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%
128.271144996114442211443611143298114255811439270.09
228.321145643114550211455720.01
单位质量响应值RSD%判断
40464.3440450.990.03数据可信
长期3月-供试品溶液-2024032121批-缬沙坦钠-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%
5min1341175-34117513.65811.3413.3313.6611.3413.34
2239598-2395989.5929.59
3303658-30365812.15612.16
4279992-27999211.20911.21
5289198-28919811.57711.58
6245884-2458849.8439.84
10min1659027-65902726.38225.168.5026.4025.188.50
2601922-60192224.09624.11
3695586-69558627.84627.87
4555753-55575322.24822.27
5666673-66667326.68826.71
6591621-59162123.68423.70
15min11001413-100141340.08936.5811.9240.1636.6411.92
2855544-85554434.24934.31
31003419-100341940.16940.24
4778534-77853431.16631.22
51026391-102639141.08841.15
6817785-81778532.73832.79
20min11227828-122782849.15244.0713.2749.2944.1913.26
2988659-98865939.57839.69
31226097-122609749.08349.22
4934202-93420237.39837.51
51244815-124481549.83249.96
6983551-98355139.37339.48
30min11307337-130733752.33548.599.2352.5548.789.24
21104458-110445844.21444.39
31309794-130979452.43452.65
41079706-107970643.22343.39
51322304-132230452.93453.15
61159201-115920146.40546.58
45min11309752-130975252.43250.145.6352.7350.425.65
21174167-117416747.00447.26
31308602-130860252.38652.69
41167248-116724846.72746.97
51320898-132089852.87853.18
61234765-123476549.43049.68
60min11309680-130968052.42951.263.0052.8251.623.04
21231357-123135749.29449.62
31305664-130566452.26852.66
41236952-123695249.51849.84
51319854-131985452.83653.23
61280012-128001251.24151.58
极限11307252-130725252.33252.390.4452.8152.840.45
21303863-130386352.19652.61
31303635-130363552.18752.66
41306807-130680752.31452.72
51318001-131800152.76253.24
61312988-131298852.56152.98
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%
128.271983497198357419835731980289197867919819220.12
228.321982541198288519827130.02
单位质量响应值RSD%判断
70106.9070011.050.10数据可信
长期3月-供试品溶液-2024032121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%
5min1586582-58658212.81210.6013.6912.8110.6013.67
2407778-4077788.9068.91
3522893-52289311.42111.42
4479106-47910610.46410.46
5495725-49572510.82710.83
6420304-4203049.1809.18
10min11135587-113558724.80223.638.6824.8223.648.68
21034682-103468222.59922.61
31199565-119956526.20026.22
4953544-95354420.82620.84
51148923-114892325.09425.11
61017999-101799922.23422.25
15min11730032-173003237.78634.4412.0637.8534.4912.06
21475106-147510632.21832.27
31733691-173369137.86637.93
41339299-133929929.25229.30
51772009-177200938.70338.76
61410298-141029830.80230.85
20min12122416-212241646.35641.4913.4246.4841.6013.41
21704677-170467737.23237.34
32119110-211911046.28446.41
41607327-160732735.10635.21
52148231-214823146.92047.04
61695774-169577437.03837.14
30min12260533-226053349.37345.759.3949.5845.949.40
21902985-190298541.56341.73
32260924-226092449.38149.58
41858956-185895640.60240.76
52286263-228626349.93450.14
61998766-199876643.65543.82
45min12261228-226122849.38847.215.7849.6747.475.80
22023835-202383544.20344.44
32261601-226160149.39649.68
42010400-201040043.90944.14
52283409-228340949.87250.16
62127591-212759146.46946.71
60min12264154-226415449.45248.303.1549.8248.633.20
22120932-212093246.32346.63
32257924-225792449.31649.68
42133329-213332946.59446.89
52282104-228210449.84450.21
62209504-220950448.25848.57
极限12259991-225999149.36149.430.4549.8149.850.46
22254412-225441249.23949.63
32254348-225434849.23749.69
42260484-226048449.37149.75
52279516-227951649.78750.24
62271125-227112549.60450.00
