沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012882432886522888572893242890802888310.15
228.022916732914782915760.05
单位质量响应值RSD%判断
10311.7110406.000.65数据可信
影响因素30天-包装高温-供试品溶液-SDR926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%
5min180251-8025112.77914.3710.6212.7814.3810.63
292650-9265014.75414.75
3100950-10095016.07516.08
493420-9342014.87614.88
597432-9743215.51515.52
676921-7692112.24912.25
10min1194707-19470731.00531.464.9531.0331.494.95
2199028-19902831.69331.73
3203584-20358432.41932.45
4199492-19949231.76731.80
5208419-20841933.18933.22
6179968-17996828.65828.69
15min1280366-28036644.64644.665.2644.7444.765.25
2258676-25867641.19241.29
3276708-27670844.06344.17
4286415-28641545.60945.71
5303846-30384648.38548.49
6276826-27682644.08244.17
20min1333104-33310453.04451.893.2853.2452.093.27
2305326-30532648.62048.81
3324129-32412951.61451.82
4330500-33050052.62952.83
5328388-32838852.29352.51
6333769-33376953.15053.34
30min1343505-34350554.70053.281.7955.0153.601.76
2334113-33411353.20453.51
3327722-32772252.18752.51
4333132-33313253.04853.37
5329577-32957752.48252.81
6339460-33946054.05654.36
45min1343122-34312254.63953.271.9155.0753.701.88
2335332-33533253.39853.82
3326875-32687552.05252.49
4332447-33244752.93953.38
5329005-32900552.39152.84
6340412-34041254.20754.63
60min1341410-34141054.36652.911.6054.9253.461.57
2333257-33325753.06853.61
3325696-32569651.86452.42
4331970-33197052.86353.42
5328838-32883852.36452.93
6332319-33231952.91953.47
极限1342435-34243554.52953.222.1555.2153.892.12
2334412-33441253.25253.91
3325884-32588451.89452.56
4331106-33110652.72553.40
5328464-32846452.30552.99
6342975-34297554.61555.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012883872883512886252884852881962884090.06
228.022938002936782937390.03
单位质量响应值RSD%判断
10296.6410483.191.27数据可信
影响因素30天-包装高温-供试品溶液-SDR926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%
5min188327-8832714.02413.784.1714.0213.784.18
288953-8895314.12314.12
389052-8905214.13914.14
482833-8283313.15213.15
590105-9010514.30614.31
681647-8164712.96312.96
10min1197839-19783931.41230.573.6731.4430.603.67
2185515-18551529.45529.49
3201659-20165932.01832.05
4192279-19227930.52930.56
5194488-19448830.88030.91
6183318-18331829.10629.13
15min1260854-26085441.41741.425.2341.5241.515.23
2261287-26128741.48641.58
3266326-26632642.28642.39
4267203-26720342.42542.52
5274495-27449543.58343.68
6234902-23490237.29637.39
20min1315569-31556950.10449.674.9950.3049.864.98
2320171-32017150.83551.02
3313484-31348449.77349.97
4326107-32610751.77751.97
5319339-31933950.70350.90
6282285-28228544.81945.00
30min1321178-32117850.99552.304.7251.3052.604.71
2329201-32920152.26952.57
3339193-33919353.85554.16
4347472-34747255.16955.48
5335825-33582553.32053.63
6303463-30346348.18248.46
45min1321214-32121451.00052.484.1751.4252.904.16
2330281-33028152.44052.86
3339599-33959953.91954.35
4347775-34777555.21855.65
5335207-33520753.22253.65
6309153-30915349.08549.47
60min1320928-32092850.95552.453.8651.4952.993.86
2330026-33002652.39952.93
3338715-33871553.77954.33
4346659-34665955.04055.59
5334707-33470753.14353.69
6311209-31120949.41249.90
极限1320249-32024950.84752.433.4551.4953.083.46
2329088-32908852.25152.90
3338025-33802553.67054.34
4345872-34587254.91555.59
5333196-33319652.90353.57
6314951-31495150.00650.61
