沙库巴曲缬沙坦片项目信息
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%
127.931138711113883311374651137952113856611383050.06
228.051140586114186611412260.08
单位质量响应值RSD%判断
40755.6440685.420.13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%
5min1150616-1506165.9913.0370.535.993.0370.56
259185-591852.3542.35
3103085-1030854.1004.10
421749-217490.8650.87
513948-139480.5550.55
6108618-1086184.3204.32
10min1480960-48096019.13012.7037.5519.1412.7137.56
2235033-2350339.3489.35
3388308-38830815.44415.45
4211724-2117248.4218.42
5196284-1962847.8077.81
6404228-40422816.07816.08
15min1832065-83206533.09423.2427.2233.1423.2727.25
2462051-46205118.37718.40
3651541-65154125.91425.95
4466357-46635718.54918.56
5426782-42678216.97516.99
6667629-66762926.55426.59
20min11021680-102168040.63630.9621.0840.7331.0221.11
2641620-64162025.52025.57
3851897-85189733.88333.96
4657318-65731826.14426.19
5616625-61662524.52524.57
6880538-88053835.02235.10
30min11131815-113181545.01639.5411.3845.1839.6611.42
2922343-92234336.68536.78
31082192-108219243.04343.17
4877746-87774634.91135.00
5881158-88115835.04735.13
61069828-106982842.55142.69
45min11190949-119094947.36843.018.5047.6143.208.56
21055093-105509341.96542.12
31155981-115598145.97846.18
4964012-96401238.34238.49
5992825-99282539.48839.63
61130004-113000444.94445.15
60min11222400-122240048.61944.837.5248.9445.087.58
21102303-110230343.84344.07
31184015-118401547.09347.37
41004597-100459739.95640.17
51061599-106159942.22442.43
61187594-118759447.23547.52
极限11244091-124409149.48248.241.9149.8848.571.97
21222179-122217948.61048.91
31213999-121399948.28548.64
41172818-117281846.64746.93
51211803-121180348.19848.48
61212921-121292148.24248.60
沙库巴曲缬沙坦片项目信息
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%
127.931987707198691619857601985765198561919863530.05
228.051987802199116019894810.12
单位质量响应值RSD%判断
71118.9870926.240.20数据可信
供试品溶液-2024032221批-缬沙坦-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%
5min1194978-1949784.2012.0376.674.202.0376.65
270729-707291.5241.52
3128568-1285682.7702.77
420697-206970.4460.45
511628-116280.2510.25
6137872-1378722.9702.97
10min1673021-67302114.5009.2841.1214.519.2841.14
2305630-3056306.5856.59
3530566-53056611.43111.44
4273045-2730455.8835.88
5249575-2495755.3775.38
6552442-55244211.90211.91
15min11179804-117980425.41917.5829.5225.4517.6029.54
2624161-62416113.44713.46
3930078-93007820.03820.06
4635731-63573113.69713.71
5576454-57645412.42012.43
6950174-95017420.47120.50
20min11482811-148281131.94723.9923.1532.0224.0423.18
2891964-89196419.21719.25
31244377-124437726.81026.87
4920992-92099219.84319.88
5859682-85968218.52218.55
61280860-128086027.59627.65
30min11728668-172866837.24431.8013.9137.3731.8913.95
21327374-132737428.59828.67
31634981-163498135.22535.33
41278852-127885227.55327.62
51271977-127197727.40427.47
61612964-161296434.75134.86
45min11883897-188389740.58835.9410.5540.7836.0810.60
21586792-158679234.18734.30
31814338-181433839.09039.25
41461773-146177331.49431.61
51498764-149876432.29132.40
61762604-176260437.97538.14
60min11973280-197328042.51438.269.2542.7738.469.31
21707678-170767836.79236.96
31899958-189995840.93441.16
41558585-155858533.57933.74
51639417-163941735.32135.48
61875467-187546740.40740.63
极限12065284-206528444.49642.792.8044.8243.052.88
21978878-197887842.63442.87
32013998-201399843.39143.68
41900970-190097040.95641.18
51956349-195634942.14942.37
62000580-200058043.10243.40
沙库巴曲缬沙坦片项目信息
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%
