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%
127.782836922838902840162837482839892838670.06
227.722854512853502854000.03
单位质量响应值RSD%判断
10218.3910295.820.54数据可信
长期12月-供试品溶液-2024032721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%
5min199249-9924915.67217.1116.6015.6717.1116.60
298249-9824915.51415.51
3106717-10671716.85116.85
4144403-14440322.80222.80
597931-9793115.46415.46
6103761-10376116.38416.38
10min1212142-21214233.49833.0811.7833.5233.1011.79
2175583-17558327.72527.75
3219651-21965134.68334.71
4248963-24896339.31239.35
5195039-19503930.79730.82
6205470-20547032.44432.47
15min1290619-29061945.88943.649.2645.9743.729.26
2230764-23076436.43836.51
3288873-28887345.61445.70
4301856-30185647.66447.77
5264154-26415441.71141.79
6282007-28200744.53044.61
20min1324490-32449051.23849.016.3651.4049.166.36
2272278-27227842.99343.13
3319259-31925950.41250.57
4323854-32385451.13751.32
5307306-30730648.52448.67
6315041-31504149.74649.90
30min1328034-32803451.79750.832.1952.0451.062.21
2308299-30829948.68148.89
3320815-32081550.65850.90
4324422-32442251.22751.50
5324832-32483251.29251.52
6324889-32488951.30151.54
45min1329828-32982852.08151.311.0052.4151.631.01
2322406-32240650.90951.19
3320849-32084950.66350.99
4324491-32449151.23851.59
5327223-32722351.66951.98
6324851-32485151.29551.62
60min1325792-32579251.44351.380.4551.8651.790.44
2324678-32467851.26751.64
3326447-32644751.54751.96
4323297-32329751.04951.49
5327406-32740651.69852.10
6324781-32478151.28451.69
极限1325918-32591851.46351.180.8051.9751.680.78
2325165-32516551.34451.80
3319662-31966250.47550.98
4323252-32325251.04251.57
5327038-32703851.64052.13
6323817-32381751.13251.63
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%
127.784911214910864915414911504913964912590.05
227.724933444933034933240.01
单位质量响应值RSD%判断
17683.9117796.680.45数据可信
长期12月-供试品溶液-2024032721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%
5min1168657-16865714.54715.9217.0414.5515.9217.04
2166973-16697314.40214.40
3181355-18135515.64315.64
4247539-24753921.35121.35
5166150-16615014.33114.33
6176463-17646315.22115.22
10min1364105-36410531.40631.0011.9731.4331.0311.97
2299852-29985225.86425.89
3377079-37707932.52532.55
4427972-42797236.91436.95
5334135-33413528.82128.84
6353603-35360330.50030.53
15min1499652-49965243.09740.989.4143.1741.069.41
2395283-39528334.09534.16
3497350-49735042.89942.98
4519332-51933244.79544.89
5453975-45397539.15739.23
6485287-48528741.85841.93
20min1559001-55900148.21646.086.4848.3646.236.49
2467382-46738240.31440.44
3550567-55056747.48947.64
4557338-55733848.07348.24
5528460-52846045.58245.72
6542710-54271046.81146.96
30min1564079-56407948.65447.812.2548.8848.032.26
2529883-52988345.70545.90
3553371-55337147.73147.96
4558398-55839848.16448.42
5559594-55959448.26748.48
6560236-56023648.32348.55
45min1568252-56825249.01448.300.9749.3248.600.97
2554763-55476347.85148.12
3553687-55368747.75848.07
4559220-55922048.23548.57
5563221-56322148.58048.87
6560807-56080748.37248.68
60min1561476-56147648.43048.310.4348.8248.690.42
2558869-55886948.20548.55
3558496-55849648.17348.56
4557535-55753548.09048.50
5564148-56414848.66049.03
6559860-55986048.29048.68
极限1561946-56194648.47048.180.7848.9448.640.76
2559828-55982848.28848.72
3551122-55112247.53748.01
4557530-55753048.08948.58
5563339-56333948.59049.05
6557681-55768148.10248.57
