利伐沙班颗粒片项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.179641729667119640689630649621489640330.18
212.249672519648369660440.18
单位质量响应值RSD%判断
79213.8978925.160.26数据可信
供试品溶液-2023072811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%
5min1283450-28345026.77925.933.2026.7825.933.19
2277535-27753526.22026.22
3278450-27845026.30626.31
4274807-27480725.96225.96
5274868-27486825.96825.97
6257814-25781424.35724.36
10min1315620-31562029.81829.511.1929.8629.561.19
2315632-31563229.81929.86
3312221-31222129.49729.54
4311016-31101629.38329.43
5313981-31398129.66329.71
6305790-30579028.88928.93
15min1330430-33043031.21730.840.8331.3130.940.83
2327469-32746930.93731.03
3325848-32584830.78430.88
4325385-32538530.74030.83
5327381-32738130.92931.02
6322310-32231030.45030.54
20min1333331-33333131.49131.400.4631.6431.550.47
2333831-33383131.53831.68
3332880-33288031.44931.59
4331826-33182631.34931.49
5332955-33295531.45631.60
6329626-32962631.14131.28
30min1339120-33912032.03832.030.4732.2432.220.47
2340651-34065132.18332.38
3340367-34036732.15632.35
4337962-33796231.92932.12
5339408-33940832.06532.26
6336449-33644931.78631.98
45min1343349-34334932.43832.430.3632.6932.680.36
2344056-34405632.50432.76
3343543-34354332.45632.71
4342330-34233032.34132.59
5344735-34473532.56932.82
6341393-34139332.25332.50
60min1345502-34550232.64132.590.2632.9532.890.26
2346218-34621832.70933.01
3345256-34525632.61832.92
4344224-34422432.52032.82
5344754-34475432.57032.87
6343847-34384732.48532.78
极限1346077-34607732.69532.680.3133.0633.040.31
2347225-34722532.80433.16
3345594-34559432.65033.01
4345345-34534532.62632.98
5346815-34681532.76533.12
6344292-34429232.52732.88
利伐沙班颗粒片项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.179639619638329641219638419641519639810.02
212.249652279649909651080.02
单位质量响应值RSD%判断
79209.6178848.690.33数据可信
供试品溶液-2023072811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%
5min1260032-26003224.57924.901.4824.5824.901.48
2267813-26781325.31425.31
3265893-26589325.13325.13
4258465-25846524.43124.43
5261636-26163624.73124.73
6266779-26677925.21725.22
10min1300896-30089628.44128.430.7128.4828.470.71
2302606-30260628.60328.65
3301973-30197328.54328.59
4297453-29745328.11628.16
5302604-30260428.60328.64
6298958-29895828.25828.30
15min1320084-32008430.25530.000.9330.3430.090.93
2319058-31905830.15830.25
3318282-31828230.08530.17
4314445-31444529.72229.81
5319504-31950430.20030.29
6312975-31297529.58329.67
20min1330196-33019631.21130.841.0931.3530.981.10
2327835-32783530.98831.13
3328295-32829531.03131.17
4324653-32465330.68730.82
5326697-32669730.88031.02
6320080-32008030.25530.39
30min1338903-33890332.03431.761.1732.2231.961.17
2338443-33844331.99132.18
3339443-33944332.08532.28
4335352-33535231.69831.89
5335240-33524031.68831.88
6328932-32893231.09131.28
45min1343733-34373332.49132.261.2032.7332.501.19
2344154-34415432.53032.78
3344841-34484132.59532.84
4341372-34137232.26732.51
5339798-33979832.11932.36
6333947-33394731.56631.81
60min1345020-34502032.61232.471.1032.9132.771.10
2346643-34664332.76633.06
3347014-34701432.80133.10
4343500-34350032.46932.76
5342217-34221732.34732.64
6336826-33682631.83832.13
极限1346506-34650632.75332.561.1733.1132.911.17
2348111-34811132.90433.26
3347418-34741832.83933.19
4344768-34476832.58832.94
5342281-34228132.35332.70
6337453-33745331.89732.24
利伐沙班颗粒片项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.179661019650009653949659209643909653610.08
