沙库巴曲缬沙坦钠片项目信息
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132859462835392851812846922855272849770.33
2 28.052851372857542854460.16
单位质量响应值RSD%判断
10130.7110176.330.32数据可信
长期24月-供试品溶液-2024032721批-缬沙坦-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%
5min172076-7207611.49716.5820.2811.5016.5820.28
2102904-10290416.41416.41
390929-9092914.50414.50
4124021-12402119.78319.78
5104677-10467716.69716.70
6129059-12905920.58620.59
10min1158306-15830625.25233.5814.0625.2733.6014.06
2215884-21588434.43634.46
3197815-19781531.55431.58
4222617-22261735.51035.54
5224288-22428835.77735.80
6244053-24405338.92938.96
15min1227056-22705636.21845.6310.3836.2845.7110.39
2294693-29469347.00747.09
3288031-28803145.94446.02
4304727-30472748.60848.70
5295607-29560747.15347.24
6306188-30618848.84148.94
20min1264327-26432742.16350.778.5642.2850.938.57
2316967-31696750.56050.72
3333723-33372353.23353.39
4334666-33466653.38353.56
5327616-32761652.25952.42
6332334-33233453.01153.19
30min1306825-30682548.94252.643.6849.1352.893.71
2329879-32987952.62052.87
3342237-34223754.59154.83
4335383-33538353.49853.76
5332230-33223052.99553.25
6333642-33364253.22053.49
45min1319690-31969050.99452.861.8251.2753.191.86
2330953-33095352.79153.13
3336156-33615653.62153.95
4335241-33524153.47553.83
5332543-33254353.04553.39
6333585-33358553.21153.57
60min1322324-32232451.41552.881.4351.7753.301.47
2332740-33274053.07653.50
3335905-33590553.58154.00
4333663-33366353.22353.66
5332183-33218352.98753.42
6332399-33239953.02253.47
极限1326737-32673752.11853.011.2852.5653.521.31
2332009-33200952.95953.47
3333241-33324153.15653.67
4339695-33969554.18554.71
5331682-33168252.90753.43
6330528-33052852.72353.26
沙库巴曲缬沙坦钠片项目信息
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134872714830684853074845574856674851740.32
2 28.054851904870584861240.28
单位质量响应值RSD%判断
17247.5617330.620.34数据可信
长期24月-供试品溶液-2024032721批-沙库巴曲-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%
5min1118882-11888210.52215.4021.0210.5215.4021.01
2172847-17284715.29815.30
3150245-15024513.29713.30
4208339-20833918.43918.44
5176309-17630915.60415.60
6217555-21755519.25519.25
10min1266669-26666923.60231.4014.0123.6231.4314.02
2364403-36440332.25232.28
3333167-33316729.48729.51
4376004-37600433.27833.31
5379538-37953833.59133.62
6409238-40923836.22036.25
15min1383194-38319433.91542.9210.5633.9742.9910.57
2499785-49978544.23444.31
3487791-48779143.17243.24
4517423-51742345.79545.88
5502027-50202744.43244.51
6519213-51921345.95346.05
20min1447532-44753239.60947.798.6539.7247.948.66
2537635-53763547.58347.74
3567044-56704450.18650.33
4567192-56719250.19950.36
5555516-55551649.16649.32
6564914-56491449.99850.17
30min1520109-52010946.03249.553.6746.2149.783.70
2559709-55970949.53749.77
3578741-57874151.22251.45
4569358-56935850.39150.64
5563926-56392649.91050.15
6567502-56750250.22750.48
45min1541374-54137447.91449.781.9548.1750.091.99
2561236-56123649.67249.99
3571064-57106450.54250.85
4569490-56949050.40350.73
5564382-56438249.95150.27
6567397-56739750.21850.55
60min1546644-54664448.38149.861.5248.7250.251.56
2566027-56602750.09650.49
3570828-57082850.52150.92
4567642-56764250.23950.65
5564201-56420149.93550.34
6564697-56469749.97950.40
极限1555878-55587849.19849.910.9549.6150.390.99
2564333-56433349.94650.43
3566220-56622050.11350.59
4572089-57208950.63351.13
5563769-56376949.89650.38
6561561-56156149.70150.20
