非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103078913101073075423085583086983085590.32
211.173092903081953087420.26
单位质量响应值RSD%判断
27798.1127640.290.41数据可信
供试品溶液-1批-恩格列净-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%
5min1298166-29816695.16594.414.1595.1694.414.15
2302865-30286596.66596.66
3301384-30138496.19296.19
4299003-29900395.43295.43
5271053-27105386.51186.51
6302395-30239596.51596.51
10min1322032-322032102.782103.520.57102.94103.680.57
2322070-322070102.794102.96
3326283-326283104.139104.30
4324908-324908103.700103.86
5325473-325473103.880104.02
6325333-325333103.836104.00
15min1324814-324814103.670104.080.67104.00104.400.67
2322409-322409102.903103.23
3327195-327195104.430104.76
4327304-327304104.465104.80
5326311-326311104.148104.47
6328475-328475104.839105.17
20min1323978-323978103.403104.030.46103.91104.530.45
2324295-324295103.504104.01
3326169-326169104.103104.61
4326581-326581104.234104.74
5327500-327500104.527105.02
6327089-327089104.396104.90
30min1323829-323829103.356103.920.56104.03104.600.56
2323236-323236103.166103.84
3326165-326165104.101104.78
4328182-328182104.745105.42
5326317-326317104.150104.81
6325884-325884104.012104.69
45min1323952-323952103.395104.120.61104.24104.970.61
2323626-323626103.291104.14
3326889-326889104.332105.19
4328092-328092104.716105.57
5326711-326711104.276105.11
6328073-328073104.710105.57
60min1322994-322994103.089103.900.61104.11104.920.61
2323220-323220103.161104.18
3326149-326149104.096105.13
4327293-327293104.461105.49
5325982-325982104.043105.06
6327578-327578104.552105.58
极限1322097-322097102.803103.700.61103.99104.890.61
2322870-322870103.050104.24
3325722-325722103.960105.16
4326573-326573104.232105.43
5325335-325335103.836105.02
6326831-326831104.314105.52
非奈利酮恩格列净片项目信息
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250201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)20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%
1 22.108078518146018081918108068120008106900.35
2 22.148125078095918110490.26
单位质量响应值RSD%判断
36682.8136632.750.10数据可信
供试品溶液-1批-非奈利酮-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%
5min1229190-22919028.13529.1613.7828.1329.1613.78
2294139-29413936.10836.11
3258544-25854431.73831.74
4218623-21862326.83826.84
5214739-21473926.36126.36
6210010-21001025.78025.78
10min1450811-45081155.34056.205.0955.3956.255.10
2485252-48525259.56859.63
3487344-48734459.82559.88
4433086-43308653.16453.21
5452594-45259455.55955.60
6437834-43783453.74753.79
15min1538716-53871666.13166.513.1866.2766.663.19
2557692-55769268.46168.62
3567401-56740169.65269.81
4523401-52340164.25164.38
5535371-53537165.72165.86
6528435-52843564.86965.00
20min1585091-58509171.82472.082.5272.0772.332.53
2601467-60146773.83474.11
3608840-60884074.73975.01
4573225-57322570.36770.61
5580520-58052071.26371.51
6573931-57393170.45470.69
30min1635412-63541278.00178.241.7378.3778.621.75
2645042-64504279.18379.58
3655546-65554680.47380.87
4632468-63246877.64078.00
5630124-63012477.35277.72
6625634-62563476.80177.16
45min1674949-67494982.85583.311.2183.3583.811.22
2682271-68227183.75484.28
3693768-69376885.16585.69
4674565-67456582.80883.29
5673900-67390082.72683.22
6672357-67235782.53783.02
60min1694951-69495185.31085.811.0885.9586.451.09
2700428-70042885.98386.65
3713514-71351487.58988.26
4697319-69731985.60186.23
5693112-69311285.08485.72
6694775-69477585.28985.91
极限1703729-70372986.38886.871.0687.1787.661.08
2709223-70922387.06287.87
3721465-72146588.56589.38
4707708-70770886.87687.64
5700001-70000185.93086.70
6703896-70389686.40887.17
