尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103105353110983114773108543117773111480.16
2103122643106303114470.38
单位质量响应值RSD%判断
31114.8031144.700.07数据可信
供试品溶液-20211122批-10mg/25mg-成分1-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182311-8231126.44139.2237.7526.4439.2237.74
2162509-16250952.20452.20
3195840-19584062.91162.91
4101820-10182032.70832.71
5101841-10184132.71532.72
688279-8827928.35828.36
10min1215139-21513969.11081.6610.8069.1681.7410.82
2276005-27600588.66388.77
3277073-27707389.00689.13
4279526-27952689.79489.86
5246427-24642779.16179.23
6231002-23100274.20674.26
15min1276689-27668988.88392.242.3289.0792.482.34
2286687-28668792.09492.38
3288863-28886392.79393.10
4297094-29709495.43795.68
5289019-28901992.84393.07
6284554-28455491.40991.61
20min1288123-28812392.55694.721.9592.9295.141.93
2288683-28868392.73593.20
3293127-29312794.16394.65
4301053-30105396.70997.14
5300445-30044596.51496.92
6297651-29765195.61696.00
30min1296155-29615595.13696.122.1695.6996.742.12
2289705-28970593.06493.72
3295359-29535994.88095.56
4303752-30375297.57698.21
5304268-30426897.74298.34
6306069-30606998.32098.90
45min1300856-30085696.64696.822.2897.3997.632.24
2290214-29021493.22794.06
3297015-29701595.41296.28
4305306-30530698.07598.90
5307963-30796398.92999.73
6307081-30708198.64699.42
60min1300223-30022396.44296.652.6897.3897.662.63
2287461-28746192.34393.37
3296466-29646695.23696.29
4304656-30465697.86798.89
5307880-30788098.90299.90
6308594-30859499.132100.10
90min1303047-30304797.35097.222.5798.4898.422.53
2289992-28999293.15694.36
3297211-29721195.47596.72
4306327-30632798.40399.62
5309473-30947399.414100.61
6309861-30986199.539100.71
120min1302241-30224197.09196.534.0098.4297.923.94
2277856-27785689.25790.65
3297428-29742895.54596.98
4307416-30741698.753100.17
5309074-30907499.286100.68
6309028-30902899.271100.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1300996-30099696.69196.682.6598.2198.262.61
2287811-28781192.45594.03
3295750-29575095.00696.64
4305134-30513498.02099.63
5307693-30769398.842100.43
6308335-30833599.048100.62
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1255548555585615572295581165571025571730.26
2255567835559025563420.12
单位质量响应值RSD%判断
22286.9222253.680.11数据可信
供试品溶液-20211122批-10mg/25mg-成分2-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127421-274214.9258.1746.664.938.1846.62
260766-6076610.91410.91
381403-8140314.62114.62
435526-355266.3816.38
538394-383946.8966.90
629537-295375.3055.31
10min1123220-12322022.13229.2325.3722.1429.2425.38
2177109-17710931.81131.83
3224305-22430540.28840.32
4190582-19058234.23134.24
5138264-13826424.83424.85
6122899-12289922.07422.08
15min1227009-22700940.77345.8114.5040.8345.8814.52
2268749-26874948.27048.36
3299797-29979753.84753.96
4293427-29342752.70352.78
5223609-22360940.16340.23
6217665-21766539.09539.15
20min1284624-28462451.12256.059.6051.2656.219.63
2322410-32241057.90958.09
3347903-34790362.48762.70
4343630-34363061.72061.91
5280922-28092250.45750.60
6292743-29274352.58052.71
30min1370376-37037666.52465.787.8066.7666.067.81
2374842-37484267.32667.62
3376358-37635867.59867.94
4395552-39555271.04671.36
5311316-31131655.91656.16
6369111-36911166.29766.53
45min1430927-43092777.39975.344.9677.7775.754.97
2417211-41721174.93675.37
3434240-43424077.99578.47
4428063-42806376.88577.34
5378691-37869168.01768.37
6427615-42761576.80577.18
60min1472075-47207584.79080.055.5985.3280.615.56
2424059-42405976.16676.75
3453965-45396581.53782.17
4452072-45207281.19781.80
5407399-40739973.17473.67
6464573-46457383.44383.97
