利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123249543257293250093258463258153254710.14
210.123261223258223259720.07
单位质量响应值RSD%判断
32161.1732210.670.11数据可信
加速6月-供试品溶液-2023072811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233022-23302264.89861.457.6264.9061.467.62
2211451-21145158.89158.89
3236817-23681765.95565.96
4213225-21322559.38559.38
5194889-19488954.27854.28
6234538-23453865.32065.32
10min1268770-26877074.85472.415.3275.0072.555.32
2257441-25744171.69971.83
3272122-27212275.78875.93
4257366-25736671.67871.81
5234937-23493765.43265.55
6269360-26936075.01975.16
15min1281878-28187878.50577.453.6578.8277.743.66
2280106-28010678.01178.30
3285716-28571679.57479.89
4279123-27912377.73878.03
5257972-25797271.84772.11
6283698-28369879.01279.32
20min1293853-29385381.84080.422.8382.3380.892.84
2292135-29213581.36281.83
3291952-29195281.31181.80
4290989-29098981.04281.51
5272246-27224675.82276.25
6291307-29130781.13181.62
30min1296710-29671082.63683.810.9483.3084.460.91
2302856-30285684.34884.99
3300704-30070483.74884.42
4301326-30132683.92184.57
5304773-30477384.88185.48
6299130-29913083.31083.98
45min1302020-30202084.11584.731.8284.9785.561.82
2310768-31076886.55187.38
3305573-30557385.10485.96
4307646-30764685.68286.51
5294704-29470482.07782.86
6304678-30467884.85585.71
60min1304588-30458884.83085.501.6385.8786.521.63
2312757-31275787.10588.13
3307705-30770585.69886.75
4310486-31048686.47387.49
5298523-29852383.14184.11
6307802-30780285.72586.77
极限1309127-30912786.09486.661.8087.3287.871.80
2317159-31715988.33189.55
3312084-31208486.91888.16
4315568-31556887.88889.10
5301402-30140283.94385.09
6311602-31160286.78388.02
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123261363267713265543260813254463261980.16
210.123288413291643290020.07
单位质量响应值RSD%判断
32233.0032510.080.61数据可信
长期6月-供试品溶液-2023072811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222355-22235561.57358.0810.5961.5758.0810.59
2195699-19569954.19254.19
3211239-21123958.49558.50
4239790-23979066.40166.40
5175320-17532048.54948.55
6214085-21408559.28359.28
10min1263026-26302672.83671.005.2072.9771.135.21
2247970-24797068.66768.79
3254789-25478970.55570.68
4274661-27466176.05876.21
5236222-23622265.41365.52
6261809-26180972.49972.63
15min1282357-28235778.18975.455.5278.4975.745.53
2276601-27660176.59576.87
3275454-27545476.27776.56
4288432-28843279.87180.19
5245759-24575968.05468.31
6266297-26629773.74274.03
20min1293330-29333081.22780.283.0681.7080.733.07
2293437-29343781.25781.70
3290944-29094480.56781.02
4296549-29654982.11982.61
5272223-27222375.38375.79
6292885-29288581.10481.56
30min1302567-30256783.78582.442.9784.4483.072.98
2303093-30309383.93184.55
3301445-30144583.47584.11
4304281-30428184.26084.94
5281581-28158177.97478.55
6293189-29318981.18881.83
45min1308566-30856685.44785.930.6786.2986.750.63
2311934-31193486.37987.19
3307657-30765785.19586.02
4309823-30982385.79586.66
5313220-31322086.73587.48
6310637-31063786.02086.84
60min1310033-31003385.85386.630.7286.8887.640.68
2314082-31408286.97487.98
3311031-31103186.12987.14
4312027-31202786.40587.46
5316089-31608987.53088.47
6313826-31382686.90387.91
极限1317547-31754787.93487.271.2089.1588.461.22
2318390-31839088.16789.36
3315464-31546487.35788.56
4316566-31656687.66288.91
5307902-30790285.26386.40
6314940-31494087.21288.41
