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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.061173940117476911701271173888116926611723980.22
228.021174233116985511720440.27
单位质量响应值RSD%判断
41781.8241828.840.08数据可信
供试品溶液-2024032121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%
5min118797-187970.7853.6459.600.793.6459.51
273680-736803.0773.08
3131823-1318235.5055.51
4123335-1233355.1515.15
536059-360591.5061.51
6139356-1393565.8205.82
10min1120957-1209575.05214.3744.505.0514.3844.51
2535298-53529822.35622.36
3387667-38766716.19016.20
4447296-44729618.68118.69
5209996-2099968.7708.77
6363927-36392715.19915.21
15min1211079-2110798.81522.9841.228.8323.0141.21
2849001-84900135.45735.50
3506827-50682721.16721.20
4730365-73036530.50330.54
5418788-41878817.49017.51
6585108-58510824.43624.47
20min1262750-26275010.97329.9536.9011.0030.0236.90
2987552-98755241.24441.35
3614981-61498125.68425.76
4957288-95728839.98040.07
5764738-76473831.93831.98
6715152-71515229.86729.94
30min1523742-52374221.87338.2425.6221.9238.3625.64
21124777-112477746.97547.15
3841422-84142235.14135.26
41170538-117053848.88649.04
5976524-97652440.78340.88
6856656-85665635.77735.90
45min1770031-77003132.15943.4417.2932.2443.6217.34
21207474-120747450.42950.68
31000652-100065241.79141.96
41253819-125381952.36452.60
51077731-107773145.01045.18
6930950-93095038.88039.07
60min1836793-83679334.94845.4215.6435.0845.6815.70
21244273-124427351.96552.30
31059425-105942544.24644.49
41288276-128827653.80354.13
51128828-112882847.14447.39
6967859-96785940.42140.67
90min1897682-89768237.49147.2614.4037.6847.5914.46
21285680-128568053.69554.11
31103664-110366446.09346.41
41315363-131536354.93455.35
51185213-118521349.49949.82
61002084-100208441.85142.17
120min11018267-101826742.52748.5111.5442.7848.9211.61
21294853-129485354.07854.59
31120864-112086446.81147.20
41323913-132391355.29255.80
51198175-119817550.04050.44
61012934-101293442.30442.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11075950-107595044.93649.2510.1645.2649.7410.24
21300910-130091054.33154.93
31139851-113985147.60448.08
41322047-132204755.21455.81
51210789-121078950.56751.05
61026400-102640042.86643.32
极限11186809-118680949.56651.945.1149.9652.515.23
21300426-130042654.31155.00
31210371-121037150.55051.10
41321995-132199555.21155.90
51273236-127323653.17553.75
61168992-116899248.82149.35
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062004480200895619995552000288199818020022920.22
228.022009519200000720047630.34
单位质量响应值RSD%判断
71357.5271547.570.19数据可信
供试品溶液-2024032121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%
5min118878-188780.4362.5262.920.442.5262.90
290920-909202.0992.10
3166383-1663833.8413.84
4158809-1588093.6663.67
541699-416990.9630.96
6178845-1788454.1294.13
10min1145150-1451503.35110.4145.853.3510.4145.84
2694749-69474916.03916.04
3502178-50217811.59311.60
4611128-61112814.10814.11
5273053-2730536.3046.31
6478962-47896211.05711.06
15min1266325-2663256.14817.2842.786.1517.3042.77
21143294-114329426.39426.42
3682791-68279115.76315.79
41039339-103933923.99424.02
5565864-56586413.06313.08
6794738-79473818.34718.37
20min1343785-3437857.93623.2638.767.9523.3138.77
21382923-138292331.92532.00
3854743-85474319.73219.78
41401005-140100532.34332.41
51060939-106093924.49224.53
61002512-100251223.14323.20
30min1729810-72981016.84831.1527.8816.8831.2427.91
21662141-166214138.37138.50
31216196-121619628.07628.16
41791779-179177941.36441.49
51426586-142658632.93333.01
61269694-126969429.31229.41