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%
128.271143781114448511442941143643114080811434020.14
228.321146974114677511468740.02
单位质量响应值RSD%判断
40445.7740496.960.09数据可信
长期3月-供试品溶液-2024032121批-缬沙坦钠-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%
5min1291674-29167411.67210.6115.8811.6710.6115.86
2231214-2312149.2539.25
3281389-28138911.26111.26
4228301-2283019.1369.14
5329215-32921513.17513.17
6229330-2293309.1779.18
10min1601979-60197924.09024.035.7924.1124.055.79
2590822-59082223.64423.66
3559274-55927422.38122.40
4581583-58158323.27423.29
5662506-66250626.51226.53
6607189-60718924.29924.31
15min1942873-94287337.73234.046.1337.7934.106.12
2816885-81688532.69032.75
3807394-80739432.31132.37
4811181-81118132.46232.52
5873148-87314834.94235.01
6852768-85276834.12634.18
20min11189502-118950247.60240.378.8447.7240.488.82
2971852-97185238.89239.00
3969763-96976338.80838.92
4956553-95655338.28038.39
5988835-98883539.57239.70
6975901-97590139.05439.17
30min11306767-130676752.29544.978.0052.5045.158.00
21087518-108751843.52143.69
31097497-109749743.92044.09
41080927-108092743.25743.43
51081735-108173543.28943.48
61087660-108766043.52643.70
45min11304762-130476252.21547.624.8652.5047.884.86
21167649-116764946.72746.97
31180185-118018547.22947.48
41181626-118162647.28747.53
51147451-114745145.91946.18
61157882-115788246.33746.59
60min11301985-130198552.10349.682.9252.4850.012.93
21231480-123148049.28249.61
31250010-125001050.02350.35
41253082-125308250.14650.47
51202223-120222348.11148.45
61209299-120929948.39448.72
极限11301799-130179952.09651.800.4852.5652.220.49
21296811-129681151.89652.30
31295665-129566551.85052.26
41287934-128793451.54151.95
51286351-128635151.47851.90
61298496-129849651.96452.37
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271982774198293419825941981226197708719813230.13
228.321987744198680019872720.04
单位质量响应值RSD%判断
70085.7170172.030.09数据可信
长期3月-供试品溶液-2024032121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%
5min1501935-50193510.9529.9016.4510.959.9016.43
2391779-3917798.5488.55
3482148-48214810.52010.52
4388902-3889028.4868.49
5566659-56665912.36412.36
6391109-3911098.5348.53
10min11035860-103586022.60222.555.9222.6222.565.93
21015736-101573622.16322.18
3960429-96042920.95620.97
41000468-100046821.83021.84
51141930-114193024.91624.94
61046051-104605122.82422.84
15min11628905-162890535.54232.006.2735.6032.066.27
21407316-140731630.70730.76
31391836-139183630.36930.42
41395072-139507230.44030.49
51506970-150697032.88132.94
61470638-147063832.08832.14
20min12055818-205581844.85737.958.9844.9738.068.97
21674247-167424736.53136.63
31670340-167034036.44636.55
41648384-164838435.96736.07
51704580-170458037.19337.31
61681883-168188336.69836.80
30min12260732-226073249.32842.258.2249.5242.428.21
21872008-187200840.84641.01
31887853-188785341.19241.36
41861312-186131240.61340.77
51862426-186242640.63740.82
61874518-187451840.90141.07
45min12256395-225639549.23344.775.0149.5145.015.02
22013642-201364243.93644.17
32033883-203388344.37844.61
42036221-203622144.42944.66
51978698-197869843.17443.42
61991985-199198543.46443.70
60min12251021-225102149.11646.713.0149.4747.023.02
22124175-212417546.34846.65
32154540-215454047.01147.32
42157555-215755547.07647.38
52073488-207348845.24245.56
62083784-208378445.46745.77
极限12252602-225260249.15048.850.5049.5949.240.52
22242651-224265148.93349.31
32241058-224105848.89849.28
42227249-222724948.59748.98
52223747-222374748.52148.91
62244547-224454748.97449.36
