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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062868672863802862712861752862292863840.10
228.022876662872472874560.11
单位质量响应值RSD%判断
10206.1310258.960.37数据可信
供试品溶液-2024032721批-沙库巴曲-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%
5min111852-118528.08910.05113.008.0910.05112.98
245220-4522030.86330.86
32599-25991.7741.77
421595-2159514.73914.74
54157-41572.8372.84
62913-29131.9881.99
10min199572-9957267.95953.9322.1767.9753.9422.18
2102098-10209869.68369.73
368356-6835646.65446.66
462463-6246342.63242.66
565536-6553644.72944.73
676039-7603951.89751.90
15min1157566-157566107.54193.6112.18107.6793.7212.19
2142718-14271897.40797.57
3142965-14296597.57597.66
4108802-10880274.25974.35
5128238-12823887.52487.60
6142670-14267097.37497.46
20min1195694-195694133.563122.349.89133.87122.609.87
2165758-165758113.132113.46
3190264-190264129.857130.10
4151407-151407103.337103.56
5178294-178294121.688121.91
6194043-194043132.437132.69
30min1232483-232483158.672150.6813.25159.20151.1413.22
2190319-190319129.895130.41
3250003-250003170.630171.09
4180150-180150122.954123.35
5224636-224636153.317153.74
6247024-247024168.597169.07
45min1274923-274923187.638171.3911.92188.43172.1111.90
2229876-229876156.893157.63
3273757-273757186.842187.59
4200817-200817137.060137.66
5256545-256545175.095175.78
6270758-270758184.795185.55
60min1287594-287594196.286181.0811.27197.39182.0811.25
2244174-244174166.652167.65
3287408-287408196.159197.21
4215061-215061146.782147.61
5270354-270354184.520185.49
6287258-287258196.057197.12
90min1306517-306517209.201193.5310.53210.63194.8410.52
2260615-260615177.873179.15
3302041-302041206.146207.53
4233401-233401159.299160.37
5294846-294846201.236202.52
6303947-303947207.447208.84
120min1315118-315118215.072201.088.89216.85202.708.90
2270543-270543184.649186.22
3310368-310368211.830213.56
4253057-253057172.714174.05
5305943-305943208.810210.43
6312636-312636213.378215.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1327673-327673223.641209.567.24225.78211.527.25
2279723-279723190.914192.79
3321017-321017219.098221.18
4277893-277893189.665191.29
5316001-316001215.674217.64
6319971-319971218.384220.47
极限1326920-326920223.127214.144.69225.64216.464.73
2295744-295744201.849204.05
3325533-325533222.180224.62
4294598-294598201.066203.01
5319573-319573218.112220.44
6320178-320178218.525220.98
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125
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%
128.024939724932674932374933354932964934210.07
228.024953924947064950490.10
单位质量响应值RSD%判断
17609.6017667.700.24数据可信
供试品溶液-2024032721批-缬沙坦钠-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%
5min113787-137875.1577.06108.935.167.06108.90
256727-5672721.22021.22
33035-30351.1351.14
427443-2744310.26610.27
57706-77062.8832.88
64545-45451.7001.70
10min1128232-12823247.96837.0423.1447.9837.0523.15
2125710-12571047.02447.06
386232-8623232.25732.26
474109-7410927.72227.74
582603-8260330.89930.90
697170-9717036.34836.35
15min1208296-20829677.91766.5813.7878.0166.6613.77
2180979-18097967.69967.81
3186118-18611869.62169.68
4135969-13596950.86250.93
5167237-16723762.55862.61
6189394-18939470.84670.91
20min1267559-267559100.08689.8411.78100.3090.0211.76
2217050-21705081.19281.42
3254971-25497195.37795.55
4196735-19673573.59273.74
5239875-23987589.73089.89
6264824-26482499.06299.24
30min1332230-332230124.277116.1214.90124.66116.4514.88
2262078-26207898.03598.40
3352345-352345131.801132.13
4245447-24544791.81492.08
5316867-316867118.530118.84
6353575-353575132.261132.61