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103068153083983073393082283073073076170.22
211.173089233094073091650.12
单位质量响应值RSD%判断
27713.2427678.160.09数据可信
供试品溶液-2批-恩格列净-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%
5min1255321-25532181.55977.2610.8481.5677.2610.84
2279422-27942289.25789.26
3217963-21796369.62569.63
4218637-21863769.84169.84
5220931-22093170.57370.57
6258992-25899282.73182.73
10min1314870-314870100.581102.131.28100.72102.261.28
2322143-322143102.904103.05
3316369-316369101.060101.18
4324128-324128103.538103.65
5316999-316999101.261101.38
6323723-323723103.409103.55
15min1324513-324513103.661103.890.81103.96104.190.82
2325847-325847104.087104.41
3323061-323061103.197103.48
4329037-329037105.106105.40
5321900-321900102.826103.11
6327001-327001104.456104.77
20min1324628-324628103.698103.970.91104.17104.440.91
2327647-327647104.662105.16
3323297-323297103.273103.73
4329079-329079105.120105.58
5321261-321261102.622103.08
6326990-326990104.452104.94
30min1324879-324879103.778103.960.56104.43104.610.56
2326979-326979104.449105.12
3325344-325344103.927104.56
4327715-327715104.684105.32
5322535-322535103.029103.66
6325304-325304103.914104.57
45min1325187-325187103.876104.000.76104.70104.820.77
2327284-327284104.546105.39
3324687-324687103.717104.52
4328837-328837105.042105.86
5321609-321609102.733103.53
6325847-325847104.087104.92
60min1325314-325314103.917104.010.48104.91105.000.49
2326197-326197104.199105.22
3325809-325809104.075105.05
4327279-327279104.545105.53
5322719-322719103.088104.06
6326341-326341104.245105.25
极限1324768-324768103.743103.680.53104.91104.850.54
2325492-325492103.974105.16
3323629-323629103.379104.53
4327098-327098104.487105.65
5322027-322027102.867104.01
6324449-324449103.641104.82
非奈利酮恩格列净片项目信息
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250201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)20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%
1 22.108052828099698069258097218072118078220.25
2 22.148111248121148116190.09
单位质量响应值RSD%判断
36553.0336658.490.21数据可信
供试品溶液-2批-非奈利酮-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%
5min1142915-14291517.56915.4616.3617.5715.4616.36
2131444-13144416.15916.16
398456-9845612.10312.10
4147415-14741518.12218.12
5131883-13188316.21316.21
6102587-10258712.61112.61
10min1413746-41374650.86348.536.0950.8948.566.09
2380718-38071846.80246.83
3379747-37974746.68346.70
4421164-42116451.77451.80
5411888-41188850.63450.66
6361389-36138944.42644.45
15min1520801-52080164.02362.493.2864.1462.603.29
2500495-50049561.52761.63
3494608-49460860.80360.90
4531806-53180665.37665.49
5514059-51405963.19463.31
6488412-48841260.04160.14
20min1575620-57562070.76269.612.4970.9869.822.50
2563749-56374969.30369.51
3554465-55446568.16168.36
4587993-58799372.28372.51
5566502-56650269.64169.86
6549312-54931267.52867.72
30min1635752-63575278.15477.141.6078.4977.471.61
2626898-62689877.06677.39
3622245-62224576.49476.81
4642179-64217978.94479.29
5623747-62374776.67877.01
6614209-61420975.50675.81
45min1681632-68163283.79482.961.3684.2683.411.37
2676459-67645983.15883.61
3668946-66894682.23582.68
4688793-68879384.67585.15
5667514-66751482.05982.52
6665530-66553081.81582.25
60min1704613-70461386.61986.061.0987.2386.661.11
2699804-69980486.02886.62
3695607-69560785.51286.09
4713075-71307587.66088.28
5693494-69349485.25285.85
6693906-69390685.30385.87
极限1715581-71558187.96887.151.0188.7287.891.02
2709450-70945087.21487.95
3703196-70319686.44587.17
4719251-71925188.41989.18
5704107-70410786.55787.30
6702094-70209486.31087.02