45min11143040-114304026.38837.1519.3626.4537.3019.41
21874086-187408643.26443.46
31516081-151608134.99935.13
42009814-200981446.39846.59
51664297-166429738.42138.55
61448978-144897833.45033.59
60min11290577-129057729.79439.9617.3829.9040.1617.44
21990679-199067945.95646.22
31656813-165681338.24838.44
42114406-211440648.81249.08
51788746-178874641.29441.49
61543528-154352835.63335.83
90min11428734-142873432.98342.6016.0033.1342.8616.06
22121567-212156748.97749.32
31769533-176953340.85141.10
42198910-219891050.76351.11
51927133-192713344.48944.75
61625356-162535637.52237.78
120min11624706-162470637.50744.0513.2537.7144.3913.32
22159533-215953349.85450.28
31819667-181966742.00842.33
42227225-222722551.41751.85
51961248-196124845.27645.61
61656601-165660138.24338.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11732268-173226839.99044.9912.0940.2645.4112.16
22191451-219145150.59151.10
31866621-186662143.09243.48
42240527-224052751.72452.25
51993241-199324146.01546.43
61670201-167020138.55738.94
极限11905720-190572043.99447.427.4144.3347.917.52
22204714-220471450.89751.49
31983682-198368245.79446.26
42244343-224434351.81252.42
52099354-209935448.46548.95
61887648-188764843.57744.03
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.061172618117203211769051172146117244111732280.18
228.021170387117171911710530.09
单位质量响应值RSD%判断
41811.4041793.470.04数据可信
供试品溶液-2024032221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%
5min128834-288341.2041.6166.741.201.6166.63
215690-156900.6550.66
383840-838403.5023.50
414768-147680.6170.62
546771-467711.9531.95
641464-414641.7321.73
10min1224225-2242259.3658.8650.219.378.8650.22
2122110-1221105.1005.10
3391269-39126916.34216.35
493048-930483.8863.89
5189169-1891697.9017.90
6252959-25295910.56510.57
15min1349076-34907614.58017.0137.8714.6017.0337.87
2273695-27369511.43111.44
3688392-68839228.75228.78
4279633-27963311.67911.69
5397800-39780016.61516.63
6455369-45536919.01919.04
20min1493808-49380820.62523.1328.9220.6723.1828.94
2404651-40465116.90116.93
3844485-84448535.27135.35
4424573-42457317.73317.76
5572430-57243023.90823.95
6582611-58261124.33424.39
30min1659897-65989727.56229.5622.7327.6429.6422.77
2504971-50497121.09121.15
3973490-97349040.65940.80
4606882-60688225.34725.40
5778014-77801432.49532.58
6723296-72329630.21030.30
45min1796894-79689433.28433.6919.5633.4133.8219.60
2564387-56438723.57323.66
31044927-104492743.64343.85
4748539-74853931.26431.36
5880614-88061436.78036.92
6804200-80420033.58933.73
60min1843372-84337235.22535.4818.3235.4035.6718.36
2598051-59805124.97925.11
31074622-107462244.88345.16
4812596-81259633.93934.09
5925307-92530738.64738.85
6843181-84318135.21735.42
90min1899206-89920637.55737.5016.8637.7937.7516.90
2641386-64138626.78926.96
31103309-110330946.08146.44
4877209-87720936.63836.85
5975683-97568340.75141.01
6890911-89091137.21037.47
120min1929241-92924138.81138.3415.6839.1138.6515.73
2671203-67120328.03428.25
31109080-110908046.32246.75
4899354-89935437.56337.83
5992436-99243641.45141.78
6906747-90674737.87238.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1957376-95737639.98639.2614.4340.3539.6414.49
2703166-70316629.36929.63
31113345-111334546.50147.01
4924279-92427938.60438.94
51011585-101158542.25042.65
6930306-93030638.85639.24
极限11159547-115954748.43047.822.7948.8648.262.89
21082853-108285345.22745.54
31149386-114938648.00648.59
41144037-114403747.78348.18
51171055-117105548.91149.38
61162312-116231248.54648.99