沙库巴曲缬沙坦钠片项目信息
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132855672871332866742862822863742864060.21
2 28.052857012858932857970.05
单位质量响应值RSD%判断
10181.5110188.840.06数据可信
长期24月-供试品溶液-2024032821批-缬沙坦-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%
5min1112423-11242317.87718.5422.1217.8818.5422.12
2143435-14343522.80822.81
3124648-12464819.82119.82
4108351-10835117.22917.23
5138560-13856022.03322.03
672184-7218411.47811.48
10min1208206-20820633.10835.189.9533.1435.219.96
2251185-25118539.94239.98
3235061-23506137.37837.41
4225123-22512335.79835.83
5220592-22059235.07835.11
6187377-18737729.79629.81
15min1269854-26985442.91145.576.3943.0045.666.39
2316295-31629550.29650.40
3300301-30030147.75247.85
4283729-28372945.11745.21
5271039-27103943.09943.19
6278130-27813044.22744.30
20min1316615-31661550.34750.944.4250.5051.104.42
2333492-33349253.03053.22
3334169-33416953.13853.31
4325293-32529351.72751.89
5296274-29627447.11247.28
6316264-31626450.29150.43
30min1329265-32926552.35852.231.9852.6052.481.98
2333350-33335053.00853.28
3332613-33261352.89153.15
4330084-33008452.48852.74
5315661-31566150.19550.44
6329900-32990052.45952.69
45min1330111-33011152.49352.421.1352.8252.761.15
2331917-33191752.78053.15
3334793-33479353.23753.59
4329157-32915752.34152.68
5323776-32377651.48551.81
6328144-32814452.18052.49
60min1330951-33095152.62652.410.8653.0452.840.87
2330327-33032752.52752.98
3333300-33330053.00053.44
4329493-32949352.39452.82
5324830-32483051.65352.07
6328665-32866552.26352.66
极限1331249-33124952.67452.410.7053.1852.920.72
2330724-33072452.59053.13
3332196-33219652.82453.35
4329573-32957352.40752.92
5327265-32726552.04052.54
6326436-32643651.90852.40
沙库巴曲缬沙坦钠片项目信息
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134863624886854877474877164876864876390.17
2 28.054862014862704862360.02
单位质量响应值RSD%判断
17335.1917334.620.01数据可信
长期24月-供试品溶液-2024032821批-沙库巴曲-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%
5min1188895-18889516.67417.2822.8216.6717.2822.82
2242038-24203821.36521.36
3209209-20920918.46718.47
4181798-18179816.04716.05
5233936-23393620.65020.65
6118617-11861710.47010.47
10min1352189-35218931.08833.039.9431.1233.069.94
2424911-42491137.50737.54
3397007-39700735.04435.07
4380670-38067033.60233.63
5373405-37340532.96133.00
6316860-31686027.96927.99
15min1455818-45581840.23542.836.5340.3142.926.53
2536493-53649347.35747.45
3508902-50890244.92145.01
4480783-48078342.43942.52
5457882-45788240.41840.51
6471587-47158741.62741.69
20min1537079-53707947.40847.974.4947.5548.134.49
2566064-56606449.96750.14
3566940-56694050.04450.21
4552159-55215948.73948.89
5501567-50156744.27444.43
6537089-53708947.40947.54
30min1558307-55830749.28249.212.0449.5149.442.04
2565752-56575249.93950.20
3564996-56499649.87350.12
4560402-56040249.46749.70
5535015-53501547.22647.46
6560138-56013849.44449.66
45min1560290-56029049.45749.381.2449.7649.701.26
2564303-56430349.81150.15
3568326-56832650.16750.50
4558817-55881749.32749.64
5548091-54809148.38048.69
6556817-55681749.15149.45
60min1562362-56236249.64049.430.9050.0349.830.91
2561141-56114149.53249.96
3566421-56642149.99850.41
4560165-56016549.44649.85
5551272-55127248.66149.05
6558487-55848749.29849.67
极限1563083-56308349.70449.450.7150.1849.930.73
2562317-56231749.63650.15
3564738-56473849.85050.35
4559852-55985249.41949.90
5556190-55619049.09549.57
6554935-55493548.98449.44
