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%
128.535861965863265865785860815861695862700.04
228.435954885949125952000.07
单位质量响应值RSD%判断
20549.2520935.631.32数据可信
供试品溶液-2024032421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%
5min1150939-15093912.00415.3616.1412.0015.3616.14
2212226-21222616.87816.88
3211290-21129016.80416.80
4227136-22713618.06418.06
5198431-19843115.78115.78
6158538-15853812.60912.61
10min1346327-34632727.54431.347.1527.5731.387.15
2416244-41624433.10433.14
3381600-38160030.34930.39
4409158-40915832.54132.58
5422214-42221433.57933.61
6389191-38919130.95330.98
15min1499837-49983739.75242.035.0939.8442.145.10
2560940-56094044.61244.72
3498546-49854639.65039.75
4540344-54034442.97443.09
5552986-55298643.97944.09
6518303-51830341.22141.32
20min1586782-58678246.66746.433.1846.8446.623.18
2608300-60830048.37848.59
3555055-55505544.14444.34
4579585-57958546.09546.30
5597715-59771547.53747.74
6575172-57517245.74445.93
30min1649733-64973351.67451.333.0051.9551.632.99
2661984-66198452.64852.97
3614955-61495548.90849.20
4632046-63204650.26750.58
5666885-66688553.03853.35
6646986-64698651.45551.75
45min1670310-67031053.31052.781.0253.7053.201.02
2663503-66350352.76953.20
3651587-65158751.82152.22
4667430-66743053.08153.50
5667902-66790253.11953.55
6661486-66148652.60853.01
60min1671392-67139253.39652.860.8753.9153.390.87
2663276-66327652.75153.30
3655511-65551152.13352.65
4668756-66875653.18753.73
5667270-66727053.06853.62
6661423-66142352.60353.12
极限1669704-66970453.26252.690.9053.8953.340.90
2661148-66114852.58153.25
3652794-65279451.91752.55
4666057-66605752.97253.63
5665520-66552052.92953.60
6659679-65967952.46553.10
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%
128.531001150100141710016481000324100175010012580.06
228.431011056100963010103430.10
单位质量响应值RSD%判断
35094.9235537.920.89数据可信
供试品溶液-2024032421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%
5min1253652-25365212.54016.2116.5912.5416.2116.58
2361235-36123517.85917.86
3360008-36000817.79817.80
4387010-38701019.13319.13
5337086-33708616.66516.67
6268358-26835813.26713.27
10min1587079-58707929.02533.067.1229.0533.107.13
2702259-70225934.71934.76
3648407-64840732.05732.10
4695487-69548734.38434.43
5717381-71738135.46735.50
6662047-66204732.73132.76
15min1850027-85002742.02544.465.0242.1244.575.02
2952064-95206447.06947.19
3849799-84979942.01342.12
4919485-91948545.45945.58
5941909-94190946.56746.68
6882922-88292243.65143.75
20min11001002-100100249.48949.143.1949.6749.353.19
21033626-103362651.10251.32
3943978-94397846.66946.87
4987475-98747548.82049.04
51018807-101880750.36950.59
6979151-97915148.40848.61
30min11107703-110770354.76454.383.0855.0654.703.07
21128277-112827755.78156.12
31045637-104563751.69552.00
41078042-107804253.29753.63
51137494-113749456.23756.57
61103041-110304154.53354.84
45min11142906-114290656.50455.971.0656.9256.411.06
21132147-113214755.97256.43
31110330-111033054.89455.32
41138545-113854556.28956.74
51140620-114062056.39156.85
61128411-112841155.78856.22
60min11145715-114571556.64356.080.8757.1956.640.87
21132214-113221455.97656.56
31117955-111795555.27155.82
41141299-114129956.42557.00
51137940-113794056.25956.84
61130692-113069255.90056.45
极限11143563-114356356.53755.910.8857.2156.600.88
21128425-112842555.78856.50
31115365-111536555.14355.81
41136497-113649756.18756.88
51135766-113576656.15156.86
61125772-112577255.65756.33
