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%
113.861518901541621544451540071539671536940.67
213.831537621540231538920.12
单位质量响应值RSD%判断
11089.0311127.400.25数据可信
中间条件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%
5min161904-6190439.28241.666.5739.2841.666.57
271024-7102445.06945.07
364284-6428440.79240.79
465511-6551141.57141.57
560701-6070138.51838.52
670508-7050844.74144.74
10min189313-8931356.67458.705.5057.1159.165.51
299811-9981163.33663.84
390329-9032957.31957.77
489681-8968156.90857.37
587830-8783055.73356.16
698089-9808962.24362.74
15min1102552-10255265.07567.965.9966.1469.085.98
2110918-11091870.38471.59
3103962-10396265.97067.06
4104672-10467266.42167.51
5102025-10202564.74165.79
6118456-11845675.16776.36
20min1114493-11449372.65373.894.8674.4475.764.87
2118956-11895675.48577.47
3110360-11036070.03071.85
4116223-11622373.75075.58
5112380-11238071.31273.08
6126252-12625280.11482.14
30min1126485-12648580.26281.264.0382.8683.954.05
2131246-13124683.28386.11
3122125-12212577.49680.10
4131080-13108083.17885.83
5122551-12255177.76680.32
6134817-13481785.54988.46
45min1136417-13641786.56586.943.5590.0590.533.57
2139357-13935788.43092.18
3129635-12963582.26185.72
4140978-14097889.45993.03
5133296-13329684.58488.01
6142338-14233890.32294.19
60min1141103-14110389.53888.613.3593.9993.173.33
2141985-14198590.09894.83
3131133-13113383.21287.59
4143847-14384791.27995.85
5137542-13754287.27991.64
6142243-14224390.26295.13
90min1146662-14666293.06690.313.6898.5195.863.58
2142699-14269990.55196.29
3132737-13273784.22989.53
4147229-14722993.42599.01
5141286-14128689.65494.99
6143303-14330390.93496.81
极限1143394-14339490.99288.553.7797.4795.103.67
2140041-14004188.86495.60
3130120-13012082.56988.81
4145092-14509292.06998.69
5138055-13805587.60493.93
6140565-14056589.19796.08
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%
113.861520121541691540771539571539861536400.60
213.831534571536191535380.08
单位质量响应值RSD%判断
11085.1411101.810.11数据可信
中间条件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%
5min165012-6501241.30939.499.9341.3139.509.94
258620-5862037.24737.25
360937-6093738.71938.72
457935-5793536.81236.81
557105-5710536.28536.28
673332-7333246.59546.60
10min183342-8334252.95655.025.5953.4155.465.61
285039-8503954.03454.45
387098-8709855.34255.77
484937-8493753.96954.38
583106-8310652.80653.21
696026-9602661.01561.53
15min196966-9696661.61264.075.9062.6665.125.91
296501-9650161.31762.33
3100648-10064863.95265.00
4102072-10207264.85765.87
596780-9678061.49462.48
6112022-11202271.17972.37
20min1108304-10830468.81671.444.5070.5573.204.54
2110165-11016569.99971.69
3112635-11263571.56873.32
4110486-11048670.20371.93
5110654-11065470.31071.98
6122368-12236877.75379.74
30min1119962-11996276.22478.763.4178.7281.313.46
2121006-12100676.88779.36
3123612-12361278.54381.09
4122065-12206577.56080.07
5125424-12542479.69582.15
6131606-13160683.62386.47
45min1129336-12933682.18085.053.0085.5288.483.05
2129769-12976982.45585.78
3134837-13483785.67689.10
4135190-13519085.90089.27
5133787-13378785.00888.35
6140211-14021189.09092.87
60min1132698-13269884.31687.643.3588.5792.013.38
2133806-13380685.02089.26
3137327-13732787.25891.63
4138558-13855888.04092.37
5139557-13955788.67592.96
6145582-14558292.50397.27
90min1133057-13305784.54589.603.4389.7494.953.38
2138078-13807887.73592.92
3140550-14055089.30694.65
4143739-14373991.33296.64
5145518-14551892.46297.73
6145153-14515392.23098.03
极限1129888-12988882.53188.203.6288.6694.553.57
2137633-13763387.45293.62
3138956-13895688.29394.63
4139364-13936488.55294.87
5143095-14309590.92397.22
6143932-14393291.45598.28
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%
