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%
128.601157423115761911584871158640115858211581500.06
228.641164608116514611648770.04
单位质量响应值RSD%判断
40494.7640673.080.32数据可信
长期3月-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%
5min181079-810793.2363.4980.173.243.4980.14
282847-828473.3063.31
371394-713942.8492.85
420915-209150.8350.83
546334-463341.8491.85
6222135-2221358.8658.86
10min1330368-33036813.18411.8536.6613.1911.8536.65
2338007-33800713.48913.49
3278365-27836511.10911.11
4109094-1090944.3544.36
5284741-28474111.36311.37
6440490-44049017.57917.59
15min1557667-55766722.25521.0420.4222.2821.0620.45
2599332-59933223.91823.95
3531507-53150721.21121.23
4319380-31938012.74612.75
5535544-53554421.37221.39
6619193-61919324.71124.75
20min1691203-69120327.58428.8315.5227.6528.8915.55
2820993-82099332.76432.83
3735029-73502929.33329.39
4530101-53010121.15521.18
5713069-71306928.45728.51
6844558-84455833.70433.79
30min1860856-86085634.35536.4411.4534.4736.5511.47
21051823-105182341.97642.10
3924613-92461336.89937.01
4773197-77319730.85630.92
5856834-85683434.19434.30
61011816-101181640.37940.52
45min1957553-95755338.21439.8910.0438.3840.0610.07
21141771-114177145.56545.76
31000878-100087839.94340.11
4879299-87929935.09135.21
5926152-92615236.96137.12
61091750-109175043.56943.78
60min11001408-100140839.96441.709.5040.2041.949.53
21182467-118246747.18947.46
31048525-104852541.84442.08
4921953-92195336.79336.97
5977003-97700338.99039.21
61138018-113801845.41645.70
极限11205376-120537648.10448.091.8448.4048.391.89
21230747-123074749.11649.46
31221934-122193448.76449.07
41187145-118714547.37647.61
51171727-117172746.76147.05
61212616-121261648.39348.75
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%
128.602000596200093920018992002382200290120017430.05
228.642010729201176220112460.04
单位质量响应值RSD%判断
69991.0170225.070.24数据可信
长期3月-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%
5min199810-998102.1782.4279.372.182.4279.31
2105664-1056642.3062.31
392011-920112.0082.01
426872-268720.5870.59
560835-608351.3281.33
6280207-2802076.1166.12
10min1432451-4324519.4398.5337.649.448.5337.67
2451201-4512019.8489.85
3365179-3651797.9707.97
4136120-1361202.9712.97
5376643-3766438.2218.22
6583317-58331712.73112.74
15min1757476-75747616.53315.6321.3316.5515.6521.34
2828137-82813718.07518.10
3724370-72437015.81015.83
4421491-4214919.1999.21
5726123-72612315.84815.86
6840376-84037618.34218.37
20min1960672-96067220.96721.8816.5821.0121.9316.61
21168101-116810125.49525.55
31021248-102124822.29022.33
4716987-71698715.64915.67
5982756-98275621.44921.49
61165829-116582925.44525.51
30min11230909-123090926.86628.5512.6226.9528.6312.64
21539665-153966533.60533.70
31331288-133128829.05629.14
41083804-108380423.65523.70
51220449-122044926.63726.72
61442328-144232831.48031.58
45min11422811-142281131.05432.3711.3631.1832.5011.39
21738670-173867037.94838.10
31488405-148840532.48632.61
41283195-128319528.00728.09
51354806-135480629.57029.69
61610933-161093335.16035.32
60min11523510-152351033.25234.6610.9133.4334.8410.93
21845175-184517540.27340.48
31596272-159627234.84035.02
41378557-137855730.08830.22
51457970-145797031.82131.99
61725402-172540237.65837.87
极限11924953-192495342.01442.022.8942.2542.262.94
22003211-200321143.72244.00
31952924-195292442.62442.87
41882154-188215441.08041.26
51845277-184527740.27540.50
61942288-194228842.39242.67