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%
128.535944955938495937995929605934975937200.10
228.435958955951875955410.09
单位质量响应值RSD%判断
20810.3820947.630.47数据可信
供试品溶液-2024032421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%
5min1224959-22495917.77314.1321.1517.7714.1321.14
2153921-15392112.16012.16
3230136-23013618.18218.18
4152504-15250412.04812.05
5154586-15458612.21312.21
6156841-15684112.39112.39
10min1401288-40128831.70329.149.0131.7429.179.02
2337268-33726826.64626.67
3406693-40669332.13132.17
4324095-32409525.60525.63
5369039-36903929.15629.18
6374861-37486129.61629.64
15min1537319-53731942.45139.587.3142.5639.687.32
2474827-47482737.51337.60
3528306-52830641.73841.85
4443899-44389935.07035.15
5494971-49497139.10539.20
6526653-52665341.60841.70
20min1624976-62497649.37645.177.0049.5845.367.01
2554703-55470343.82443.99
3582110-58211045.98946.19
4508084-50808440.14140.30
5563428-56342844.51344.69
6597364-59736447.19447.38
30min1662240-66224052.32048.905.3452.6349.185.35
2596238-59623847.10547.37
3618747-61874748.88449.19
4568621-56862144.92445.17
5627680-62768049.58949.87
6640233-64023350.58150.87
45min1662721-66272152.35851.232.9652.7951.632.98
2629351-62935149.72150.09
3654789-65478951.73152.15
4627500-62750049.57549.93
5641156-64115650.65451.04
6675477-67547753.36653.77
60min1662046-66204652.30551.941.7652.8552.441.79
2647054-64705451.12051.60
3668070-66807052.78053.31
4651435-65143551.46651.93
5643908-64390850.87251.37
6671836-67183653.07853.60
极限1662224-66222452.31952.451.6652.9853.071.63
2669060-66906052.85953.45
3654422-65442251.70252.35
4673611-67361153.21853.79
5648069-64806951.20051.81
6675838-67583853.39454.03
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.531010266100940010104081009385101173910102400.10
228.431011425101012110107730.10
单位质量响应值RSD%判断
35409.7435553.040.29数据可信
供试品溶液-2024032421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%
5min1383984-38398418.89514.9321.6118.8914.9321.61
2260094-26009412.79912.80
3391940-39194019.28619.29
4257202-25720212.65612.66
5261616-26161612.87312.87
6265877-26587713.08313.08
10min1682830-68283033.60030.809.2633.6430.849.27
2570738-57073828.08528.11
3691603-69160334.03234.07
4547904-54790426.96126.99
5626779-62677930.84230.87
6636214-63621431.30731.34
15min1915135-91513545.03241.887.4745.1541.987.48
2804288-80428839.57739.67
3897986-89798644.18844.31
4753149-75314937.06137.15
5840386-84038641.35341.45
6895508-89550844.06644.16
20min11064754-106475452.39447.837.1352.6148.037.14
2940429-94042946.27646.46
3990286-99028648.73048.95
4862818-86281842.45742.63
5957592-95759247.12147.31
61016120-101612050.00150.20
30min11128645-112864555.53851.815.4455.8752.125.45
21012444-101244449.82050.10
31054352-105435251.88252.21
4966124-96612447.54147.81
51067421-106742152.52552.82
61088614-108861453.56853.88
45min11129998-112999855.60454.322.9856.0654.733.01
21071269-107126952.71553.11
31115588-111558854.89555.34
41066777-106677752.49352.86
51090976-109097653.68454.09
61148386-114838656.50956.94
60min11129120-112912055.56155.091.8956.1455.631.91
21100565-110056554.15654.67
31141559-114155956.17356.74
41107857-110785754.51555.00
51095217-109521753.89354.42
61143171-114317156.25356.80
极限11129648-112964855.58755.741.6556.2956.401.61
21141436-114143656.16756.80
31117712-111771255.00055.69
41149072-114907256.54357.15
51105451-110545154.39755.05
61152844-115284456.72957.41