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103092353080303089123095793076233086760.27
211.173078023091383084700.31
单位质量响应值RSD%判断
27808.6527615.940.50数据可信
供试品溶液-3批-恩格列净-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%
5min1187036-18703659.71161.548.1259.7161.548.12
2167406-16740653.44453.44
3210717-21071767.27167.27
4188883-18888360.30160.30
5195524-19552462.42162.42
6207013-20701366.08966.09
10min1330383-330383105.474104.951.87105.57105.061.87
2332135-332135106.034106.12
3336882-336882107.549107.66
4329092-329092105.062105.16
5324961-324961103.743103.85
6319071-319071101.863101.97
15min1336210-336210107.335107.982.25107.61108.262.24
2344060-344060109.841110.11
3347856-347856111.052111.34
4339259-339259108.308108.58
5336106-336106107.301107.58
6325944-325944104.057104.34
20min1339347-339347108.336107.922.45108.79108.382.45
2343681-343681109.720110.17
3349205-349205111.483111.96
4338365-338365108.023108.48
5331434-331434105.810106.27
6326194-326194104.137104.59
30min1337630-337630107.788107.992.51108.42108.622.50
2345506-345506110.302110.93
3348000-348000111.098111.76
4339492-339492108.382109.02
5334699-334699106.852107.48
6324239-324239103.513104.14
45min1338347-338347108.017107.792.53108.83108.602.52
2344245-344245109.900110.72
3348110-348110111.134111.98
4339570-339570108.407109.22
5329908-329908105.323106.13
6325600-325600103.947104.75
60min1336915-336915107.560107.872.23108.55108.872.22
2344749-344749110.061111.06
3347904-347904111.068112.10
4337244-337244107.665108.66
5333248-333248106.389107.37
6327329-327329104.499105.47
极限1337824-337824107.850107.482.75109.02108.652.74
2343304-343304109.599110.78
3347571-347571110.962112.18
4339066-339066108.246109.42
5330074-330074105.376106.54
6322081-322081102.824103.97
非奈利酮恩格列净片项目信息
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250201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)20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%
1 22.108109558086698101818121548073568098630.24
2 22.148082928118228100570.31
单位质量响应值RSD%判断
36645.3836587.940.12数据可信
供试品溶液-3批-非奈利酮-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%
5min1102569-10256912.60511.4122.6312.6111.4122.65
269723-697238.5698.57
3108774-10877413.36813.37
466595-665958.1848.18
591240-9124011.21311.21
6117966-11796614.49714.50
10min1391887-39188748.16146.764.7148.1846.784.72
2382018-38201846.94846.96
3394451-39445148.47648.50
4348434-34843442.82142.83
5372298-37229845.75445.77
6394009-39400948.42248.45
15min1515282-51528263.32662.801.2463.4362.901.25
2510458-51045862.73362.83
3519747-51974763.87463.98
4501340-50134061.61261.70
5507850-50785062.41262.51
6511469-51146962.85762.96
20min1577265-57726570.94370.320.9071.1570.520.91
2569370-56937069.97370.17
3580058-58005871.28671.50
4568084-56808469.81570.00
5568829-56882969.90670.11
6569564-56956469.99770.21
30min1635240-63524078.06878.060.5278.3978.380.51
2632605-63260577.74478.06
3638377-63837778.45378.78
4637091-63709178.29578.60
5637771-63777178.37978.69
6630072-63007277.43377.76
45min1680057-68005783.57683.540.7884.0383.990.77
2673972-67397282.82883.27
3685379-68537984.23084.69
4686708-68670884.39384.83
5676938-67693883.19283.64
6675711-67571183.04183.50
60min1699684-69968485.98886.570.5386.5887.160.53
2700594-70059486.09986.68
3708928-70892887.12487.72
4706746-70674686.85687.43
5706766-70676686.85887.44
6703826-70382686.49787.09
极限1711216-71121687.40587.560.9688.1488.290.95
2707338-70733886.92887.65
3716254-71625488.02488.77
4723266-72326688.88689.61
5712600-71260087.57588.30
6704054-70405486.52587.26
