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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.18 2111012112132109122110132110092110500.06
216.22 2117402118422117910.04
单位质量响应值RSD%判断
13043.8813057.400.08数据可信
供试品溶液-2022060701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%
5min113157-131576.74611.4235.626.7511.4335.60
213002-130026.6666.67
328105-2810514.41014.41
427014-2701413.85013.85
531609-3160916.20616.21
620810-2081010.66910.67
10min173750-7375037.81236.7412.0137.8536.8112.04
262115-6211531.84731.88
382832-8283242.46842.55
471443-7144336.62936.71
578418-7841840.20540.30
661443-6144331.50231.56
15min1118815-11881560.91756.596.5261.1656.866.52
2107445-10744555.08855.30
3116838-11683859.90360.22
4109582-10958256.18356.46
5110861-11086156.83957.15
698715-9871550.61250.85
20min1135527-13552769.48564.184.9370.0764.764.92
2125798-12579864.49765.02
3127208-12720865.22065.87
4122316-12231662.71263.30
5123147-12314763.13863.77
6117035-11703560.00460.52
30min1137530-13753070.51266.404.2971.4867.344.27
2131958-13195867.65568.53
3133181-13318168.28269.29
4124704-12470463.93664.88
5126290-12629064.74965.73
6123428-12342863.28264.13
45min1140879-14087972.22968.424.5573.5969.734.51
2138117-13811770.81372.07
3135682-13568269.56570.96
4124893-12489364.03365.33
5133046-13304668.21369.55
6128112-12811265.68466.88
60min1144136-14413673.89969.564.7275.6671.254.67
2140555-14055572.06373.71
3137172-13717270.32972.11
4126092-12609264.64866.30
5133815-13381568.60870.33
6132256-13225667.80869.37
极限1152446-15244678.16073.885.6680.3475.965.59
2150030-15003076.92178.97
3149065-14906576.42678.59
4130812-13081267.06869.08
5143139-14313973.38875.49
6139092-13909271.31373.26
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.18 2115262114572113172112322110592113180.09
216.22 2116132118722117420.09
单位质量响应值RSD%判断
13060.4413054.380.04数据可信
供试品溶液-2022060701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%
5min130125-3012515.43711.2220.5815.4411.2220.59
221793-2179311.16811.17
323358-2335811.97011.97
418767-187679.6179.62
519191-191919.8349.83
618097-180979.2749.27
10min184093-8409343.09238.1310.7743.1838.1910.78
282338-8233842.19342.26
368748-6874835.22935.30
475029-7502938.44838.50
562985-6298532.27632.33
673264-7326437.54337.59
15min1115535-11553559.20557.274.5959.5357.544.61
2117297-11729760.10760.40
3115061-11506158.96259.22
4110132-11013256.43656.70
5103766-10376653.17453.41
6108762-10876255.73455.99
20min1127878-12787865.53063.993.7866.1864.583.81
2130203-13020366.72167.35
3127959-12795965.57166.16
4123825-12382563.45364.03
5117555-11755560.24060.77
6121778-12177862.40462.97
30min1131393-13139367.33166.743.7468.3567.693.75
2136381-13638169.88770.89
3135463-13546369.41670.37
4126261-12626164.70165.63
5126216-12621664.67865.54
6125740-12574064.43465.35
45min1134598-13459868.97369.032.9670.3770.352.98
2139107-13910771.28472.67
3139884-13988471.68273.02
4132988-13298868.14869.44
5130768-13076867.01168.23
6130886-13088667.07168.35
60min1137593-13759370.50871.192.3272.2872.892.33
2142354-14235472.94874.73
3143026-14302673.29275.03
4138751-13875171.10172.77
5137081-13708170.24671.84
6134686-13468669.01870.67
极限1144795-14479574.19974.542.7876.3776.642.79
2148822-14882276.26278.45
3150912-15091277.33379.48
4146184-14618474.91076.98
5140798-14079872.15074.14
6141241-14124172.37774.41