90min1514798-51479892.46485.746.0493.1686.466.00
2461599-46159982.90883.64
3477834-47783485.82486.62
4474598-47459885.24386.01
5433786-43378677.91378.55
6501713-50171390.11390.80
120min1543212-54321297.56785.6011.6298.4586.4911.51
2394938-39493870.93571.84
3489335-48933587.89088.86
4482984-48298486.74987.69
5429768-42976877.19177.99
6519169-51916993.24994.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1576504-576504103.54796.625.65104.6297.685.60
2496931-49693189.25590.30
3529297-52929795.06896.21
4531207-53120795.41196.52
5522710-52271093.88594.83
6570858-570858102.533103.59
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103223213227683230573229093232113228530.11
2103251253248353249800.07
单位质量响应值RSD%判断
32285.3032498.000.47数据可信
供试品溶液-20211122批-10mg/25mg-成分1-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183653-18365356.69853.3430.8656.7053.3430.86
2115118-11511835.54035.54
3231028-23102871.32471.32
4123410-12341038.10038.10
5237709-23770973.38773.39
6145821-14582145.01945.02
10min1292635-29263590.34492.413.6490.4692.523.65
2311928-31192896.30096.37
3306384-30638494.58894.73
4285515-28551588.14688.22
5308346-30834695.19495.34
6291156-29115689.88789.98
15min1300677-30067792.82695.221.9893.1295.511.99
2313560-31356096.80497.07
3310962-31096296.00296.33
4310028-31002895.71395.97
5314362-31436297.05197.39
6301007-30100792.92893.20
20min1301609-30160993.11495.661.8293.5996.141.82
2313422-31342296.76197.22
3311774-31177496.25296.78
4314416-31441697.06897.51
5313990-31399096.93797.47
6303877-30387793.81494.27
30min1304555-30455594.02496.031.5794.6996.701.57
2312744-31274496.55297.20
3310038-31003895.71696.43
4316623-31662397.74998.39
5315748-31574897.47998.20
6306622-30662294.66295.31
45min1304973-30497394.15396.391.5995.0197.261.59
2314173-31417396.99397.84
3311543-31154396.18197.09
4317905-31790598.14598.98
5316484-31648497.70698.63
6308250-30825095.16496.00
60min1304191-30419193.91196.271.6194.9597.331.60
2313470-31347096.77697.81
3311905-31190596.29397.39
4318207-31820798.23899.27
5315004-31500497.25098.37
6308245-30824595.16396.19
90min1305570-30557094.33796.611.4595.5797.871.44
2314275-31427597.02598.26
3311922-31192296.29897.59
4318817-31881798.42799.65
5315803-31580397.49698.81
6311294-31129496.10497.32
120min1302793-30279393.48096.221.6394.9097.661.62
2312428-31242896.45497.88
3310887-31088795.97997.46
4316775-31677597.79699.22
5316258-31625897.63799.14
6310818-31081895.95797.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1302716-30271693.45695.921.5395.0697.561.52
2312570-31257096.49898.12
3309473-30947395.54297.22
4316047-31604797.57299.19
5314290-31429097.02998.73
6309124-30912495.43497.03
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1255936265931655930915934295929355932490.05
2255929035940405934720.14
单位质量响应值RSD%判断
23729.9623738.880.03数据可信
供试品溶液-20211122批-10mg/25mg-成分2-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176479-7647912.88910.6231.0312.8910.6231.04
237490-374906.3186.32
379672-7967213.42713.43
448666-486668.2028.20
584411-8441114.22614.23
651309-513098.6478.65
10min1221430-22143037.31835.1016.3637.3435.1216.36
2260386-26038643.88343.90
3203267-20326734.25734.28
4174656-17465629.43529.45
5221528-22152837.33437.36
6168484-16848428.39528.41
15min1310429-31042952.31749.5612.3252.4249.6612.32
2339376-33937657.19657.30
3295622-29562249.82249.92
4283933-28393347.85247.93
5304565-30456551.32951.43
6230647-23064738.87138.95
20min1365612-36561261.61759.0011.7261.8259.1911.72
2394656-39465666.51266.73
3352686-35268659.43959.63
4339880-33988057.28157.45
