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%
127.781139118113965011407141139949113921811397300.06
227.721138234113984711390400.11
单位质量响应值RSD%判断
41027.0041090.910.12数据可信
长期12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%
5min1305389-30538912.04611.5030.4112.0511.5030.40
2414111-41411116.33516.33
3219890-2198908.6748.67
4354281-35428113.97513.97
5169033-1690336.6686.67
6286985-28698511.32011.32
10min1584850-58485023.07025.0620.7223.0925.0820.74
2860176-86017633.93033.96
3565810-56581022.31922.33
4651249-65124925.68925.71
5472096-47209618.62218.63
6677861-67786126.73926.76
15min1828468-82846832.68035.9816.9432.7436.0416.94
21179289-117928946.51846.60
3847802-84780233.44233.49
4908877-90887735.85135.92
5731764-73176428.86528.91
6977102-97710238.54338.61
20min11031041-103104140.67043.5113.3040.7843.6313.31
21313324-131332451.80551.97
3990966-99096639.08939.20
41178762-117876246.49746.62
5920445-92044536.30836.40
61183055-118305546.66646.79
30min11159724-115972445.74648.167.5345.9348.357.57
21318597-131859752.01352.26
31131435-113143544.63044.80
41305157-130515751.48351.69
51123358-112335844.31244.46
61286583-128658350.75050.96
45min11218405-121840548.06149.853.6948.3250.123.73
21318685-131868552.01752.35
31218698-121869848.07248.32
41307687-130768751.58351.87
51229873-122987348.51348.74
61289184-128918450.85351.14
60min11264593-126459349.88350.452.1950.2250.812.25
21315291-131529151.88352.30
31248464-124846449.24749.57
41306578-130657851.53951.91
51253388-125338849.44149.75
61285725-128572550.71651.09
极限11325585-132558552.28951.461.1352.7151.901.13
21313941-131394151.82952.34
31303459-130345951.41651.83
41304412-130441251.45451.91
51297774-129777451.19251.58
61282385-128238550.58551.04
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%
127.781970023197059319714321970761196922619704070.05
227.721967715196959619686560.07
单位质量响应值RSD%判断
70928.9871019.340.10数据可信
长期12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%
5min1522617-52261711.26710.7431.4311.2710.7431.42
2712663-71266315.36515.36
3372154-3721548.0238.02
4610449-61044913.16113.16
5280609-2806096.0506.05
6490185-49018510.56810.57
10min11003939-100393921.64423.5521.0021.6623.5721.02
21483803-148380331.99032.02
3971518-97151820.94520.96
41121611-112161124.18124.20
5807715-80771517.41417.42
61166717-116671725.15425.17
15min11424954-142495430.72133.8717.1030.7833.9217.10
22034976-203497643.87343.95
31457297-145729731.41931.47
41565999-156599933.76233.82
51257730-125773027.11627.16
61684077-168407736.30836.37
20min11775721-177572138.28441.0013.4938.3941.1113.51
22269414-226941448.92749.08
31703800-170380036.73336.83
42035142-203514243.87744.00
51583630-158363034.14234.23
62042032-204203244.02544.15
30min11996303-199630343.03945.377.7443.2145.557.77
22277668-227766849.10549.34
31944095-194409541.91442.08
42253500-225350048.58448.78
51933607-193360741.68841.83
62221303-222130347.89048.08
45min12096554-209655445.20146.983.8945.4447.243.93
22277691-227769149.10649.42
32096212-209621245.19345.42
42258852-225885248.70048.97
52118114-211811445.66545.88
62226613-222661348.00548.28
60min12177881-217788146.95447.562.3947.2747.902.45
22272310-227231048.99049.39
32146580-214658046.27946.59
42257971-225797148.68149.03
52159298-215929846.55346.84
62222300-222230047.91248.26
极限12290790-229079049.38848.601.1349.7849.011.13
22270179-227017948.94449.42
32251281-225128148.53648.92
42254837-225483748.61349.05
52241655-224165548.32948.69
62216056-221605647.77748.21
