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%
128.272917852910962920402914932909972914820.16
228.322924962922412923680.07
单位质量响应值RSD%判断
10310.6510323.730.09数据可信
长期3月-供试品溶液-SDR926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%
5min178902-7890212.38613.768.3012.3913.778.28
289295-8929514.01814.02
381770-8177012.83612.84
499702-9970215.65115.65
589732-8973214.08614.09
686683-8668313.60813.61
10min1204488-20448832.10129.286.0432.1229.306.03
2174220-17422027.34927.37
3191599-19159930.07730.10
4177761-17776127.90527.93
5180295-18029528.30328.33
6190855-19085529.96129.98
15min1300277-30027747.13841.109.6547.2141.179.63
2278374-27837443.69943.77
3262406-26240641.19341.26
4259342-25934240.71240.78
5237788-23778837.32837.40
6232687-23268736.52736.60
20min1330677-33067751.91046.729.6452.0646.869.63
2331846-33184652.09352.24
3286951-28695145.04645.19
4298945-29894546.92947.07
5273078-27307842.86843.00
6264049-26404941.45141.58
30min1331516-33151652.04249.844.1452.2850.054.14
2335951-33595152.73852.97
3315491-31549149.52649.74
4305551-30555147.96648.18
5308858-30885848.48548.69
6307416-30741648.25848.46
45min1331904-33190452.10351.053.7152.4351.353.71
2345402-34540254.22154.54
3322053-32205350.55650.85
4310336-31033648.71749.02
5321752-32175250.50950.79
6319794-31979450.20250.48
60min1331656-33165652.06450.872.6052.4851.262.60
2334905-33490552.57452.98
3323178-32317850.73351.11
4311764-31176448.94149.32
5319057-31905750.08650.46
6323755-32375550.82351.19
极限1331460-33146052.03351.022.3652.5351.492.37
2334444-33444452.50153.00
3323574-32357450.79551.26
4313131-31313149.15649.62
5320887-32088750.37350.83
6326591-32659151.26951.72
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%
128.275051245041345049915046405038795045540.11
228.325056345053365054850.05
单位质量响应值RSD%判断
17847.6817849.050.01数据可信
长期3月-供试品溶液-SDR926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%
5min1129843-12984311.13212.468.8311.1312.468.83
2148032-14803212.69112.69
3134450-13445011.52711.53
4166325-16632514.25914.26
5149190-14919012.79012.79
6144270-14427012.36812.37
10min1346801-34680129.73226.946.5329.7526.966.51
2292173-29217325.04825.07
3324198-32419827.79427.81
4298533-29853325.59425.62
5302073-30207325.89725.92
6321872-32187227.59527.62
15min1516329-51632944.26638.2510.3644.3338.3210.34
2475860-47586040.79640.86
3448495-44849538.45038.52
4442211-44221137.91137.98
5401763-40176334.44434.51
6392578-39257833.65633.72
20min1569735-56973548.84443.6910.3148.9943.8210.29
2571413-57141348.98849.12
3491466-49146642.13442.26
4513917-51391744.05944.19
5463713-46371339.75539.88
6447207-44720738.34038.46
30min1571264-57126448.97546.784.4049.2046.984.40
2579469-57946949.67949.89
3542084-54208446.47446.67
4524458-52445844.96245.17
5529833-52983345.42345.61
6526761-52676145.16045.35
45min1572233-57223349.05847.913.8749.3648.193.86
2594628-59462850.97851.27
3554186-55418647.51147.79
4533066-53306645.70045.98
5551052-55105247.24247.51
6547850-54785046.96847.23
60min1570701-57070148.92747.792.7149.3148.142.72
2577734-57773449.53049.91
3556364-55636447.69848.05
4536197-53619745.96946.32
5547608-54760846.94747.29
6555848-55584847.65447.99
极限1571487-57148748.99448.062.3449.4648.502.36
2576852-57685249.45449.92
3558255-55825547.86048.30
4540079-54007946.30246.73
5553917-55391747.48847.91
6563231-56323148.28748.71
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%
128.275776285780775775895776935774035776780.05
