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%
128.532926942920592913022923422926652922120.20
228.432949382952752951060.09
单位质量响应值RSD%判断
10242.2710380.090.95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%
5min119681-196813.1493.2891.193.153.2891.16
246052-460527.3677.37
340146-401466.4236.42
410097-100971.6151.62
57067-70671.1311.13
6-0.0000.00
10min184607-8460713.53514.7721.6713.5414.7821.69
2116125-11612518.57818.59
3106872-10687217.09717.11
4103208-10320816.51116.51
581440-8144013.02913.03
661872-618729.8989.90
15min1151306-15130624.20625.1511.3124.2425.1911.33
2172639-17263927.61927.68
3156385-15638525.01925.07
4175549-17554928.08428.12
5161089-16108925.77125.80
6126309-12630920.20720.23
20min1194616-19461631.13532.419.0431.2332.509.04
2222908-22290835.66135.78
3189327-18932730.28930.40
4211931-21193133.90534.01
5219501-21950135.11635.20
6177117-17711728.33528.40
30min1251800-25180040.28339.436.5740.4439.606.58
2254971-25497140.79040.99
3231270-23127036.99937.17
4252953-25295340.46840.65
5265414-26541442.46142.63
6222471-22247135.59135.72
45min1284174-28417445.46243.585.5745.7143.845.57
2279470-27947044.71045.00
3254892-25489240.77841.04
4272995-27299543.67443.94
5289560-28956046.32446.59
6253456-25345640.54840.76
60min1290519-29051946.47745.484.5646.8345.834.57
2288138-28813846.09646.48
3266758-26675842.67643.02
4287277-28727745.95946.32
5301677-30167748.26248.63
6271390-27139043.41743.72
极限1305318-30531848.84548.791.8949.3049.241.90
2306658-30665849.05949.55
3295976-29597647.35047.79
4304171-30417148.66149.13
5313844-31384450.20950.68
6303912-30391248.62049.02
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535066055054955039435060735061465056520.21
228.435109995122685116340.18
单位质量响应值RSD%判断
17723.5217996.271.08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%
5min122035-220352.1542.2897.912.152.2897.86
254240-542405.3035.30
348042-480424.6974.70
49165-91650.8960.90
56317-63170.6180.62
6-0.0000.00
10min1105803-10580310.34411.4522.8110.3511.4522.84
2147522-14752214.42214.43
3138379-13837913.52813.54
4131604-13160412.86612.87
5102833-10283310.05310.05
676518-765187.4817.48
15min1199094-19909419.46420.4712.0219.4920.5012.05
2230085-23008522.49422.54
3208625-20862520.39620.44
4235756-23575623.04823.08
5216595-21659521.17521.20
6165987-16598716.22716.24
20min1263753-26375325.78527.3610.1225.8627.4410.12
2308429-30842930.15330.25
3260114-26011425.43025.52
4295235-29523528.86328.95
5309405-30940530.24930.32
6242061-24206123.66523.72
30min1360101-36010135.20534.927.2135.3335.067.22
2372528-37252836.42036.58
3333142-33314232.56932.71
4369918-36991836.16436.31
5387674-38767437.90038.04
6319779-31977931.26331.37
45min1425984-42598441.64640.606.2641.8540.816.26
2430027-43002742.04142.28
3386152-38615237.75237.97
4419236-41923640.98641.21
5448121-44812143.81044.03
6382097-38209737.35537.53
60min1454875-45487544.47043.805.3844.7744.115.39
2457467-45746744.72445.06
3417737-41773740.83941.14
4455957-45595744.57644.89
5480828-48082847.00747.33
6421332-42133241.19141.45
极限1492056-49205648.10548.262.8548.5048.662.86
2500477-50047748.92849.36
3473382-47338246.28046.67
4495933-49593348.48448.90
5514804-51480450.32950.75
6485108-48510847.42647.78
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%
128.532965132952832963042957922963842960550.18
228.433020772990563005660.72
单位质量响应值RSD%判断
10376.9710572.141.32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%
5min136100-361005.6854.1066.465.694.1066.43
28615-86151.3571.36
338623-386236.0836.08
4-0.0000.00
540832-408326.4316.43
631959-319595.0335.03
10min192880-9288014.62812.7747.7114.6412.7847.70
282715-8271513.02713.03
3110036-11003617.33017.34
44553-45530.7170.72
5103660-10366016.32616.34
692779-9277914.61214.62
15min1135852-13585221.39621.5218.1621.4421.5518.20
2142566-14256622.45322.48
3158751-15875125.00225.05
490442-9044214.24414.25
