199022-199022100.199101.95
3193180-19318097.25898.93
4188063-18806394.68296.50
5186266-18626693.77795.66
6188148-18814894.72496.61
极限1189408-18940895.35995.993.6497.9398.373.49
2202534-202534101.967104.27
3194917-19491798.132100.35
4187660-18766094.47996.82
5184224-18422492.74995.16
6185266-18526693.27395.68
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792089932091032090262088542089432089840.05
215.682098992097362098180.06
单位质量响应值RSD%判断
13235.2113381.250.78数据可信
供试品溶液-2024042221批-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%
5min17755-77553.9056.3452.593.906.3352.61
27466-74663.7593.76
39280-92804.6724.67
423821-2382111.99411.99
59701-97014.8844.88
617471-174718.7978.80
10min177004-7700438.77250.2826.7538.7950.3226.75
264740-6474032.59732.62
396173-9617348.42348.45
4104388-10438852.55952.63
5136921-13692168.94068.97
6119935-11993560.38760.44
15min1179211-17921190.23389.565.6890.4789.875.72
2159014-15901480.06480.27
3182985-18298592.13392.43
4177795-17779589.52089.88
5188981-18898195.15295.56
6179245-17924590.25090.63
20min1188691-18869195.00694.012.1695.7494.822.22
2180934-18093491.10091.75
3186672-18667293.98994.80
4182893-18289392.08792.94
5190492-19049295.91396.85
6190579-19057995.95796.84
30min1189950-18995095.64095.281.7796.9196.611.75
2187835-18783594.57595.73
3188139-18813994.72896.06
4195619-19561998.49499.86
5187483-18748394.39895.87
6186347-18634793.82695.24
45min1189192-18919295.25895.953.4797.0697.813.47
2184164-18416492.72794.40
3186638-18663893.97295.83
4202408-202408101.913103.83
5193618-19361897.48799.48
6187366-18736694.33996.28
极限1190037-19003795.68496.491.7898.0198.891.79
2191334-19133496.33798.53
3189740-18974095.53497.91
4194876-19487698.120100.60
5196451-19645198.913101.45
6187408-18740894.36096.82
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792091202090592089792088502086822089380.09
215.682079722082952081340.11
单位质量响应值RSD%判断
13232.3013273.850.23数据可信
供试品溶液-2024042321批-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%
5min111924-119246.0294.1771.776.034.1771.78
25910-59102.9882.99
318383-183839.2949.29
43958-39582.0012.00
52437-24371.2321.23
66932-69323.5053.50
10min199441-9944150.27639.8230.7650.3139.8430.76
267533-6753334.14334.16
378493-7849339.68539.74
458230-5823029.44029.45
553668-5366827.13427.14
6115206-11520658.24658.27
15min1176729-17672989.35186.145.4389.6686.385.49
2161268-16126881.53481.74
3177006-17700689.49189.76
4173356-17335687.64687.82
5156261-15626179.00379.16
6177615-17761589.79990.14
20min1191694-19169496.91793.083.4497.7393.803.51
2178331-17833190.16190.82
3189297-18929795.70596.47
4182365-18236592.20092.86
5175739-17573988.85089.45
6187158-18715894.62495.47
30min1172876-17287687.40393.924.1188.7595.164.05
2188275-18827595.18896.35
3195219-19521998.699100.00
4188311-18831195.20796.38
5181696-18169691.86292.95
6188221-18822195.16196.53
45min1191819-19181996.98095.721.2198.8197.481.21
2191307-19130796.72198.41
3188443-18844395.27397.12
4190633-19063396.38198.08
5186023-18602394.05095.65
6187771-18777194.93496.83
极限1192071-19207197.10896.051.0299.4898.341.02
2192435-19243597.29299.52
3187897-18789794.99797.38
4189375-18937595.74597.98
5188151-18815195.12697.25
6189886-18988696.00398.43
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792091232089782087752087192088402088870.08
215.682090212090092090150.01
单位质量响应值RSD%判断
13229.0713330.040.54数据可信
供试品溶液-2024042321批-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%
5min16583-65833.3222.7260.143.322.7260.10
22621-26211.3231.32
31974-19740.9961.00
45898-58982.9762.98
510919-109195.5105.51
64374-43742.2072.21
10min186128-8612843.45838.8923.6143.4838.9123.63
259858-5985830.20330.21
355682-5568228.09628.10
491528-9152846.18346.20
5100401-10040150.66050.69
668905-6890534.76834.78
15min1171935-17193586.75587.836.7087.0188.066.74
2165121-16512183.31783.49