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012898722899022891942888672884072892480.23
228.022951522949882950700.04
单位质量响应值RSD%判断
10326.6010530.691.39数据可信
影响因素30天-包装高湿-供试品溶液-SDR926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%
5min184128-8412813.30814.045.7113.3114.045.72
289209-8920914.11214.11
382327-8232713.02313.02
493070-9307014.72214.72
588191-8819113.95113.95
695577-9557715.11915.12
10min1188027-18802729.74329.604.4129.7729.634.40
2187471-18747129.65529.69
3175605-17560527.77827.81
4189665-18966530.00230.04
5181782-18178228.75528.79
6200190-20019031.66731.70
15min1259649-25964941.07339.449.5641.1739.539.56
2268793-26879342.51942.62
3215900-21590034.15234.24
4237378-23737837.55037.65
5234957-23495737.16737.26
6279117-27911744.15344.26
20min1309934-30993449.02745.399.7749.2145.589.76
2318163-31816350.32950.52
3247970-24797039.22639.39
4271524-27152442.95143.13
5268793-26879342.51942.70
6305394-30539448.30948.51
30min1324107-32410751.26949.285.5651.5749.575.56
2334111-33411152.85253.16
3284140-28414044.94745.20
4303719-30371948.04448.32
5314534-31453449.75550.03
6308687-30868748.83049.14
45min1325548-32554851.49750.244.3951.9150.644.40
2336432-33643253.21953.64
3295917-29591746.81047.16
4313682-31368249.62050.01
5322920-32292051.08251.46
6311264-31126449.23849.66
60min1324501-32450151.33250.533.8151.8651.043.82
2335694-33569453.10253.64
3300391-30039147.51847.98
4318089-31808950.31750.81
5325497-32549751.48951.99
6312514-31251449.43649.96
极限1324808-32480851.38051.372.9552.0251.982.96
2335532-33553253.07753.73
3310587-31058749.13149.69
4325853-32585351.54652.15
5334057-33405752.84353.45
6317447-31744750.21650.85
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012855042853142851222852182851662852650.06
228.022907842909502908670.05
单位质量响应值RSD%判断
10184.4010380.691.35数据可信
影响因素30天-包装高湿-供试品溶液-SDR926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%
5min178392-7839212.57714.9018.4512.5814.9118.43
289913-8991314.42514.43
3126543-12654320.30220.30
488769-8876914.24214.24
583204-8320413.34913.35
690601-9060114.53514.54
10min1199149-19914931.95031.488.3431.9831.518.34
2211725-21172533.96834.00
3218990-21899035.13335.18
4182354-18235429.25629.29
5183580-18358029.45229.48
6181465-18146529.11329.15
15min1243109-24310939.00342.879.9639.1042.989.96
2296445-29644547.56047.67
3291299-29129946.73446.86
4230514-23051436.98237.08
5279621-27962144.86144.96
6262334-26233442.08742.18
20min1300497-30049748.21048.216.6048.4048.416.60
2313872-31387250.35650.57
3315973-31597350.69350.92
4262713-26271342.14842.33
5298664-29866447.91648.11
6311126-31112649.91550.11
30min1324169-32416952.00851.762.9752.3052.072.97
2315485-31548550.61450.94
3332131-33213153.28553.62
4310942-31094249.88650.16
5335133-33513353.76754.07
6318007-31800751.01951.32
45min1330230-33023052.98052.372.6653.3952.792.66
2316243-31624350.73651.17
3334072-33407253.59654.05
4322242-32224251.69852.08
5337406-33740654.13154.55
6318563-31856351.10851.52
60min1330591-33059153.03852.532.5053.5653.072.48
2316453-31645350.77051.32
3333756-33375653.54654.12
4326808-32680852.43152.93
5337466-33746654.14154.68
6319618-31961851.27751.81
极限1330146-33014652.96652.662.6153.6153.312.57
2315646-31564650.64051.30
3332705-33270553.37754.07
4335502-33550253.82654.44
5335778-33577853.87054.53
6319685-31968551.28851.93