沙库巴曲缬沙坦钠片项目信息
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132841442848442863882862882848822853090.35
2 28.052855502866362860930.27
单位质量响应值RSD%判断
10142.5210199.390.40数据可信
长期24月-供试品溶液-2024032921批-缬沙坦-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%
5min175168-7516811.97015.3221.1511.9715.3221.15
2101068-10106816.09416.09
396621-9662115.38615.39
4129046-12904620.54920.55
5101529-10152916.16716.17
673909-7390911.76911.77
10min1160326-16032625.53030.4213.5625.5530.4413.56
2200940-20094031.99732.02
3215330-21533034.28934.31
4219943-21994335.02435.06
5188121-18812129.95629.98
6161461-16146125.71125.73
15min1232178-23217836.97240.979.7437.0341.059.75
2268767-26876742.79842.88
3293033-29303346.66246.75
4268095-26809542.69142.78
5255632-25563240.70740.78
6226070-22607035.99936.06
20min1274634-27463443.73247.148.8843.8647.288.88
2316163-31616350.34550.50
3335906-33590653.48953.65
4291774-29177446.46246.63
5292656-29265646.60246.75
6264958-26495842.19242.31
30min1315658-31565850.26550.884.2750.4651.104.29
2323724-32372451.54951.78
3336748-33674853.62353.87
4324560-32456051.68351.92
5320881-32088151.09751.32
6295645-29564547.07847.27
45min1330236-33023652.58652.032.3452.8752.342.36
2325143-32514351.77552.10
3336660-33666053.60953.95
4325874-32587451.89252.22
5328970-32897052.38552.69
6313629-31362949.94250.21
60min1331265-33126552.75052.231.4253.1252.621.44
2324752-32475251.71352.12
3334610-33461053.28353.71
4326053-32605351.92052.33
5329316-32931652.44052.83
6321868-32186851.25451.61
极限1335356-33535653.40252.531.3253.8653.011.30
2325189-32518951.78352.28
3333503-33350353.10753.62
4325481-32548151.82952.33
5332058-33205852.87753.36
6327612-32761252.16952.61
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134832374848004870024871924846814853820.35
2 28.054860594879834870210.28
单位质量响应值RSD%判断
17254.9617362.600.44数据可信
长期24月-供试品溶液-2024032921批-沙库巴曲-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%
5min1123853-12385310.94914.1821.9110.9514.1821.91
2169383-16938314.97414.97
3160960-16096014.23014.23
4217060-21706019.18919.19
5169292-16929214.96614.97
6122038-12203810.78910.79
10min1268689-26868923.75328.4513.7323.7728.4813.74
2339208-33920829.98830.01
3363371-36337132.12432.15
4371064-37106432.80432.84
5316576-31657627.98728.01
6272290-27229024.07224.09
15min1391694-39169434.62838.449.9034.6938.529.90
2454283-45428340.16140.24
3496500-49650043.89343.97
4453619-45361940.10240.19
5431509-43150938.14738.22
6381461-38146133.72333.78
20min1463612-46361240.98644.309.0441.1044.439.04
2536229-53622947.40547.55
3569577-56957750.35350.50
4494285-49428543.69743.85
5494808-49480843.74343.88
6447888-44788839.59539.71
30min1534624-53462447.26347.874.3447.4548.084.36
2547719-54771948.42148.64
3572042-57204250.57150.81
4551111-55111148.72148.95
5542434-54243447.95448.16
6500947-50094744.28644.47
45min1559552-55955249.46748.992.3749.7349.272.39
2551467-55146748.75249.05
3571799-57179950.55050.87
4553093-55309348.89649.20
5557057-55705749.24649.53
6531704-53170447.00547.26
60min1560405-56040549.54249.171.4749.8949.541.49
2550369-55036948.65549.04
3568981-56898150.30150.70
4554027-55402748.97949.37
5558015-55801549.33149.70
6545684-54568448.24148.57
极限1569627-56962750.35849.551.3450.7950.001.33
2552658-55265848.85849.32
3567080-56708050.13350.62
4552733-55273348.86449.33
5564346-56434649.89150.34
6556505-55650549.19849.61