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%
128.271145479114658011461171146353114603511461130.04
228.321148503114832811484160.02
单位质量响应值RSD%判断
40541.6740551.410.02数据可信
长期3月-供试品溶液-2024032221批-缬沙坦钠-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%
5min1281794-28179411.25611.7119.7611.2611.7119.75
2210464-2104648.4078.41
3319108-31910812.74712.75
4257868-25786810.30010.30
5380462-38046215.19715.20
6309003-30900312.34312.34
10min1642348-64234825.65826.3715.4325.6826.4015.44
2535629-53562921.39521.41
3707022-70702228.24128.26
4576059-57605923.01023.03
5822932-82293232.87132.90
6677803-67780327.07427.09
15min1907937-90793736.26736.0014.1036.3336.0614.10
2791940-79194031.63331.68
3918428-91842836.68636.75
4790396-79039631.57231.63
51135159-113515945.34345.42
6863542-86354234.49434.56
20min11007419-100741940.24141.0412.5240.3641.1612.52
2962448-96244838.44438.55
31015915-101591540.58040.71
4926236-92623636.99837.11
51281261-128126151.17951.33
6970646-97064638.77238.89
30min11103071-110307144.06145.207.2644.2545.397.28
21092550-109255043.64143.81
31099619-109961943.92344.12
41083706-108370643.28843.46
51297788-129778851.83952.08
61112080-111208044.42144.61
45min11178745-117874547.08448.474.6247.3548.734.64
21155039-115503946.13746.38
31171076-117107646.77847.05
41215995-121599548.57248.81
51295682-129568251.75552.08
61263581-126358150.47350.73
60min11233856-123385649.28549.823.0049.6350.173.03
21192253-119225347.62447.94
31226435-122643548.98949.34
41256762-125676250.20050.52
51292821-129282151.64152.05
61281773-128177351.19951.55
极限11294518-129451851.70951.660.4252.1352.090.42
21289759-128975951.51851.91
31301705-130170551.99652.43
41296653-129665351.79452.20
51290763-129076351.55952.06
61286723-128672351.39751.83
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.271983573198533919845611984536198434419844710.04
228.321987418198763419875260.01
单位质量响应值RSD%判断
70197.0670181.000.02数据可信
长期3月-供试品溶液-2024032221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%
5min1480411-48041110.47310.9020.4910.4710.9020.48
2354050-3540507.7197.72
3545754-54575411.89811.90
4437070-4370709.5289.53
5654691-65469114.27314.27
6527601-52760111.50211.50
10min11104511-110451124.07924.7615.7424.1024.7815.74
2916870-91687019.98820.00
31218948-121894826.57426.59
4987611-98761121.53121.55
51420357-142035730.96530.99
61166139-116613925.42325.44
15min11563561-156356134.08733.8414.3134.1433.9014.32
21360163-136016329.65229.70
31583806-158380634.52834.59
41358322-135832229.61229.66
51960575-196057542.74242.82
61487174-148717432.42132.48
20min11734342-173434237.81038.6012.7337.9238.7112.73
21655251-165525136.08536.18
31751918-175191838.19338.31
41593829-159382934.74634.85
52215455-221545548.29848.44
61671629-167162936.44336.56
30min11898941-189894141.39842.507.4741.5842.687.48
21880089-188008940.98741.14
31891222-189122241.23041.42
41865419-186541940.66740.83
52244324-224432448.92849.15
61916921-191692141.79041.97
45min12030360-203036044.26345.624.7144.5145.874.73
21992502-199250243.43843.66
32018088-201808843.99644.25
42094827-209482745.66945.90
52238814-223881448.80849.12
62180094-218009447.52747.77
60min12126631-212663146.36246.913.0646.6847.243.08
22057778-205777844.86145.16
32115552-211555246.12046.45
42163927-216392747.17547.48
52235357-223535748.73249.12
62212065-221206548.22448.55
极限12237074-223707448.77048.740.4249.1749.150.42
22229134-222913448.59648.97
32250447-225044749.06149.47
42241516-224151648.86649.25
52233102-223310248.68349.15
62224378-222437848.49348.90