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.18 2114902113282112172112462112362113030.06
216.22 2118342118922118630.02
单位质量响应值RSD%判断
13059.5213061.840.02数据可信
供试品溶液-2022060801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%
5min18398-83984.30211.9532.264.3011.9532.27
226840-2684013.75013.75
326680-2668013.66813.67
423459-2345912.01812.02
525644-2564413.13813.14
628904-2890414.80814.81
10min159865-5986530.66936.6511.2530.6936.7111.27
267079-6707934.36534.44
368839-6883935.26735.34
479774-7977440.86940.94
581092-8109241.54441.62
672551-7255137.16937.25
15min1100632-10063251.55556.596.2451.7556.866.27
2105579-10557954.08954.36
3110590-11059056.65656.93
4112734-11273457.75558.05
5120832-12083261.90362.21
6112423-11242357.59557.88
20min1118732-11873260.82864.694.7061.3165.284.73
2120813-12081361.89462.46
3129065-12906566.12166.71
4129818-12981866.50767.12
5134413-13441368.86169.51
6124799-12479963.93664.54
30min1127081-12708165.10568.473.9965.9269.424.03
2128070-12807065.61266.52
3135276-13527669.30370.26
4132956-13295668.11569.10
5138346-13834670.87671.91
6140176-14017671.81472.78
45min1130715-13071566.96769.843.3668.1571.173.38
2131162-13116267.19668.47
3140917-14091772.19373.53
4140139-14013971.79573.16
5135524-13552469.43070.85
6139539-13953971.48772.85
60min1135725-13572569.53370.855.7171.0972.565.64
2133159-13315968.21969.87
3126885-12688565.00466.74
4140917-14091772.19373.95
5148129-14812975.88877.70
6144929-14492974.24976.01
极限1144209-14420973.88076.542.0875.8278.642.13
2148936-14893676.30178.33
3152970-15297078.36880.47
4148060-14806075.85378.02
5151709-15170977.72279.95
6150505-15050577.10579.28
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86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%
116.18 2120482122162123222124022123062122590.07
216.22 2131752131372131560.02
单位质量响应值RSD%判断
13118.6013141.550.13数据可信
供试品溶液-2022060801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%
5min130915-3091515.75411.2445.3115.7511.2445.32
220775-2077510.58710.59
34971-49712.5332.53
427672-2767214.10214.10
530632-3063215.61015.61
617355-173558.8448.84
10min186088-8608843.87140.279.9743.9640.3310.00
287729-8772944.70744.77
371916-7191636.64936.66
472881-7288137.14037.22
584563-8456343.09443.18
670927-7092736.14536.19
15min1120176-12017661.24258.843.1961.5759.133.24
2118610-11861060.44460.75
3111938-11193857.04457.26
4113401-11340157.78958.07
5117197-11719759.72460.05
6111488-11148856.81557.06
20min1131469-13146966.99765.662.7467.6766.282.79
2132070-13207067.30367.95
3124631-12463163.51264.05
4130928-13092866.72167.33
5129833-12983366.16366.82
6124187-12418763.28663.85
30min1134090-13409068.33368.063.0469.3869.043.05
2135843-13584369.22670.24
3128853-12885365.66466.55
4139918-13991871.30372.28
5132728-13272867.63968.66
6129928-12992866.21267.13
45min1143261-14326173.00671.532.4974.4372.892.52
2142018-14201872.37373.77
3136113-13611369.36470.62
4144792-14479273.78675.16
5138791-13879170.72872.13
6137262-13726269.94971.23
60min1144105-14410573.43673.362.6575.2775.112.67
2145980-14598074.39276.20
3138692-13869270.67872.32
4148822-14882275.84077.62
5145815-14581574.30876.10
6140281-14028171.48873.16
极限1148802-14880275.83076.512.0978.0778.672.12
2154867-15486778.92181.14
3147197-14719775.01277.04
4150929-15092976.91479.12
5152237-15223777.58079.79
6146780-14678074.79976.87
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