5157009-15700924.72824.78
6135034-13503421.26721.31
20min1163250-16325025.71127.6115.2225.8027.6915.25
2193934-19393430.54330.62
3204086-20408632.14232.25
4133727-13372721.06121.09
5194038-19403830.55930.66
6162847-16284725.64725.74
30min1185115-18511529.15433.3916.9929.3033.5417.00
2246934-24693438.89039.04
3242914-24291438.25738.44
4165693-16569326.09526.18
5242350-24235038.16838.34
6189142-18914229.78829.94
45min1203645-20364532.07236.8316.4532.2937.0516.46
2270178-27017842.55142.79
3265887-26588741.87542.14
4185204-18520429.16829.31
5268337-26833742.26142.52
6209709-20970933.02733.24
60min1215063-21506333.87139.5715.1134.1639.8715.12
2283149-28314944.59444.92
3278470-27847043.85744.21
4197389-19738931.08731.29
5286070-28607045.05445.41
6247282-24728238.94539.23
极限1289362-28936245.57246.222.3945.9346.612.49
2293896-29389646.28646.72
3295299-29529946.50746.96
4285840-28584045.01745.29
5305982-30598248.19048.64
6290443-29044345.74246.12
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535131725112775133655125465138755128470.20
228.435193505150165171830.60
单位质量响应值RSD%判断
17975.7118191.450.85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%
5min141429-414294.0002.8869.174.002.8869.19
28076-80760.7800.78
345538-455384.3974.40
4-0.0000.00
548639-486394.6964.70
635231-352313.4023.40
10min1115226-11522611.1259.8249.0911.139.8249.11
2105027-10502710.14110.14
3141511-14151113.66313.67
43341-33410.3230.32
5130804-13080412.62912.64
6114170-11417011.02311.03
15min1175634-17563416.95817.2519.1416.9917.2819.19
2188143-18814318.16618.19
3211944-21194420.46420.50
4116338-11633811.23311.23
5205720-20572019.86319.90
6174111-17411116.81116.84
20min1218487-21848721.09522.8716.2321.1722.9416.26
2263507-26350725.44225.51
3280703-28070327.10227.19
4178192-17819217.20517.23
5262049-26204925.30125.38
6218392-21839221.08621.16
30min1261241-26124125.22329.1517.9525.3429.2617.96
2354461-35446134.22434.35
3350989-35098933.88934.03
4232185-23218522.41822.48
5344603-34460333.27233.41
6267879-26787925.86425.98
45min1300913-30091329.05433.7917.6329.2333.9717.63
2408864-40886439.47739.67
3403717-40371738.98039.20
4272199-27219926.28126.40
5402342-40234238.84739.06
6311736-31173630.09930.27
60min1326859-32685931.55937.4816.5531.8037.7316.57
2444467-44446742.91443.20
3437916-43791642.28242.59
4298094-29809428.78228.95
5443030-44303042.77543.07
6378468-37846836.54236.78
极限1461479-46147944.55745.212.8044.8745.552.91
2472989-47298945.66846.05
3475999-47599945.95946.36
4451418-45141843.58543.82
5487688-48768847.08747.48
6459891-45989144.40344.73
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%
128.532951562948782957502944222932782946970.32
228.433015613008753012180.17
单位质量响应值RSD%判断
10329.3710595.081.80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%
5min13113-31130.4913.8969.090.493.8969.12
235863-358635.6555.66
331525-315254.9714.97
423119-231193.6463.65
57194-71941.1341.13
647198-471987.4437.44
10min14620-46200.72911.4271.010.7311.4371.01
2122785-12278519.36219.37
3105367-10536716.61516.63
442255-422556.6636.67
535118-351185.5385.54
6124434-12443419.62219.64
15min1107041-10704116.87923.9225.1716.8823.9625.23
2185174-18517429.20029.26
3162429-16242925.61325.66
4133108-13310820.99021.01
5119263-11926318.80618.82
6203266-20326632.05332.11
20min1169972-16997226.80331.2116.1626.8431.2916.23
2234224-23422436.93537.06
3199824-19982431.51031.61
4177498-17749827.99028.06
5167282-16728226.37926.44
6238564-23856437.61937.75
30min1250410-25041039.48738.229.3339.5938.389.38
2266214-26621441.97942.18
3238868-23886837.66737.84
4227983-22798335.95036.08
5207076-20707632.65432.77
6263795-26379541.59841.81
45min1285055-28505544.95042.607.0145.1442.847.04
2284801-28480144.91045.21
3263822-26382241.60241.86
4265096-26509641.80342.01
5237389-23738937.43437.62
6284819-28481944.91345.22
60min1300202-30020247.33945.485.3047.6345.825.33