45min1414452-414452155.034138.8413.83155.63139.3713.82
2333751-333751124.846125.37
3407352-407352152.378152.93
4285523-285523106.805107.23
5380594-380594142.368142.88
6405313-405313151.615152.18
60min1446937-446937167.185151.7013.18168.04152.4613.17
2368065-368065137.682138.42
3442690-442690165.597166.40
4315621-315621118.064118.67
5414415-414415155.020155.76
6445577-445577166.677167.50
90min1495915-495915185.506168.8712.30186.64169.8912.29
2409602-409602153.219154.18
3483768-483768180.963182.04
4358164-358164133.978134.78
5470094-470094175.848176.85
6491161-491161183.728184.83
120min1518519-518519193.962178.8910.87195.40180.1810.88
2434392-434392162.493163.71
3508930-508930190.375191.76
4393373-393373147.149148.17
5498565-498565186.498187.79
6515621-515621192.878194.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1552823-552823206.794189.949.62208.56191.539.63
2456301-456301170.688172.18
3537369-537369201.013202.71
4436534-436534163.294164.56
5523745-523745195.917197.52
6539761-539761201.908203.63
极限1552922-552922206.831195.726.64208.94197.636.68
2487933-487933182.521184.29
3550279-550279205.842207.88
4471588-471588176.406177.95
5533953-533953199.735201.67
6542677-542677202.999205.06
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062872952876322882572884532885242880320.19
228.022850512862402856460.30
单位质量响应值RSD%判断
10264.8610194.360.49数据可信
供试品溶液-2024032821批-沙库巴曲-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%
5min11732-17321.1829.99127.791.189.99127.78
251270-5127035.00335.00
32276-22761.5541.55
45984-59844.0854.09
511246-112467.6787.68
615289-1528910.43810.44
10min13328-33282.27242.0759.832.2742.0859.83
297350-9735066.46266.52
376558-7655852.26752.27
494423-9442364.46464.47
564915-6491544.31844.33
633151-3315122.63322.65
15min190629-9062961.87396.5020.9861.8896.5921.00
2143719-14371998.11898.29
3160760-160760109.753109.84
4175776-175776120.004120.12
5149605-149605102.137102.22
6127644-12764487.14487.20
20min1144804-14480498.859131.9815.6298.97132.2215.63
2170263-170263116.240116.57
3215739-215739147.287147.56
4223546-223546152.617152.93
5208976-208976142.670142.93
6196540-196540134.180134.38
30min1193246-193246131.931158.8012.45132.20159.2612.45
2200345-200345136.778137.30
3259617-259617177.243177.76
4258574-258574176.531177.10
5245068-245068167.311167.81
6238726-238726162.981163.40
45min1231798-231798158.251175.649.10158.74176.379.11
2225763-225763154.131154.89
3277797-277797189.655190.47
4280432-280432191.454192.32
5268760-268760183.485184.26
6259056-259056176.860177.56
60min1246247-246247168.115185.148.59168.87186.178.60
2238979-238979163.153164.16
3292532-292532199.715200.84
4292345-292345199.587200.77
5282898-282898193.137194.22
6274131-274131187.152188.14
90min1260882-260882178.107197.698.70179.14199.028.71
2254132-254132173.499174.78
3312055-312055213.043214.51
4305933-305933208.864210.38
5303050-303050206.895208.30
6301322-301322205.716207.02
120min1269216-269216183.797203.768.37185.13205.428.39
2264929-264929180.870182.44
3324578-324578221.593223.41
4313176-313176213.809215.67
5310344-310344211.875213.62
6308479-308479210.602212.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1282416-282416192.808210.287.25194.45212.287.27
2277358-277358189.355191.23
3330901-330901225.910228.10
4318896-318896217.714219.93
5319203-319203217.923220.02
6319271-319271217.970219.97
极限1300253-300253204.986215.554.59206.95217.904.64
2295506-295506201.745203.93
3332320-332320226.878229.44
4323691-323691220.987223.57
5321259-321259219.327221.79
6321350-321350219.389221.75
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125