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%
128.601158955115827311581611158382115837311584290.03
228.641173230117211611726730.07
单位质量响应值RSD%判断
40504.5140945.290.77数据可信
长期3月-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%
5min162033-620332.4671.8247.292.471.8247.39
210894-108940.4330.43
355973-559732.2262.23
454825-548252.1802.18
564100-641002.5492.55
627175-271751.0811.08
10min1253024-25302410.0639.0934.7310.079.0934.73
2134094-1340945.3335.33
3224759-2247598.9398.94
4290984-29098411.57311.58
5329096-32909613.08813.09
6139412-1394125.5445.55
15min1488524-48852419.42917.9519.3119.4517.9719.33
2360603-36060314.34114.35
3457518-45751818.19618.21
4487209-48720919.37719.40
5573437-57343722.80622.83
6341260-34126013.57213.58
20min1683067-68306727.16625.5313.3027.2225.5813.32
2542562-54256221.57821.61
3681344-68134427.09727.15
4649806-64980625.84325.90
5755282-75528230.03830.10
6539980-53998021.47521.51
30min1878466-87846634.93733.3910.1435.0433.4810.16
2749159-74915929.79429.86
3890322-89032235.40935.50
4826981-82698132.88932.99
5955262-95526237.99138.11
6737742-73774229.34029.41
45min1956366-95636638.03537.609.1938.1937.749.20
2858335-85833534.13634.26
31003936-100393639.92740.08
4914101-91410136.35436.51
51080112-108011242.95743.13
6859153-85915334.16934.29
60min11012573-101257340.27040.097.9440.4940.307.97
2938512-93851237.32537.50
31064148-106414842.32242.54
4987061-98706139.25639.47
51130418-113041844.95745.21
6915398-91539836.40636.58
极限11222713-122271348.62847.502.2648.9247.772.31
21167003-116700346.41246.65
31188670-118867047.27447.56
41181756-118175646.99947.28
51232308-123230849.00949.33
61173143-117314346.65646.89
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%
128.602003487200285420023172002997200257120028450.03
228.642023202202253920228700.03
单位质量响应值RSD%判断
70029.5570630.940.61数据可信
长期3月-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%
5min172762-727621.5831.2049.681.581.2049.57
29924-99240.2160.22
366954-669541.4571.46
468773-687731.4961.50
579685-796851.7341.73
633221-332210.7230.72
10min1323823-3238237.0456.4136.037.056.4136.01
2168899-1688993.6753.68
3292670-2926706.3686.37
4376606-3766068.1948.20
5430735-4307359.3729.37
6174661-1746613.8003.80
15min1647463-64746314.08713.0920.3114.1013.1020.34
2473596-47359610.30410.31
3614467-61446713.36913.38
4649997-64999714.14214.16
5775846-77584616.88016.90
6448911-4489119.7679.77
20min1935814-93581420.36119.1114.6220.4019.1414.64
2727071-72707115.81915.84
3939799-93979920.44720.48
4885686-88568619.27019.31
51051734-105173422.88322.93
6729110-72911015.86315.89
30min11249821-124982127.19325.8711.3227.2625.9411.34
21039218-103921822.61122.66
31271955-127195527.67427.74
41166351-116635125.37725.45
51371751-137175129.84629.93
61035491-103549122.52922.58
45min11413589-141358930.75630.2610.3630.8730.3710.38
21238410-123841026.94427.03
31485746-148574632.32632.44
41341127-134112729.17929.29
51613024-161302435.09535.23
61252660-125266027.25427.34
60min11531530-153153033.32233.129.2533.4933.289.28
21385112-138511230.13630.27
31614901-161490135.13635.31
41494551-149455132.51732.68
51739819-173981937.85438.05
61368750-136875029.78029.91
极限11952514-195251442.48141.372.9742.7141.593.02
21842014-184201440.07740.26
31893994-189399441.20841.44
41877674-187767440.85341.07
51986083-198608343.21243.47
61856544-185654440.39340.58
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%
