利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174903444903894902984899744907224903450.06
215.124890394895444892920.08
单位质量响应值RSD%判断
32323.3432360.580.09数据可信
供试品溶液-JPS7157批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312177-31217757.68358.211.6457.6858.201.64
2318075-31807558.77258.77
3315600-31560058.31558.32
4320644-32064459.24759.25
5317319-31731958.63358.63
6306217-30621756.58156.58
10min1407643-40764375.32275.532.6475.4275.632.64
2403241-40324174.50974.61
3402157-40215774.30974.41
4423907-42390778.32878.43
5419533-41953377.51977.62
6396178-39617873.20473.30
15min1439996-43999681.30081.502.9381.5281.722.92
2432787-43278779.96880.19
3434068-43406880.20580.43
4460862-46086285.15685.39
5451924-45192483.50483.73
6426851-42685178.87279.09
20min1457261-45726184.49184.872.7284.8585.232.72
2448727-44872782.91483.27
3451391-45139183.40683.76
4478189-47818988.35888.73
5471244-47124487.07487.44
6449190-44919082.99983.35
30min1474401-47440187.65888.242.9388.1688.742.93
2470180-47018086.87887.37
3469295-46929586.71487.21
4498767-49876792.16092.68
5490242-49024290.58591.10
6462278-46227885.41885.90
45min1489406-48940690.43090.873.1491.0791.523.14
2482307-48230789.11989.76
3484312-48431289.48990.13
4514870-51487095.13595.81
5505705-50570593.44294.10
6474137-47413787.60988.24
60min1492123-49212390.93291.873.3091.7392.673.29
2485356-48535689.68290.47
3489573-48957390.46191.25
4521787-52178796.41397.24
5513137-51313794.81595.63
6481217-48121788.91789.69
极限1495530-49553091.56292.473.4292.5193.423.41
2488088-48808890.18791.12
3492441-49244190.99191.93
4526682-52668297.31898.31
5516239-51623995.38896.36
6483753-48375389.38690.31
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174887274887944895424898904899034893710.12
215.124884664876374880520.13
单位质量响应值RSD%判断
32259.1332278.570.05数据可信
供试品溶液-JPS7664批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312364-31236457.84857.413.2057.8557.423.20
2301770-30177055.88655.89
3321864-32186459.60759.61
4311454-31145457.67957.68
5317468-31746858.79358.79
6295218-29521854.67354.67
10min1401941-40194174.43773.412.6674.5373.512.66
2382931-38293170.91771.01
3408814-40881475.71075.81
4397086-39708673.53873.63
5403160-40316074.66374.76
6384548-38454871.21671.31
15min1434967-43496780.55379.082.6680.7779.302.66
2412917-41291776.47076.68
3439375-43937581.37081.60
4426241-42624178.93779.16
5434508-43450880.46880.69
6413980-41398076.66776.88
20min1452595-45259583.81882.062.6384.1782.412.63
2427888-42788879.24279.58
3454323-45432384.13884.50
4443488-44348882.13182.48
5450533-45053383.43683.79
6429894-42989479.61479.95
30min1469321-46932186.91585.522.5287.4186.002.52
2446686-44668682.72483.19
3473173-47317387.62988.13
4464140-46414085.95686.44
5469495-46949586.94887.44
6447873-44787382.94383.41
45min1483912-48391289.61887.932.5590.2688.562.55
2459374-45937485.07385.68
3486950-48695090.18090.83
4474831-47483187.93688.57
5482911-48291189.43290.07
6460882-46088285.35385.96
60min1493857-49385791.45989.062.9592.2589.832.95
2461873-46187385.53686.29
3493159-49315991.33092.13
4482733-48273389.39990.18
5488796-48879690.52291.31
6464854-46485486.08886.84
极限1491669-49166991.05489.332.7592.0090.262.75
2463982-46398285.92786.82
3493799-49379991.44992.40
4484078-48407889.64890.57
5492772-49277291.25892.20
6467957-46795786.66387.56