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%
128.024957434963004969574972874970274966630.13
228.024914184933344923760.28
单位质量响应值RSD%判断
17725.3017572.310.62数据可信
供试品溶液-2024032821批-缬沙坦钠-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%
5min1-0.0005.86140.760.005.86140.77
258803-5880321.98421.98
3-0.0000.00
47360-73602.7522.75
512101-121014.5244.52
615777-157775.8985.90
10min11728-17280.64628.2962.440.6528.3062.43
2119992-11999244.86044.90
394383-9438335.28635.29
4119944-11994444.84244.85
579711-7971129.80129.81
638253-3825314.30114.31
15min1117073-11707343.76969.2922.3543.7769.3522.37
2185642-18564269.40469.52
3212443-21244379.42479.48
4236394-23639488.37888.46
5196413-19641373.43173.49
6164070-16407061.33961.37
20min1193448-19344872.32297.8316.5672.4098.0016.57
2228140-22814085.29285.52
3293564-293564109.752109.94
4307617-307617115.006115.23
5283358-283358105.936106.12
6263914-26391498.66798.80
30min1270877-270877101.270123.1213.63101.46123.4513.64
2278543-278543104.136104.51
3370958-370958138.686139.06
4374138-374138139.875140.29
5346730-346730129.628129.98
6334680-334680125.123125.42
45min1341707-341707127.751142.4110.66128.11142.9510.67
2325052-325052121.524122.07
3413841-413841154.719155.32
4427311-427311159.754160.41
5399365-399365149.307149.88
6378274-378274141.421141.93
60min1375620-375620140.429155.3810.35141.01156.1610.36
2353472-353472132.149132.89
3451313-451313168.728169.59
4461035-461035172.362173.28
5436826-436826163.312164.13
6415363-415363155.288156.03
90min1408891-408891152.868172.3510.79153.68173.3810.80
2387553-387553144.891145.86
3502228-502228187.763188.91
4499550-499550186.762187.97
5487616-487616182.300183.39
6480107-480107179.493180.50
120min1426397-426397159.413180.9910.67160.48182.3210.67
2411654-411654153.901155.11
3533575-533575199.482200.94
4519825-519825194.342195.86
5509215-509215190.375191.77
6504047-504047188.443189.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1455145-455145170.160190.089.31171.49191.709.32
2441767-441767165.159166.62
3553481-553481206.924208.71
4535150-535150200.071201.91
5532978-532978199.259200.97
6531977-531977198.885200.50
极限1490390-490390183.337196.606.34184.95198.546.38
2478305-478305178.819180.56
3561204-561204209.812211.95
4545787-545787204.048206.22
5539650-539650201.753203.80
6539835-539835201.823203.77
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125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062876222877952876732876882863352874230.22
228.022881322884302882810.08
单位质量响应值RSD%判断
10243.1610288.400.32数据可信
供试品溶液-2024032921批-沙库巴曲-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%
5min141066-4106627.93713.0368.0927.9413.0368.10
26943-69434.7234.72
34687-46873.1893.19
420034-2003413.62913.63
522363-2236315.21415.21
619815-1981513.48013.48
10min1133768-13376891.00259.9732.6991.0559.9932.70
286362-8636258.75258.76
348725-4872533.14833.15
4101757-10175769.22569.25
570043-7004347.65047.68
688253-8825360.03960.06
15min1199474-199474135.702112.4614.64135.90112.5814.65
2154608-154608105.180105.29
3142787-14278797.13897.20
4184956-184956125.826125.96
5138617-13861794.30194.41
6171403-171403116.606116.73
20min1223958-223958152.359142.357.69152.78142.667.71
2201848-201848137.317137.60
3199431-199431135.673135.90
4222920-222920151.653152.00
5185303-185303126.062126.32
6222046-222046151.058151.37
30min1244600-244600166.401167.764.64167.08168.314.64
2244903-244903166.608167.12
3248943-248943169.356169.80
4260360-260360177.123177.72
5226729-226729154.244154.72
6254073-254073172.846173.41
45min1267469-267469181.959184.053.80182.91184.873.81