127.931139326113921511365511137450113900111383090.11
228.051135693113742811365600.11
单位质量响应值RSD%判断
40755.7840519.070.42数据可信
供试品溶液-TYN28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%
5min1162091-1620916.4605.5320.656.465.5320.67
2100287-1002873.9974.00
3139081-1390815.5435.54
4116993-1169934.6634.66
5178775-1787757.1257.13
6135757-1357575.4115.41
10min1422370-42237016.83415.7410.6016.8415.7410.60
2425412-42541216.95516.96
3384687-38468715.33215.34
4343552-34355213.69213.70
5443014-44301417.65617.67
6350137-35013713.95513.96
15min1593753-59375323.66423.347.7523.7023.387.75
2583906-58390623.27223.31
3602410-60241024.00924.04
4531625-53162521.18821.22
5658434-65843426.24226.28
6544028-54402821.68221.71
20min1762410-76241030.38630.146.2930.4630.226.29
2722242-72224228.78528.86
3793646-79364631.63131.71
4693577-69357727.64327.71
5823925-82392532.83832.92
6742147-74214729.57829.65
30min11028252-102825240.98139.584.4641.1139.714.47
2931138-93113837.11137.23
31006778-100677840.12540.25
4990757-99075739.48739.60
51047942-104794241.76641.91
6953985-95398538.02138.14
45min11133381-113338145.17144.343.1645.3744.533.16
21055152-105515242.05342.24
31114889-111488944.43444.63
41147535-114753545.73545.91
51136681-113668145.30345.51
61087471-108747143.34143.52
60min11185340-118534047.24246.382.6447.5146.642.64
21111403-111140344.29544.55
31159886-115988646.22846.50
41192778-119277847.53847.79
51184135-118413547.19447.48
61148654-114865445.78046.03
极限11221504-122150448.68349.081.4249.0349.421.38
21258704-125870450.16650.49
31216508-121650848.48448.83
41238368-123836849.35549.69
51213233-121323348.35448.72
61240138-124013849.42649.76
沙库巴曲缬沙坦片项目信息
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%
127.931982600198542919818711985384198558819841740.10
228.051981277198248319818800.05
单位质量响应值RSD%判断
71040.9670655.260.39数据可信
供试品溶液-TYN28批-缬沙坦-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%
5min1206858-2068584.4683.7821.704.473.7821.66
2127568-1275682.7552.76
3173332-1733323.7443.74
4144259-1442593.1163.12
5229645-2296454.9604.96
6169627-1696273.6643.66
10min1574472-57447212.40711.5811.1412.4111.5911.12
2584566-58456612.62512.63
3519317-51931711.21611.22
4465935-46593510.06310.07
5603047-60304713.02513.03
6470414-47041410.16010.17
15min1838703-83870318.11417.847.9118.1417.867.91
2832085-83208517.97118.00
3850249-85024918.36418.39
4750110-75011016.20116.22
5926148-92614820.00320.03
6757373-75737316.35816.38
20min11101329-110132923.78623.546.1523.8423.606.16
21048973-104897322.65622.71
31146513-114651324.76224.82
41000755-100075521.61421.66
51182661-118266125.54325.61
61060660-106066022.90822.96
30min11514423-151442332.70831.854.1932.8131.954.20
21393624-139362430.09930.19
31512308-151230832.66332.76
41474800-147480031.85331.94
51545916-154591633.38933.49
61408129-140812930.41330.50
45min11743883-174388337.66437.253.2537.8237.393.25
21641095-164109535.44435.59
31762825-176282538.07338.22
41781684-178168438.48138.62
51748053-174805337.75437.92
61669364-166936436.05536.19
60min11887340-188734040.76340.212.8540.9840.422.85
21774412-177441238.32438.53
31897682-189768240.98641.20
41907230-190723041.19241.39
51885436-188543640.72240.95
61818763-181876339.28239.48
极限12007891-200789143.36643.771.2543.6544.041.22
22062734-206273444.55144.82
32029420-202942043.83144.11
42041883-204188344.10144.37
51990966-199096643.00143.29
62026167-202616743.76144.03
沙库巴曲缬沙坦片项目信息
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%
127.931162867116233211633281163628116420511632720.07
