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%
113.691592941594321593341594191594291593820.04
213.731603911598411601160.25
单位质量响应值RSD%判断
11642.2211661.760.12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%
5min173560-7356044.50041.725.0944.5041.725.10
267829-6782941.03341.03
364278-6427838.88538.88
466289-6628940.10140.10
572027-7202743.57243.57
669786-6978642.21742.22
10min198302-9830259.46758.862.4859.9659.322.48
296106-9610658.13958.59
394043-9404356.89157.32
498303-9830359.46859.91
596038-9603858.09858.58
6100964-10096461.07861.55
15min1116516-11651670.48667.262.6571.6468.382.64
2108589-10858965.69066.79
3111054-11105467.18168.25
4109153-10915366.03167.14
5109484-10948466.23267.36
6112274-11227467.92069.07
20min1126920-12692076.78073.223.1578.7275.083.11
2120702-12070273.01874.85
3120734-12073473.03774.85
4118671-11867171.78973.63
5115852-11585270.08471.95
6123304-12330474.59276.49
30min1138888-13888884.01980.153.3986.8182.833.34
2132944-13294480.42483.07
3132738-13273880.29982.92
4127312-12731277.01779.65
5127622-12762277.20479.85
6135435-13543581.93184.66
45min1147727-14772789.36785.702.9993.0989.272.96
2144047-14404787.14090.68
3142028-14202885.91989.43
4136846-13684682.78486.28
5136856-13685682.79086.29
6142518-14251886.21589.86
60min1150708-15070891.17087.192.6795.8991.712.65
2144185-14418587.22491.73
3145498-14549888.01892.49
4139709-13970984.51688.93
5141175-14117585.40389.83
6143454-14345486.78291.38
90min1153139-15313992.64188.223.2598.3793.713.18
2144495-14449587.41192.89
3149995-14999590.73996.19
4141153-14115385.39090.74
5141944-14194485.86891.24
6144216-14421687.24392.81
极限1148687-14868789.94786.382.9796.7192.852.92
2142579-14257986.25292.70
3146918-14691888.87795.33
4138067-13806783.52389.82
5139096-13909684.14590.47
6141391-14139185.53492.07
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%
113.6915198015252115115109515126012140155.84
213.731498041499181498610.06
单位质量响应值RSD%判断
8867.8610914.8614.64数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min157632-5763241.51446.719.3741.5146.719.37
268837-6883749.58649.59
360604-6060443.65543.66
462100-6210044.73344.73
565551-6555147.21947.22
674350-7435053.55753.56
10min186793-8679362.52065.145.5262.9865.665.55
295490-9549068.78569.34
386600-8660062.38162.87
486861-8686162.56963.07
588899-8889964.03764.56
697899-9789970.52071.12
15min1102637-10263773.93376.734.8475.0977.974.87
2110445-11044579.55780.87
3104238-10423875.08676.26
4100139-10013972.13473.33
5107699-10769977.57978.82
6113930-11393082.06883.45
20min1113617-11361781.84284.233.5783.8286.333.59
2119975-11997586.42288.62
3119520-11952086.09488.11
4110188-11018879.37281.37
5117609-11760984.71886.82
6120677-12067786.92889.22
30min1125691-12569190.54093.563.4593.4396.593.49
2133619-13361996.25099.41
3130978-13097894.34897.32
4124788-12478889.88992.76
5128144-12814492.30795.35
6136099-13609998.037101.29
45min1137325-13732598.920100.542.88102.81104.612.93
2143440-143440103.325107.55
3140834-140834101.448105.46
4133371-13337196.07299.95
5138528-13852899.787103.85
6143963-143963103.702108.05
60min1139965-139965100.822102.982.91105.81108.162.95
2144476-144476104.071109.45
3144298-144298103.943109.09
4136577-13657798.381103.32
5143861-143861103.628108.80
6148571-148571107.021112.52
90min1143575-143575103.422104.702.72109.53111.032.76
2145805-145805105.028111.56
3147491-147491106.243112.54
4138734-13873499.935105.97
5146037-146037105.195111.52
6150437-150437108.365115.05
极限1139367-139367100.391102.691.71107.65110.181.83
2143378-143378103.280110.98
3144057-144057103.769111.25
4139963-139963100.820107.97
5142898-142898102.934110.43
6145681-145681104.939112.83
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%
113.691588441604601599411603471605801600340.45
213.731602021598791600400.15
单位质量响应值RSD%判断
11689.8511656.230.21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%
5min168670-6867041.46742.346.7941.4742.346.79
267881-6788140.99040.99
374980-7498045.27745.28
468983-6898341.65641.66
576461-7646146.17146.17
663724-6372438.48038.48
10min190344-9034454.55556.524.1455.0257.004.15
292251-9225155.70656.16
3100250-10025060.53661.04
491393-9139355.18855.65
596286-9628658.14358.66
691110-9111055.01755.44
15min1103987-10398762.79364.924.0263.8666.024.02
2103528-10352862.51663.59
3113698-11369868.65769.83
4109907-10990766.36867.44
5110142-11014266.51067.67
6103770-10377062.66263.70
20min1113493-11349368.53371.023.3170.3072.843.33
2114982-11498269.43271.20
3122299-12229973.85175.79
4120113-12011372.53174.34
5120795-12079572.94374.84
6113941-11394168.80470.54
30min1126921-12692176.64278.492.7179.1781.102.75
2126810-12681076.57579.12
3134041-13404180.94183.70
4132114-13211479.77882.40
5133245-13324580.46183.17
6126714-12671476.51779.02
45min1136051-13605182.15585.392.9685.5388.872.97
2139423-13942384.19187.58
3147076-14707688.81292.47
4145134-14513487.64091.15
5142168-14216885.84989.45
6138562-13856283.67187.02
60min1139109-13910984.00287.653.9988.2992.073.94
2142224-14222485.88390.21
3152081-15208191.83596.48
4151864-15186491.70496.18
5145791-14579188.03792.59
6139787-13978784.41188.69
90min1140803-14080385.02588.983.1990.2594.383.17
2146659-14665988.56193.84
3150115-15011590.64896.31
4153433-15343392.65198.15
5149728-14972890.41495.95
6143331-14333186.55191.77
极限1139708-13970884.36387.373.3490.5393.763.32
2142468-14246886.03092.29
3147703-14770389.19195.86
4151580-15158091.53298.06
5146968-14696888.74795.29
6139700-13970084.35890.54
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