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.782845012840022840002844372843502842580.09
227.722838372840732839550.06
单位质量响应值RSD%判断
10232.4710243.690.08数据可信
长期12月-供试品溶液-2024032821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%
5min1114613-11461318.13118.9416.6418.1318.9416.64
2140242-14024222.18522.19
397700-9770015.45615.46
4123004-12300419.45819.46
598684-9868415.61115.61
6144189-14418922.81022.81
10min1230608-23060836.48136.297.6436.5136.327.64
2251500-25150039.78639.82
3209368-20936833.12133.15
4239089-23908937.82237.85
5207672-20767232.85232.88
6238054-23805437.65937.70
15min1266653-26665342.18346.205.2342.2746.305.24
2295474-29547446.74246.85
3291133-29113346.05546.14
4301666-30166647.72247.82
5285978-28597845.24045.32
6311523-31152349.28149.38
20min1287956-28795645.55350.705.2345.7150.875.23
2327414-32741451.79551.98
3325864-32586451.55051.71
4325751-32575151.53251.71
5320111-32011150.64050.80
6335908-33590853.13953.32
30min1314138-31413849.69551.872.1549.9352.122.16
2332614-33261452.61752.88
3331050-33105052.37052.61
4326938-32693851.72051.98
5330409-33040952.26952.51
6332252-33225252.56052.83
45min1328625-32862551.98652.250.7252.3152.600.73
2332883-33288352.66053.02
3331402-33140252.42652.76
4326385-32638551.63251.98
5331007-33100752.36352.69
6331577-33157752.45352.81
60min1328494-32849451.96652.140.6852.3752.570.68
2331932-33193252.51052.95
3330826-33082652.33552.75
4325682-32568251.52151.95
5330470-33047052.27852.69
6330354-33035452.26052.71
极限1326948-32694851.72152.030.7352.2152.540.74
2331233-33123352.39952.93
3330036-33003652.21052.72
4324969-32496951.40851.93
5329787-32978752.17052.67
6330313-33031352.25352.79
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%
127.784917064920444921504927304926664922590.09
227.724922834919834921330.05
单位质量响应值RSD%判断
17719.9117753.720.14数据可信
长期12月-供试品溶液-2024032821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%
5min1195707-19570716.88417.6517.1016.8817.6417.11
2240152-24015220.71820.72
3166333-16633314.35014.35
4210379-21037918.15018.15
5166924-16692414.40114.40
6247686-24768621.36821.37
10min1395847-39584734.15033.977.7034.1834.007.71
2432095-43209537.27737.31
3359212-35921230.98931.01
4410387-41038735.40435.43
5356124-35612430.72330.75
6408993-40899335.28435.32
15min1458192-45819239.52843.355.3139.6143.445.31
2507654-50765443.79643.89
3501212-50121243.24043.32
4519475-51947544.81544.90
5491961-49196142.44242.52
6536653-53665346.29746.39
20min1494606-49460642.67047.615.3342.8247.765.32
2563466-56346648.61148.78
3561057-56105748.40348.55
4561151-56115148.41148.57
5551810-55181047.60547.75
6578867-57886749.93950.11
30min1540393-54039346.62048.742.2146.8448.982.22
2573041-57304149.43749.69
3570288-57028849.19949.43
4564171-56417148.67148.92
5569305-56930549.11449.34
6572828-57282849.41849.67
45min1566013-56601348.83049.110.7149.1349.430.71
2573852-57385249.50749.84
3570724-57072449.23749.55
4563031-56303148.57348.90
5570567-57056749.22349.53
6571635-57163549.31549.65
60min1566558-56655848.87749.050.6749.2649.450.67
2572401-57240149.38149.80
3570838-57083849.24749.64
4561845-56184548.47148.88
5569838-56983849.16049.55
6569781-56978149.15549.57
极限1564360-56436048.68848.950.7249.1549.430.72
2571305-57130549.28749.78
3569625-56962549.14249.62
4560565-56056548.36048.85
5568992-56899249.08749.56
6569530-56953049.13449.63