228.051192573119258411925780.01
单位质量响应值RSD%判断
41649.5542516.151.46数据可信
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%
5min1249519-2495199.60412.6218.189.6012.6218.17
2333593-33359312.84012.84
3279736-27973610.76710.77
4376295-37629514.48414.48
5410559-41055915.80215.80
6318322-31832212.25212.25
10min1640414-64041424.65027.0913.0724.6727.1113.07
2667168-66716825.67925.70
3589923-58992322.70622.72
4816004-81600431.40831.43
5810223-81022331.18631.21
6698927-69892726.90226.92
15min1854530-85453032.89137.2214.9832.9537.2914.97
2857012-85701232.98633.05
3816902-81690231.44331.50
41140172-114017243.88543.96
51128715-112871543.44443.52
61004892-100489238.67838.74
20min11026046-102604639.49343.3014.0539.6043.4314.05
2969957-96995737.33437.45
3957400-95740036.85036.96
41292993-129299349.76749.92
51287277-128727749.54749.70
61216512-121651246.82446.95
30min11190235-119023545.81247.079.0345.9947.279.04
21092268-109226842.04142.22
31099581-109958142.32342.49
41319701-131970150.79551.03
51318293-131829350.74150.97
61318151-131815150.73650.94
45min11274035-127403549.03848.445.9449.2948.725.97
21163112-116311244.76845.02
31165772-116577244.87145.11
41312524-131252450.51950.84
51317580-131758050.71451.03
61318305-131830550.74251.03
60min11282483-128248349.36349.083.9249.7049.443.96
21212562-121256246.67247.00
31212709-121270946.67746.99
41309412-130941250.39950.80
51318804-131880450.76151.16
61314147-131414750.58250.96
极限11303208-130320850.16150.300.5850.5850.740.60
21315297-131529750.62651.03
31295072-129507249.84750.24
41304145-130414550.19750.68
51312954-131295450.53651.02
61309992-130999250.42250.88
沙库巴曲缬沙坦片项目信息
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%
127.932026517202545420252672025329202416820253470.05
228.052060999205655720587780.16
单位质量响应值RSD%判断
72515.1173396.720.86数据可信
供试品溶液-2024032221批-缬沙坦-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%
5min1438985-4389859.20812.2218.259.2112.2218.25
2593764-59376412.45412.45
3498781-49878110.46210.46
4664350-66435013.93413.93
5730317-73031715.31815.32
6568380-56838011.92211.92
10min11113958-111395823.36525.7913.1823.3825.8113.19
21168902-116890224.51724.54
31028544-102854421.57321.59
41424218-142421829.87229.90
51418962-141896229.76229.79
61222031-122203125.63225.65
15min11482560-148256031.09635.3915.1331.1535.4515.12
21497870-149787031.41731.48
31423481-142348129.85729.91
41988551-198855141.70941.78
51974689-197468941.41841.49
61755164-175516436.81436.88
20min11784206-178420637.42341.1814.1937.5341.3114.19
21694608-169460835.54435.66
31667659-166765934.97835.08
42256450-225645047.32847.47
52253067-225306747.25747.40
62125053-212505344.57244.70
30min12069633-206963343.41044.729.2443.5844.919.25
21900748-190074839.86740.04
31912592-191259240.11640.28
42302328-230232848.29048.51
52308514-230851448.42048.64
62299650-229965048.23448.43
45min12217786-221778646.51746.066.1146.7646.336.14
22025060-202506042.47542.71
32031387-203138742.60742.84
42292739-229273948.08948.39
52306597-230659748.38048.68
62303577-230357748.31748.60
60min12231881-223188146.81346.664.1147.1347.004.15
22112035-211203544.29944.61
32111743-211174344.29344.59
42286302-228630247.95448.34
52305252-230525248.35248.74
62301081-230108148.26448.62
极限12275304-227530447.72447.930.7248.1248.350.75
22301881-230188148.28148.67
32260692-226069247.41747.79
42279475-227947547.81148.27
52301993-230199348.28348.75
62290733-229073348.04748.49
沙库巴曲缬沙坦片项目信息
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%