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%
128.271144598114545211444651144453114431611446570.04
228.321141783114179911417910.01
单位质量响应值RSD%判断
40490.1740317.480.31数据可信
长期3月-供试品溶液-2024032221批-缬沙坦钠-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%
5min1261100-26110010.46610.9426.5910.4710.9426.59
2264670-26467010.60910.61
3386079-38607915.47615.48
4324685-32468513.01513.02
5207692-2076928.3258.33
6193075-1930757.7407.74
10min1562636-56263622.55424.3616.6822.5724.3816.69
2602093-60209324.13524.15
3764631-76463130.65130.68
4688786-68878627.61027.63
5532928-53292821.36321.38
6495825-49582519.87519.89
15min1774408-77440831.04334.5212.2131.1034.5812.21
2935584-93558437.50337.56
31028476-102847641.22741.30
4870922-87092234.91134.98
5795740-79574031.89831.95
6762107-76210730.54930.60
20min1906932-90693236.35541.5011.9336.4641.6211.94
21128167-112816745.22345.34
31238716-123871649.65549.80
4994907-99490739.88140.01
5966267-96626738.73338.84
6977099-97709939.16839.26
30min11061276-106127642.54246.957.0942.7147.147.10
21215371-121537148.71948.91
31302644-130264452.21752.45
41116019-111601944.73644.93
51162315-116231546.59246.76
61169956-116995646.89847.06
45min11159918-115991846.49649.734.5446.7350.004.56
21284811-128481151.50251.78
31301300-130130052.16352.48
41193245-119324547.83248.10
51228198-122819849.23349.48
61276746-127674651.17951.42
60min11218848-121884848.85850.762.3949.1751.112.42
21288598-128859851.65452.02
31299199-129919952.07952.48
41249831-124983150.10050.45
51255960-125596050.34650.67
61285400-128540051.52651.85
极限11302520-130252052.21251.990.5352.6152.420.50
21286731-128673151.57952.03
31297241-129724152.00152.49
41292189-129218951.79852.23
51297868-129786852.02652.44
61305375-130537552.32752.74
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%
128.271981079198202819805901981048198103219811550.03
228.321977147197697119770590.01
单位质量响应值RSD%判断
70079.7769811.410.28数据可信
长期3月-供试品溶液-2024032221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%
5min1443521-4435219.70310.1527.829.7010.1427.83
2448135-4481359.8049.80
3664669-66466914.54114.54
4556744-55674412.18012.18
5348024-3480247.6147.61
6321781-3217817.0397.04
10min1964853-96485321.10822.8517.0321.1222.8617.03
21034238-103423822.62622.64
31319876-131987628.87428.90
41185867-118586725.94325.96
5914395-91439520.00420.02
6847245-84724518.53518.55
15min11331342-133134229.12532.4612.4429.1832.5112.45
21614448-161444835.31935.37
31777042-177704238.87638.95
41500313-150031332.82232.89
51370804-137080429.98830.03
61308139-130813928.61828.66
20min11560675-156067534.14239.0612.1234.2439.1612.13
21947668-194766842.60842.72
32141728-214172846.85446.99
41714970-171497037.51837.64
51664957-166495736.42436.52
61681914-168191436.79536.88
30min11826928-182692839.96744.197.2540.1244.367.26
22096419-209641945.86246.05
32252948-225294849.28749.50
41923223-192322342.07442.25
52004761-200476143.85744.01
62014224-201422444.06444.22
45min12000193-200019343.75746.824.6443.9847.074.65
22218050-221805048.52348.78
32251064-225106449.24649.54
42055057-205505744.95845.21
52117477-211747746.32346.55
62199289-219928948.11348.34
60min12100989-210098945.96247.792.4846.2648.122.51
22229047-222904748.76449.11
32243939-224393949.09049.47
42152979-215297947.10047.43
52166963-216696347.40647.71
62214137-221413748.43848.74
极限12251989-225198949.26649.060.5349.6449.470.50
22225738-222573848.69249.11
32243012-224301249.06949.53
42233254-223325448.85649.26
52244871-224487149.11049.50
62257535-225753549.38749.77