5372220-37222062.73162.94
6275357-27535746.40646.56
30min1422494-42249471.20467.219.5471.5367.519.54
2412051-41205169.44469.79
3382399-38239964.44664.76
4417398-41739870.34570.63
5429642-42964272.40872.74
6328646-32864655.38755.63
45min1461165-46116577.72176.4110.0078.1976.8510.00
2483004-48300481.40181.89
3456359-45635976.91177.35
4476647-47664780.33080.76
5479549-47954980.81981.30
6363428-36342861.24961.60
60min1479528-47952880.81679.909.6481.4480.509.64
2485885-48588581.88782.54
3471731-47173179.50280.10
4513394-51339486.52387.11
5507319-50731985.49986.14
6386828-38682865.19365.67
90min1516560-51656087.05785.359.6187.8486.109.61
2527000-52700088.81689.63
3502465-50246584.68185.44
4545949-54594992.01092.77
5534697-53469790.11390.92
6411920-41192069.42270.03
120min1509027-50902785.78787.0810.2586.7588.0110.24
2545895-54589592.00192.99
3512159-51215986.31587.24
4568006-56800695.72796.67
5546331-54633192.07493.06
6418848-41884870.58971.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1584347-58434798.48197.394.7899.6198.504.81
2574617-57461796.84198.02
3554988-55498893.53394.63
4606355-606355102.190103.33
5608044-608044102.475103.65
6539059-53905990.84891.74
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103223163226633227183231553216643225030.18
2103214443221513217980.16
单位质量响应值RSD%判断
32250.3032179.800.16数据可信
供试品溶液-20211122批-10mg/25mg-成分1-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%
5min1210648-21064865.38827.7766.4565.3927.7766.45
262905-6290519.52719.53
363654-6365419.75919.76
467665-6766521.00421.00
568992-6899221.41621.42
662830-6283019.50319.50
10min1295938-29593891.86370.2516.2991.9970.3116.33
2224806-22480669.78369.82
3188369-18836958.47258.51
4226643-22664370.35370.40
5215443-21544366.87766.92
6206709-20670964.16564.20
15min1304113-30411394.40190.022.8294.7290.222.87
2289645-28964589.91090.09
3286238-28623888.85289.01
4280476-28047687.06487.25
5293582-29358291.13291.31
6285944-28594488.76188.93
20min1304484-30448494.51694.170.7795.0294.550.78
2305057-30505794.69495.05
3304428-30442894.49994.83
4299064-29906492.83493.19
5304816-30481694.61994.98
6302374-30237493.86194.21
30min1305300-30530094.76995.670.7895.4696.230.74
2309328-30932896.02096.57
3308040-30804095.62096.14
4305931-30593194.96595.51
5308593-30859395.79296.34
6311921-31192196.82597.36
45min1305568-30556894.85396.591.1995.7397.351.14
2310973-31097396.53097.27
3310848-31084896.49297.21
4309341-30934196.02496.76
5314152-31415297.51798.26
6316114-31611498.12698.85
60min1305091-30509194.70596.551.4795.7897.501.42
2311023-31102396.54697.48
3310913-31091396.51297.42
4306887-30688795.26296.19
5316132-31613298.13299.07
6316076-31607698.11599.04
90min1304307-30430794.46196.361.5795.7297.501.52
2309379-30937996.03697.16
3309514-30951496.07897.18
4307022-30702295.30496.42
5315533-31553397.94699.08
6316847-31684798.35499.47
120min1302725-30272593.97095.931.5395.4297.261.48
2308923-30892395.89497.21
3308502-30850295.76397.06
4305336-30533694.78196.09
5314654-31465497.67399.00
6314082-31408297.49698.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1302825-30282594.00195.661.5695.6497.191.52
2308423-30842395.73997.25
3307280-30728095.38496.87
4303167-30316794.10795.60
5313345-31334597.26798.79
6314018-31401897.47698.99
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1256019816020536028066010486017336019240.11
2256015676003936009800.14
单位质量响应值RSD%判断
24076.9624039.200.12数据可信
供试品溶液-20211122批-10mg/25mg-成分2-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%
5min177347-7734712.8605.3768.6312.865.3768.58
222893-228933.8063.81