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%
127.781143971114385211436911143262114341611436380.03
227.721148300114972411490120.09
单位质量响应值RSD%判断
41167.6741450.650.49数据可信
长期12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%
5min1272732-27273210.6938.7219.1110.698.7219.09
2170265-1702656.6766.68
3251649-2516499.8669.87
4246550-2465509.6679.67
5219175-2191758.5938.59
6174161-1741616.8286.83
10min1606993-60699323.79921.479.1623.8221.499.17
2468060-46806018.35118.36
3590049-59004923.13423.15
4561279-56127922.00622.02
5537284-53728421.06521.08
6522553-52255320.48820.50
15min1869098-86909834.07531.855.5434.1331.905.54
2732349-73234928.71328.76
3817585-81758532.05532.11
4832635-83263532.64532.70
5815381-81538131.96932.02
6806556-80655631.62331.67
20min11043622-104362240.91838.914.7141.0339.014.71
2929694-92969436.45136.54
3948423-94842337.18537.29
41032039-103203940.46340.57
5981327-98132738.47538.58
61019383-101938339.96740.07
30min11154818-115481845.27745.043.8745.4645.213.86
21140385-114038544.71144.86
31093703-109370342.88143.05
41225097-122509748.03348.21
51120739-112073943.94144.11
61158227-115822745.41145.58
45min11205847-120584747.27847.712.7847.5447.962.78
21236538-123653848.48148.71
31211019-121101947.48147.72
41271506-127150649.85250.11
51171530-117153045.93246.17
61205263-120526347.25547.50
60min11238408-123840848.55548.712.0848.8949.032.08
21257620-125762049.30849.61
31257606-125760649.30749.63
41271941-127194149.86950.21
51200202-120020247.05747.37
61228185-122818548.15448.47
极限11289572-128957250.56150.700.6750.9851.110.65
21295376-129537650.78851.18
31291006-129100650.61751.02
41283112-128311250.30750.73
51291628-129162850.64151.04
61308828-130882851.31651.72
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%
127.781980713198060519786351979130197987519797920.05
227.721978329197982219790760.06
单位质量响应值RSD%判断
71266.8171395.240.13数据可信
长期12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%
5min1461162-4611629.8938.0519.899.898.0519.88
2282336-2823366.0576.06
3428731-4287319.1979.20
4419085-4190858.9908.99
5369443-3694437.9257.93
6291370-2913706.2506.25
10min11042139-104213922.35620.159.3322.3720.169.33
2800365-80036517.16917.18
31013877-101387721.74921.76
4963425-96342520.66720.68
5920556-92055619.74719.76
6894963-89496319.19819.21
15min11494742-149474232.06529.985.5532.1230.025.57
21259245-125924527.01327.05
31407072-140707230.18430.24
41432848-143284830.73730.79
51403032-140303230.09730.14
61387351-138735129.76129.80
20min11795187-179518738.51036.654.7438.6236.754.74
21599108-159910834.30334.39
31632273-163227335.01535.12
41778281-177828138.14738.25
51690928-169092836.27336.37
61755850-175585037.66637.76
30min11986284-198628442.60942.433.9142.7842.593.91
21963675-196367542.12442.26
31882503-188250340.38340.54
42111820-211182045.30245.47
51929676-192967641.39541.55
61993650-199365042.76742.92
45min12075845-207584544.53044.942.8744.7745.162.86
22128355-212835545.65745.87
32084068-208406844.70744.93
42192535-219253547.03347.27
52014627-201462743.21743.44
62073827-207382744.48744.71
60min12134933-213493345.79845.882.0846.1146.192.07
22164408-216440846.43046.72
32162948-216294846.39946.70
42190702-219070246.99447.31
52066059-206605944.32044.62
62114575-211457545.36145.66
极限12227128-222712847.77547.920.6648.1748.300.64
22237640-223764048.00148.37
32229305-222930547.82248.20
42217195-221719547.56247.96
52230739-223073947.85348.22
62260290-226029048.48748.86
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%