3168968-16896885.25885.42
4184462-18446293.07693.35
5191853-19185396.80597.12
6162039-16203981.76281.97
20min1191224-19122496.48894.852.4897.2395.572.51
2189169-18916995.45196.09
3186443-18644394.07594.71
4191654-19165496.70597.49
5190126-19012695.93496.78
6179282-17928290.46291.12
30min1194698-19469898.24197.322.2099.5298.572.21
2195897-19589798.846100.01
3190841-19084196.29597.45
4197573-19757399.691101.02
5192518-19251897.14198.52
6185767-18576793.73494.90
45min1190301-19030196.02297.761.4297.8599.551.35
2198335-198335100.076101.79
3194913-19491398.349100.04
4193899-19389997.83899.72
5192243-19224397.00298.92
6192792-19279297.27998.96
极限1194969-19496998.37797.530.86100.7399.860.88
2193262-19326297.51699.79
3190638-19063896.19298.43
4195048-19504898.417100.84
5192520-19252097.14299.60
6193276-19327697.52399.75
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792073812075992074882070742077752074630.13
215.682089112092582090840.12
单位质量响应值RSD%判断
13138.8913334.441.05数据可信
供试品溶液-2024042421批-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%
5min112513-125136.3359.5771.416.339.5771.43
28087-80874.0944.09
335456-3545617.94917.95
435142-3514217.79017.79
517939-179399.0819.08
64264-42642.1592.16
10min194363-9436347.77051.5517.5547.8151.6117.57
270129-7012935.50235.52
3103093-10309352.18952.29
4117326-11732659.39559.49
5117645-11764559.55659.61
6108455-10845554.90454.92
15min1181232-18123291.74690.584.0792.0590.924.11
2166149-16614984.11084.33
3185736-18573694.02694.42
4175848-17584889.02089.45
5185246-18524693.77894.16
6179307-17930790.77291.09
20min1188882-18888295.61993.962.9096.4394.802.95
2176912-17691289.55990.25
3192219-19221997.30898.22
4186561-18656194.44495.37
5186843-18684394.58795.49
6182226-18222692.24993.07
30min1185404-18540493.85894.431.4395.2095.801.43
2185531-18553193.92295.11
3190457-19045796.41697.87
4183253-18325392.76994.22
5185591-18559193.95395.38
6189004-18900495.68097.01
45min1189872-18987296.12095.711.1897.9897.601.05
2192735-19273597.56999.28
3187281-18728194.80896.80
4187337-18733794.83796.80
5187225-18722594.78096.73
6189965-18996596.16798.03
极限1189777-18977796.07296.520.9098.4798.940.89
2191862-19186297.12799.38
3192364-19236497.38199.90
4189285-18928595.82398.31
5192284-19228497.34199.82
6188433-18843395.39197.79
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)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.792096712101172098162102222104222100500.15
215.682097402104052100720.23
单位质量响应值RSD%判断
13302.7213397.450.51数据可信
供试品溶液-2024042421批-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%
5min123245-2324511.6675.2984.8811.675.2984.92
25275-52752.6482.65
32739-27391.3751.37
42617-26171.3141.31
59516-95164.7764.78
619803-198039.9399.94
10min198802-9880249.59045.5015.5149.6545.5215.53
269830-6983035.04935.06
384514-8451442.41942.43
483117-8311741.71841.72
5108645-10864554.53054.56
698965-9896549.67249.73
15min1178566-17856689.62590.392.3289.9690.672.34
2174894-17489487.78287.99
3178522-17852289.60389.85
4183911-18391192.30792.55
5186219-18621993.46693.80
6178391-17839189.53789.87
20min1187387-18738794.05294.291.9094.8995.081.93
2185193-18519392.95193.65
3182635-18263591.66792.41
4189726-18972695.22695.98
5192576-19257696.65697.51
6189647-18964795.18696.01
30min1186729-18672993.72294.791.3595.0896.101.33
2191327-19132796.03097.24
3185088-18508892.89894.15
4191231-19123195.98197.26
5190247-19024795.48796.87
6188558-18855894.64096.00
45min1183870-18387092.28794.732.3994.1796.562.38
2184825-18482592.76694.51
3185468-18546893.08994.86
4192060-19206096.39798.21
5194200-19420097.47299.39
6192005-19200596.37098.25
极限1189479-18947995.10294.022.7497.5096.382.71
2189157-18915794.94097.20
3177003-17700388.84091.12
4190115-19011595.42197.77
5187989-18798994.35496.81
6190246-19024695.48797.91
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