228.325794415794755794580.01
单位质量响应值RSD%判断
20434.3120461.090.10数据可信
长期3月-供试品溶液-TAWW4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%
5min1192606-19260615.25613.9014.0115.2613.9014.03
2185714-18571414.71014.71
3143191-14319111.34211.34
4208151-20815116.48716.49
5169840-16984013.45313.45
6153552-15355212.16212.16
10min1393147-39314731.14029.046.9931.1729.067.00
2379966-37996630.09630.12
3324631-32463125.71325.73
4387428-38742830.68730.71
5361110-36111028.60228.62
6353677-35367728.01428.03
15min1542676-54267642.98440.805.6143.0640.885.61
2540302-54030242.79642.87
3462627-46262736.64336.71
4514739-51473940.77140.85
5518076-51807641.03541.11
6512347-51234740.58140.65
20min1616117-61611748.80147.703.6648.9547.843.65
2618957-61895749.02649.17
3606866-60686648.06848.19
4558693-55869344.25244.40
5606383-60638348.03048.17
6606325-60632548.02548.16
30min1617271-61727148.89250.213.6249.1250.433.60
2642595-64259550.89851.13
3648750-64875051.38651.59
4594722-59472247.10647.33
5649782-64978251.46751.69
6650354-65035451.51351.73
45min1615483-61548348.75150.593.0449.0650.893.02
2641758-64175850.83251.14
3647925-64792551.32051.61
4614232-61423248.65148.95
5652107-65210751.65151.96
6660384-66038452.30752.61
60min1614436-61443648.66850.622.9449.0651.002.92
2646917-64691751.24051.64
3646217-64621751.18551.56
4616727-61672748.84949.23
5650750-65075051.54451.93
6659161-65916152.21052.60
极限1614092-61409248.64050.452.7949.1150.922.77
2638686-63868650.58851.07
3645369-64536951.11851.58
4617030-61703048.87349.33
5648906-64890651.39851.87
6657719-65771952.09652.57
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%
128.279993789992859984669990459984309989210.05
228.321001034100043010007320.05
单位质量响应值RSD%判断
35335.0235336.580.01数据可信
长期3月-供试品溶液-TAWW4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%
5min1328954-32895414.24512.9014.3414.2412.9014.33
2315123-31512313.64613.65
3241125-24112510.44210.44
4353890-35389015.32515.32
5288673-28867312.50112.50
6260263-26026311.27011.27
10min1675692-67569229.26027.227.1229.2827.247.11
2651122-65112228.19628.22
3555108-55510824.03824.06
4664251-66425128.76428.79
5619974-61997426.84726.87
6605673-60567326.22826.25
15min1935451-93545140.50838.395.7040.5838.465.70
2929569-92956940.25440.32
3794631-79463134.41034.47
4885404-88540438.34138.41
5892236-89223638.63738.70
6882018-88201838.19438.26
20min11062014-106201445.98944.943.7046.1345.073.68
21066115-106611546.16746.30
31046669-104666945.32445.44
4961796-96179641.64941.79
51045136-104513645.25845.39
61045328-104532845.26645.39
30min11065993-106599346.16147.353.6946.3847.563.67
21108398-110839847.99848.21
31119757-111975748.48948.68
41023581-102358144.32544.53
51121606-112160648.56948.77
61121441-112144148.56248.76
45min11062282-106228246.00147.723.1046.2948.013.07
21106919-110691947.93348.23
31118172-111817248.42148.69
41058628-105862845.84246.12
51125930-112593048.75749.04
61140555-114055549.39049.67
60min11060274-106027445.91447.752.9746.2848.122.95
21114421-111442148.25848.63
31115656-111565648.31248.66
41063747-106374746.06446.42
51124641-112464148.70149.07
61137987-113798749.27949.64
极限11060391-106039145.91947.632.7846.3748.072.75
21103135-110313547.77048.22
31113801-111380148.23148.66
41065611-106561146.14546.58
51120762-112076248.53348.98
61135568-113556849.17449.62
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%
128.271151118115162211521431152186115227111518680.05