127.781145072114659511465811146002114669911461900.06
227.721151180115173911514600.04
单位质量响应值RSD%判断
41259.5441538.960.48数据可信
长期12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%
5min1303053-30305311.85610.3911.9311.8610.3811.95
2235271-2352719.2049.20
3227103-2271038.8858.88
4294757-29475711.53111.53
5279755-27975510.94510.94
6253089-2530899.9019.90
10min1698857-69885727.34124.099.5127.3624.119.51
2592639-59263923.18523.20
3561763-56176321.97721.99
4680885-68088526.63826.66
5579942-57994222.68822.71
6580622-58062222.71522.73
15min1931857-93185736.45634.627.2436.5234.687.24
2888282-88828234.75134.81
3833958-83395832.62632.68
4986929-98692938.61138.67
5826349-82634932.32832.38
6842028-84202832.94233.00
20min11103418-110341843.16842.486.2143.2942.606.22
21107320-110732043.32043.43
31036183-103618340.53740.64
41203126-120312647.06947.20
51037940-103794040.60640.72
61027439-102743940.19540.30
30min11202783-120278347.05547.034.7247.2547.214.73
21242099-124209948.59348.78
31170632-117063245.79745.97
41289905-128990550.46450.67
51176487-117648746.02646.20
61130737-113073744.23744.41
45min11275044-127504449.88248.613.4150.1648.883.43
21257989-125798949.21549.48
31208875-120887547.29447.54
41289961-128996150.46650.76
51246262-124626248.75649.01
61177185-117718546.05446.30
60min11294945-129494550.66149.352.7651.0249.702.77
21266654-126665449.55449.90
31234203-123420348.28448.61
41287027-128702750.35150.73
51280115-128011550.08150.42
61205537-120553747.16347.49
极限11303560-130356050.99850.481.0051.4450.911.00
21282096-128209650.15850.59
31290524-129052450.48850.90
41283042-128304250.19550.65
51307890-130789051.16751.59
61275296-127529649.89250.30
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.781985219198577119868691985709198628919859710.04
227.721981710198193019818200.01
单位质量响应值RSD%判断
71489.2471494.230.01数据可信
长期12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%
5min1517370-51737011.0739.6412.5811.079.6412.56
2396030-3960308.4768.48
3381914-3819148.1748.17
4502764-50276410.76110.76
5476318-47631810.19510.19
6428291-4282919.1679.17
10min11204151-120415125.77322.649.7725.7922.659.77
21016948-101694821.76621.78
3962450-96245020.60020.61
41172486-117248625.09525.11
5995505-99550521.30721.32
6993727-99372721.26921.28
15min11606797-160679734.39132.607.4134.4532.667.41
21528284-152828432.71032.76
31433501-143350130.68230.73
41702829-170282936.44636.51
51422175-142217530.43930.49
61445647-144564730.94230.99
20min11902922-190292240.72940.036.3640.8540.146.36
21905918-190591840.79340.90
31780895-178089538.11738.22
42076894-207689444.45344.57
51787646-178764638.26238.36
61766652-176665237.81237.91
30min12072158-207215844.35144.324.8744.5444.504.88
22141510-214151045.83646.01
32012727-201272743.07943.24
42226796-222679647.66147.86
52027751-202775143.40143.57
61943522-194352241.59841.76
45min12194818-219481846.97645.823.4747.2446.073.48
22167405-216740546.39046.64
32083000-208300044.58344.82
42227802-222780247.68247.96
52145274-214527445.91646.16
62026907-202690743.38343.62
60min12229955-222995547.72946.522.8048.0746.852.81
22182455-218245546.71247.04
32126262-212626245.50945.82
42223890-222389047.59947.95
52203921-220392147.17147.49
62075846-207584644.43044.74
极限12251083-225108348.18147.701.0048.6048.100.99
22214446-221444647.39747.80
32228885-222888547.70648.09
42217344-221734447.45947.89
52258522-225852248.34048.73
62201909-220190947.12847.51
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%