128.601166500116638311658751164133116310211651990.13
228.641161194116056111608780.04
单位质量响应值RSD%判断
40741.2240533.450.37数据可信
长期3月-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%
5min196134-961343.8314.2588.513.834.2588.42
2277114-27711411.04411.04
315440-154400.6150.62
4142988-1429885.6995.70
563105-631052.5152.52
644906-449061.7901.79
10min1434632-43463217.32213.0728.1617.3313.0828.17
2362005-36200514.42814.45
3157618-1576186.2826.28
4350756-35075613.97913.99
5347012-34701213.83013.83
6315276-31527612.56512.57
15min1646624-64662425.77121.7915.3925.8121.8215.41
2600278-60027823.92423.97
3405334-40533416.15516.17
4535016-53501621.32321.36
5581536-58153623.17723.20
6512105-51210520.41020.43
20min1863971-86397134.43430.1412.6034.5130.2012.62
2796580-79658031.74831.83
3586215-58621523.36423.40
4723491-72349128.83528.90
5801218-80121831.93332.00
6765873-76587330.52430.58
30min11038462-103846241.38838.198.8841.5238.318.90
21043791-104379141.60141.74
3857638-85763834.18134.26
4856090-85609034.12034.24
5952387-95238737.95838.08
61001380-100138039.91040.02
45min11065475-106547542.46541.477.4742.6741.657.48
21155880-115588046.06846.27
3985680-98568039.28539.42
4931088-93108837.10937.28
51031209-103120941.09941.28
61074463-107446342.82343.00
60min11116635-111663544.50443.386.4244.7843.626.44
21190473-119047347.44747.73
31031476-103147641.11041.31
4992528-99252839.55739.79
51084130-108413043.20843.46
61114946-111494644.43644.68
极限11209528-120952848.20648.321.7748.5648.641.80
21245881-124588149.65550.02
31210182-121018248.23248.50
41184324-118432447.20247.50
51225952-122595248.86149.18
61198542-119854247.76848.09
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%
128.602014802201470120130382011398200940620126690.12
228.642008301200699420076480.05
单位质量响应值RSD%判断
70373.0470099.440.28数据可信
长期3月-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%
5min1126986-1269862.7673.0282.982.773.0282.93
2342552-3425527.4637.46
323079-230790.5030.50
4191422-1914224.1704.17
581937-819371.7851.79
666508-665081.4491.45
10min1576561-57656112.5619.4728.8812.579.4728.92
2489651-48965110.66810.68
3201227-2012274.3844.38
4460510-46051010.03310.04
5453026-4530269.8709.87
6426442-4264429.2909.29
15min1879857-87985719.16916.1416.1219.1916.1616.15
2825706-82570617.98918.02
3539647-53964711.75711.76
4717438-71743815.63015.65
5784375-78437517.08817.11
6697925-69792515.20515.22
20min11197360-119736026.08622.7913.1726.1422.8413.20
21124600-112460024.50124.56
3801752-80175217.46717.49
4992965-99296521.63321.68
51102526-110252624.02024.07
61058069-105806923.05123.09
30min11484459-148445932.34029.809.3432.4429.889.35
21515315-151531533.01333.11
31215420-121542026.47926.54
41223819-122381926.66226.75
51354291-135429129.50529.59
61412872-141287230.78130.86
45min11573617-157361734.28333.508.1234.4433.638.12
21736824-173682437.83937.99
31458602-145860231.77731.88
41367524-136752429.79329.92
51516418-151641833.03733.17
61572561-157256134.26034.39
60min11691496-169149636.85135.967.3737.0636.147.39
21844195-184419540.17840.40
31566132-156613234.12034.27
41488275-148827532.42432.60
51631778-163177835.55035.74
61680443-168044336.61036.80
极限11940533-194053342.27742.242.3942.5542.492.41
22017704-201770443.95844.24
31934235-193423542.13942.35
41883419-188341941.03241.27
51951634-195163442.51842.77
61904463-190446341.49141.74
