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%
115.762104982102252099082100282101652101650.11
215.802094622094452094540.01
单位质量响应值RSD%判断
13335.3413256.580.42数据可信
供试品溶液-2024042221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124769-2476912.48216.4050.5512.4816.4050.54
237100-3710018.69718.70
39281-92814.6774.68
423176-2317611.68011.68
550536-5053625.46825.47
650398-5039825.39825.40
10min1164013-16401382.65581.098.6982.7281.188.73
2159751-15975180.50780.61
3150685-15068575.93875.96
4140131-14013170.62070.68
5177148-17714889.27589.42
6173759-17375987.56787.71
15min1183954-18395492.70495.225.3593.2395.775.40
2194532-19453298.03598.59
3180528-18052890.97891.43
4178075-17807589.74290.20
5205026-205026103.324103.96
6191606-19160696.56197.19
20min1187496-18749694.48996.483.1995.5397.553.26
2191677-19167796.59697.69
3188573-18857395.03295.99
4184228-18422892.84393.80
5201090-201090101.340102.55
6195603-19560398.57599.74
30min1192068-19206896.79497.622.1498.3699.222.21
2195722-19572298.635100.27
3192682-19268297.10398.58
4187656-18765694.57096.04
5200112-200112100.847102.62
6193955-19395597.74499.46
45min1188549-18854995.02096.631.9297.1398.781.98
2191865-19186596.69198.87
3190870-19087096.19098.21
4189297-18929795.39797.39
5198801-198801100.187102.52
6191073-19107396.29298.55
极限1186688-18668894.08296.682.1996.7299.372.20
2192834-19283497.18099.90
3189810-18981095.65698.21
4193767-19376797.650100.18
5198627-198627100.099102.99
6189376-18937695.43798.23
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%
115.762091122091712092962090742089132091130.07
215.802097482103862100670.22
单位质量响应值RSD%判断
13268.5913295.380.15数据可信
供试品溶液-2024042221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13835-38351.93510.9390.401.9310.9390.43
217805-178058.9828.98
33339-33391.6841.68
431015-3101515.64615.65
518434-184349.3009.30
655619-5561928.05928.06
10min1161864-16186481.65778.886.0981.6778.946.11
2148618-14861874.97575.02
3152051-15205176.70776.72
4171599-17159986.56886.66
5145917-14591773.61273.66
6158120-15812079.76979.92
15min1182350-18235091.99292.533.6292.4693.043.66
2176714-17671489.14989.62
3177922-17792289.75890.19
4193979-19397997.85998.43
5181029-18102991.32691.79
6188547-18854795.11895.72
20min1183831-18383192.73994.912.3693.7195.922.41
2185174-18517493.41794.38
3184669-18466993.16294.10
4195296-19529698.52399.63
5189006-18900695.35096.32
6190802-19080296.25697.38
30min1187429-18742994.55495.721.3796.0597.261.44
2190088-19008895.89697.38
3187587-18758794.63496.09
4193255-19325597.49399.15
5187710-18771094.69696.19
6192406-19240697.06598.73
45min1189432-18943295.56595.922.0997.5898.002.05
2190001-19000195.85297.87
3187171-18717194.42496.40
4194584-19458498.164100.36
5194810-19481098.278100.30
6184856-18485693.25695.46
极限1186165-18616593.91794.681.9796.4697.281.98
2187149-18714994.41396.96
3183122-18312292.38294.88
4193439-19343997.586100.33
5190413-19041396.06098.63
6185727-18572793.69696.42
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%
115.762113862113302109222112762108352111500.12
215.802102622104302103460.06
单位质量响应值RSD%判断
13397.8413313.040.45数据可信
供试品溶液-2024042321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17266-72663.64510.9457.843.6510.9457.82
27295-72953.6603.66
322305-2230511.19111.19
437791-3779118.96018.96
523709-2370911.89511.90
632497-3249716.30416.30
10min1154574-15457477.55181.445.0677.5781.505.08
2168624-16862484.60084.62
3153076-15307676.80076.86
4172007-17200786.29886.40
5157446-15744678.99279.06
6168163-16816384.36984.46
15min1183548-18354892.08892.763.2092.5493.273.21
2190827-19082795.74096.23
3177128-17712888.86789.36
4192225-19222596.44197.03
5180079-18007990.34890.85
6185509-18550993.07293.63
20min1188225-18822594.43494.541.9495.4095.561.97
2189899-18989995.27496.30
3184664-18466492.64893.63
4192669-19266996.66497.78
5183635-18363592.13293.14
6191472-19147296.06497.14
30min1187060-18706093.85095.011.4495.3496.571.47
2191575-19157596.11597.67
3187404-18740494.02395.52
4189486-18948695.06796.72
5187146-18714693.89395.41
6193617-19361797.14098.75
45min1187500-18750094.07195.151.6996.0897.231.69
2194062-19406297.36399.45
3188581-18858194.61396.63
4189225-18922594.93697.12
5185701-18570193.16895.21
6192842-19284296.75198.90
极限1185498-18549893.06693.940.9295.6096.550.89
2190053-19005395.35297.98
3187492-18749294.06796.61
4185527-18552793.08195.79
5187973-18797394.30896.87
6186927-18692793.78396.47
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%
115.762094922095012095682097382097422096080.06
215.802086532088452087490.07
单位质量响应值RSD%判断
13300.0013211.960.47数据可信
供试品溶液-2024042321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141786-4178621.12217.5542.8621.1217.5542.88
230206-3020615.26815.27
357920-5792029.27729.28
439496-3949619.96419.96
521550-2155010.89310.89
617338-173388.7648.76
10min1149380-14938075.50882.426.2275.6382.526.19
2152839-15283977.25677.34
3164884-16488483.34583.51
4166161-16616183.99084.10
5168741-16874185.29485.35
6176332-17633289.13289.18
15min1189074-18907495.57294.913.2796.1195.473.28
2179352-17935290.65891.17
3195572-19557298.85799.48
4186631-18663194.33794.91
5182854-18285492.42892.96
6193152-19315297.63498.18
20min1193069-19306997.59296.121.4998.6697.201.51
2187489-18748994.77195.79
3193502-19350297.81198.99
4187624-18762494.83995.94
5187854-18785494.95696.00
6191412-19141296.75497.84
30min1193119-19311997.61796.380.8799.2398.000.88
2188516-18851695.29096.83
3191138-19113896.61698.33
4190479-19047996.28297.91
5191571-19157196.83498.41
6189247-18924795.66097.28
45min1189904-18990495.99295.700.9498.1497.860.92
2190466-19046696.27698.35
3190801-19080196.44598.70
4189488-18948895.78297.94
5189439-18943995.75797.87
6185905-18590593.97096.13
极限1188500-18850095.28295.301.9597.9797.981.86
2192335-19233597.22199.83
3185191-18519193.61096.40
4192765-19276597.438100.13
5188748-18874895.40798.05
6183686-18368692.84995.53
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