2297508-29750846.91447.31
3275901-27590143.50743.86
4289147-28914745.59545.90
5264572-26457241.72041.99
6303207-30320747.81248.22
极限1319686-31968650.41148.812.7150.8049.252.74
2311925-31192549.18749.69
3304217-30421747.97248.42
4308625-30862548.66749.07
5296590-29659046.76947.13
6316165-31616549.85650.37
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535117745109445122855109985096885111380.20
228.435191255175285183260.22
单位质量响应值RSD%判断
17915.8118231.661.24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%
5min15204-52040.5033.0367.810.503.0367.91
245268-452684.3734.37
340372-403723.9003.90
428806-288062.7832.78
59038-90380.8730.87
659690-596905.7675.77
10min16053-60530.5859.1172.460.599.1272.44
2163140-16314015.76115.77
3136834-13683413.21913.23
453381-533815.1575.16
543349-433494.1884.19
6163240-16324015.77015.78
15min1143743-14374313.88719.8226.5913.8919.8526.64
2253813-25381324.52124.57
3217604-21760421.02221.06
4178350-17835017.23017.25
5157510-15751015.21715.23
6279947-27994727.04527.09
20min1235355-23535522.73726.7217.8822.7726.7917.94
2332294-33229432.10232.20
3277010-27701026.76226.85
4245451-24545123.71323.77
5228461-22846122.07122.12
6340891-34089132.93333.04
30min1364356-36435635.20034.3510.9135.2834.4810.95
2398419-39841938.49138.66
3347600-34760033.58133.73
4329750-32975031.85731.97
5298025-29802528.79228.89
6395143-39514338.17438.36
45min1439553-43955342.46540.138.3942.6340.348.42
2444542-44454242.94743.20
3402796-40279638.91439.13
4402004-40200438.83739.02
5357517-35751734.53934.70
6446191-44619143.10643.37
60min1478983-47898346.27443.996.8446.5344.296.87
2476149-47614946.00046.35
3433217-43321741.85242.16
4451495-45149543.61843.88
5406279-40627939.25039.48
6486047-48604746.95647.32
极限1525167-52516750.73648.623.9651.0949.024.00
2511725-51172549.43749.89
3490450-49045047.38247.78
4498134-49813448.12448.49
5473063-47306345.70246.02
6521332-52133250.36550.83
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%
128.532995333002603000902978982976102990780.42
228.433021073020783020920.01
单位质量响应值RSD%判断
10482.9310625.820.96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%
5min13526-35260.5512.5298.630.552.5298.73
213463-134632.1042.10
332670-326705.1065.11
43964-39640.6200.62
53992-39920.6240.62
639155-391556.1206.12
10min121176-211763.3108.9367.263.318.9467.27
240752-407526.3696.37
3102560-10256016.03016.04
467469-6746910.54510.55
512756-127561.9942.00
698224-9822415.35215.37
15min196741-9674115.12019.5425.4915.1319.5725.55
295506-9550614.92714.95
3164945-16494525.78025.83
4138303-13830321.61621.64
598839-9883915.44815.45
6155855-15585524.35924.41
20min1150817-15081723.57227.7418.1023.6127.8118.14
2159221-15922124.88524.94
3223098-22309834.86934.97
4193499-19349930.24330.32
5140536-14053621.96522.01
6197660-19766030.89330.99
30min1214554-21455433.53435.7113.4333.6335.8413.49
2215330-21533033.65533.76
3265046-26504641.42541.61
4245521-24552138.37438.51
5180823-18082328.26228.35
6249423-24942338.98339.15
45min1246351-24635138.50339.8611.8438.6740.0711.90
2241182-24118237.69537.88
3287654-28765444.95945.23
4276854-27685443.27143.50
5205579-20557932.13132.28
6272428-27242842.57942.84
60min1261250-26125040.83242.0910.9241.0942.3910.97
2257141-25714140.19040.46
3298926-29892646.72047.09
4291186-29118645.51145.83
5220074-22007434.39634.62
6287344-28734444.91045.26
极限1295687-29568746.21447.213.1746.5647.603.29
2299745-29974546.84847.20
3316538-31653849.47349.95
4305623-30562347.76748.19
5288820-28882045.14145.44
6305835-30583547.80048.25
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535162835171075182675143265130875158140.41
228.435185675196425191040.15
单位质量响应值RSD%判断
18079.7118259.020.70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%
5min15557-55570.5342.0493.510.532.0493.48
216555-165551.5911.59
341421-414213.9803.98
45890-58900.5660.57
57342-73420.7060.71