2267541-267541182.008182.80
3273233-273233185.881186.61
4281207-281207191.305192.20
5253444-253444172.418173.15
6280340-280340190.715191.57
60min1278858-278858189.707193.863.36190.97194.993.36
2284816-284816193.760194.85
3288534-288534196.290197.33
4293961-293961199.982201.20
5269424-269424183.289184.31
6294141-294141200.104201.28
90min1292210-292210198.791204.722.71200.37206.182.70
2297233-297233202.208203.62
3305619-305619207.913209.28
4307037-307037208.877210.43
5292239-292239198.810200.13
6311206-311206211.714213.22
120min1299591-299591203.812210.192.38205.72211.992.37
2304947-304947207.456209.21
3313664-313664213.386215.10
4313610-313610213.349215.25
5303440-303440206.430208.08
6318550-318550216.710218.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1310079-310079210.947215.291.86213.19217.431.85
2311300-311300211.778213.87
3319912-319912217.636219.71
4319724-319724217.508219.76
5312928-312928212.885214.88
6324793-324793220.957223.18
极限1315616-315616214.714218.681.65217.31221.191.65
2321218-321218218.525220.97
3321724-321724218.869221.30
4327590-327590222.860225.47
5315489-315489214.627216.98
6327081-327081222.513225.10
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125
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%
128.024951274954684953404957554937284950840.16
228.024973964977194975580.05
单位质量响应值RSD%判断
17668.9517757.240.36数据可信
供试品溶液-2024032921批-缬沙坦钠-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%
5min150705-5070518.8888.3473.6318.898.3473.62
27478-74782.7862.79
34372-43721.6291.63
422707-227078.4588.46
525151-251519.3699.37
623929-239298.9148.91
10min1178193-17819366.37741.6136.5066.4141.6236.52
2106952-10695239.83939.84
359775-5977522.26622.27
4129898-12989848.38748.40
582756-8275630.82630.84
6112588-11258841.93941.95
15min1273463-273463101.86481.7317.43102.0181.8117.45
2200899-20089974.83574.91
3188161-18816170.09070.13
4248323-24832392.50092.59
5173803-17380364.74164.81
6231742-23174286.32386.41
20min1316095-316095117.745106.0710.24118.06106.2910.27
2270432-270432100.735100.93
3269124-269124100.248100.40
4307121-307121114.402114.65
5240979-24097989.76489.94
6304727-304727113.510113.74
30min1357732-357732133.255130.206.41133.76130.606.43
2344095-344095128.175128.54
3349161-349161130.062130.39
4373112-373112138.984139.42
5309042-309042115.118115.44
6364114-364114135.632136.05
45min1404960-404960150.847149.645.20151.58150.265.21
2394814-394814147.068147.64
3403611-403611150.344150.88
4421695-421695157.081157.75
5364815-364815135.893136.41
6420491-420491156.632157.28
60min1433227-433227161.376163.174.36162.36164.044.37
2436402-436402162.559163.38
3443701-443701165.278166.07
4454512-454512169.305170.24
5404058-404058150.511151.25
6456398-456398170.007170.91
90min1467127-467127174.004179.823.45175.25180.953.44
2477282-477282177.787178.88
3492873-492873183.594184.66
4492729-492729183.541184.76
5461928-461928172.067173.06
6504458-504458187.910189.10
120min1489321-489321182.271188.903.03183.81190.343.02
2499750-499750186.156187.55
3518435-518435193.116194.49
4512621-512621190.950192.47
5493770-493770183.928185.21
6528791-528791196.974198.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1515213-515213191.916196.692.36193.76198.442.36
2518401-518401193.103194.80
3536945-536945200.011201.71
4528518-528518196.872198.71
5521195-521195194.144195.73
6547853-547853204.074205.90
极限1529210-529210197.130201.481.85199.29203.551.86
2541337-541337201.647203.67
3543196-543196202.340204.37
4546244-546244203.475205.64
5529965-529965197.411199.32
6555301-555301206.849209.02
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