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601166817116637211656231165629116566711660220.05
228.641170203117038211702920.02
单位质量响应值RSD%判断
40770.0040862.150.16数据可信
长期3月-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%
5min1135251-1352515.3673.5860.745.373.5860.77
228086-280861.1141.11
3118960-1189604.7204.72
413073-130730.5190.52
5113043-1130434.4864.49
6133043-1330435.2795.28
10min1459113-45911318.21814.5824.5118.2314.5924.52
2231689-2316899.1949.20
3414013-41401316.42816.44
4308450-30845012.23912.24
5339157-33915713.45813.47
6452816-45281617.96817.98
15min1740385-74038529.37924.4718.4129.4224.5018.42
2481078-48107819.08919.11
3680229-68022926.99227.03
4513993-51399320.39520.42
5555804-55580422.05522.08
6728161-72816128.89428.93
20min1959958-95995838.09232.0716.5738.1832.1416.59
2667212-66721226.47526.52
3890310-89031035.32835.41
4702628-70262827.88127.94
5694978-69497827.57727.64
6934847-93484737.09537.18
30min11094701-109470143.43839.0611.3843.5939.1811.41
2838602-83860233.27633.37
31066726-106672642.32842.47
4905243-90524335.92036.02
5911401-91140136.16536.28
61088904-108890443.20843.36
45min11144495-114449545.41442.168.5145.6442.358.55
2947291-94729137.58937.74
31130384-113038444.85445.06
4994880-99488039.47739.64
51004813-100481339.87140.04
61153587-115358745.77546.00
60min11173913-117391346.58143.717.8246.8843.977.85
2992484-99248439.38239.59
31165972-116597246.26646.55
41043570-104357041.40941.64
51039206-103920641.23641.48
61193727-119372747.36847.66
极限11237058-123705849.08747.882.5349.4648.222.60
21181737-118173746.89247.17
31220264-122026448.42148.78
41175160-117516046.63146.93
51182865-118286546.93747.24
61243391-124339149.33849.71
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602012547201176620113412011394201112920116350.03
228.642020336202066620205010.02
单位质量响应值RSD%判断
70336.8970548.220.22数据可信
长期3月-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%
5min1180174-1801743.9142.5961.133.912.5961.15
235767-357670.7770.78
3152363-1523633.3103.31
417241-172410.3750.37
5154850-1548503.3643.36
6175062-1750623.8033.80
10min1627134-62713413.62310.6926.4713.6310.7026.49
2298286-2982866.4796.48
3556404-55640412.08612.09
4409449-4094498.8948.89
5444516-4445169.6569.66
6617981-61798113.42413.43
15min11039678-103967822.58418.4020.3822.6118.4220.39
2644864-64486414.00814.02
3937822-93782220.37220.40
4693716-69371615.06915.08
5747848-74784816.24516.27
61018422-101842222.12222.15
20min11369880-136988029.75724.6218.1029.8224.6718.11
2922804-92280420.04520.08
31248704-124870427.12527.18
4967731-96773121.02121.06
5959988-95998820.85320.90
61331637-133163728.92628.99
30min11613300-161330035.04430.9613.1335.1631.0613.16
21193705-119370525.93026.00
31556953-155695333.82033.93
41286764-128676427.95128.03
51295840-129584028.14828.23
61606449-160644934.89635.01
45min11735750-173575037.70434.5110.3737.8834.6510.40
21388934-138893430.17130.28
31705199-170519937.04137.20
41460936-146093631.73531.86
51475140-147514032.04332.17
61765148-176514838.34338.51
60min11816396-181639639.45636.5710.0039.6936.7710.03
21480997-148099732.17132.33
31806380-180638039.23939.46
41566126-156612634.02034.19
51555078-155507833.78033.96
61877126-187712640.77541.01
极限12001215-200121543.47142.163.8743.7742.433.93
21873319-187331940.69340.91
31982620-198262043.06743.36
41870687-187068740.63540.87
51879682-187968240.83141.07
62038338-203833844.27744.58
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%
