依折麦布片项目信息
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%
111.173792613795423794353792123790543793010.06
211.153807073816623811840.18
单位质量响应值RSD%判断
33957.1234186.910.48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%
5min113389-133893.5373.257.433.543.257.50
212606-126063.3303.33
311972-119723.1623.16
413201-132013.4873.49
511322-113222.9912.99
611297-112972.9842.98
10min125847-258476.8276.705.706.836.715.72
226663-266637.0437.05
325200-252006.6576.66
427071-270717.1517.16
524011-240116.3426.35
623429-234296.1896.19
15min127669-276697.3097.433.227.337.453.22
228776-287767.6017.62
328317-283177.4807.50
429538-295387.8027.82
527414-274147.2417.26
627168-271687.1767.19
20min128183-281837.4457.364.317.477.394.30
229679-296797.8407.87
327464-274647.2557.28
428619-286197.5607.59
526799-267997.0797.11
626476-264766.9947.02
30min124994-249946.6027.014.466.647.054.48
227644-276447.3027.35
326427-264276.9817.02
428048-280487.4097.45
525499-254996.7366.77
626526-265267.0077.05
45min124785-247856.5476.863.506.606.923.46
225970-259706.8606.92
325657-256576.7776.83
427557-275577.2797.33
526157-261576.9096.96
625724-257246.7956.85
60min123773-237736.2806.684.196.346.744.18
224921-249216.5836.65
325705-257056.7906.85
426995-269957.1317.20
525002-250026.6046.67
625323-253236.6896.75
极限124190-241906.3906.573.766.466.653.76
225891-258916.8396.92
324959-249596.5936.67
426136-261366.9046.98
524018-240186.3446.42
624138-241386.3766.45
依折麦布片项目信息
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%
111.173803973813763814053806243808873809380.12
211.153811053823713817380.24
单位质量响应值RSD%判断
34103.6734236.590.28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%
5min16799-67991.7911.986.311.791.986.39
28003-80032.1082.11
37926-79262.0882.09
47194-71941.8951.89
57359-73591.9381.94
67787-77872.0512.05
10min121662-216625.7065.884.805.715.894.83
223697-236976.2426.25
323437-234376.1736.18
422437-224375.9105.91
521829-218295.7505.75
620938-209385.5155.52
15min127932-279327.3577.312.957.377.332.95
227519-275197.2487.26
328981-289817.6337.65
426439-264396.9646.98
527943-279437.3607.37
627804-278047.3237.34
20min127433-274337.2267.452.907.257.482.92
229182-291827.6867.71
329126-291267.6717.70
427260-272607.1807.20
528560-285607.5227.55
628227-282277.4357.46
30min129639-296397.8077.686.387.847.716.32
232446-324468.5468.58
327110-271107.1407.18
428685-286857.5557.59
529139-291397.6757.71
627822-278227.3287.37
45min128281-282817.4497.443.517.507.503.50
226751-267517.0467.10
329515-295157.7747.83
428944-289447.6247.67
527543-275437.2557.30
628541-285417.5177.57
60min128178-281787.4227.652.887.487.712.86
228042-280427.3867.45
329043-290437.6507.71
429906-299067.8777.94
530038-300387.9127.97
628952-289527.6267.69
极限129138-291387.6757.503.097.757.583.08
228938-289387.6227.70
328859-288597.6017.68
428811-288117.5887.66
526763-267637.0497.12
628371-283717.4737.55
依折麦布片项目信息
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%
111.173838923842133836293831173830573835820.13
211.153830223835853833040.11
单位质量响应值RSD%判断
34340.3834377.040.08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%
5min119295-192955.0545.214.935.055.214.93
218879-188794.9454.95
319767-197675.1785.18
419677-196775.1545.15
521722-217225.6905.69
619977-199775.2335.23
10min127249-272497.1387.223.127.157.223.12
227840-278407.2927.30
329064-290647.6137.62
426585-265856.9646.97
527543-275437.2157.22
627010-270107.0757.08
15min129840-298407.8167.672.287.847.692.28
228687-286877.5147.53
330088-300887.8817.90
429619-296197.7587.78
529017-290177.6017.62
628426-284267.4467.47
20min129889-298897.8297.644.797.867.674.74
228336-283367.4227.46
329038-290387.6067.64
430888-308888.0918.12
529911-299117.8357.87
626931-269317.0547.09
30min127189-271897.1227.332.527.177.382.51
227293-272937.1497.19
328776-287767.5387.58
428824-288247.5507.60
527979-279797.3297.38
627810-278107.2857.33
45min126978-269787.0677.443.627.127.493.60
229497-294977.7277.78
328208-282087.3897.45
428112-281127.3647.42
529668-296687.7717.83
627842-278427.2937.35
60min123546-235466.1686.785.516.246.855.46
227433-274337.1867.26
324954-249546.5376.61
427022-270227.0787.15
526164-261646.8536.93
626085-260856.8336.90
极限123161-231616.0676.867.786.156.947.69
226876-268767.0407.12
325333-253336.6366.72
426964-269647.0637.15
529238-292387.6597.74
625506-255066.6816.76
依折麦布片项目信息
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%
111.173869013875033879163887983885283879290.20
211.153837013849123843060.23
单位质量响应值RSD%判断
34729.5434466.910.54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%
5min115532-155324.0404.426.544.044.426.51
218354-183544.7744.77
315751-157514.0974.10
417286-172864.4974.50
517642-176424.5894.59
617355-173554.5154.51
10min125865-258656.7287.113.746.747.123.72
228557-285577.4297.44
326725-267256.9526.96
428242-282427.3477.35
527732-277327.2147.22
626878-268786.9927.00
15min128239-282397.3467.562.427.367.582.45
230323-303237.8887.91
328664-286647.4567.47
429125-291257.5767.60
529138-291387.5807.60
628898-288987.5177.54
20min131099-310998.0907.584.818.127.624.77
229230-292307.6047.64
327120-271207.0557.09
430165-301657.8477.88
528233-282337.3447.38
629015-290157.5487.58
30min128391-283917.3857.565.427.437.615.39
230714-307147.9908.04
330023-300237.8107.85
429348-293487.6347.68
529703-297037.7277.77
626267-262676.8336.88
45min127322-273227.1077.365.447.167.425.42
228220-282207.3417.40
330347-303477.8947.95
429715-297157.7307.79
527938-279387.2687.33
626175-261756.8096.86
60min127944-279447.2697.455.247.347.525.22
229782-297827.7477.82
328136-281367.3197.39
429430-294307.6567.73
530357-303577.8977.97
626267-262676.8336.90
极限129054-290547.5587.556.397.647.636.34
227216-272167.0807.16
332356-323568.4178.50
429488-294887.6717.75
528630-286307.4487.53
627455-274557.1427.22
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