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%
128.535845605847345843735844845852525846810.06
228.435877655877195877420.01
单位质量响应值RSD%判断
20493.5520673.300.62数据可信
供试品溶液-2024032521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%
5min1159390-15939012.77316.0417.1012.7716.0417.10
2212714-21271417.04717.05
3224121-22412117.96117.96
4245604-24560419.68319.68
5162940-16294013.05813.06
6196435-19643515.74215.74
10min1340370-34037027.27732.4011.5327.3132.4411.53
2416052-41605233.34233.38
3453149-45314936.31536.36
4445645-44564535.71435.76
5355231-35523128.46828.50
6415511-41551133.29933.33
15min1476432-47643238.18142.836.3538.2742.946.35
2520148-52014841.68441.80
3533696-53369642.77042.89
4542361-54236143.46543.59
5567064-56706445.44445.54
6566965-56696545.43645.55
20min1554496-55449644.43748.035.9644.6148.235.95
2581310-58131046.58646.79
3580546-58054646.52546.74
4595435-59543547.71847.94
5645959-64595951.76751.96
6638020-63802051.13151.34
30min1619108-61910849.61552.333.3449.8952.643.34
2664287-66428753.23653.54
3636578-63657851.01551.33
4652549-65254952.29552.62
5667303-66730353.47753.79
6677874-67787454.32454.65
45min1670062-67006253.69853.791.0954.0854.221.09
2681465-68146554.61255.04
3661260-66126052.99353.43
4673224-67322453.95254.39
5665287-66528753.31653.74
6675833-67583354.16154.61
60min1670387-67038753.72453.691.0454.2354.241.04
2680030-68003054.49755.05
3661021-66102152.97453.52
4670329-67032953.72054.28
5663632-66363253.18353.73
6674433-67443354.04954.61
极限1668446-66844653.56953.780.9154.1954.440.91
2678290-67829054.35855.03
3675503-67550354.13454.80
4668601-66860153.58154.26
5661554-66155453.01753.68
6674018-67401854.01554.70
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%
128.539981129977469961289994559989979980880.13
228.431002462100401710032400.11
单位质量响应值RSD%判断
34983.8135288.080.62数据可信
供试品溶液-2024032521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%
5min1268064-26806413.32116.8817.6613.3216.8817.67
2361072-36107217.94217.94
3381551-38155118.96018.96
4419520-41952020.84720.85
5274727-27472713.65213.65
6332974-33297416.54616.55
10min1575428-57542828.59434.1011.7528.6234.1411.75
2704361-70436135.00135.04
3770899-77089938.30838.35
4758675-75867537.70037.75
5602290-60229029.92929.96
6705903-70590335.07835.11
15min1808723-80872340.18745.146.5340.2845.256.53
2877840-87784043.62243.74
3908813-90881345.16145.29
4923941-92394145.91346.04
5965576-96557647.98148.08
6965055-96505547.95648.07
20min1941879-94187946.80450.666.1246.9950.886.10
2987497-98749749.07149.29
3986101-98610149.00149.23
41013414-101341450.35950.59
51100334-110033454.67854.88
61087888-108788854.05954.28
30min11048870-104887052.12155.213.5352.4155.543.53
21126269-112626955.96756.29
31083856-108385653.85954.20
41112498-111249855.28255.63
51137265-113726556.51356.84
61157253-115725357.50657.85
45min11137417-113741756.52156.811.1356.9257.261.14
21161850-116185057.73558.18
31126627-112662755.98456.44
41146716-114671656.98357.45
51134649-113464956.38356.83
61152673-115267357.27957.75
60min11142709-114270956.78456.741.0857.3157.321.07
21158322-115832257.55958.14
31124886-112488655.89856.48
41142556-114255656.77657.37
51131377-113137756.22056.80
61150951-115095157.19357.79
极限11139567-113956756.62756.830.9657.2857.540.96
21155936-115593657.44158.15
31153778-115377857.33458.04
41139421-113942156.62057.34
51126493-112649355.97856.68
61146931-114693156.99357.72