127.781149526114980011500981150193115047111500180.04
227.721162314116250211624080.02
单位质量响应值RSD%判断
41397.3441933.910.92数据可信
长期12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%
5min1278121-27812110.81112.3420.1310.8112.3420.13
2296189-29618911.51411.51
3414014-41401416.09416.09
4245075-2450759.5279.53
5295677-29567711.49411.49
6375515-37551514.59714.60
10min1661729-66172925.72327.4010.5725.7427.4210.58
2635648-63564824.71024.73
3842237-84223732.74032.77
4719887-71988727.98428.00
5660284-66028425.66725.69
6709664-70966427.58727.61
15min11003685-100368539.01638.918.9239.0838.988.92
2903325-90332535.11535.18
31149585-114958544.68844.77
41051811-105181140.88740.95
5957581-95758137.22437.29
6939895-93989536.53736.61
20min11220829-122082947.45744.749.5247.5844.879.51
21011412-101141239.31739.44
31275722-127572249.59149.75
41244666-124466648.38448.51
51079938-107993841.98042.10
61072381-107238141.68741.82
30min11290692-129069250.17347.476.3350.3847.686.33
21103360-110336042.89143.08
31275623-127562349.58749.83
41289463-128946350.12550.34
51202386-120238646.74046.93
61165140-116514045.29245.49
45min11289567-128956750.12948.574.3550.4248.854.36
21160160-116016045.09945.35
31274927-127492749.56049.88
41286950-128695050.02850.32
51281432-128143249.81350.08
61203792-120379246.79547.07
60min11287946-128794650.06649.072.4850.4449.432.50
21213723-121372347.18147.51
31270435-127043549.38649.79
41284214-128421449.92150.30
51284016-128401649.91450.27
61233094-123309447.93448.29
极限11284485-128448549.93249.930.9150.3950.370.86
21303282-130328250.66251.07
31266654-126665449.23949.72
41281720-128172049.82450.29
51285607-128560749.97550.41
61284376-128437649.92850.36
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.781981186198204519830121983169198435319827530.07
227.722001117200207920015980.04
单位质量响应值RSD%判断
71373.4072207.720.83数据可信
长期12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%
5min1474365-47436510.11111.5720.7310.1111.5720.74
2505478-50547810.77410.77
3713117-71311715.20015.20
4414804-4148048.8428.84
5504600-50460010.75610.76
6644753-64475313.74313.74
10min11139657-113965724.29225.8710.7024.3125.8910.70
21092030-109203023.27723.29
31452478-145247830.96030.98
41240690-124069026.44526.46
51135597-113559724.20524.22
61222190-122219026.05126.07
15min11732137-173213736.92036.778.9536.9836.848.95
21555760-155576033.16133.22
31983123-198312342.27042.35
41809696-180969638.57438.63
51650727-165072735.18535.24
61619873-161987334.52834.59
20min12107945-210794544.93142.319.6245.0542.449.62
21741629-174162937.12337.23
32203212-220321246.96147.11
42147428-214742845.77245.90
51861680-186168039.68239.80
61848191-184819139.39439.52
30min12225998-222599847.44744.866.5047.6445.066.50
21896218-189621840.41840.59
32202397-220239746.94447.17
42226607-222660747.46047.66
52070406-207040644.13144.31
62006509-200650942.76942.96
45min12226838-222683847.46545.924.5247.7446.204.53
21994967-199496742.52342.76
32200956-220095646.91347.22
42223635-222363547.39747.68
52208942-220894247.08447.34
62072174-207217444.16844.43
60min12224169-222416947.40846.422.6347.7646.772.65
22089452-208945244.53744.85
32195478-219547846.79747.18
42219139-221913947.30147.66
52215857-221585747.23147.57
62123347-212334745.25945.59
极限12219565-221956547.31047.300.8947.7447.730.83
22251520-225152047.99148.38
32189882-218988246.67747.14
42214340-221434047.19947.63
52221327-222132747.34847.76
62218873-221887347.29547.71
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%
