他克莫司缓释颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.691510921515321513941509161512411512350.17
213.731511951514241513100.11
单位质量响应值RSD%判断
11047.1111020.390.18数据可信
长期6月-供试品溶液-2025051921批-pH4.5含0.005%羟丙基千维素
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178159-7815949.93146.245.7849.9346.245.78
273773-7377347.12947.13
368021-6802143.45543.45
467591-6759143.18043.18
575369-7536948.14948.15
671358-7135845.58645.59
10min1101685-10168564.96162.505.6665.5263.015.63
298822-9882263.13263.66
391789-9178958.63959.12
494011-9401160.05860.54
594264-9426460.22060.75
6106390-10639067.96668.47
15min1118329-11832975.59371.284.2476.8772.494.24
2111952-11195271.51972.74
3107080-10708068.40769.54
4109455-10945569.92471.07
5106798-10679868.22769.43
6115866-11586674.02075.28
20min1127375-12737581.37278.033.7283.4980.033.73
2122796-12279678.44780.47
3116664-11666474.53076.42
4121017-12101777.31179.23
5117828-11782875.27377.24
6127163-12716381.23783.32
30min1138986-13898688.79085.412.7691.8188.282.79
2132874-13287484.88587.78
3128509-12850982.09784.82
4131193-13119383.81186.59
5134712-13471286.05988.86
6135871-13587186.80089.79
45min1148066-14806694.59191.202.3898.6095.022.42
2144128-14412892.07595.91
3138558-13855888.51692.15
4141310-14131090.27593.99
5140377-14037789.67993.43
6144106-14410692.06196.01
60min1149770-14977095.67992.762.41100.7497.592.46
2145523-14552392.96697.82
3140051-14005189.47094.09
4144920-14492092.58197.30
5142895-14289591.28796.04
6148055-14805594.58499.56
90min1151639-15163996.87393.912.46102.9999.772.49
2148549-14854994.899100.79
3142639-14263991.12496.74
4146816-14681693.79299.54
5142933-14293391.31197.08
6149391-14939195.437101.46
极限1148441-14844194.83092.262.24102.0399.162.27
2145056-14505692.66899.61
3140302-14030289.63196.26
4145981-14598193.259100.05
5140740-14074089.91096.69
6145976-14597693.255100.34
他克莫司缓释颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.691523171523361523731506501505831516520.63
213.731510431508351509390.10
单位质量响应值RSD%判断
11077.5710993.370.54数据可信
长期6月-供试品溶液-2025052021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164002-6400240.88142.104.4640.8842.104.46
264760-6476041.36541.37
361890-6189039.53239.53
467806-6780643.31143.31
566923-6692342.74742.75
670079-7007944.76344.76
10min190450-9045057.77558.576.9158.2359.046.88
289310-8931057.04757.51
382061-8206152.41652.86
496907-9690761.89962.38
591215-9121558.26458.74
6100226-10022664.01964.52
15min1102659-10265965.57367.765.7766.6768.885.77
2104993-10499367.06468.16
396864-9686461.87262.89
4110829-11082970.79271.96
5106970-10697068.32769.45
6114179-11417972.93274.14
20min1112819-11281972.06374.505.4173.8976.375.41
2117239-11723974.88676.72
3107147-10714768.44070.15
4123783-12378379.06681.02
5115702-11570273.90575.79
6123083-12308378.61980.64
30min1125505-12550580.16682.474.9182.7985.164.93
2127433-12743381.39884.07
3120008-12000876.65579.12
4133383-13338385.19888.03
5130115-13011583.11185.81
6138181-13818188.26391.16
45min1133343-13334385.17388.044.8488.6991.664.85
2137182-13718287.62591.20
3128261-12826181.92785.25
4139739-13973989.25893.04
5140731-14073189.89293.52
6147719-14771994.35598.23
60min1136532-13653287.21090.514.1391.6795.114.15
2143790-14379091.84696.39
3133752-13375285.43489.67
4141240-14124090.21794.99
5145261-14526192.78597.41
6149663-14966395.597100.52
90min1138514-13851488.47691.604.1093.9197.204.11
2145195-14519592.74398.31
3135017-13501786.24291.42
4142725-14272591.16696.94
5149104-14910495.240100.90
6149863-14986395.725101.71
极限1135817-13581786.75390.174.7693.1796.794.71
2143816-14381691.86298.46
3132101-13210184.37990.52
4138889-13888988.71595.50
5146985-14698593.887100.60
6149416-14941695.439102.49
他克莫司缓释颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.691611391607201611871613811612891611430.16
213.731609211606681607940.12
单位质量响应值RSD%判断
11770.8511711.140.36数据可信
长期6月-供试品溶液-2025052121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173489-7348944.12042.206.9044.1242.206.90
263869-6386938.34438.34
367963-6796340.80240.80
466531-6653139.94339.94
576119-7611945.69945.70
673816-7381644.31644.32
10min196400-9640057.87557.142.0858.3757.612.12
292694-9269455.65056.08
393567-9356756.17456.63
494020-9402056.44656.89
596945-9694558.20258.71
697382-9738258.46458.96
15min1111273-11127366.80467.112.7467.9468.222.75
2108848-10884865.34866.39
3113289-11328968.01469.09
4107965-10796564.81865.89
5116166-11616669.74270.90
6113185-11318567.95269.09
20min1119897-11989771.98273.121.7673.8674.961.76
2120885-12088572.57574.35
3124121-12412174.51776.35
4119833-11983371.94373.73
5124770-12477074.90776.84
6121205-12120572.76774.66
30min1133306-13330680.03280.741.9982.7183.402.00
2130992-13099278.64381.22
3134541-13454180.77383.43
4133384-13338480.07982.67
5138803-13880383.33286.09
6135914-13591481.59884.30
45min1144725-14472586.88786.632.0390.4590.192.04
2139278-13927883.61787.07
3144111-14411186.51990.08
4144146-14414686.54090.02
5148367-14836789.07492.76
6145135-14513587.13390.75
60min1150632-15063290.43488.542.9994.9693.062.95
2141320-14132084.84389.22
3147671-14767188.65693.18
4143029-14302985.86990.31
5152237-15223791.39796.07
6149989-14998990.04894.63
90min1154284-15428492.62690.283.7198.1695.783.62
2143567-14356786.19291.51
3147683-14768388.66394.17
4145132-14513287.13292.53
5155994-15599493.65399.35
6155561-15556193.39398.97
极限1152041-15204191.28088.753.8897.8495.263.77
2141833-14183385.15191.43
3145036-14503687.07493.56
4141388-14138884.88491.25
5153469-15346992.13798.87
6153202-15320291.97798.60
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