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 27.672845672851662846412847482846512847550.09
2 27.672856072863232859650.18
单位质量响应值RSD%判断
10291.1110334.840.30数据可信
供试品溶液-2024032821批-缬沙坦钠-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12120-21200.3330.3453.870.330.3453.82
22093-20930.3290.33
32914-29140.4580.46
4-0.0000.00
52420-24200.3800.38
63336-33360.5240.52
15min13431-34310.5390.3852.700.540.3852.72
22678-26780.4210.42
32233-22330.3510.35
4-0.0000.00
53450-34500.5420.54
62733-27330.4290.43
20min14424-44240.6951.59134.700.701.59134.64
215731-157312.4702.47
32598-25980.4080.41
4-0.0000.00
52372-23720.3730.37
635461-354615.5695.57
30min156662-566628.8995.5271.198.905.5271.18
247559-475597.4697.47
33608-36080.5670.57
42939-29390.4620.46
554355-543558.5368.54
645772-457727.1887.20
45min176659-7665912.0398.2647.5212.068.2747.53
255970-559708.7908.81
35098-50980.8010.80
458338-583389.1629.16
568012-6801210.68110.70
651301-513018.0578.08
60min181893-8189312.86110.9515.5412.9010.9815.46
261144-611449.6029.63
381216-8121612.75512.76
465994-6599410.36410.38
572817-7281711.43611.47
655268-552688.6808.72
90min188052-8805213.82812.2014.5413.8912.2414.46
267369-6736910.58010.63
391531-9153114.37514.40
478586-7858612.34212.37
578014-7801412.25212.31
662490-624909.8149.86
120min193140-9314014.62713.1814.2914.7113.2414.23
273141-7314111.48611.55
396423-9642315.14315.19
478879-7887912.38812.44
593585-9358514.69714.77
668360-6836010.73610.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1139676-13967621.93620.844.8122.0420.924.83
2137457-13745721.58721.67
3121667-12166719.10719.18
4132600-13260020.82420.90
5134502-13450221.12321.22
6130151-13015120.44020.52
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 27.674884854896224882004885974876694885150.15
2 27.674895614907644901620.18
单位质量响应值RSD%判断
17655.0417714.560.24数据可信
供试品溶液-2024032821批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.05244.950.000.06244.95
23785-37850.3270.33
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.19110.850.000.19110.80
24925-49250.4260.43
33773-37730.3260.33
4-0.0000.00
5-0.0000.00
64564-45640.3950.39
20min18191-81910.7091.67138.220.711.68138.04
229772-297722.5762.58
34573-45730.3960.40
4-0.0000.00
54035-40350.3490.35
669485-694856.0126.01
30min1111631-1116319.6595.8475.029.665.8575.00
291874-918747.9497.95
36220-62200.5380.54
4-0.0000.00
5106434-1064349.2099.21
689071-890717.7077.72
45min1148775-14877512.8738.8148.3812.898.8248.38
2108131-1081319.3569.37
38221-82210.7110.71
4114718-1147189.9269.93
5132745-13274511.48611.50
698540-985408.5268.55
60min1157580-15758013.63511.6116.1713.6711.6416.08
2116185-11618510.05310.09
3158028-15802813.67313.68
4128129-12812911.08611.10
5140154-14015412.12712.16
6105158-1051589.0999.14
90min1167031-16703114.45212.7315.2914.5112.7815.17
2126070-12607010.90810.96
3174838-17483815.12815.15
4149321-14932112.92012.95
5148750-14875012.87112.93
6116905-11690510.11510.17
120min1175142-17514215.15413.6215.2415.2413.6915.17
2134729-13472911.65711.73
3182334-18233415.77615.83
4148768-14876812.87212.93
5177203-17720315.33215.41
6126405-12640510.93711.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1254155-25415521.99120.814.5122.1020.904.53
2245154-24515421.21221.30
3222832-22283219.28019.36
4240774-24077420.83320.91
5245909-24590921.27721.38
6234462-23446220.28720.37
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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 27.672858742857212852612852032853292854780.11
2 27.672859652857822858740.05
单位质量响应值RSD%判断
10317.2410331.550.10数据可信
