依折麦布片片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173718353718303715063724783717943718890.10
211.153726383733653730020.14
单位质量响应值RSD%判断
33293.5533453.090.34数据可信
供试品溶液-2024012321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%
5min112810-128103.4553.116.243.453.116.21
211209-112093.0233.02
311334-113343.0573.06
411931-119313.2183.22
511123-111233.0003.00
610838-108382.9232.92
10min125214-252146.8006.573.416.816.583.46
224739-247396.6726.68
324572-245726.6276.63
424792-247926.6866.69
522877-228776.1696.17
623991-239916.4706.47
15min126803-268037.2287.402.677.257.422.68
228405-284057.6607.68
327201-272017.3367.35
428141-281417.5897.61
527629-276297.4517.47
626571-265717.1667.18
20min126394-263947.1187.352.777.157.382.73
227755-277557.4857.51
327467-274677.4077.44
427722-277227.4767.51
528018-280187.5567.58
626255-262557.0807.11
30min126136-261367.0487.154.157.097.194.16
226846-268467.2407.28
326516-265167.1517.19
427618-276187.4487.49
527388-273887.3867.43
624566-245666.6256.66
45min126094-260947.0376.965.327.097.015.32
226896-268967.2537.31
326802-268027.2287.28
426120-261207.0447.10
525809-258096.9607.01
623150-231506.2436.29
60min127315-273157.3666.944.887.437.004.86
225880-258806.9797.04
325687-256876.9276.99
425793-257936.9567.02
526255-262557.0807.14
623480-234806.3326.39
极限125796-257966.9576.825.967.036.905.95
227595-275957.4427.52
325434-254346.8596.94
425446-254466.8626.94
524574-245746.6276.70
623003-230036.2036.27
依折麦布片片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173595493600573595823609513611323602540.21
211.153641513657013649260.31
单位质量响应值RSD%判断
32251.9232728.791.04数据可信
供试品溶液-2024012421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%
5min16765-67651.8741.949.571.871.949.54
27130-71301.9751.98
35957-59571.6501.65
46740-67401.8671.87
57834-78342.1702.17
67562-75622.0952.09
10min122596-225966.2606.303.646.266.303.65
222631-226316.2696.27
321230-212305.8815.88
423136-231366.4096.41
523502-235026.5116.51
623347-233476.4686.47
15min127341-273417.5747.573.107.597.593.09
228874-288747.9998.01
326494-264947.3397.35
427592-275927.6447.66
526806-268067.4267.44
626948-269487.4657.48
20min127914-279147.7337.651.397.767.681.37
227955-279557.7447.77
327501-275017.6187.64
426965-269657.4707.50
527480-274807.6137.64
627887-278877.7257.75
30min127763-277637.6917.743.267.737.783.22
227958-279587.7457.78
328584-285847.9187.96
429181-291818.0848.12
526518-265187.3467.39
627589-275897.6437.68
45min127931-279317.7377.583.147.797.633.13
227612-276127.6497.70
325733-257337.1297.18
427197-271977.5347.59
528138-281387.7957.85
627480-274807.6137.66
60min127047-270477.4937.543.107.567.613.07
227804-278047.7027.77
328028-280287.7647.83
427961-279617.7467.81
526077-260777.2247.29
626406-264067.3157.38
极限125433-254337.0457.685.497.127.765.45
228906-289068.0088.09
329437-294378.1558.23
428573-285737.9157.99
526632-266327.3787.45
627464-274647.6087.69
依折麦布片片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173743383753923757743745703769473754040.28
211.153754413758823756620.09
单位质量响应值RSD%判断
33608.2433691.660.18数据可信
供试品溶液-2024012521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%
5min119159-191595.1245.124.435.125.114.41
218633-186334.9844.98
320432-204325.4655.46
419116-191165.1135.11
519506-195065.2175.22
617910-179104.7904.79
10min126116-261166.9857.313.076.997.323.09
227386-273867.3257.33
327788-277887.4327.44
427118-271187.2537.26
528605-286057.6517.66
626935-269357.2047.21
15min128040-280407.5007.612.927.527.632.94
229234-292347.8197.84
329551-295517.9047.93
428532-285327.6317.65
527330-273307.3107.33
628015-280157.4937.51
20min126727-267277.1487.463.597.187.503.61
228435-284357.6057.64
329172-291727.8027.84
426657-266577.1307.16
528201-282017.5437.58
628179-281797.5377.57
30min128622-286227.6557.553.197.707.593.17
229089-290897.7807.83
327266-272667.2937.34
427468-274687.3477.39
529304-293047.8387.88
627524-275247.3627.41
45min127382-273827.3247.172.757.387.232.71
228023-280237.4957.55
326611-266117.1177.18
426212-262127.0117.07
526519-265197.0937.15
626152-261526.9957.05
60min126828-268287.1757.032.767.247.102.77
227015-270157.2257.30
326255-262557.0227.09
425252-252526.7546.82
526723-267237.1477.22
625547-255476.8336.90
极限127399-273997.3287.105.187.417.185.14
228174-281747.5357.62
326898-268987.1947.28
425707-257076.8766.96
526749-267497.1547.24
624270-242706.4916.57
依折麦布片片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173758133763223777273783823792343774960.38
211.153794773813353804060.35
单位质量响应值RSD%判断
33795.5234117.130.67数据可信
供试品溶液-X013576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%
5min116800-168004.4534.234.864.454.234.87
215165-151654.0204.02
315963-159634.2314.23
416742-167424.4384.44
516136-161364.2774.28
614952-149523.9633.96
10min128098-280987.4476.886.637.456.886.62
225777-257776.8326.84
323306-233066.1776.18
424854-248546.5886.60
527280-272807.2317.24
626337-263376.9816.99
15min130039-300397.9627.773.207.987.793.18
229869-298697.9177.93
328412-284127.5317.55
429956-299567.9407.96
529741-297417.8837.90
627850-278507.3827.40
20min126605-266057.0527.447.987.087.477.98
226858-268587.1197.15
330059-300597.9678.00
430350-303508.0448.08
529584-295847.8417.87
624904-249046.6016.63
30min129508-295087.8217.852.547.877.902.55
229142-291427.7247.77
329855-298557.9137.96
430977-309778.2118.26
529339-293397.7767.82
628852-288527.6477.69
45min127689-276897.3397.344.647.407.404.60
227917-279177.3997.46
328836-288367.6437.70
425216-252166.6846.74
528385-283857.5247.58
628220-282207.4807.53
60min128074-280747.4417.494.507.517.564.49
227932-279327.4037.47
329839-298397.9097.98
428343-283437.5127.58
529194-291947.7387.81
626131-261316.9266.99
极限127407-274077.2647.224.747.357.304.67
227819-278197.3737.45
325413-254136.7366.82
429092-290927.7117.79
526185-261856.9407.02
627540-275407.3007.38
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