托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457883227879637875457868747865967874600.10
216.527954417961747958080.07
单位质量响应值RSD%判断
47869.9148172.400.45数据可信
供试品溶液-4D88SDA1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141687-416875.2095.464.965.215.464.94
246529-465295.8145.81
345223-452235.6505.65
443127-431275.3895.39
544637-446375.5775.58
640896-408965.1105.11
10min193969-9396911.74112.032.8711.7512.042.86
298435-9843512.29912.31
3100275-10027512.52912.54
496317-9631712.03412.04
595573-9557311.94111.95
692900-9290011.60711.62
15min1138995-13899517.36718.072.6417.4018.102.63
2142480-14248017.80217.83
3150244-15024418.77218.80
4146217-14621718.26918.30
5145922-14592218.23218.26
6143855-14385517.97418.00
20min1180905-18090522.60323.302.6622.6623.362.66
2180101-18010122.50322.56
3192083-19208324.00024.06
4190582-19058223.81223.87
5187367-18736723.41123.47
6187815-18781523.46723.52
30min1239960-23996029.98230.432.3130.0830.532.32
2234864-23486429.34529.44
3250324-25032431.27731.38
4242470-24247030.29630.39
5245850-24585030.71830.82
6247703-24770330.95031.05
45min1303867-30386737.96738.340.9538.1138.480.95
2303056-30305637.86638.01
3310731-31073138.82538.98
4307301-30730138.39638.55
5307442-30744238.41438.56
6308543-30854338.55138.70
60min1348431-34843143.53543.620.6743.7443.830.68
2346999-34699943.35643.57
3351658-35165843.93844.16
4346513-34651343.29543.51
5348808-34880843.58243.80
6352113-35211343.99544.21
90min1409746-40974651.19650.380.8951.4850.670.88
2403855-40385550.46050.74
3401950-40195050.22250.51
4402070-40207050.23750.52
5402760-40276050.32350.61
6399041-39904149.85950.14
120min1445084-44508455.61254.961.0455.9855.331.03
2445742-44574255.69456.06
3435689-43568954.43854.81
4435194-43519454.37654.75
5438951-43895154.84555.22
6438598-43859854.80155.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1485295-48529560.63659.392.0661.0959.852.04
2483431-48343160.40360.86
3469278-46927858.63459.10
4476141-47614159.49259.95
5459082-45908257.36157.82
6478937-47893759.84160.30
240min1513963-51396364.21862.941.6764.7863.501.65
2512238-51223864.00264.56
3491065-49106561.35761.92
4502697-50269762.81063.37
5501328-50132862.63963.20
6501117-50111762.61363.17
300min1531208-53120866.37265.122.0567.0465.782.03
2516964-51696464.59365.26
3513405-51340564.14864.81
4537540-53754067.16467.83
5516769-51676964.56865.23
6511214-51121463.87464.54
360min1536803-53680367.07165.551.3567.8566.321.34
2526186-52618665.74566.52
3522494-52249465.28466.06
4520637-52063765.05265.83
5525700-52570065.68466.45
6515906-51590664.46065.23
极限1538892-53889267.33266.061.2468.2266.941.22
2529113-52911366.11166.99
3529650-52965066.17867.06
4519190-51919064.87165.76
5530290-53029066.25867.14
6524891-52489165.58366.46
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457932667934977938247952287946467940920.11
216.527996998002677999830.06
单位质量响应值RSD%判断
48273.0748425.120.23数据可信
供试品溶液-4D88SDA1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min158360-583607.2425.6314.347.245.6314.34
242061-420615.2205.22
343259-432595.3685.37
443686-436865.4215.42
544439-444395.5155.51
640479-404795.0235.02
10min1101103-10110312.54712.004.0812.5612.014.07
294952-9495211.78311.79
399125-9912512.30112.31
497247-9724712.06812.08
597940-9794012.15412.16
689823-8982311.14711.16
15min1145165-14516518.01518.113.1718.0518.143.17
2141836-14183617.60217.63
3150513-15051318.67818.71
4149693-14969318.57718.61
5148970-14897018.48718.52
6139249-13924917.28017.31
20min1184758-18475822.92823.193.0622.9923.243.06
2180589-18058922.41122.47
3193815-19381524.05224.11
4191697-19169723.78923.85
5189644-18964423.53423.59
6180576-18057622.40922.46
30min1242500-24250030.09430.492.6530.1930.592.65
2237674-23767429.49529.59
3252884-25288431.38231.48
4251984-25198431.27131.37
5249217-24921730.92731.03
6239914-23991429.77329.87
45min1304358-30435837.77038.161.8337.9238.311.83
2304425-30442537.77837.92
3313669-31366938.92639.08
4312435-31243538.77238.92
5310660-31066038.55238.70
6299397-29939737.15437.30
60min1348974-34897443.30743.481.2343.5243.691.24
2348135-34813543.20343.41
3356029-35602944.18244.40
4353385-35338543.85444.07
5351838-35183843.66243.88
6343862-34386242.67342.88
90min1404126-40412650.15149.651.3750.4449.931.37
2395919-39591949.13349.41
3403344-40334450.05450.35
4404377-40437750.18250.47
5401625-40162549.84150.13
6390906-39090648.51148.79
120min1445724-44572455.31354.541.5355.6854.901.52
2446932-44693255.46355.82
3439469-43946954.53754.91
4439834-43983454.58254.96
5436404-43640454.15754.53
6428466-42846653.17253.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1485466-48546660.24559.282.1360.7159.742.11
2490244-49024460.83861.29
3480273-48027359.60160.07
4471785-47178558.54759.01
5476400-47640059.12059.58
6461817-46181757.31057.76
240min1493689-49368961.26661.871.4761.8362.431.46
2511954-51195463.53264.09
3495840-49584061.53362.10
4496895-49689561.66462.23
5501461-50146162.23062.79
6491736-49173661.02361.56
300min1524168-52416865.04863.172.4165.7163.832.39
2521458-52145864.71265.37
3511556-51155663.48364.15
4493645-49364561.26061.92
5504523-50452362.61063.27
6498812-49881261.90162.54
360min1528242-52824265.55464.351.1566.3365.111.14
2521462-52146264.71265.48
3514742-51474263.87864.65
4519802-51980264.50665.27
5514689-51468963.87264.64
6512110-51211063.55264.30
极限1537646-53764666.72164.681.7767.6065.561.75
2523803-52380365.00365.88
3514732-51473263.87764.76
4512427-51242763.59164.47
5522768-52276864.87465.75
6516041-51604164.04064.89
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