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%
128.271144025114441211445861144025114422611442550.03
228.321147481114731811474000.02
单位质量响应值RSD%判断
40475.9540515.540.07数据可信
长期3月-供试品溶液-2024032321批-缬沙坦钠-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%
5min1181819-1818197.2729.9525.367.279.9525.35
2332249-33224913.28813.29
3288953-28895311.55611.56
4173159-1731596.9256.93
5236723-2367239.4689.47
6279836-27983611.19211.19
10min1494500-49450019.77722.9013.1619.7922.9213.17
2668327-66832726.72926.75
3568968-56896822.75522.77
4493496-49349619.73719.75
5556708-55670822.26522.28
6653879-65387926.15126.17
15min1746584-74658429.85932.828.6529.9032.888.66
2943439-94343937.73237.80
3799866-79986631.99032.05
4771674-77167430.86330.91
5803351-80335132.12932.18
6859044-85904434.35734.42
20min1910747-91074736.42538.944.9136.5239.044.93
21055389-105538942.21042.34
3956947-95694738.27238.38
4965725-96572538.62438.72
5961977-96197738.47438.58
6990317-99031739.60739.73
30min11056599-105659942.25844.794.9342.4144.964.93
21160628-116062846.41946.62
31085143-108514343.40043.57
41208332-120833248.32648.49
51099647-109964743.98044.15
61108724-110872444.34344.53
45min11126434-112643445.05148.405.3445.2848.645.34
21269234-126923450.76251.04
31158236-115823646.32346.57
41275948-127594851.03151.27
51174823-117482346.98647.23
61255752-125575250.22350.48
60min11189282-118928247.56549.913.4747.8750.243.48
21289485-128948551.57251.93
31213489-121348948.53348.86
41279918-127991851.18951.52
51227431-122743149.09049.41
61287331-128733151.48651.83
极限11291756-129175651.66351.900.7152.0452.310.72
21304988-130498852.19252.64
31292197-129219751.68152.09
41288828-128882851.54651.96
51312459-131245952.49152.89
61295608-129560851.81752.25
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.271981544198273819831381982101198133319821710.04
228.321986439198649319864660.01
单位质量响应值RSD%判断
70115.7170143.570.03数据可信
长期3月-供试品溶液-2024032321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%
5min1302601-3026016.6029.2226.646.609.2226.64
2570664-57066412.45112.45
3494755-49475510.79510.80
4286835-2868356.2586.26
5403373-4033738.8018.80
6477406-47740610.41710.42
10min1846316-84631618.46621.4513.3918.4821.4613.40
21149504-114950425.08125.10
3976095-97609521.29721.32
4844376-84437618.42418.43
5956772-95677220.87620.89
61125129-112512924.54924.57
15min11284755-128475528.03230.848.7028.0730.898.72
21625950-162595035.47735.54
31376469-137646930.03330.09
41328783-132878328.99329.03
51384230-138423030.20330.25
61479779-147977932.28732.35
20min11569343-156934334.24236.604.8934.3336.714.91
21818174-181817439.67139.79
31649349-164934935.98736.09
41664135-166413536.31036.40
51658453-165845336.18636.29
61706220-170622037.22837.34
30min11820320-182032039.71842.114.9939.8642.274.98
22001602-200160243.67343.86
31868361-186836140.76640.93
42084108-208410845.47345.62
51894246-189424641.33141.49
61911363-191136341.70441.88
45min11941625-194162542.36445.505.3642.5845.745.36
22187523-218752347.73047.99
31994353-199435343.51543.75
42199496-219949647.99148.22
52024316-202431644.16944.40
62164237-216423747.22247.47
60min12052233-205223344.77846.973.4645.0647.283.48
22222770-222277048.49948.84
32093204-209320445.67245.98
42207393-220739348.16348.47
52117701-211770146.20646.51
62223159-222315948.50748.83
极限12233118-223311848.72548.960.7049.0849.340.71
22257203-225720349.25049.67
32234372-223437248.75249.13
42229461-222946148.64549.03
52268655-226865549.50049.88
62240023-224002348.87549.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.271151527115099811515421151087115050211511310.04