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062007810200173320065542001928200197020039990.15
228.021997935200137719996560.13
单位质量响应值RSD%判断
71418.3571365.310.06数据可信
供试品溶液-2024032221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%
5min133064-330640.7641.0773.790.761.0773.85
216113-161130.3720.37
3107086-1070862.4742.47
415565-155650.3600.36
555600-556001.2851.28
650121-501211.1581.16
10min1294362-2943626.8016.4154.206.806.4154.19
2152886-1528863.5323.53
3536645-53664512.39912.40
4114115-1141152.6372.64
5242647-2426475.6065.61
6323729-3237297.4807.48
15min1470423-47042310.86912.6841.8410.8812.7041.84
2354487-3544878.1908.20
3976797-97679722.56922.59
4365159-3651598.4378.44
5528450-52845012.21012.22
6598593-59859313.83113.84
20min1682961-68296115.78017.7032.8215.8117.7432.84
2539660-53966012.46912.49
31234385-123438528.52128.58
4571419-57141913.20313.22
5776310-77631017.93717.97
6792809-79280918.31818.36
30min1956799-95679922.10723.7825.6822.1623.8425.72
2716054-71605416.54416.59
31487504-148750434.36934.48
4860243-86024319.87619.92
51113879-111387925.73625.80
61040277-104027724.03624.10
45min11210637-121063727.97228.4621.8328.0728.5621.87
2842358-84235819.46319.53
31662588-166258838.41438.58
41119437-111943725.86525.94
51336577-133657730.88230.99
61219074-121907428.16728.27
60min11315679-131567930.39930.8220.2930.5430.9720.34
2917139-91713921.19121.29
31748742-174874240.40540.64
41254353-125435328.98229.10
51449759-144975933.49733.65
61317697-131769730.44630.60
90min11423787-142378732.89733.2418.7933.0933.4418.83
2995140-99514022.99323.13
31823162-182316242.12442.42
41390461-139046132.12732.29
51573008-157300836.34436.56
61426141-142614132.95133.16
120min11473446-147344634.04434.1617.8534.2934.4217.90
21037705-103770523.97624.15
31844597-184459742.62042.99
41439417-143941733.25833.48
51612671-161267137.26137.53
61462665-146266533.79534.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11517428-151742835.06034.9816.8935.3635.2916.94
21077763-107776324.90225.12
31856954-185695442.90543.34
41483025-148302534.26534.54
51647088-164708838.05638.39
61500442-150044234.66834.98
极限11845558-184555842.64242.594.4843.0042.964.61
21687535-168753538.99139.25
31919261-191926144.34544.86
41840085-184008542.51542.85
51902450-190245043.95644.35
61864177-186417743.07243.45
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.061177103117926511781921177435117434811772690.16
228.021169092116886711689800.02
单位质量响应值RSD%判断
41955.4241719.490.40数据可信
供试品溶液-2024032321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%
5min130875-308751.2883.8750.341.293.8750.35
2100657-1006574.2014.20
355625-556252.3212.32
4151242-1512426.3126.31
579912-799123.3353.33
6137685-1376855.7465.75
10min1266630-26663011.12716.0133.7411.1316.0233.73
2289666-28966612.08812.10
3272772-27277211.38311.39
4553300-55330023.09023.10
5394515-39451516.46416.47
6525287-52528721.92121.93
15min1460687-46068719.22525.3422.1519.2525.3822.16
2482747-48274720.14620.17
3525548-52554821.93221.95
4770492-77049232.15432.20
5669822-66982227.95327.99
6734615-73461530.65730.70
20min1614325-61432525.63732.3516.3925.6932.4216.39
2623613-62361326.02526.09
3778761-77876132.49932.56
4872762-87276236.42236.52
5879005-87900536.68336.76
6882154-88215436.81436.91
30min1851621-85162135.54040.7213.1335.6440.8513.13
2808053-80805333.72233.83
31007161-100716142.03142.14
4968693-96869340.42540.59
51138419-113841947.50847.65
61080582-108058245.09545.25
45min11032638-103263843.09445.399.8843.2545.599.89
2930692-93069238.84039.00