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%
127.782852352854652852742855152844742851930.15
227.722874222870962872590.09
单位质量响应值RSD%判断
10266.1310362.880.67数据可信
长期12月-供试品溶液-2024032921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%
5min185808-8580813.47415.3719.4613.4715.3719.46
289341-8934114.02914.03
381689-8168912.82712.83
4104374-10437416.38916.39
5133403-13340320.94820.95
692637-9263714.54614.55
10min1217662-21766234.17831.4112.6934.2031.4412.69
2168347-16834726.43526.46
3178343-17834328.00428.03
4219570-21957034.47834.51
5229587-22958736.05136.09
6186642-18664229.30729.33
15min1295312-29531246.37142.4711.9846.4542.5511.99
2225359-22535935.38735.45
3248992-24899239.09839.17
4292898-29289845.99246.08
5307075-30707548.21848.31
6253341-25334139.78139.85
20min1305728-30572848.00747.727.9848.1647.877.99
2268746-26874642.20042.33
3291799-29179945.82045.95
4329234-32923451.69851.86
5332758-33275852.25152.43
6295043-29504346.32946.47
30min1321349-32134950.46050.804.8750.7051.034.89
2296472-29647246.55446.75
3322726-32272650.67650.89
4329647-32964751.76352.01
5344978-34497854.17054.43
6325831-32583151.16451.38
45min1330893-33089351.95951.721.9352.2852.031.96
2317071-31707149.78850.06
3332311-33231152.18152.48
4328888-32888851.64451.98
5334946-33494652.59552.95
6332117-33211752.15152.45
60min1334221-33422152.48151.991.4152.8952.391.43
2322774-32277450.68451.04
3333905-33390552.43152.81
4328381-32838151.56451.98
5334258-33425852.48752.93
6333111-33311152.30752.70
极限1333817-33381752.41851.891.5152.9152.381.52
2321959-32195950.55651.00
3335069-33506952.61453.08
4327222-32722251.38251.89
5333094-33309452.30452.83
6331628-33162852.07452.55
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%
127.784928504929004930954931564922134928430.08
227.724951524952904952210.02
单位质量响应值RSD%判断
17740.9317865.120.50数据可信
长期12月-供试品溶液-2024032921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%
5min1144366-14436612.40814.2320.3212.4114.2320.30
2150201-15020112.91012.91
3136568-13656811.73811.74
4177255-17725515.23515.24
5228092-22809219.60519.60
6156708-15670813.46913.47
10min1372913-37291332.05229.4012.8732.0729.4212.86
2286990-28699024.66724.69
3304575-30457526.17826.20
4376040-37604032.32132.35
5393003-39300333.77933.81
6318845-31884527.40527.43
15min1507279-50727943.60139.9312.2043.6840.0012.20
2385784-38578433.15833.22
3426977-42697736.69936.76
4504135-50413543.33143.41
5528717-52871745.44445.53
6434204-43420437.32037.39
20min1523775-52377545.01944.838.1245.1744.978.14
2460864-46086439.61239.73
3500464-50046443.01543.14
4565950-56595048.64448.80
5572598-57259849.21549.38
6505772-50577243.47143.60
30min1550976-55097647.35747.795.0947.5848.015.10
2508337-50833743.69243.88
3554389-55438947.65047.85
4567555-56755548.78249.01
5595269-59526951.16451.41
6559838-55983848.11848.32
45min1569420-56942048.94248.752.0249.2449.042.04
2544946-54494646.83847.10
3571601-57160149.13049.40
4567314-56731448.76149.07
5577573-57757349.64349.97
6572426-57242649.20049.48
60min1576555-57655549.55549.031.4549.9449.411.47
2555861-55586147.77748.11
3574225-57422549.35549.71
4565589-56558948.61349.01
5576552-57655249.55549.97
6574073-57407349.34249.71
极限1575624-57562449.47549.001.5349.9449.451.54
2555358-55535847.73348.15
3578519-57851949.72450.16
4564542-56454248.52349.00
5575070-57507049.42849.93
6571153-57115349.09149.54