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174887694892504898984891884887324891670.10
215.124888814883854886330.08
单位质量响应值RSD%判断
32245.6832317.000.16数据可信
供试品溶液-JPS7157批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1354920-35492065.70464.792.4365.7064.792.43
2357043-35704366.09766.10
3336088-33608862.21862.22
4356301-35630165.95965.96
5343179-34317963.53063.53
6352425-35242565.24265.24
10min1435888-43588880.69379.912.1180.8080.022.11
2433284-43328480.21180.32
3416465-41646577.09777.20
4435132-43513280.55380.66
5426364-42636478.93079.04
6442759-44275981.96582.07
15min1463732-46373285.84785.082.0486.0985.322.04
2460273-46027385.20785.45
3444079-44407982.20982.44
4461458-46145885.42685.67
5455607-45560784.34384.58
6472240-47224087.42287.67
20min1478739-47873988.62587.922.1689.0188.302.16
2475037-47503787.94088.33
3458516-45851684.88285.25
4475812-47581288.08488.47
5471429-47142987.27287.65
6489986-48998690.70891.10
30min1496363-49636391.88891.152.1092.4291.682.10
2491864-49186491.05591.59
3475780-47578088.07888.59
4494305-49430591.50792.04
5488646-48864690.45990.98
6507352-50735293.92294.46
45min1510487-51048794.50393.922.4895.1994.602.47
2504197-50419793.33894.02
3487678-48767890.28090.94
4514564-51456495.25795.94
5502248-50224892.97793.65
6524737-52473797.14197.84
60min1518061-51806195.90594.972.1196.7595.812.11
2510691-51069194.54095.38
3496722-49672291.95492.76
4514331-51433195.21496.06
5508827-50882794.19595.02
6529441-52944198.01298.87
极限1521090-52109096.46695.522.5097.4796.512.50
2514060-51406095.16496.16
3496372-49637291.89092.85
4516833-51683395.67796.68
5511570-51157094.70395.69
6535893-53589399.206100.23
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174889474885044889634882454881764885670.08
215.124884804883114883960.03
单位质量响应值RSD%判断
32206.1332301.320.21数据可信
供试品溶液-JPS7664批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369464-36946468.45568.051.0868.4568.051.08
2361286-36128666.94066.94
3365495-36549567.71967.72
4365505-36550567.72167.72
5369383-36938368.44068.44
6372458-37245869.01069.01
10min1446992-44699282.81982.171.4082.9382.281.40
2440224-44022481.56581.68
3448204-44820483.04483.16
4434334-43433480.47480.59
5440318-44031881.58381.70
6450707-45070783.50883.62
15min1474873-47487387.98588.142.4588.2488.392.45
2467487-46748786.61786.86
3476705-47670588.32588.58
4461908-46190885.58385.83
5496130-49613091.92492.17
6477052-47705288.38988.64
20min1490305-49030590.84490.161.4591.2490.561.45
2481520-48152089.21789.61
3493717-49371791.47791.88
4478143-47814388.59188.98
5481639-48163989.23989.64
6494500-49450091.62292.02
30min1507508-50750894.03293.641.4694.5894.191.46
2500130-50013092.66593.21
3514349-51434995.29995.85
4496027-49602791.90592.44
5501531-50153192.92493.48
6512812-51281295.01495.57
45min1522253-52225396.76496.111.4597.4796.811.45
2513095-51309595.06795.76
3526146-52614697.48598.19
4509494-50949494.40095.09
5513943-51394395.22495.93
6527390-52739097.71698.43
60min1560443-560443103.84098.583.03104.7199.443.01
2519932-51993296.33497.19
3535714-53571499.258100.13
4518873-51887396.13796.99
5520582-52058296.45497.32
6536735-53673599.447100.32
极限1534431-53443199.02098.261.68100.0699.291.67
2524467-52446797.17498.19
3537650-53765099.617100.65
4519753-51975396.30197.31
5523847-52384797.05998.09
6541920-541920100.408101.45
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