320787-207873.4563.46
425973-259734.3184.32
524245-242454.0314.03
622425-224253.7283.73
10min1213203-21320335.44820.1139.1235.4720.1239.13
2118818-11881819.75519.76
381897-8189713.61713.62
4117532-11753219.54119.55
598061-9806116.30416.31
696168-9616815.98916.00
15min1296767-29676749.34237.1117.2849.4437.1617.32
2230043-23004338.24838.30
3193423-19342332.15932.19
4217074-21707436.09236.14
5195349-19534932.48032.52
6206662-20666234.36134.40
20min1355651-35565159.13249.5610.5459.3349.6910.59
2307008-30700851.04551.17
3280818-28081846.69046.79
4293548-29354848.80748.93
5265175-26517544.08944.19
6286312-28631247.60347.71
30min1413501-41350168.75064.703.2469.0664.923.29
2390569-39056964.93865.16
3378356-37835662.90763.10
4383202-38320263.71363.93
5383321-38332163.73363.93
6385747-38574764.13664.34
45min1456647-45664775.92474.803.2976.3875.153.29
2454302-45430275.53475.89
3452255-45225575.19475.51
4451297-45129775.03575.38
5421111-42111170.01670.34
6463657-46365777.09077.42
60min1479921-47992179.79481.003.5780.4081.503.54
2493056-49305681.97882.48
3487822-48782281.10781.58
4495450-49545082.37682.87
5457734-45773476.10576.57
6509117-50911784.64885.13
90min1498141-49814182.82386.323.9683.5986.983.92
2519946-51994686.44987.12
3522920-52292086.94387.57
4533454-53345488.69489.35
5493325-49332582.02282.64
6547152-54715290.97291.63
120min1510914-51091484.94790.184.8885.8791.024.82
2541409-54140990.01790.86
3550640-55064091.55292.36
4559018-55901892.94593.78
5513570-51357085.38886.17
6578820-57882096.23797.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1562347-56234793.49897.223.6394.6098.243.57
2561151-56115193.29994.32
3607905-607905101.073102.06
4583848-58384897.07398.10
5582933-58293396.92197.87
6610074-610074101.434102.46
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103213843230973229483225933230353226110.23
2103219193217073218130.05
单位质量响应值RSD%判断
32261.1032181.300.18数据可信
供试品溶液-20211122批-10mg/25mg-成分1-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%
5min154893-5489317.03629.4341.4617.0429.4341.46
2132366-13236641.08041.08
369125-6912521.45321.45
4150937-15093746.84446.84
596980-9698030.09830.10
664680-6468020.07420.07
10min1179216-17921655.62173.5215.2655.6573.5815.28
2256604-25660479.63879.72
3209268-20926864.94764.99
4272905-27290584.69784.79
5264313-26431382.03182.09
6239061-23906174.19474.23
15min1255744-25574479.37186.296.2379.5286.506.26
2285239-28523988.52588.77
3260264-26026480.77480.95
4295154-29515491.60391.87
5296309-29630991.96192.19
6275473-27547385.49485.68
20min1285286-28528688.54091.802.4988.8492.182.54
2297747-29774792.40792.83
3292700-29270090.84191.18
4303119-30311994.07594.52
5304437-30443794.48494.89
6291506-29150690.47090.83
30min1303867-30386794.30795.270.8394.7995.830.83
2306527-30652795.13295.74
3311247-31124796.59797.11
4307711-30771195.50096.13
5307189-30718995.33895.93
6305239-30523994.73295.27
45min1309404-30940496.02596.161.1296.6996.911.08
2308326-30832695.69196.48
3316399-31639998.19698.91
4309031-30903195.90996.73
5306211-30621195.03495.82
6309638-30963896.09896.83
60min1309708-30970896.11996.341.3296.9897.281.28
2308996-30899695.89896.88
3317906-31790698.66499.57
4309388-30938896.02097.04
5305591-30559194.84295.82
6310842-31084296.47197.39
90min1309654-30965496.10396.121.2497.1697.261.20
2309077-30907795.92497.10
3316701-31670198.29099.39
4308581-30858195.77096.98
5305010-30501094.66195.83
6309311-30931195.99697.11
120min1311106-31110696.55396.081.1897.8097.421.14
2307738-30773895.50896.88
3315529-31552997.92699.23
4309466-30946696.04497.45
5304621-30462194.54195.90