128.601170356117038611698371169822116992011700640.03
228.641161928116123211615800.05
单位质量响应值RSD%判断
40911.3340557.960.62数据可信
长期3月-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%
5min148647-486471.9343.2326.151.933.2326.15
280385-803853.1963.20
392889-928893.6933.69
4106685-1066854.2424.24
565286-652862.5962.60
693742-937423.7273.73
10min1382932-38293215.22613.8213.7615.2313.8213.76
2278132-27813211.05911.06
3374523-37452314.89114.90
4371820-37182014.78414.79
5294799-29479911.72111.73
6382986-38298615.22815.23
15min1579974-57997423.06022.8912.4223.0922.9212.41
2455852-45585218.12518.15
3639151-63915125.41325.44
4641168-64116825.49325.52
5531809-53180921.14521.17
6606044-60604424.09724.13
20min1719645-71964528.61329.5610.7928.6829.6210.79
2633860-63386025.20325.26
3822744-82274432.71332.79
4833680-83368033.14833.22
5677876-67787626.95327.01
6772293-77229330.70730.78
30min1892182-89218235.47435.395.1735.5935.505.20
2827659-82765932.90833.00
3956454-95645438.02938.16
4922796-92279636.69136.82
5855770-85577034.02634.13
6885332-88533235.20135.32
45min11009402-100940240.13438.464.5040.3138.634.51
2905900-90590036.01936.17
31020128-102012840.56140.75
4971275-97127538.61838.81
5934530-93453037.15737.32
6962178-96217838.25738.44
60min11051971-105197141.82740.114.0442.0740.344.06
2944482-94448237.55337.76
31051133-105113341.79442.05
41007015-100701540.03940.29
5986897-98689739.24039.46
61010531-101053140.17940.42
极限11180121-118012146.92246.900.9547.2347.200.95
21166134-116613446.36646.64
31170624-117062446.54546.87
41190614-119061447.33947.66
51194178-119417847.48147.77
61174984-117498446.71847.03
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.602018497201764320173372018241201858220180600.03
228.642006689200655320066210.01
单位质量响应值RSD%判断
70561.5470063.580.51数据可信
长期3月-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%
5min172420-724201.5762.4722.851.582.4722.80
2116759-1167592.5412.54
3123054-1230542.6782.68
4143745-1437453.1283.13
594194-941942.0502.05
6130253-1302532.8352.83
10min1508577-50857711.06810.1114.0011.0710.1214.01
2366239-3662397.9707.97
3498313-49831310.84510.85
4503626-50362610.96010.97
5397676-3976768.6548.66
6513519-51351911.17511.18
15min1789180-78918017.17517.1213.2617.2017.1413.25
2611115-61111513.29913.32
3874250-87425019.02619.05
4890842-89084219.38719.41
5728396-72839615.85215.87
6826876-82687617.99518.02
20min1995069-99506921.65522.5111.7721.7022.5511.79
2865937-86593718.84518.88
31146198-114619824.94425.00
41182847-118284725.74225.80
5943743-94374320.53820.58
61071099-107109923.31023.36
30min11268352-126835227.60327.715.9427.6927.805.95
21169002-116900225.44125.51
31367831-136783129.76829.86
41349784-134978429.37529.47
51220535-122053526.56226.64
61264538-126453827.52027.61
45min11480321-148032132.21631.034.7232.3531.164.73
21324455-132445528.82428.94
31500401-150040132.65332.80
41456941-145694131.70731.85
51373391-137339129.88930.01
61420075-142007530.90431.04
60min11581863-158186334.42533.014.1934.6133.194.20
21407131-140713130.62330.78
31565284-156528434.06534.26
41538164-153816433.47433.67
51484814-148481432.31332.49
61523451-152345133.15433.34
极限11869289-186928940.68140.781.4340.9241.021.44
21837018-183701839.97840.19
31855562-185556240.38240.64
41909711-190971141.56041.82
51897835-189783541.30241.53
61874230-187423040.78841.03