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123259853254453253383252123256113255180.10
210.123272013273903272960.05
单位质量响应值RSD%判断
32165.8132341.500.39数据可信
中间条件6月-供试品溶液-2023072811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211991-21199158.91759.564.6158.9259.564.61
2205958-20595857.24157.24
3207803-20780357.75357.75
4231976-23197664.47264.47
5208716-20871658.00758.01
6219375-21937560.97060.97
10min1241465-24146567.10971.895.0867.2472.025.08
2259280-25928072.06072.19
3247258-24725868.71968.85
4278554-27855477.41777.56
5260811-26081172.48672.61
6264681-26468173.56173.70
15min1253365-25336570.41677.515.5670.7077.815.55
2283800-28380078.87579.16
3266672-26667274.11574.40
4292874-29287481.39781.71
5288087-28808780.06680.36
6288590-28859080.20680.51
20min1259586-25958672.14580.346.0872.5880.816.07
2294699-29469981.90482.37
3275921-27592176.68577.13
4302049-30204983.94784.44
5303362-30336284.31284.78
6298913-29891383.07583.55
30min1265884-26588473.89683.985.9774.4984.625.96
2307242-30724285.39086.03
3305329-30532984.85885.47
4311436-31143686.55687.24
5313749-31374987.19887.85
6309418-30941885.99586.66
45min1270730-27073075.24284.966.3876.0085.796.37
2313965-31396587.25888.09
3294556-29455681.86482.67
4317116-31711688.13489.01
5320823-32082389.16490.01
6316951-31695188.08888.94
60min1272373-27237375.69985.496.6576.6386.516.63
2317074-31707488.12289.15
3293148-29314881.47382.46
4319950-31995088.92289.99
5323516-32351689.91390.96
6319564-31956488.81589.86
极限1276181-27618176.75786.856.7877.8588.056.76
2321623-32162389.38790.61
3297301-29730182.62783.79
4324701-32470190.24291.51
5328643-32864391.33892.58
6326474-32647490.73591.98
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123269893268433275153275543274733272750.11
210.123265113269333267220.10
单位质量响应值RSD%判断
32339.4332284.780.12数据可信
加速6月-供试品溶液-2023072911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1235684-23568465.38365.503.8265.3865.503.82
2220287-22028761.11261.11
3248229-24822968.86468.86
4236565-23656565.62865.63
5237171-23717165.79665.80
6238791-23879166.24566.25
10min1268939-26893974.60976.433.2674.7576.583.26
2261219-26121972.46772.60
3286186-28618679.39479.55
4278758-27875877.33377.48
5280555-28055577.83177.98
6277408-27740876.95877.11
15min1287111-28711179.65080.922.3979.9681.242.40
2280123-28012377.71278.01
3299456-29945683.07583.40
4294276-29427681.63881.96
5295982-29598282.11182.43
6293284-29328481.36381.68
20min1293392-29339281.39382.982.1381.8883.482.14
2289266-28926680.24880.72
3305002-30500284.61385.13
4301346-30134683.59984.10
5304463-30446384.46484.97
6301221-30122183.56584.06
30min1307477-30747785.30085.711.7485.9786.391.75
2299715-29971583.14783.79
3315691-31569187.57988.28
4309964-30996485.99086.67
5312036-31203686.56587.25
6308833-30883385.67686.36
45min1310560-31056086.15587.191.9087.0188.061.91
2304101-30410184.36485.20
3320540-32054088.92489.82
4316356-31635687.76388.64
5317930-31793088.20089.08
6316212-31621287.72388.60
60min1314511-31451187.25187.791.6188.3088.851.62
2307203-30720385.22486.24
3321664-32166489.23690.33
4317604-31760488.11089.18
5319048-31904888.51089.59
6318614-31861488.39089.46
极限1317505-31750588.08288.851.7789.3390.111.78
2310267-31026786.07487.28
3326162-32616290.48491.78
4321714-32171489.25090.52
5323610-32361089.77691.05
6322302-32230289.41390.68