6309066-30906695.92097.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1309832-30983296.15895.691.2897.6097.211.23
2305310-30531094.75596.31
3314414-31441497.58099.08
4308839-30883995.85097.44
5303032-30303294.04895.59
6308533-30853395.75597.25
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1256038436012706012966041466047036030520.28
2256023936001086012500.27
单位质量响应值RSD%判断
24122.0824050.000.22数据可信
供试品溶液-20211122批-10mg/25mg-成分2-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%
5min118240-182403.0295.7637.173.035.7637.16
244606-446067.4087.41
330953-309535.1405.14
453248-532488.8438.84
536598-365986.0786.08
624631-246314.0914.09
10min193613-9361315.54623.3521.2415.5523.3621.26
2161567-16156726.83226.85
3125452-12545220.83420.84
4173416-17341628.79928.82
5160055-16005526.58126.59
6129403-12940321.49021.50
15min1190521-19052131.64038.3511.9431.6838.4111.96
2249331-24933141.40741.48
3210178-21017834.90534.96
4259190-25919043.04443.12
5253813-25381342.15142.22
6222434-22243436.94036.99
20min1269435-26943544.74649.057.5644.8549.187.58
2306355-30635550.87751.03
3274877-27487745.64945.77
4314086-31408652.16152.32
5323506-32350653.72553.87
6283845-28384547.13947.26
30min1361231-36123159.99061.445.4160.1861.675.42
2372700-37270061.89562.15
3346674-34667457.57357.79
4376584-37658462.54062.81
5404388-40438867.15767.41
6358048-35804859.46259.68
45min1430809-43080971.54570.794.6971.8671.154.69
2422914-42291470.23470.61
3400294-40029466.47766.81
4422140-42214070.10570.50
5461346-46134676.61777.01
6420040-42004069.75770.09
60min1474745-47474578.84276.174.7979.2976.664.77
2448084-44808474.41474.93
3432332-43233271.79872.26
4444171-44417173.76474.30
5492226-49222681.74582.29
6460274-46027476.43876.92
90min1531599-53159988.28481.555.8388.8982.205.79
2473240-47324078.59279.26
3460766-46076676.52077.12
4473353-47335378.61179.29
5520659-52065986.46787.17
6486605-48660580.81181.44
120min1567464-56746494.24085.166.4495.0385.976.39
2489531-48953181.29782.12
3480275-48027579.76080.52
4495808-49580882.34083.18
5536130-53613089.03689.92
6507485-50748584.27985.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1597844-59784499.28593.833.41100.2694.813.36
2550627-55062791.44492.43
3573913-57391395.31196.23
4543642-54364290.28491.28
5563753-56375393.62394.68
6560050-56005093.00893.97
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103058653060743060123061213059023059950.04
2103064763065783065270.03
单位质量响应值RSD%判断
30599.5030652.700.13数据可信
供试品溶液-20211122批-10mg/25mg-成分1-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%
5min168220-6822022.27539.6946.2822.2839.6946.28
2176083-17608357.49457.49
386901-8690128.37528.37
4180455-18045558.92258.92
5158882-15888251.87851.88
658804-5880419.20119.20
10min1235917-23591777.03183.3016.5077.0883.3816.52
2286734-28673493.62493.74
3277295-27729590.54290.60
4283684-28368492.62892.75
5269320-26932087.93888.04
6177780-17778058.04958.09
15min1281870-28187092.03694.543.0292.2394.793.07
2298159-29815997.35597.66
3295322-29532296.42896.67
4297337-29733797.08697.39
5287160-28716093.76394.04
6277412-27741290.58090.73
20min1293581-29358195.86096.901.6596.2497.341.69
2302731-30273198.84799.34
3297321-29732197.08197.51
4302306-30230698.70999.21
5290992-29099295.01495.48
6293683-29368395.89396.23
30min1296801-29680196.91197.521.2897.4998.151.28
2303525-30352599.10799.80
3297637-29763797.18497.81
4300982-30098298.27698.97
5292671-29267195.56396.22
6300353-30035398.07198.60
45min1298433-29843397.44497.871.0598.2198.701.05
2303558-30355899.117100.01
3298404-29840497.43598.25