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601162677116228611621841162387116193811622940.03
228.641161890116197011619300.01
单位质量响应值RSD%判断
40639.6540570.180.13数据可信
长期3月-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%
5min1123010-1230104.9063.3531.324.913.3531.33
283408-834083.3273.33
359223-592232.3622.36
463881-638812.5482.55
566239-662392.6422.64
6108680-1086804.3354.33
10min1391269-39126915.60614.019.4515.6114.029.46
2379380-37938015.13215.14
3338143-33814313.48713.49
4303751-30375112.11612.12
5329397-32939713.13913.14
6365598-36559814.58314.59
15min1617065-61706524.61322.796.1124.6522.826.12
2609431-60943124.30824.34
3546488-54648821.79821.82
4552909-55290922.05422.08
5570811-57081122.76822.79
6531465-53146521.19821.23
20min1819130-81913032.67230.277.0332.7530.347.03
2807207-80720732.19732.27
3724306-72430628.89028.95
4754882-75488230.11030.17
5771643-77164330.77830.84
6676078-67607826.96727.03
30min11034056-103405641.24539.238.4441.3739.358.42
21024036-102403640.84640.97
31006498-100649840.14640.26
41015139-101513940.49140.60
51006345-100634540.14040.26
6815643-81564332.53332.65
45min11091626-109162643.54142.327.1143.7442.507.10
21081023-108102343.11943.31
31085166-108516643.28443.46
41087696-108769643.38543.56
51111546-111154644.33644.52
6908560-90856036.24036.41
60min11132476-113247645.17144.045.8145.4444.295.81
21116188-111618844.52144.79
31121461-112146144.73244.98
41124221-112422144.84245.09
51154170-115417046.03646.29
6976087-97608738.93339.16
极限11206519-120651948.12447.970.9048.4748.300.93
21195766-119576647.69548.03
31212984-121298448.38248.71
41200966-120096647.90348.23
51214146-121414648.42848.76
61185929-118592947.30347.59
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%
128.602009502200927920099972009425200900720094420.02
228.642006493200737920069360.04
单位质量响应值RSD%判断
70260.2170074.580.19数据可信
长期3月-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%
5min1168005-1680053.6642.5031.863.662.5031.85
2109567-1095672.3892.39
376771-767711.6741.67
490225-902251.9681.97
593178-931782.0322.03
6151002-1510023.2933.29
10min1524228-52422811.43210.309.5911.4410.309.60
2510800-51080011.13911.14
3449602-4496029.8059.81
4405359-4053598.8408.84
5448309-4483099.7769.78
6494469-49446910.78310.79
15min1844344-84434418.41317.106.2318.4417.126.23
2836957-83695718.25218.27
3742494-74249416.19216.21
4759916-75991616.57216.59
5793789-79378917.31017.33
6728584-72858415.88915.91
20min11139640-113964024.85323.107.3424.9123.167.33
21128015-112801524.59924.65
31000910-100091021.82721.87
41056508-105650823.04023.09
51092691-109269123.82923.88
6939056-93905620.47820.53
30min11478601-147860132.24430.738.6332.3430.818.62
21468682-146868232.02832.12
31421632-142163231.00231.08
41455922-145592231.75031.83
51465090-146509031.95032.04
61164202-116420225.38825.47
45min11613449-161344935.18534.287.4635.3434.427.45
21604770-160477034.99635.14
31587548-158754834.62034.75
41614613-161461335.21035.35
51671910-167191036.46036.60
61339923-133992329.22029.35
60min11713464-171346437.36636.576.3237.5836.776.32
21697441-169744137.01737.22
31677971-167797136.59236.78
41712963-171296337.35537.55
51785780-178578038.94339.15
61474119-147411932.14732.32
极限11939143-193914342.28842.191.1342.5642.451.15
21925983-192598342.00142.27
31941704-194170442.34342.60
41931063-193106342.11142.37
51968247-196824742.92243.19
61901925-190192541.47641.70
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