127.931142049114220811448531143415114472411434500.12
228.051151729115157611516520.01
单位质量响应值RSD%判断
40939.8541057.110.21数据可信
供试品溶液-TYN28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%
5min1226784-2267848.95911.6114.018.9611.6114.02
2342375-34237513.52513.53
3313909-31390912.40112.40
4287275-28727511.34911.35
5320641-32064112.66712.67
6272392-27239210.76110.76
10min1532735-53273521.04524.9111.1021.0624.9211.10
2651450-65145025.73525.76
3666522-66652226.33026.35
4648357-64835725.61325.63
5721110-72111028.48728.51
6562498-56249822.22122.24
15min1762914-76291430.13833.557.7730.1933.627.78
2880062-88006234.76634.83
3892693-89269335.26535.33
4864928-86492834.16834.23
5922704-92270436.45036.52
6772981-77298130.53630.59
20min1966973-96697338.19939.346.8738.3039.466.86
21086359-108635942.91643.04
31045124-104512441.28741.41
41031082-103108240.73240.85
5930537-93053736.76036.89
6915753-91575336.17636.28
30min11109371-110937143.82546.817.1843.9946.997.17
21237967-123796748.90549.10
31151510-115151045.48945.68
41285388-128538850.77850.96
51250452-125045249.39849.59
61074922-107492242.46442.63
45min11206731-120673147.67149.023.2747.9149.283.28
21240776-124077649.01649.29
31217798-121779848.10848.38
41313983-131398351.90852.18
51255795-125579549.60949.88
61210150-121015047.80648.04
60min11269326-126932650.14349.902.0450.4650.242.03
21233323-123332348.72149.08
31260191-126019149.78350.13
41309804-130980451.74252.10
51252046-125204649.46149.82
61254760-125476049.56849.88
极限11284547-128454750.74550.582.0451.1451.002.01
21234170-123417048.75549.19
31299044-129904451.31751.75
41306861-130686151.62652.07
51269343-126934350.14450.58
61287860-128786050.87651.27
沙库巴曲缬沙坦片项目信息
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%
127.931989864198923219881991989616199264019899100.09
228.052000876200094520009100.01
单位质量响应值RSD%判断
71246.3371333.690.09数据可信
供试品溶液-TYN28批-缬沙坦-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%
5min1393671-3936718.45011.0814.398.4511.0814.40
2598473-59847312.84612.85
3545579-54557911.71011.71
4503952-50395210.81710.82
5575491-57549112.35212.35
6480368-48036810.31110.31
10min1919150-91915019.72923.4911.3419.7423.5111.34
21131808-113180824.29324.31
31155633-115563324.80424.82
41125477-112547724.15724.18
51257439-125743926.99027.01
6978009-97800920.99221.01
15min11318890-131889028.30931.657.9628.3631.717.96
21529854-152985432.83732.90
31550013-155001333.26933.33
41503610-150361032.27332.33
51604803-160480334.44534.51
61340065-134006528.76328.82
20min11674834-167483435.94937.097.0836.0437.207.08
21891057-189105740.59040.71
31811643-181164338.88539.00
41794152-179415238.51038.62
51612080-161208034.60234.72
61584480-158448034.00934.11
30min11922561-192256141.26644.217.4941.4244.397.48
22160523-216052346.37346.56
31994396-199439642.80842.99
42239563-223956348.07048.25
52179670-217967046.78446.96
61862610-186261039.97940.14
45min12093266-209326644.93046.313.4845.1546.563.48
22159212-215921246.34546.61
32111390-211139045.31945.57
42289336-228933649.13849.39
52192293-219229347.05547.31
62100625-210062545.08845.31
60min12208592-220859247.40547.212.0747.7047.542.06
22153607-215360746.22546.56
32188018-218801846.96347.29
42284911-228491149.04349.38
52185153-218515346.90247.24
62177885-217788546.74647.04
极限12239724-223972448.07347.881.9848.4548.291.96
22155433-215543346.26446.68
32259229-225922948.49248.90
42279192-227919248.92049.34
52206195-220619547.35447.77
62245904-224590448.20648.58
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