供试品溶液-2024032821批-缬沙坦钠-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.07244.950.000.07244.95
22705-27050.4240.42
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min18218-82181.2890.6387.391.290.6487.28
25285-52850.8290.83
37270-72701.1401.14
4-0.0000.00
5-0.0000.00
63480-34800.5460.55
15min1-0.0000.8384.380.000.8384.34
211395-113951.7881.79
39773-97731.5331.54
43452-34520.5420.54
52014-20140.3160.32
65089-50890.7980.80
20min1-0.0001.0291.580.001.0291.61
210662-106621.6731.68
315192-151922.3832.39
4-0.0000.00
56578-65781.0321.03
66591-65911.0341.04
30min12222-22220.3493.8890.690.353.8890.58
213925-139252.1842.19
355619-556198.7258.73
450178-501787.8717.87
517051-170512.6752.68
69463-94631.4841.49
45min12321-23210.3647.6959.320.377.7059.31
269133-6913310.84510.86
374378-7437811.66811.69
461920-619209.7139.73
523638-236383.7083.71
662752-627529.8449.85
60min160275-602759.45510.3831.349.4610.4131.34
276160-7616011.94711.98
379601-7960112.48712.53
466685-6668510.46110.49
528269-282694.4354.45
686136-8613613.51213.54
90min170027-7002710.98511.6028.4811.0011.6428.51
283495-8349513.09813.15
387270-8727013.69013.75
473820-7382011.58011.63
534948-349485.4825.50
694292-9429214.79214.84
120min176494-7649412.00012.5627.0012.0412.6227.01
288939-8893913.95214.02
395015-9501514.90514.99
479890-7989012.53212.60
539896-398966.2596.29
6100266-10026615.72915.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1109330-10933017.15120.328.1517.2120.408.17
2126369-12636919.82419.92
3136391-13639121.39621.51
4135890-13589021.31721.41
5134953-13495321.17021.21
6134257-13425721.06121.16
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 27.674902054903434892224892384891584896330.13
2 27.674901314904054902680.04
单位质量响应值RSD%判断
17695.4517718.400.10数据可信
供试品溶液-2024032821批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min114488-144881.2520.6586.171.250.6486.24
29901-99010.8560.86
313765-137651.1901.19
4-0.0000.00
5-0.0000.00
66649-66490.5750.57
15min1-0.0000.8484.950.000.8485.12
220386-203861.7621.76
318622-186221.6091.61
45920-59200.5120.51
53528-35280.3050.30
69803-98030.8470.85
20min1-0.0001.0791.760.001.0791.71
220032-200321.7311.74
329041-290412.5102.51
4-0.0000.00
512317-123171.0641.06
612766-127661.1031.11
30min1-0.0004.0795.300.004.0795.21
225931-259312.2412.25
3108370-1083709.3659.37
497810-978108.4528.45
532087-320872.7732.78
618140-181401.5681.57
45min13832-38320.3318.1460.080.338.1660.08
2132343-13234311.43711.45
3142860-14286012.34512.37
4120064-12006410.37510.39
543636-436363.7713.78
6122687-12268710.60210.61
60min1116527-11652710.07010.9032.3710.0710.9232.38
2144155-14415512.45712.49
3151595-15159513.10013.15
4128195-12819511.07811.11
550653-506534.3774.39
6165703-16570314.31914.34
90min1133884-13388411.57011.9830.2511.5912.0230.28
2155302-15530213.42113.47
3163565-16356514.13514.20
4139467-13946712.05212.10
559874-598745.1745.19
6179351-17935115.49915.55
120min1144325-14432512.47212.8029.1112.5112.8629.11
2163648-16364814.14214.22
3176571-17657115.25915.35
4148959-14895912.87212.94
566852-668525.7775.81
6188362-18836216.27816.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1197451-19745117.06319.977.7417.1220.067.78
2226158-22615819.54419.64
3244202-24420221.10321.22
4244377-24437721.11821.21
5234506-23450620.26520.30
6240035-24003520.74320.84
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 27.675745325744075759275753405755245751460.12
2 27.675756715749045752880.10
单位质量响应值RSD%判断
20785.9120791.040.02数据可信
供试品溶液-2024032521批-缬沙坦钠-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12325-23250.1810.2735.610.180.2734.96