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103073973100263088793097753104723093100.40
211.173084223080343082280.09
单位质量响应值RSD%判断
27865.7727594.270.70数据可信
供试品溶液-2批-恩格列净-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255410-25541081.48864.0026.3481.4964.0026.35
2206176-20617665.78065.78
3268440-26844085.64585.65
4135318-13531843.17343.17
5175470-17547055.98355.98
6162843-16284351.95551.95
10min1319336-319336101.884101.461.53102.02101.561.53
2316156-316156100.869100.98
3318253-318253101.538101.68
4309812-30981298.84598.92
5324405-324405103.501103.59
6320050-320050102.111102.20
15min1321179-321179102.472103.251.36102.78103.531.35
2327252-327252104.409104.69
3318526-318526101.625101.94
4322532-322532102.903103.14
5330467-330467105.435105.70
6321737-321737102.650102.91
20min1323656-323656103.262103.081.43103.74103.531.41
2320329-320329102.200102.65
3318588-318588101.645102.13
4322153-322153102.782103.19
5331770-331770105.851106.29
6322099-322099102.765103.19
30min1323251-323251103.133104.023.49103.78104.643.47
2321442-321442102.555103.18
3318831-318831101.722102.37
4322339-322339102.842103.42
5349001-349001111.348111.97
6321287-321287102.506103.11
45min1323288-323288103.144103.050.95103.96103.840.96
2320795-320795102.349103.14
3321669-321669102.628103.45
4321557-321557102.592103.34
5329018-329018104.973105.78
6321617-321617102.611103.38
60min1321242-321242102.492102.990.71103.48103.960.70
2321244-321244102.492103.46
3321915-321915102.706103.70
4322821-322821102.995103.92
5327249-327249104.408105.39
6322436-322436102.873103.81
极限1327099-327099104.360104.060.94105.52105.200.93
2323251-323251103.133104.27
3325411-325411103.822104.98
4329768-329768105.212106.31
5329067-329067104.988106.14
6322331-322331102.839103.95
非奈利酮恩格列净片项目信息
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250201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)20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%
1 22.108078818132988104728135908149168120310.35
2 22.148093868079748086800.13
单位质量响应值RSD%判断
36743.4836525.750.43数据可信
供试品溶液-2批-非奈利酮-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1281269-28126934.55024.5346.5034.5524.5246.51
2203662-20366225.01725.02
3337657-33765741.47641.48
4126785-12678515.57415.57
5105620-10562012.97412.97
6142991-14299117.56417.56
10min1677698-67769883.24680.215.8383.3080.255.83
2583079-58307971.62371.66
3690986-69098684.87884.95
4644776-64477679.20279.23
5653650-65365080.29280.31
6667644-66764482.01182.04
15min1707584-70758486.91787.631.2587.1187.801.25
2701257-70125786.13986.30
3714979-71497987.82588.04
4717984-71798488.19488.35
5727087-72708789.31289.47
6711313-71131387.37587.54
20min1719394-71939488.36788.711.3288.7189.031.32
2708668-70866887.05087.35
3721210-72121088.59088.95
4726411-72641189.22989.53
5737600-73760090.60490.91
6719795-71979588.41788.73
30min1723145-72314588.82889.792.2189.3290.262.19
2717225-71722588.10188.55
3728952-72895289.54190.05
4732085-73208589.92690.38
5762148-76214893.61994.07
6722485-72248588.74789.21
45min1727181-72718189.32489.781.2189.9690.401.22
2717896-71789688.18388.78
3740369-74036990.94491.60
4732243-73224389.94690.55
5740754-74075490.99191.60
6726760-72676089.27289.88
60min1727095-72709589.31390.041.1790.1090.811.18
2720401-72040188.49189.23
3743081-74308191.27792.08
4737602-73760290.60491.36
5739542-73954290.84291.61
6730288-73028889.70590.46
极限1754069-75406992.62792.641.1993.5693.561.19
2741765-74176591.11592.01
3757508-75750893.04994.01
4767248-76724894.24595.15
5757710-75771093.07493.99
6746923-74692391.74992.65
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