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.536020526006375999175994675996466003440.18
228.436073586071076072320.03
单位质量响应值RSD%判断
21042.5521358.851.06数据可信
供试品溶液-2024032521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%
5min1233635-23363518.17915.0218.0418.1815.0218.03
2167354-16735413.02213.02
3200596-20059615.60815.61
4232281-23228118.07418.07
5150762-15076211.73111.73
6173849-17384913.52713.53
10min1416537-41653732.41029.847.7732.4529.887.79
2378550-37855029.45529.48
3399234-39923431.06431.10
4406207-40620731.60731.65
5336955-33695526.21826.24
6363718-36371828.30128.33
15min1540996-54099642.09440.854.0142.2140.944.03
2538365-53836541.89041.98
3536490-53649041.74441.85
4529150-52915041.17341.28
5485042-48504237.74137.82
6519607-51960740.43040.52
20min1583079-58307945.36946.133.3245.5746.323.30
2620141-62014148.25348.44
3595555-59555546.34046.54
4583918-58391845.43445.64
5565499-56549944.00144.17
6608647-60864747.35847.54
30min1638066-63806649.64750.374.0049.9550.664.00
2667531-66753151.94052.23
3674146-67414652.45552.75
4636747-63674749.54549.85
5605031-60503147.07747.34
6662697-66269751.56451.85
45min1666332-66633251.84751.852.2152.2652.262.23
2672140-67214052.29952.71
3676094-67609452.60653.02
4668563-66856352.02052.43
5637724-63772449.62149.99
6677729-67772952.73353.14
60min1668338-66833852.00352.131.3952.5452.651.41
2670107-67010752.14052.67
3674614-67461452.49153.02
4673436-67343652.39952.93
5653024-65302450.81151.29
6680344-68034452.93753.46
极限1666877-66687751.88952.270.9052.5452.900.90
2669420-66942052.08752.73
3672495-67249552.32652.98
4673789-67378952.42753.07
5665670-66567051.79552.39
6682242-68224253.08553.72
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.531021068102011010206501020848102082410207000.04
228.431026884102643410266590.04
单位质量响应值RSD%判断
35776.3836111.820.66数据可信
供试品溶液-2024032521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%
5min1398430-39843019.35415.9018.5819.3515.9018.58
2282247-28224713.71013.71
3340052-34005216.51816.52
4396083-39608319.24019.24
5253879-25387912.33212.33
6293769-29376914.27014.27
10min1708925-70892534.43631.627.8634.4831.657.87
2642811-64281131.22531.25
3677219-67721932.89632.93
4688486-68848633.44333.49
5571069-57106927.74027.77
6616894-61689429.96630.00
15min1921342-92134244.75443.384.1044.8743.484.11
2915827-91582744.48644.59
3912031-91203144.30244.41
4901646-90164643.79743.91
5823498-82349840.00140.09
6883980-88398042.93943.04
20min1993576-99357648.26349.013.2548.4849.223.24
21057543-105754351.37051.57
31013976-101397649.25449.46
4993113-99311348.24048.45
5964486-96448646.85047.03
61031566-103156650.10850.30
30min11086013-108601352.75353.504.0653.0853.824.05
21136323-113632355.19755.51
31148299-114829955.77956.10
41083881-108388152.64952.97
51027983-102798349.93450.22
61126150-112615054.70355.01
45min11135717-113571755.16755.152.2255.6155.582.23
21146044-114604455.66956.10
31152461-115246155.98156.42
41141702-114170255.45855.90
51085600-108560052.73353.13
61151133-115113355.91656.34
60min11138953-113895355.32555.441.4555.8956.001.47
21143666-114366655.55456.11
31150255-115025555.87456.44
41147831-114783155.75656.32
51110204-111020453.92854.44
61157505-115750556.22656.78
极限11138706-113870655.31355.650.9056.0056.330.91
21139565-113956555.35456.04
31147675-114767555.74856.44
41149146-114914655.82056.51
51135331-113533155.14955.78
61163562-116356256.52057.20
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%