113.861550741557061568961554821557191557750.44
213.831557461561671559560.20
单位质量响应值RSD%判断
11239.1811276.640.24数据可信
中间条件6月-供试品溶液-2025051921批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166364-6636441.55241.464.1741.5541.464.17
268479-6847942.87642.88
361859-6185938.73138.73
469134-6913443.28643.29
564157-6415740.17040.17
667283-6728342.12742.13
10min191611-9161157.36056.734.9457.8257.194.94
294387-9438759.09859.57
385124-8512453.29853.73
495964-9596460.08560.57
585523-8552353.54853.99
691014-9101456.98657.45
15min1108623-10862368.01167.555.2969.1168.645.27
2114036-11403671.40072.53
3102236-10223664.01265.03
4114426-11442671.64572.79
5100904-10090463.17864.22
6107083-10708367.04768.15
20min1119531-11953174.84173.255.1776.7075.095.16
2122549-12254976.73178.66
3111763-11176369.97771.71
4123118-12311877.08779.03
5108016-10801667.63169.37
6116959-11695973.23175.08
30min1129429-12942981.03881.023.6683.7283.683.69
2133772-13377283.75886.54
3127678-12767879.94282.45
4134215-13421584.03586.84
5121268-12126875.92878.42
6130078-13007881.44584.10
45min1138248-13824886.56086.503.0790.1590.063.12
2141118-14111888.35792.07
3135313-13531384.72288.12
4143193-14319389.65693.39
5131447-13144782.30285.64
6139624-13962487.42290.99
60min1141838-14183888.80888.572.6393.3693.092.67
2142166-14216689.01393.70
3141293-14129388.46792.81
4144721-14472190.61395.34
5134426-13442684.16788.42
6144329-14432990.36794.90
90min1144172-14417290.26990.222.8395.8095.722.84
2143630-14363089.93095.61
3143634-14363489.93295.26
4147937-14793792.62798.36
5136965-13696585.75790.94
6148219-14821992.80398.34
极限1142024-14202488.92488.942.3895.4695.442.41
2141018-14101888.29494.97
3141539-14153988.62194.94
4145969-14596991.39498.16
5136563-13656385.50591.65
6145206-14520690.91797.49
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%
113.861544901546201545311544191544421545000.06
213.831546291547531546910.06
单位质量响应值RSD%判断
11147.1911185.180.25数据可信
中间条件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%
5min161393-6139338.75541.384.8338.7641.384.83
261630-6163038.90538.90
368152-6815243.02243.02
467651-6765142.70642.71
567661-6766142.71242.71
666855-6685542.20342.20
10min185841-8584154.18857.324.6054.6257.784.60
287731-8773155.38255.81
396033-9603360.62261.10
495649-9564960.38060.85
589537-8953756.52257.00
689992-8999256.80957.28
15min198164-9816461.96866.574.1563.0067.664.13
2103907-10390765.59366.64
3108676-10867668.60369.75
4107000-10700067.54568.69
5104415-10441565.91467.02
6110550-11055069.78670.89
20min1108075-10807568.22471.624.2069.9573.464.17
2110117-11011769.51371.29
3116836-11683673.75475.67
4114567-11456772.32274.22
5110525-11052569.77171.61
6120646-12064676.16078.04
30min1120881-12088176.30879.753.4578.7982.383.43
2127147-12714780.26382.81
3128497-12849781.11683.85
4126436-12643679.81582.51
5122181-12218177.12979.74
6132839-13283983.85786.58
45min1130487-13048782.37285.963.4185.7089.483.40
2135372-13537285.45688.90
3137916-13791687.06290.70
4136217-13621785.98989.58
5133007-13300783.96387.43
6143994-14399490.89894.55
60min1135761-13576185.70188.614.6189.9493.094.52
2137250-13725086.64191.03
3142365-14236589.87094.47
4139555-13955588.09692.64
5134960-13496085.19689.60
6152354-15235496.176100.84
90min1142894-14289490.20490.374.1695.4095.824.04
2143394-14339490.52095.87
3140802-14080288.88394.48
4140891-14089188.94094.46
5136654-13665486.26591.61
6154266-15426697.383103.11
极限1140736-14073688.84288.864.6695.0495.324.49
2143973-14397390.88597.24
3139834-13983488.27294.86
4136699-13669986.29392.80
5132024-13202483.34289.65
6151280-15128095.498102.31
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