212.249665849674819670320.07
单位质量响应值RSD%判断
79323.0179005.880.29数据可信
供试品溶液-2023072911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%
5min1275659-27565926.01125.881.9226.0125.881.93
2275776-27577626.02226.02
3282612-28261226.66826.67
4268909-26890925.37525.37
5268357-26835725.32225.32
6274545-27454525.90625.91
10min1305952-30595228.87028.860.9628.9128.900.95
2306807-30680728.95128.99
3310830-31083029.33029.37
4302857-30285728.57828.62
5305453-30545328.82328.87
6303019-30301928.59328.64
15min1318899-31889930.09229.970.7630.1830.060.75
2318261-31826130.03130.12
3320039-32003930.19930.29
4316703-31670329.88429.97
5318749-31874930.07730.17
6313332-31333229.56629.66
20min1325488-32548830.71330.650.9930.8530.790.99
2324457-32445730.61630.76
3324937-32493730.66130.81
4329445-32944531.08731.23
5325233-32523330.68930.83
6319430-31943030.14230.28
30min1331606-33160631.29131.190.7531.4831.380.75
2331970-33197031.32531.52
3330284-33028431.16631.36
4331547-33154731.28531.48
5332147-33214731.34231.53
6325664-32566430.73030.92
45min1335534-33553431.66131.710.7231.9131.960.72
2337362-33736231.83432.08
3336230-33623031.72731.97
4338209-33820931.91432.16
5337539-33753931.85032.09
6331547-33154731.28531.53
60min1339309-33930932.01831.930.6432.3232.230.64
2339360-33936032.02232.32
3338452-33845231.93732.24
4338958-33895831.98432.28
5340097-34009732.09232.39
6334104-33410431.52631.82
极限1338919-33891931.98131.950.5632.3332.300.55
2340067-34006732.08932.44
3338675-33867531.95832.31
4339037-33903731.99232.34
5340100-34010032.09232.44
6335038-33503831.61431.96
利伐沙班颗粒片项目信息
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对照品来源中检院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400
标示量(mg)30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%
112.179648009650129644329643549662539649700.08
212.249675129667899671500.06
单位质量响应值RSD%判断
79290.8879015.520.25数据可信
供试品溶液-2023072911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%
5min1269433-26943325.42825.323.0625.4325.323.06
2279455-27945526.37326.37
3272223-27222325.69125.69
4270902-27090225.56625.57
5260376-26037624.57324.57
6257065-25706524.26024.26
10min1302070-30207028.50828.452.0628.5528.492.06
2309830-30983029.24029.28
3303287-30328728.62228.67
4303746-30374628.66628.71
5298181-29818128.14128.18
6291398-29139827.50027.54
15min1314557-31455729.68629.741.3329.7829.831.33
2319969-31996930.19730.29
3317085-31708529.92530.02
4317503-31750329.96430.05
5313747-31374729.61029.70
6307953-30795329.06329.15
20min1322966-32296630.48030.420.9630.6230.560.96
2325091-32509130.68030.82
3324781-32478130.65130.79
4323480-32348030.52830.67
5320872-32087230.28230.42
6316878-31687829.90530.04
30min1330337-33033731.17531.070.6631.3731.260.66
2329946-32994631.13831.33
3331581-33158131.29331.48
4329885-32988531.13331.32
5328030-32803030.95831.15
6325462-32546230.71530.90
45min1335817-33581731.69231.620.5031.9331.860.51
2335012-33501231.61731.86
3337415-33741531.84332.09
4335154-33515431.63031.87
5334327-33432731.55231.79
6332388-33238831.36931.60
60min1338494-33849431.94531.850.3632.2432.140.36
2337418-33741831.84432.14
3339236-33923632.01532.31
4336908-33690831.79532.09
5336249-33624931.73332.03
6336391-33639131.74732.03
极限1339716-33971632.06031.920.3832.4132.260.38
2337917-33791731.89132.24
3339754-33975432.06432.41
4336995-33699531.80432.15
5337941-33794131.89332.24
6336843-33684331.78932.13
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