650749-507494.8774.88
10min125144-251442.4167.0668.662.427.0768.64
250658-506584.8684.87
3131958-13195812.68112.69
487338-873388.3938.39
517004-170041.6341.64
6128945-12894512.39112.40
15min1126525-12652512.15815.9926.8312.1616.0126.89
2123732-12373211.89011.90
3221186-22118621.25521.29
4186572-18657217.92917.95
5130789-13078912.56812.57
6209724-20972420.15320.19
20min1203143-20314319.52123.4019.4519.5523.4519.49
2214398-21439820.60320.64
3310094-31009429.79929.88
4268706-26870625.82125.88
5190977-19097718.35218.39
6273443-27344326.27726.36
30min1304267-30426729.23931.6814.6029.3231.7914.65
2306765-30676529.47929.57
3389565-38956537.43537.59
4356664-35666434.27434.39
5258727-25872724.86224.94
6362193-36219334.80534.95
45min1368645-36864535.42537.1712.9835.5737.3513.02
2361856-36185634.77334.92
3443487-44348742.61742.85
4422369-42236940.58840.78
5307695-30769529.56829.70
6416734-41673440.04640.27
60min1401726-40172638.60440.4812.1438.8240.7412.19
2397571-39757138.20538.43
3475695-47569545.71246.04
4457409-45740943.95544.24
5339499-33949932.62432.82
6455355-45535543.75744.07
极限1472410-47241045.39646.814.3945.7047.164.48
2475178-47517845.66245.98
3519297-51929749.90250.33
4498208-49820847.87548.26
5461122-46112244.31244.58
6496237-49623747.68648.09
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%
128.532933672933002937092946162927172935420.24
228.432917192916452916820.02
单位质量响应值RSD%判断
10288.8910259.660.21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%
5min13238-32380.5203.5585.620.523.5585.64
230246-302464.8564.86
347869-478697.6857.69
49472-94721.5211.52
54429-44290.7110.71
637241-372415.9795.98
10min153594-535948.60415.4233.368.6115.4333.37
2110321-11032117.71217.72
3134077-13407721.52621.54
490168-9016814.47614.48
565423-6542310.50410.51
6122638-12263819.68919.70
15min1134011-13401121.51525.6115.4121.5425.6515.45
2172892-17289227.75827.81
3175986-17598628.25428.32
4136397-13639721.89821.93
5144250-14425023.15923.18
6193398-19339831.05031.11
20min1201674-20167432.37832.479.8032.4532.579.81
2220218-22021835.35635.47
3196677-19667731.57631.70
4170428-17042827.36227.45
5198128-19812831.80931.89
6226332-22633236.33736.46
30min1262835-26283542.19839.246.7642.3439.416.72
2258766-25876641.54441.73
3224993-22499336.12236.32
4225202-22520236.15636.30
5252630-25263040.55940.71
6242040-24204038.85939.07
45min1284295-28429545.64342.895.6545.8843.155.62
2279008-27900844.79445.08
3247784-24778439.78140.06
4250820-25082040.26940.49
5274893-27489344.13444.37
6266181-26618142.73543.03
60min1295045-29504547.36945.045.3047.7045.405.26
2291049-29104946.72747.11
3259290-25929041.62942.00
4265100-26510042.56142.88
5289842-28984246.53446.87
6283093-28309345.45045.84
极限1310227-31022749.80648.502.1450.2548.962.12
2301467-30146748.40048.89
3293552-29355247.12947.59
4297073-29707347.69548.10
5308619-30861949.54849.99
6301718-30171848.44048.93
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535115135104135116425133275098975113580.26
228.435043875036835040350.10
单位质量响应值RSD%判断
17923.5217728.980.78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%
5min15101-51010.5002.9078.270.502.9078.31
236165-361653.5423.54
362058-620586.0786.08
416148-161481.5821.58
58988-89880.8800.88
649074-490744.8074.81
10min170386-703866.89412.3733.596.9012.3833.59
2138660-13866013.58113.59
3179162-17916217.54817.56
4119617-11961711.71611.72
587139-871398.5358.54
6162998-16299815.96515.98
15min1181160-18116017.74421.1216.2817.7621.1516.31
2229145-22914522.44422.48
3242162-24216223.71923.77
4181042-18104217.73217.76
5195003-19500319.10019.12
6265210-26521025.97626.02
20min1279886-27988627.41427.5210.7527.4727.6010.75
2300388-30038829.42229.51
3277016-27701627.13227.24
4231930-23193022.71622.79
5274294-27429426.86626.93
6322359-32235931.57431.68
30min1387366-38736637.94134.847.6038.0634.987.55
2375307-37530736.76036.91
3328735-32873532.19832.36