127.781138418113825411381291138793113865111384490.03
227.721148133114723211476820.06
单位质量响应值RSD%判断
40980.8941402.670.73数据可信
长期12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%
5min1414355-41435516.29211.8923.1316.2911.8923.14
2239151-2391519.4039.40
3284242-28424211.17611.18
4223927-2239278.8058.80
5314229-31422912.35512.36
6338340-33834013.30313.30
10min1863713-86371333.96126.6114.8333.9926.6314.83
2614338-61433824.15524.17
3644044-64404425.32425.34
4576833-57683322.68122.70
5667273-66727326.23726.26
6693675-69367527.27527.30
15min11185669-118566946.62036.8213.3346.7036.8813.33
2871745-87174534.27734.33
3852202-85220233.50833.57
4881487-88148734.66034.71
5900078-90007835.39135.45
6926924-92692436.44636.51
20min11297970-129797051.03642.7511.1751.2042.8711.17
21040530-104053040.91341.03
3992423-99242339.02239.14
41009052-100905239.67539.79
51014281-101428139.88140.00
61168510-116851045.94546.07
30min11299896-129989651.11146.786.2251.3646.986.24
21165435-116543545.82446.01
31133543-113354344.57044.75
41127227-112722744.32244.50
51147256-114725645.11045.30
61265431-126543149.75649.96
45min11300166-130016651.12249.352.4651.4549.622.50
21266459-126645949.79750.05
31229775-122977548.35448.61
41212426-121242647.67247.92
51255211-125521149.35449.62
61266904-126690449.81450.10
60min11294915-129491550.91550.191.1951.3350.551.21
21293598-129359850.86451.20
31272439-127243950.03250.37
41257746-125774649.45449.78
51275631-127563150.15750.50
61264788-126478849.73150.10
极限11292518-129251850.82150.561.3451.3251.001.32
21301042-130104251.15651.58
31305364-130536451.32651.75
41281398-128139850.38450.80
51274217-127421750.10250.53
61260035-126003549.54450.00
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.781967675196838319677951968686196814019681360.03
227.721983200198227619827380.04
单位质量响应值RSD%判断
70847.2371527.340.68数据可信
长期12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%
5min1713264-71326415.33211.1023.8715.3311.1023.86
2405259-4052598.7118.71
3484719-48471910.41910.42
4377533-3775338.1158.12
5537265-53726511.54911.55
6580633-58063312.48112.48
10min11490111-149011132.03125.0415.0132.0625.0615.02
21057221-105722122.72522.74
31108672-110867223.83123.85
4988417-98841721.24621.26
51149586-114958624.71124.73
61194729-119472925.68125.70
15min12046829-204682943.99734.7113.4144.0834.7713.42
21502328-150232832.29332.35
31467388-146738831.54231.60
41518543-151854332.64232.69
51553831-155383133.40033.46
61599164-159916434.37534.44
20min12241401-224140148.18040.3111.2648.3340.4311.26
21795270-179527038.59038.70
31709139-170913936.73936.85
41739603-173960337.39337.50
51749224-174922437.60037.72
62018049-201804943.37943.50
30min12244559-224455948.24844.116.3448.4844.306.36
22010080-201008043.20743.38
31952943-195294341.97942.15
41941795-194179541.74041.91
51976567-197656742.48742.67
62185898-218589846.98747.18
45min12245762-224576248.27446.542.5648.5946.802.60
22182901-218290146.92247.16
32118841-211884145.54545.79
42089275-208927544.91045.15
52164393-216439346.52446.77
62189353-218935347.06147.33
60min12237173-223717348.08947.371.2248.4847.701.25
22231917-223191747.97648.30
32194640-219464047.17547.49
42168207-216820746.60646.92
52203599-220359947.36747.69
62186110-218611046.99147.34
极限12233574-223357448.01247.771.3248.4948.191.30
22248204-224820448.32648.73
32255880-225588048.49148.89
42215356-221535647.62048.01
52203094-220309447.35647.76
62178467-217846746.82747.26