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%
127.782848082845842847422848862845892847220.05
227.722861392858672860030.07
单位质量响应值RSD%判断
10249.1710317.570.48数据可信
长期12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%
5min196867-9686715.25614.675.2415.2614.675.25
296139-9613915.14215.14
397035-9703515.28315.28
488776-8877613.98213.98
585405-8540513.45113.45
694525-9452514.88814.89
10min1213314-21331433.59731.016.6233.6231.036.61
2179610-17961028.28828.31
3201771-20177131.77931.80
4207672-20767232.70832.73
5185628-18562829.23629.26
6193381-19338130.45730.48
15min1270539-27053942.61042.043.5342.6942.113.53
2277232-27723243.66443.74
3273905-27390543.14043.22
4261371-26137141.16641.24
5267073-26707342.06442.13
6251294-25129439.57839.65
20min1323290-32329050.91848.982.9451.0749.122.93
2297289-29728946.82346.97
3306211-30621148.22848.38
4318294-31829450.13150.28
5309825-30982548.79748.94
6310855-31085548.95949.10
30min1335422-33542252.82951.142.6253.0751.362.62
2315293-31529349.65849.88
3314144-31414449.47749.71
4328637-32863751.76051.99
5324389-32438951.09151.31
6330205-33020552.00752.23
45min1329784-32978451.94151.341.9652.2751.661.95
2318734-31873450.20050.51
3317055-31705549.93650.25
4330057-33005751.98452.30
5328306-32830651.70852.02
6331903-33190352.27452.58
60min1328928-32892851.80651.321.8452.2251.721.84
2319399-31939950.30550.69
3317249-31724949.96650.36
4330927-33092752.12152.52
5327911-32791151.64652.04
6330805-33080552.10152.50
极限1327833-32783351.63351.231.3652.1351.721.36
2318474-31847450.15950.63
3321405-32140550.62151.10
4327692-32769251.61152.10
5326338-32633851.39851.88
6330006-33000651.97652.46
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%
127.784925464924784924584928144923734925340.04
227.724938024937044937530.02
单位质量响应值RSD%判断
17729.8117812.160.33数据可信
长期12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%
5min1161536-16153613.90913.305.6513.9113.305.66
2159383-15938313.72413.72
3161053-16105313.86713.87
4147193-14719312.67412.67
5140295-14029512.08012.08
6157438-15743813.55613.56
10min1362646-36264631.22628.677.0731.2528.707.06
2302049-30204926.00826.03
3341689-34168929.42129.44
4352677-35267730.36730.39
5312405-31240526.90026.92
6326537-32653728.11628.14
15min1462276-46227639.80439.173.7139.8839.243.70
2472221-47222140.66140.73
3468173-46817340.31240.38
4445365-44536538.34838.42
5454458-45445839.13139.20
6426637-42663736.73636.81
20min1557201-55720147.97846.023.1148.1246.163.10
2510182-51018243.92944.06
3526342-52634245.32145.46
4548320-54832047.21347.35
5531774-53177445.78845.92
6532938-53293845.88946.02
30min1578341-57834149.79848.132.7150.0248.342.71
2542319-54231946.69646.90
3540349-54034946.52746.74
4566449-56644948.77448.99
5557858-55785848.03448.24
6568380-56838048.94049.15
45min1569274-56927449.01748.382.1349.3248.672.12
2548294-54829447.21147.50
3545056-54505646.93247.22
4569579-56957949.04449.34
5566276-56627648.75949.05
6572437-57243749.29049.58
60min1567021-56702148.82348.341.9349.2148.721.92
2549380-54938047.30447.67
3546140-54614047.02547.40
4569723-56972349.05649.43
5565561-56556148.69849.07
6570832-57083249.15249.52
极限1569536-56953649.04048.501.5049.5148.951.50
2550514-55051447.40247.84
3555312-55531247.81548.26
4566860-56686048.81049.27
5565719-56571948.71149.16
6571536-57153649.21249.66
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