228.321154720115417811544490.04
单位质量响应值RSD%判断
40745.2440764.440.04数据可信
长期3月-供试品溶液-TYN28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%
5min1277132-27713211.01311.227.5811.0111.227.59
2304537-30453712.10212.10
3261005-26100510.37210.37
4269607-26960710.71410.71
5313331-31333112.45212.45
6268547-26854710.67210.67
10min1614065-61406524.40324.356.4424.4224.376.45
2634505-63450525.21525.24
3552416-55241621.95321.97
4600711-60071123.87223.89
5671298-67129826.67726.70
6603370-60337023.97824.00
15min1879438-87943834.94933.824.6035.0133.884.61
2864664-86466434.36234.42
3788140-78814031.32131.37
4843095-84309533.50533.56
5898637-89863735.71235.78
6832019-83201933.06433.12
20min11057441-105744142.02341.302.0442.1441.422.05
21058263-105826342.05542.17
31012883-101288340.25240.36
41013681-101368140.28440.40
51053382-105338241.86141.99
61040503-104050341.35041.46
30min11260341-126034150.08648.194.5950.2748.384.57
21254070-125407049.83750.03
31247699-124769949.58449.76
41115053-111505344.31244.49
51212470-121247048.18448.38
61186553-118655347.15447.34
45min11261728-126172850.14151.183.0050.4151.443.00
21317487-131748752.35752.63
31260231-126023150.08250.34
41248650-124865049.62149.88
51347731-134773153.55953.83
61291492-129149251.32451.58
60min11258652-125865250.01951.292.9250.3751.642.92
21315982-131598252.29752.66
31258513-125851350.01350.35
41264785-126478550.26350.60
51351439-135143953.70654.07
61294413-129441351.44051.79
极限11255297-125529749.88651.192.8950.3251.622.89
21313382-131338252.19452.64
31255621-125562149.89850.32
41263342-126334250.20550.63
51347284-134728453.54153.99
61293733-129373351.41351.84
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%
128.271989730199133119925251992529199308219918390.07
228.321997056199600019965280.04
单位质量响应值RSD%判断
70457.6970498.870.05数据可信
长期3月-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%
5min1473205-47320510.27410.447.7410.2710.447.72
2519278-51927811.27411.27
3443052-4430529.6199.62
4458281-4582819.9509.95
5534798-53479811.61111.61
6457662-4576629.9369.94
10min11056552-105655222.93922.846.5422.9622.866.54
21088568-108856823.63423.65
3945677-94567720.53220.55
41030425-103042522.37222.39
51153343-115334325.04025.06
61036719-103671922.50822.52
15min11516865-151686532.93331.814.6432.9931.864.64
21486544-148654432.27532.33
31355578-135557829.43129.48
41452291-145229131.53131.58
51546689-154668933.58033.64
61432314-143231431.09731.15
20min11823785-182378539.59638.892.0339.7139.002.04
21822775-182277539.57539.69
31747396-174739637.93838.04
41745221-174522137.89138.00
51812982-181298239.36239.48
61795490-179549038.98239.09
30min12177441-217744147.27545.384.7047.4545.564.68
22162767-216276746.95647.13
32151963-215196346.72246.88
41919158-191915841.66741.84
52086187-208618745.29345.48
62044124-204412444.38044.55
45min12180612-218061247.34448.262.9847.6048.512.98
22274051-227405149.37249.63
32175737-217573747.23847.48
42153380-215338046.75246.99
52324721-232472150.47250.73
62229012-222901248.39448.64
60min12173186-217318647.18248.372.9447.5248.702.94
22272276-227227649.33449.67
32174223-217422347.20547.52
42180761-218076147.34747.66
52334394-233439450.68251.02
62233742-223374248.49748.82
极限12167776-216777647.06548.312.9247.4848.722.92
22268913-226891349.26149.68
32169520-216952047.10347.50
42181340-218134047.35947.76
52328766-232876650.56050.99
62233869-223386948.50048.91
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