128.535952895980125948065954825962485959670.22
228.436007286008396007840.02
单位质量响应值RSD%判断
20889.1321132.040.82数据可信
供试品溶液-2024032621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%
5min1252728-25272819.84216.2620.3519.8416.2620.34
2170762-17076213.40713.41
3152159-15215911.94611.95
4249591-24959119.59619.60
5226427-22642717.77717.78
6190699-19069914.97214.97
10min1439341-43934134.49332.218.4934.5432.248.50
2405377-40537731.82731.86
3354243-35424327.81227.84
4446725-44672535.07335.12
5426558-42655833.49033.53
6388993-38899330.54030.57
15min1570934-57093444.82543.845.2144.9543.955.22
2574377-57437745.09545.20
3504377-50437739.59939.69
4580599-58059945.58445.71
5546041-54604142.87042.98
6574037-57403745.06845.17
20min1620649-62064948.72848.113.8648.9548.313.86
2618510-61851048.56048.76
3573346-57334645.01445.19
4619826-61982648.66348.89
5600597-60059747.15447.36
6643371-64337150.51250.71
30min1673664-67366452.89052.613.1753.2252.923.18
2666871-66687152.35752.67
3632131-63213149.62949.91
4680809-68080953.45153.78
5671073-67107352.68753.00
6695960-69596054.64154.95
45min1677410-67741053.18453.341.4253.6353.771.43
2670536-67053652.64553.07
3670342-67034252.62953.02
4682281-68228153.56754.02
5679410-67941053.34153.77
6696361-69636154.67255.11
60min1674351-67435152.94453.281.3953.5153.831.39
2668664-66866452.49853.04
3674308-67430852.94153.44
4680736-68073653.44554.01
5677855-67785553.21953.77
6695875-69587554.63455.19
极限1674335-67433552.94353.231.3753.6253.901.37
2667716-66771652.42353.08
3673738-67373852.89653.52
4678880-67888053.30053.99
5678120-67812053.24053.91
6695032-69503254.56855.25
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%
128.531011054101273910094561011053101242710113460.13
228.431017589101756010175740.01
单位质量响应值RSD%判断
35448.5135792.260.69数据可信
供试品溶液-2024032621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%
5min1429974-42997421.07617.1920.9521.0817.1920.96
2287590-28759014.09714.10
3254506-25450612.47512.47
4424856-42485620.82520.82
5384654-38465418.85418.85
6322249-32224915.79615.80
10min1746239-74623936.57834.108.6536.6234.148.66
2682224-68222433.44033.47
3600022-60002229.41129.44
4758975-75897537.20237.25
5726162-72616235.59435.64
6660218-66021832.36232.40
15min1970132-97013247.55246.505.1847.6846.615.18
2970166-97016647.55447.66
3857318-85731842.02342.12
4987405-98740548.39948.53
5928663-92866345.52045.64
6978022-97802247.93948.05
20min11053847-105384751.65651.063.9351.8951.283.93
21049517-104951751.44451.65
3974476-97447647.76547.95
41054220-105422051.67451.91
51021649-102164950.07850.30
61097026-109702653.77253.99
30min11145662-114566256.15655.913.3856.5056.243.39
21135201-113520155.64455.97
31071723-107172352.53252.82
41159297-115929756.82557.18
51144057-114405756.07856.41
61187841-118784158.22458.56
45min11154849-115484956.60756.751.4557.0857.201.46
21142403-114240355.99756.45
31141073-114107355.93156.34
41163249-116324957.01857.50
51158237-115823756.77357.23
61186700-118670058.16858.63
60min11149619-114961956.35056.711.3856.9557.291.38
21140004-114000455.87956.45
31149369-114936956.33856.87
41160056-116005656.86257.47
51155999-115599956.66357.25
61186123-118612358.14058.73
极限11148997-114899756.32056.651.4157.0457.361.41
21137800-113780055.77156.47
31147931-114793156.26856.93
41157409-115740956.73257.46
51157132-115713256.71957.43
61185489-118548958.10858.83
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%