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012876312876442877632875292878732876880.05
228.022919822919612919720.01
单位质量响应值RSD%判断
10270.9010420.131.02数据可信
影响因素30天-包装光照-供试品溶液-SDR926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%
5min187601-8760113.96814.1210.7513.9714.1210.74
290888-9088814.49214.49
390266-9026614.39314.39
493307-9330714.87814.88
570715-7071511.27611.28
698723-9872315.74115.74
10min1194781-19478131.05831.223.6531.0931.253.65
2184356-18435629.39629.43
3201411-20141132.11532.15
4190896-19089630.43930.47
5201372-20137232.10932.13
6201848-20184832.18532.22
15min1260057-26005741.46641.458.0041.5741.557.99
2239070-23907038.12038.22
3246734-24673439.34239.45
4248476-24847639.62039.72
5268662-26866242.83842.93
6296589-29658947.29147.40
20min1283353-28335345.18147.276.1545.3747.466.15
2282669-28266945.07245.25
3306314-30631448.84249.03
4291003-29100346.40146.59
5286128-28612845.62345.81
6329100-32910052.47552.69
30min1315102-31510250.24350.882.6150.5451.182.61
2320500-32050051.10451.39
3320476-32047651.10051.40
4305958-30595848.78549.08
5321073-32107351.19551.49
6331281-33128152.82353.15
45min1321620-32162051.28351.672.0151.6952.082.02
2325729-32572951.93852.33
3323331-32333151.55551.97
4313687-31368750.01850.42
5326269-32626952.02452.43
6333544-33354453.18453.63
60min1323838-32383851.63651.941.6952.1552.461.70
2328782-32878252.42552.94
3323442-32344251.57352.10
4317829-31782950.67851.19
5326439-32643952.05152.57
6334035-33403553.26253.83
极限1325842-32584251.95652.420.9152.5953.060.94
2330245-33024552.65853.29
3328535-32853552.38553.03
4327124-32712452.16052.78
5326798-32679852.10852.75
6333993-33399353.25553.94
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.012973902972042968602967672972482970940.09
228.023019753015993017870.09
单位质量响应值RSD%判断
10606.7110770.411.09数据可信
影响因素30天-包装光照-供试品溶液-SDR926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%
5min187140-8714013.44913.733.1113.4513.733.10
285313-8531313.16713.17
393183-9318314.38114.38
488184-8818413.61013.61
590723-9072314.00214.00
689086-8908613.74913.75
10min1191381-19138129.53728.805.5429.5728.835.54
2176433-17643327.23027.26
3174433-17443326.92126.95
4199478-19947830.78630.82
5182506-18250628.16728.20
6195324-19532430.14530.18
15min1259572-25957240.06137.709.0240.1637.809.01
2224080-22408034.58334.67
3217379-21737933.54933.64
4241100-24110037.21037.31
5276588-27658842.68742.78
6246925-24692538.10938.21
20min1309319-30931947.73943.008.0547.9243.188.02
2270694-27069441.77741.94
3252020-25202038.89539.06
4257000-25700039.66439.85
5292640-29264045.16445.35
6290132-29013244.77744.96
30min1316792-31679248.89247.374.9949.1847.654.98
2303710-30371046.87347.13
3303232-30323246.79947.05
4283189-28318943.70643.98
5328961-32896150.77051.06
6305876-30587647.20747.49
45min1318013-31801349.08048.743.8349.4849.123.83
2318432-31843249.14549.51
3313518-31351848.38748.74
4296655-29665545.78446.15
5334327-33432751.59852.00
6313933-31393348.45148.84
60min1318202-31820249.10949.333.0149.6249.823.01
2322986-32298649.84850.32
3318608-31860849.17249.64
4304665-30466547.02047.49
5334539-33453951.63152.15
6318937-31893749.22349.72
极限1318323-31832349.12850.522.1149.7551.122.09
2328790-32879050.74451.33
3331919-33191951.22651.80
4319754-31975449.34949.92
5335723-33572351.81452.44
6329585-32958550.86651.47
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