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.132859202849282859102861362854382856660.17
2 28.052862082861202861640.03
单位质量响应值RSD%判断
10155.2110201.930.33数据可信
长期24月-供试品溶液-SDR926批-缬沙坦-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%
5min1112231-11223117.85816.9814.0817.8616.9814.08
2131511-13151120.92620.93
390348-9034814.37614.38
499185-9918515.78215.78
595190-9519015.14715.15
6111626-11162617.76217.76
10min1225774-22577435.92534.617.6635.9534.647.67
2225730-22573035.91835.95
3215986-21598634.36834.39
4203477-20347732.37732.40
5194176-19417630.89730.92
6240060-24006038.19838.23
15min1310057-31005749.33646.388.1449.4346.468.13
2274839-27483943.73243.83
3300329-30032947.78847.87
4251515-25151540.02140.10
5299403-29940347.64147.72
6312646-31264649.74849.84
20min1313874-31387449.94349.025.4650.1249.195.45
2294271-29427146.82446.99
3323335-32333551.44951.61
4280684-28068444.66244.81
5318062-31806250.61050.77
6318245-31824550.63950.82
30min1315531-31553150.20749.594.0050.4649.844.00
2301225-30122547.93148.18
3323915-32391551.54151.79
4291742-29174246.42246.64
5317906-31790650.58550.83
6319773-31977350.88251.14
45min1315110-31511050.14049.882.8250.4850.202.81
2305055-30505548.54048.87
3323356-32335651.45251.78
4300645-30064547.83848.14
5320063-32006350.92851.25
6316451-31645150.35450.70
60min1314207-31420749.99650.072.3050.4250.482.30
2309531-30953149.25249.66
3323377-32337751.45651.87
4303461-30346148.28748.67
5319093-31909350.77451.18
6318178-31817850.62851.06
极限1313649-31364949.90850.600.9250.4151.090.91
2317960-31796050.59451.08
3322086-32208651.25051.75
4318772-31877250.72351.18
5319520-31952050.84251.34
6315971-31597150.27750.79
沙库巴曲缬沙坦钠片项目信息
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.134869454851594869314872704859634864540.18
2 28.054875064867244871150.12
单位质量响应值RSD%判断
17293.0717365.950.30数据可信
长期24月-供试品溶液-SDR926批-沙库巴曲-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%
5min1185219-18521916.35515.4914.9316.3515.4914.92
2218846-21884619.32419.32
3146193-14619312.90912.91
4162309-16230914.33214.33
5156588-15658813.82613.83
6183589-18358916.21116.21
10min1378930-37893033.45932.148.1133.4932.168.11
2378030-37803033.37933.41
3361804-36180431.94731.97
4338766-33876629.91329.94
5322550-32255028.48128.50
6403703-40370335.64635.67
15min1526167-52616746.46043.488.6446.5443.568.63
2462124-46212440.80540.89
3508192-50819244.87344.95
4421040-42104037.17737.25
5506883-50688344.75744.83
6530365-53036546.83046.92
20min1533211-53321147.08246.055.9547.2446.205.94
2495743-49574343.77343.93
3549056-54905648.48148.63
4470967-47096741.58641.72
5539826-53982647.66647.81
6540386-54038647.71547.88
30min1534825-53482547.22446.574.4247.4646.804.42
2507550-50755044.81645.04
3549591-54959148.52848.76
4490218-49021843.28643.49
5538955-53895547.58947.81
6543253-54325347.96848.21
45min1535510-53551047.28546.823.4147.6047.123.41
2512788-51278845.27845.58
3548290-54829048.41348.72
4503112-50311244.42444.70
5542821-54282147.93048.23
6538886-53888647.58347.91
60min1534275-53427547.17647.012.8847.5747.392.89
2520539-52053945.96346.34
3549034-54903448.47948.87
4507977-50797744.85445.20
5541323-54132347.79848.18
6540977-54097747.76748.17
极限1533643-53364347.12047.740.9247.5948.200.90
2540679-54067947.74148.20
3548201-54820148.40548.88
4541022-54102247.77148.20
5543048-54304847.95048.41
6537560-53756047.46647.95
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