4318810-31881031.22631.35
5368793-36879336.12236.24
6355101-35510134.78034.95
45min1440100-44010043.10639.816.7343.3140.046.69
2423533-42353341.48341.72
3375323-37532336.76137.00
4372868-37286836.52136.71
5421019-42101941.23741.44
6406098-40609839.77540.03
60min1469294-46929445.96543.076.3346.2643.386.29
2457662-45766244.82645.15
3403421-40342139.51339.83
4407570-40757039.92040.19
5457034-45703444.76445.06
6443644-44364443.45343.79
极限1508648-50864849.82047.893.0550.2248.293.04
2487548-48754847.75348.18
3471345-47134546.16646.57
4474318-47431846.45746.82
5502930-50293049.26049.65
6488693-48869347.86548.30
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%
128.532994312995092988492994652993212993150.10
228.433030163030003030080.01
单位质量响应值RSD%判断
10491.2410658.041.12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%
5min15302-53020.8272.6481.810.832.6481.75
229912-299124.6664.67
35319-53190.8300.83
44984-49840.7770.78
519844-198443.0963.10
636078-360785.6285.63
10min136789-367895.7399.8760.935.749.8860.93
266620-6662010.39310.40
364932-6493210.12910.13
45929-59290.9250.93
589985-8998514.03714.04
6115343-11534317.99318.01
15min1117008-11700818.25321.2320.2318.2721.2620.29
2130181-13018120.30820.34
3134712-13471221.01521.04
4103599-10359916.16116.16
5148442-14844223.15723.19
6182783-18278328.51428.57
20min1164963-16496325.73428.6513.0125.7928.7313.07
2178121-17812127.78627.87
3186463-18646329.08829.16
4152500-15250023.79023.83
5202685-20268531.61831.71
6217324-21732433.90234.02
30min1216886-21688633.83435.757.2333.9535.897.28
2219350-21935034.21834.36
3247019-24701938.53438.67
4207576-20757632.38132.47
5240703-24070337.54937.71
6243449-24344937.97738.17
45min1237690-23769037.07940.165.1137.2740.385.15
2254228-25422839.65939.88
3273763-27376342.70642.93
4248905-24890538.82938.99
5262750-26275040.98841.23
6267298-26729841.69841.97
60min1269198-26919841.99442.993.3742.2643.303.43
2267825-26782541.78042.08
3287633-28763344.87045.19
4265322-26532241.39041.64
5281188-28118843.86544.20
6282433-28243344.05944.43
极限1295914-29591446.16246.231.0146.5346.641.03
2292162-29216245.57745.97
3301213-30121346.98847.40
4295858-29585846.15346.50
5295427-29542746.08646.52
6297576-29757646.42146.89
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.535189425183375175095182025185705183120.11
228.435214505216205215350.03
单位质量响应值RSD%判断
18167.2618344.530.69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%
5min110703-107031.0241.9397.391.021.9397.43
239310-393103.7603.76
3-0.0000.00
4-0.0000.00
525884-258842.4762.48
645372-453724.3394.34
10min146889-468894.4847.7761.324.497.7861.30
286088-860888.2338.24
384747-847478.1058.11
46863-68630.6560.66
5113672-11367210.87210.88
6149059-14905914.25614.27
15min1153264-15326414.65817.2420.5614.6717.2620.60
2174403-17440316.68016.71
3178030-17803017.02717.04
4137646-13764613.16413.17
5193755-19375518.53118.56
6244256-24425623.36123.40
20min1221325-22132521.16723.8014.0421.2123.8614.09
2244915-24491523.42423.49
3253171-25317124.21324.27
4201979-20197919.31719.35
5272024-27202426.01626.09
6299538-29953828.64828.74
30min1305948-30594829.26131.088.2229.3531.198.27
2315050-31505030.13130.25
3351767-35176733.64333.75
4286434-28643427.39427.47
5339338-33933832.45432.58
6351386-35138633.60633.76
45min1353381-35338133.79736.705.8833.9536.895.92
2382036-38203636.53836.72
3411081-41108139.31639.50
4362787-36278734.69734.83
5389948-38994837.29437.50
6403478-40347838.58838.82
60min1414146-41414639.60940.764.2339.8441.034.28
2415381-41538139.72739.99
3448636-44863642.90743.18
4403503-40350338.59138.80
5432063-43206341.32241.61
6443613-44361342.42742.74
极限1469666-46966644.91945.181.7245.2445.531.75
2465874-46587444.55644.91
3485609-48560946.44346.81
4466157-46615744.58344.88
5467992-46799244.75945.13
6479021-47902145.81346.22
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