228.321145942114543511456880.04
单位质量响应值RSD%判断
40719.1740455.080.47数据可信
长期3月-供试品溶液-2024032321批-缬沙坦钠-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%
5min1286405-28640511.42911.9913.8611.4311.9913.86
2295117-29511711.77711.78
3312315-31231512.46312.46
4341627-34162713.63313.63
5338398-33839813.50413.50
6228628-2286289.1239.12
10min1635237-63523725.34925.426.5725.3725.446.58
2647002-64700225.81825.84
3685310-68531027.34727.37
4648235-64823525.86825.89
5646812-64681225.81125.83
6559020-55902022.30822.32
15min1894271-89427135.68635.143.8035.7535.213.81
2870909-87090934.75334.82
3894744-89474435.70435.77
4893180-89318035.64235.71
5913020-91302036.43436.50
6818102-81810232.64632.70
20min11056907-105690742.17642.026.0742.3042.146.06
2996305-99630539.75739.88
31044451-104445141.67941.80
41042690-104269041.60841.73
51173939-117393946.84646.97
61004417-100441740.08140.19
30min11163247-116324746.41946.695.8146.6146.885.80
21090372-109037243.51143.70
31163304-116330446.42146.62
41136676-113667645.35945.55
51294618-129461851.66151.87
61171495-117149546.74846.92
45min11298069-129806951.79949.594.5052.0749.854.49
21177281-117728146.97947.24
31260764-126076450.31050.58
41181328-118132847.14147.41
51306216-130621652.12452.41
61231948-123194849.16149.41
60min11303698-130369852.02450.562.7852.3850.922.78
21237976-123797649.40149.74
31269826-126982650.67251.03
41217440-121744048.58248.93
51305982-130598252.11552.49
61267933-126793350.59650.93
极限11307496-130749652.17551.701.1452.6252.141.14
21305593-130559352.09952.52
31274686-127468650.86651.31
41278836-127883651.03251.46
51305232-130523252.08552.55
61301829-130182951.94952.37
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271992147199222919925911992067199110319920270.03
228.321984673198382519842490.04
单位质量响应值RSD%判断
70464.3470065.290.41数据可信
长期3月-供试品溶液-2024032321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%
5min1491169-49116910.69611.2114.1810.7011.2114.18
2505203-50520311.00211.00
3534821-53482111.64711.65
4586536-58653612.77312.77
5582910-58291012.69412.69
6389009-3890098.4728.47
10min11092987-109298723.80223.866.6623.8223.886.66
21111377-111137724.20324.22
31181252-118125225.72425.74
41115072-111507224.28324.30
51113459-111345924.24824.27
6960432-96043220.91620.93
15min11542136-154213633.58433.063.8133.6433.113.82
21499692-149969232.65932.72
31542666-154266633.59533.66
41538425-153842533.50333.56
51573956-157395634.27634.34
61410305-141030530.71330.76
20min11824079-182407939.72339.566.1539.8439.676.14
21716061-171606137.37137.48
31802286-180228639.24939.37
41796326-179632639.11939.24
52027535-202753544.15444.27
61732352-173235237.72637.83
30min12006626-200662643.69943.915.9643.8844.085.94
21875120-187512040.83541.01
32001566-200156643.58943.77
41958122-195812242.64342.83
52236192-223619248.69848.89
62019037-201903743.96944.13
45min12241720-224172048.81946.684.6249.0746.944.60
22028368-202836844.17244.42
32174789-217478947.36147.62
42035667-203566744.33144.59
52257407-225740749.16049.43
62124517-212451746.26646.50
60min12253201-225320149.06947.632.9049.4047.962.89
22135087-213508746.49646.81
32192351-219235147.74348.08
42099012-209901245.71146.04
52258691-225869149.18849.54
62184352-218435247.56947.88
极限12262895-226289549.28048.811.1349.7049.221.13
22257513-225751349.16249.56
32206199-220619948.04548.46
42212094-221209448.17348.58
52258099-225809949.17549.61
62250881-225088149.01849.41
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