22395-23950.1870.19
35065-50650.3950.39
43093-30930.2410.24
55059-50590.3940.39
63109-31090.2420.24
10min112055-120550.9390.7582.270.940.7582.29
25448-54480.4240.42
324654-246541.9211.92
45029-50290.3920.39
57000-70000.5450.55
63589-35890.2800.28
15min118857-188571.4691.67140.681.471.68140.53
27047-70470.5490.55
382179-821796.4026.41
45997-59970.4670.47
510229-102290.7970.80
64443-44430.3460.35
20min124832-248321.9352.05125.191.942.06125.11
29510-95100.7410.74
392396-923967.1987.21
48335-83350.6490.65
59016-90160.7020.71
613848-138481.0791.08
30min124596-245961.9162.8291.481.922.8391.47
211325-113250.8820.89
399058-990587.7177.74
410054-100540.7830.79
529264-292642.2802.28
642869-428693.3403.34
45min127946-279462.1774.3976.182.194.4076.11
216863-168631.3141.32
3109811-1098118.5558.59
413130-131301.0231.03
5100282-1002827.8137.82
669980-699805.4525.46
60min131422-314222.4488.4644.392.468.4844.27
2139698-13969810.88410.89
3120848-1208489.4159.47
4169272-16927213.18813.19
5110578-1105788.6158.64
679462-794626.1916.21
90min185916-859166.69410.4434.716.7110.4734.60
2166974-16697413.00913.03
3128111-1281119.98110.05
4207800-20780016.18916.22
5123898-1238989.6539.69
691231-912317.1087.14
120min1151811-15181111.82712.0427.3011.8612.1027.21
2181142-18114214.11314.16
3136674-13667410.64810.73
4222330-22233017.32117.38
5134594-13459410.48610.54
6100943-1009437.8647.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1232493-23249318.11320.115.8118.1620.185.85
2272558-27255821.23521.30
3268826-26882620.94421.05
4262498-26249820.45120.53
5248666-24866619.37319.44
6263804-26380420.55320.61
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 27.679855269849199880679867059876879865810.14
2 27.679871169859719865440.09
单位质量响应值RSD%判断
35655.2635653.920.01数据可信
供试品溶液-2024032521批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13694-36940.1590.2538.850.160.2538.49
23924-39240.1680.17
38612-86120.3700.37
45065-50650.2170.22
58765-87650.3760.38
65024-50240.2160.22
10min122861-228610.9810.7687.250.980.7687.32
29479-94790.4070.41
347065-470652.0202.02
48492-84920.3640.36
512396-123960.5320.53
66265-62650.2690.27
15min136305-363051.5581.73144.691.561.74144.42
212252-122520.5260.53
3157560-1575606.7626.77
410407-104070.4470.45
517851-178510.7660.77
67578-75780.3250.33
20min145870-458701.9692.08129.961.972.08129.97
216636-166360.7140.72
3174859-1748597.5047.52
414050-140500.6030.60
516278-162780.6990.70
623210-232100.9961.00
30min145143-451431.9372.8793.941.952.8893.99
218861-188610.8090.81
3185637-1856377.9677.99
416360-163600.7020.70
554868-548682.3552.36
680830-808303.4693.47
45min149737-497372.1354.4879.302.154.4979.28
227501-275011.1801.18
3202697-2026978.6998.74
421306-213060.9140.92
5194126-1941268.3318.34
6130373-1303735.5955.60
60min154724-547242.3498.7546.422.368.7746.31
2264928-26492811.37011.38
3219604-2196049.4259.48
4326258-32625814.00214.01
5212132-2121329.1049.13
6145052-1450526.2256.24
90min1157056-1570566.74010.6236.426.7610.6636.29
2311499-31149913.36813.39
3229612-2296129.8549.93
4390787-39078716.77116.80
5234045-23404510.04410.08
6162001-1620016.9526.98
120min1276869-27686911.88212.1229.3111.9112.1729.17
2334267-33426714.34614.39
3242054-24205410.38810.48
4414377-41437717.78417.84
5250786-25078610.76310.82
6175392-1753927.5277.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1411387-41138717.65519.795.9617.7019.866.01
2487587-48758720.92521.00
3475915-47591520.42520.53
4474731-47473120.37420.46
5449136-44913619.27519.35
6468038-46803820.08620.14
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