31121437-112143746.80046.98
41042988-104298843.52643.76
51231081-123108151.37551.60
61167007-116700748.70148.94
60min11099378-109937845.87947.358.7446.1147.628.75
2989395-98939541.28941.51
31164122-116412248.58148.84
41079929-107992945.06845.37
51267153-126715352.88153.19
61207343-120734350.38550.70
90min11149000-114900047.95049.057.9448.2549.407.96
21037710-103771043.30643.60
31199788-119978850.07050.41
41119124-111912446.70347.08
51295798-129579854.07654.47
61250110-125011052.17052.57
120min11164369-116436948.59149.497.4848.9749.927.50
21054340-105434044.00044.37
31205036-120503650.28950.71
41132269-113226947.25247.71
51298223-129822354.17754.66
61261476-126147652.64453.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11179777-117977749.23449.957.0449.7050.467.06
21069192-106919244.61945.06
31213222-121322250.63051.14
41147552-114755247.89048.42
51298453-129845354.18754.76
61273111-127311153.12953.70
极限11228144-122814451.25351.893.5951.8052.493.65
21179327-117932749.21649.73
31251642-125164252.23352.83
41217046-121704650.79051.40
51297076-129707654.13054.79
61287577-128757753.73354.40
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.062010147200733620073082006273200293820068000.13
228.021997569199768219976260.01
单位质量响应值RSD%判断
71518.1871292.860.23数据可信
供试品溶液-2024032321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%
5min136650-366500.8472.6952.360.852.6952.36
2126592-1265922.9242.92
366365-663651.5331.53
4192905-1929054.4564.46
5100368-1003682.3192.32
6175476-1754764.0544.05
10min1349851-3498518.08211.6733.708.0811.6733.72
2376600-3766008.7008.70
3357986-3579868.2708.27
4723006-72300616.70216.71
5532471-53247112.30012.30
6690300-69030015.94615.95
15min1630785-63078514.57219.1622.3714.5919.1822.39
2645937-64593714.92214.94
3717779-71777916.58116.60
41045872-104587224.16024.20
5941564-94156421.75121.78
6993659-99365922.95422.99
20min1870223-87022320.10325.2217.0120.1425.2717.03
2859142-85914219.84719.89
31094750-109475025.29025.33
41224212-122421228.28028.36
51274098-127409829.43329.49
61227214-122721428.35028.42
30min11259676-125967629.09933.3114.1229.1733.4114.13
21173810-117381027.11627.19
31490767-149076734.43834.52
41427512-142751232.97733.10
51729806-172980639.96040.07
61571192-157119236.29636.41
45min11602668-160266837.02338.9911.1437.1439.1411.15
21419524-141952432.79232.91
31750103-175010340.42940.57
41603158-160315837.03437.21
51964412-196441245.37945.56
61786801-178680141.27641.46
60min11754317-175431740.52641.839.9540.7142.059.95
21553971-155397135.89836.08
31874233-187423343.29643.51
41704028-170402839.36439.60
52072645-207264547.88048.13
61905107-190510744.00944.26
90min11877390-187739043.36944.409.0643.6244.689.08
21671175-167117538.60538.84
31977353-197735345.67845.96
41809720-180972041.80642.11
52165511-216551150.02550.36
62030126-203012646.89747.22
120min11921632-192163244.39145.248.6544.7145.608.67
21711233-171123339.53139.83
31999882-199988246.19946.56
41849695-184969542.72943.10
52187512-218751250.53350.95
62080511-208051148.06148.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min11949361-194936145.03245.878.3345.4346.318.34
21738510-173851040.16140.53
32022131-202213146.71347.15
41886271-188627143.57444.02
52196649-219664950.74451.24
62121234-212123449.00249.48
极限12038440-203844047.08947.805.0847.5648.315.14
21914662-191466244.23044.66
32095550-209555048.40948.92
42004599-200459946.30846.83
52199993-219999350.82151.41
62160754-216075449.91550.48
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