128.536080146075506073306073336065346073520.09
228.436180646167046173840.16
单位质量响应值RSD%判断
21288.1921715.931.41数据可信
供试品溶液-2024032621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%
5min1178410-17841013.68814.2115.3613.6914.2115.35
2182326-18232613.98813.99
3209775-20977516.09416.09
4218379-21837916.75416.75
5137384-13738410.54010.54
6185013-18501314.19514.19
10min1374635-37463528.74328.468.7228.7728.498.72
2379972-37997229.15229.18
3374136-37413628.70428.74
4418385-41838532.09932.14
5318597-31859724.44324.47
6359664-35966427.59427.63
15min1504781-50478138.72838.167.0438.8238.257.04
2545662-54566241.86441.96
3492539-49253937.78837.89
4522652-52265240.09940.21
5450089-45008934.53234.61
6468427-46842735.93936.03
20min1570402-57040243.76243.034.8843.9443.214.89
2603372-60337246.29246.48
3552870-55287042.41742.60
4573645-57364544.01144.21
5529358-52935840.61340.77
6535803-53580341.10841.28
30min1615902-61590247.25347.264.2847.5347.534.28
2661056-66105650.71751.01
3604555-60455546.38346.66
4629251-62925148.27748.57
5595100-59510045.65745.90
6589802-58980245.25145.51
45min1648941-64894149.78850.521.8150.1750.901.83
2677498-67749851.97952.38
3656317-65631750.35450.73
4668072-66807251.25651.66
5647522-64752249.67950.03
6652293-65229350.04550.41
60min1670342-67034251.43051.880.8951.9252.380.91
2678010-67801052.01852.54
3682435-68243552.35852.85
4682962-68296252.39852.91
5668741-66874151.30751.76
6675049-67504951.79152.27
极限1671661-67166151.53152.180.8052.1452.780.78
2676370-67637051.89252.53
3682454-68245452.35952.97
4685564-68556452.59853.23
5684940-68494052.55053.12
6679380-67938052.12352.71
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.531029305102893910278971030121102746610287460.11
228.431037778103737410375760.03
单位质量响应值RSD%判断
36058.3936495.810.86数据可信
供试品溶液-2024032621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%
5min1300768-30076814.47615.0515.8814.4815.0515.88
2307662-30766214.80814.81
3355685-35568517.11917.12
4370099-37009917.81317.81
5229016-22901611.02211.02
6312812-31281215.05615.06
10min1634671-63467130.54730.228.9430.5830.258.95
2644055-64405530.99831.03
3633851-63385130.50730.55
4709876-70987634.16634.21
5537081-53708125.85025.87
6607386-60738629.23329.27
15min1856513-85651341.22440.607.1041.3240.707.10
2925814-92581444.55944.66
3835809-83580940.22740.33
4887075-88707542.69542.81
5762235-76223536.68636.77
6794251-79425138.22738.33
20min1969061-96906146.64145.834.9946.8346.024.99
21026066-102606649.38449.59
3937913-93791345.14245.34
4973593-97359346.85947.07
5897557-89755743.19943.36
6909055-90905543.75343.94
30min11043902-104390250.24350.354.3850.5450.644.39
21124844-112484454.13854.45
31026773-102677349.41849.71
41070242-107024251.51051.83
51010241-101024148.62348.88
61000856-100085648.17148.45
45min11103315-110331553.10253.931.8653.5154.341.88
21153738-115373855.52955.96
31116576-111657653.74154.15
41137542-113754254.75055.18
51102151-110215153.04653.41
61109823-110982353.41653.80
60min11140632-114063254.89855.400.9755.4255.931.00
21156309-115630955.65356.21
31162552-116255255.95356.48
41162875-116287555.96956.52
51136987-113698754.72355.21
61147395-114739555.22455.73
极限11145841-114584155.14955.820.7755.8056.470.76
21154379-115437955.56056.24
31163578-116357856.00356.65
41169707-116970756.29856.97
51167497-116749756.19156.80
61158281-115828155.74856.38
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