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.781135242114974811502341150113114916211469000.57
227.721162188116155611618720.04
单位质量响应值RSD%判断
41285.1041914.571.07数据可信
长期12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%
5min1346702-34670213.49910.5926.2613.5010.5926.28
2161674-1616746.2956.29
3299124-29912411.64611.65
4216086-2160868.4138.41
5273880-27388010.66410.66
6334220-33422013.01313.01
10min1759295-75929529.56323.6817.9429.5923.7017.94
2468194-46819418.22918.24
3674598-67459826.26626.28
4520202-52020220.25420.27
5564249-56424921.96921.99
6662462-66246225.79325.81
15min11079225-107922542.02035.4215.2342.0935.4815.24
2737176-73717628.70228.74
3981059-98105938.19838.26
4846945-84694532.97633.02
5787855-78785530.67530.73
61025927-102592739.94540.01
20min11243525-124352548.41742.4413.6048.5642.5613.60
2938680-93868036.54836.64
31199943-119994346.72046.85
4998917-99891738.89339.00
5933623-93362336.35136.46
61225986-122598647.73447.87
30min11271447-127144749.50446.907.2849.7347.097.31
21119857-111985743.60243.75
31294396-129439650.39750.60
41143829-114382944.53544.70
51112755-111275543.32543.49
61285414-128541450.04850.26
45min11265970-126597049.29148.992.1949.6049.252.25
21222781-122278147.60947.83
31292103-129210350.30850.60
41240749-124074948.30948.55
51241958-124195848.35648.59
61285597-128559750.05550.35
60min11260633-126063349.08349.381.1749.4749.731.21
21257315-125731548.95449.26
31290161-129016150.23350.61
41255835-125583548.89649.22
51261760-126176049.12749.45
61283640-128364049.97950.36
极限11262182-126218249.14349.801.0649.6150.231.03
21297348-129734850.51250.90
31284297-128429750.00450.46
41264150-126415049.22049.62
51282870-128287049.94950.35
61284145-128414549.99850.46
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%
127.781960576198850419880841987112198423219817020.61
227.721993166199411419936400.04
单位质量响应值RSD%判断
71335.5771920.630.58数据可信
长期12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%
5min1594406-59440612.6989.8927.3912.709.8927.39
2266892-2668925.7025.70
3511974-51197410.93710.94
4363581-3635817.7677.77
5466896-4668969.9749.97
6574013-57401312.26312.26
10min11307790-130779027.93822.3318.2227.9622.3418.23
2800120-80012017.09317.10
31162082-116208224.82624.84
4891379-89137919.04319.06
5968592-96859220.69220.71
61140247-114024724.35924.38
15min11860863-186086339.75433.4815.3539.8233.5415.36
21266968-126696827.06627.10
31692551-169255136.15836.22
41460368-146036831.19831.24
51354614-135461428.93928.99
61768995-176899537.79137.85
20min12147594-214759445.87940.1613.7646.0140.2713.77
21616200-161620034.52734.61
32072479-207247944.27444.39
41722213-172221336.79236.89
51605348-160534834.29534.39
62115989-211598945.20445.33
30min12196617-219661746.92644.377.4347.1444.547.46
21928062-192806241.18941.33
32234238-223423847.73047.92
41969783-196978342.08042.24
51914627-191462740.90241.06
62217539-221753947.37347.57
45min12189383-218938346.77246.362.3247.0646.622.37
22105888-210588844.98845.20
32232450-223245047.69247.96
42138621-213862145.68745.92
52137840-213784045.67145.90
62217500-221750047.37247.65
60min12179211-217921146.55446.751.3146.9247.081.35
22164268-216426846.23546.52
32230707-223070747.65548.01
42165454-216545446.26146.56
52172769-217276946.41746.72
62217223-221722347.36647.72
极限12181678-218167846.60747.231.0547.0547.641.02
22242414-224241447.90548.27
32220202-222020247.43047.86
42185455-218545546.68847.07
52216855-221685547.35947.74
62218320-221832047.39047.83
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