4301122-30112298.32299.21
5294860-29486096.27797.13
6302085-30208598.63799.36
60min1298703-29870397.53297.751.2398.5098.771.21
2302398-30239898.73999.83
3298407-29840797.43698.45
4301216-30121698.35399.44
5292875-29287595.62996.67
6302643-30264398.81999.74
90min1296908-29690896.94697.361.2798.1098.581.24
2301368-30136898.40299.69
3296900-29690096.94498.15
4299028-29902897.63898.92
5292169-29216995.39996.63
6302712-30271298.84199.96
120min1295977-29597796.64297.191.1597.9998.601.15
2301123-30112398.32299.81
3296641-29664196.85998.26
4299085-29908597.65799.14
5292209-29220995.41296.83
6300933-30093398.26099.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1294729-29472996.23596.901.3197.7898.501.29
2300499-30049998.11999.80
3295653-29565396.53698.13
4297647-29764797.18798.86
5290806-29080694.95496.57
6301202-30120298.34899.86
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1255580185582005593655579185576785582360.12
2255585345583495584420.03
单位质量响应值RSD%判断
22329.4422337.680.03数据可信
供试品溶液-20211122批-10mg/25mg-成分2-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%
5min127518-275184.9297.8541.734.937.8541.74
253441-534419.5719.57
338998-389986.9856.98
462422-6242211.18011.18
561810-6181011.07011.07
618871-188713.3803.38
10min1131447-13144723.54327.4025.4823.5527.4225.49
2179055-17905532.06932.09
3150808-15080827.01027.02
4192101-19210134.40634.43
5177349-17734931.76431.79
687235-8723515.62415.63
15min1234548-23454842.00843.9811.7942.0744.0511.81
2262328-26232846.98447.07
3248082-24808244.43244.50
4277222-27722249.65149.74
5256873-25687346.00746.09
6194125-19412534.76834.81
20min1303577-30357754.37155.106.8254.5155.266.85
2317707-31770756.90257.08
3308713-30871355.29155.45
4336048-33604860.18760.38
5307682-30768255.10755.28
6272024-27202448.72048.83
30min1382141-38214168.44267.243.7668.6967.513.78
2375988-37598867.34067.63
3369432-36943266.16666.43
4399446-39944671.54271.85
5365610-36561065.48265.77
6360041-36004164.48464.69
45min1449628-44962880.53076.943.8680.9277.343.84
2419472-41947275.12975.55
3421734-42173475.53475.93
4448147-44814780.26480.72
5408152-40815273.10173.52
6430265-43026577.06277.40
60min1494950-49495088.64782.615.0589.1983.175.01
2442910-44291079.32679.90
3448986-44898680.41580.97
4475431-47543185.15185.77
5433416-43341677.62678.19
6471826-47182684.50584.99
90min1534780-53478095.78188.085.9496.5188.805.89
2464409-46440983.17783.91
3473605-47360584.82485.54
4499734-49973489.50490.29
5464037-46403783.11083.83
6514183-51418392.09292.75
120min1557724-55772499.89091.426.20100.8192.326.14
2481080-48108086.16387.06
3491083-49108387.95488.84
4515018-51501892.24193.20
5481463-48146386.23187.12
6536203-53620396.03596.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1568585-568585101.83597.203.40102.9598.293.37
2528303-52830394.62095.69
3528369-52836994.63295.69
4539509-53950996.62897.78
5528736-52873694.69895.76
6562875-562875100.812101.85
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1103176043176343187383194403192933185420.28
2103173793173433173610.01
单位质量响应值RSD%判断
31854.2031736.100.27数据可信
供试品溶液-20211122批-10mg/25mg-成分1-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%
5min158287-5828718.33232.7548.6218.3332.7548.62
2144964-14496445.59345.59
3160050-16005050.33850.34
454842-5484217.24917.25
561549-6154919.35819.36
6145066-14506645.62545.63
10min1193224-19322460.77273.5519.0860.8173.6119.11
2282130-28213088.73488.83
3279226-27922687.82187.92
4189923-18992359.73459.77
5198137-19813762.31762.36
6260400-26040081.90081.99
15min1280910-28091088.35090.054.4088.5190.264.45