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123264193264633265283265523264983264920.02
210.123277723278283278000.02
单位质量响应值RSD%判断
32262.0632391.300.29数据可信
长期6月-供试品溶液-2023072911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1250025-25002569.33162.6710.0569.3362.6610.05
2237995-23799565.99565.99
3242868-24286867.34667.35
4190254-19025452.75752.76
5225980-22598062.66362.66
6208804-20880457.90057.90
10min1284913-28491379.00575.206.1279.1675.346.12
2281471-28147178.05178.20
3284231-28423178.81678.97
4247844-24784468.72668.84
5275972-27597276.52676.66
6252727-25272770.08070.21
15min1296968-29696882.34880.592.9482.6880.902.96
2295119-29511981.83582.16
3295713-29571382.00082.32
4275898-27589876.50576.78
5295487-29548781.93782.25
6284532-28453278.89979.18
20min1305643-30564384.75383.731.5885.2784.221.60
2303100-30310084.04884.55
3306882-30688285.09785.60
4295131-29513181.83882.28
5303869-30386984.26184.75
6297105-29710582.38682.85
30min1313528-31352886.94086.780.2587.6487.460.27
2313342-31334286.88887.58
3312535-31253586.66487.36
4312047-31204786.52987.15
5313956-31395687.05987.74
6312352-31235286.61487.26
45min1319290-31929088.53888.420.4989.4389.280.48
2317891-31789188.15089.03
3316423-31642387.74388.63
4319110-31911088.48889.30
5320984-32098489.00789.88
6319411-31941188.57189.41
60min1321901-32190189.26289.541.0090.3590.600.99
2318676-31867688.36789.45
3328557-32855791.10792.19
4322500-32250089.42890.44
5323119-32311989.59990.67
6322645-32264589.46890.50
极限1326181-32618190.44890.400.5691.7491.660.53
2324267-32426789.91891.19
3323389-32338989.67490.96
4327250-32725090.74591.95
5327953-32795390.94092.21
6327014-32701490.67991.91
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.123292343289143289123289993290043290130.04
210.123257843262783260310.11
单位质量响应值RSD%判断
32511.1732216.500.65数据可信
中间条件6月-供试品溶液-2023072911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213578-21357859.15765.106.0059.1665.106.00
2234612-23461264.98364.98
3244729-24472967.78567.79
4228377-22837763.25663.26
5254863-25486370.59270.59
6234137-23413764.85264.85
10min1259971-25997172.00775.094.3772.1475.234.37
2273670-27367075.80275.95
3254246-25424670.42170.57
4277593-27759376.88877.03
5286256-28625679.28879.44
6274806-27480676.11676.26
15min1282274-28227478.18580.142.8178.4880.452.81
2288855-28885580.00880.32
3277764-27776476.93677.24
4296839-29683982.21982.53
5298387-29838782.64882.98
6291876-29187680.84481.16
20min1296331-29633182.07883.332.2082.5483.822.20
2297208-29720882.32182.81
3293505-29350581.29581.77
4311714-31171486.33986.83
5304246-30424684.27184.79
6302058-30205883.66584.16
30min1309281-30928185.66586.011.2086.3186.691.21
2305679-30567984.66785.34
3307465-30746585.16285.82
4315690-31569087.44088.13
5312770-31277086.63287.34
6312304-31230486.50287.18
45min1316357-31635787.62587.741.3388.4688.601.33
2310419-31041985.98086.84
3316191-31619187.57988.43
4323499-32349989.60390.48
5315943-31594387.51088.41
6318132-31813288.11788.99
60min1317341-31734187.89888.271.2688.9389.331.25
2313560-31356086.85087.90
3317841-31784188.03689.08
4325668-32566890.20491.28
5317775-31777588.01889.11
6319884-31988488.60289.67
极限1321838-32183889.14389.591.0090.3790.851.00
2319146-31914688.39889.64
3323243-32324389.53290.77
4328702-32870291.04492.32
5322821-32282189.41590.70
6325042-32504290.03191.29
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