2302712-30271295.20795.48
3298470-29847093.87394.15
4268126-26812684.33084.48
5282491-28249188.84889.01
6285188-28518889.69689.95
20min1306018-30601896.24795.071.6896.5895.461.69
2307678-30767896.76997.23
3303132-30313295.33995.80
4296104-29610493.12993.45
5304745-30474595.84796.19
6295914-29591493.06993.50
30min1313042-31304298.45696.961.5298.9897.541.46
2309413-30941397.31597.97
3302945-30294595.28195.94
4311695-31169598.03398.54
5310608-31060897.69198.22
6301945-30194594.96695.59
45min1315384-31538499.19397.701.4599.9298.481.38
2309332-30933297.28998.14
3304218-30421895.68196.53
4315708-31570899.295100.00
5311606-31160698.00598.73
6307600-30760096.74597.56
60min1315250-31525099.15197.851.15100.0798.821.09
2310877-31087797.77598.82
3305420-30542096.05997.10
4314037-31403798.76999.67
5312118-31211898.16699.09
6308946-30894697.16898.17
90min1315729-31572999.30198.021.10100.4299.191.03
2310486-31048697.65298.89
3306121-30612196.27997.51
4314649-31464998.962100.06
5311824-31182498.07399.19
6311200-31120097.87799.08
120min1315541-31554199.24297.311.63100.5698.681.56
2303588-30358895.48396.92
3303547-30354795.47096.89
4313937-31393798.738100.04
5310036-31003697.51198.83
6309797-30979797.43698.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1312945-31294598.42697.491.2599.9499.041.20
2308978-30897897.17898.80
3303386-30338695.41997.03
4313414-31341498.573100.07
5308425-30842597.00498.52
6312622-31262298.32499.91
尚未录入该项目项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1255967335973505967465959125971665967810.10
2255951385935345943360.20
单位质量响应值RSD%判断
23871.2423773.440.30数据可信
供试品溶液-20211122批-10mg/25mg-成分2-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%
5min119827-198273.3296.8557.833.336.8657.83
256610-566109.5059.51
360049-6004910.08310.08
417987-179873.0203.02
521088-210883.5413.54
669387-6938711.65111.65
10min193916-9391615.76923.1736.1515.7823.1936.16
2189310-18931031.78731.81
3194657-19465732.68532.71
492807-9280715.58315.59
593748-9374815.74115.75
6163549-16354927.46227.48
15min1205055-20505534.43139.2815.9134.4739.3415.95
2284111-28411147.70547.79
3277114-27711446.53046.62
4205845-20584534.56434.60
5204457-20445734.33034.37
6226873-22687338.09438.17
20min1288050-28805048.36750.7010.7348.4750.8410.75
2347580-34758058.36258.54
3334962-33496256.24456.42
4287046-28704648.19848.30
5291451-29145148.93849.04
6262583-26258344.09044.24
30min1380371-38037163.86863.2810.7264.0763.5210.70
2420615-42061570.62670.92
3400176-40017667.19467.48
4372911-37291162.61662.82
5384919-38491964.63264.84
6302044-30204450.71650.96
45min1452381-45238175.95973.0111.8476.2973.3811.81
2473191-47319179.45479.89
3449370-44937075.45475.88
4443743-44374374.50974.84
5458542-45854276.99477.33
6331785-33178555.71056.05
60min1499732-49973283.91078.8112.7284.3979.3212.68
2506335-50633585.01985.61
3476630-47663080.03180.61
4481951-48195180.92581.40
5501633-50163384.22984.72
6349881-34988158.74959.20
90min1546616-54661691.78284.7213.1192.4385.3913.05
2537331-53733190.22390.99
3502601-50260184.39285.13
4518465-51846587.05687.69
5547852-54785291.99092.65
6374380-37438062.86263.44
120min1571986-57198696.04287.2413.1296.8888.0813.05
2515761-51576186.60287.55
3518189-51818987.00987.91
4544355-54435591.40392.22
5576478-57647896.79797.64
6390734-39073465.60866.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1602008-602008101.08397.284.58102.1198.294.55
2573233-57323396.25297.37
3546913-54691391.83292.91
4603047-603047101.258102.25
5601064-601064100.925101.96
6549828-54982892.32293.15
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