非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.111890441891941889911892251889011890710.08
211.161898601895941897270.10
单位质量响应值RSD%判断
17018.0917000.630.08数据可信
供试品溶液-2批-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%
5min148783-4878325.79121.1416.9925.7921.1417.00
240018-4001821.15721.16
340024-4002421.16121.16
445006-4500623.79523.79
529080-2908015.37515.37
636968-3696819.54519.54
10min1135100-13510071.42765.446.7871.4765.476.78
2126885-12688567.08467.12
3124802-12480265.98266.02
4125896-12589666.56166.60
5109843-10984358.07458.10
6120075-12007563.48363.52
15min1162051-16205185.67683.222.3885.8483.362.39
2161513-16151385.39185.54
3157723-15772383.38883.53
4153856-15385681.34381.49
5153311-15331181.05581.18
6155982-15598282.46782.61
20min1172918-17291891.42189.822.1291.7390.102.12
2175018-17501892.53292.82
3169525-16952589.62789.91
4164962-16496287.21587.50
5167965-16796588.80389.06
6168918-16891889.30689.58
30min1182626-18262696.55495.431.8597.0195.861.85
2184633-18463397.61598.06
3180005-18000595.16895.60
4174684-17468492.35592.79
5180459-18045995.40895.81
6180600-18060095.48395.91
45min1188152-18815299.47598.611.87100.0999.201.87
2191008-191008100.985101.59
3185655-18565598.15598.75
4180480-18048095.41996.00
5186687-18668798.70199.27
6187138-18713898.93999.52
60min1190479-190479100.70699.901.76101.49100.661.75
2192685-192685101.872102.65
3188203-18820399.502100.26
4182905-18290596.70197.45
5189417-189417100.144100.87
6190066-190066100.487101.24
极限1193215-193215102.152101.651.48103.10102.571.48
2195642-195642103.435104.38
3192367-192367101.704102.63
4187085-18708598.91199.82
5193224-193224102.157103.05
6192037-192037101.529102.45
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.111890871890641888591888181887041889060.09
211.161903271899281901280.15
单位质量响应值RSD%判断
17003.2417036.560.14数据可信
供试品溶液-2批-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%
5min134362-3436218.15635.7129.8818.1635.7129.87
276308-7630840.31940.32
352913-5291327.95827.96
472402-7240238.25538.26
588663-8866346.84746.85
680807-8080742.69642.70
10min1108267-10826757.20565.888.5657.2465.948.58
2131318-13131869.38569.45
3114758-11475860.63560.68
4127970-12797067.61667.68
5135230-13523071.45271.53
6130566-13056668.98769.06
15min1137219-13721972.50278.025.2872.6378.195.31
2152151-15215180.39280.57
3139363-13936373.63573.78
4148241-14824178.32678.50
5156934-15693482.91983.12
6152078-15207880.35380.54
20min1151234-15123479.90884.494.4880.1584.794.51
2165307-16530787.34387.66
3152564-15256480.61080.88
4157953-15795383.45883.76
5168935-16893589.26089.60
6163452-16345286.36386.68
30min1165168-16516887.27090.673.3887.6591.113.40
2177974-17797494.03694.50
3166058-16605887.74088.14
4169207-16920789.40489.85
5178516-17851694.32394.81
6172674-17267491.23691.70
45min1172072-17207290.91894.142.9891.4494.733.01
2183203-18320396.79997.42
3173641-17364191.74792.30
4175377-17537792.66493.26
5185089-18508997.79698.44
6179653-17965394.92395.54
60min1177467-17746793.76895.362.4894.4496.112.51
2184961-18496197.72898.51
3175951-17595192.96793.67
4176651-17665193.33794.09
5186369-18636998.47299.28
6181534-18153495.91796.69
极限1190286-190286100.54199.231.31101.37100.141.31
2190382-190382100.592101.54
3185053-18505397.77698.64
4185170-18517097.83898.74
5189104-18910499.917100.89
6186786-18678698.69299.63
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.113754093752023757693754683751703754040.07
211.163789153780733784940.16
单位质量响应值RSD%判断
33789.7433915.230.27数据可信
供试品溶液-1批-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%
5min197185-9718525.81719.9537.3025.8219.9637.29
299539-9953926.44226.44
377377-7737720.55520.56
492353-9235324.53324.53
555519-5551914.74814.75
628711-287117.6277.63
10min1247512-24751265.75156.0324.1065.7956.0724.11
2249752-24975266.34666.39
3223346-22334659.33159.37
4235537-23553762.57062.61
5193384-19338451.37251.40
6116044-11604430.82730.84
15min1296458-29645878.75372.7811.6078.9172.9011.62
2297687-29768779.08079.23
3281590-28159074.80474.94
4284858-28485875.67275.82
5270690-27069071.90872.02
6212445-21244556.43556.50
20min1320973-32097385.26680.226.9485.5580.466.98
2317197-31719784.26384.55
3304428-30442880.87181.13
4307565-30756581.70481.98
5299057-29905779.44479.67
6262582-26258269.75469.91
30min1337034-33703489.53286.723.1789.9687.103.22
2336379-33637989.35889.79
3323893-32389386.04186.43
4327776-32777687.07387.48
5324820-32482086.28886.65
6308776-30877682.02682.30
45min1349955-34995592.96590.931.8693.5491.461.91
2349342-34934292.80293.38
3337991-33799189.78690.32
4342022-34202290.85791.41
5340709-34070990.50991.01
6333796-33379688.67289.08
60min1356372-35637294.66992.561.8795.4093.241.90
2355651-35565194.47895.21
3343757-34375791.31892.00
4341272-34127290.65891.36
5349785-34978592.92093.58
6343830-34383091.33891.90
极限1362883-36288396.39994.941.1797.2995.771.19
2360442-36044295.75196.64
3350616-35061693.14093.98
4356309-35630994.65395.51
5356512-35651294.70795.52
6357501-35750194.96995.68
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
111.113756633775363767743774463768803768600.20
211.163759823764033761920.08
单位质量响应值RSD%判断
33920.7933708.960.45数据可信
供试品溶液-1批-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%
5min1114353-11435330.41241.7021.1830.4141.7021.18
2169329-16932945.03245.03
3115976-11597630.84330.84
4168834-16883444.90144.90
5183667-18366748.84548.85
6188712-18871250.18750.19
10min1238927-23892763.54169.485.6763.5969.555.68
2257869-25786968.57968.65
3252846-25284667.24367.29
4281719-28171974.92275.00
5268523-26852371.41271.49
6267748-26774871.20671.29
15min1281831-28183174.95178.643.6575.1178.823.66
2291537-29153777.53377.72
3291849-29184977.61677.78
4314420-31442083.61883.82
5298111-29811179.28179.48
6296455-29645578.84179.04
20min1304706-30470681.03583.323.2081.3283.643.20
2307508-30750881.78082.10
3310029-31002982.45182.74
4332752-33275288.49488.83
5313711-31371183.43083.76
6311169-31116982.75483.09
30min1326335-32633586.78788.072.4287.2088.522.43
2325879-32587986.66687.12
3328269-32826987.30187.73
4347045-34704592.29592.78
5331119-33111988.05988.53
6328226-32822687.29087.76
45min1339895-33989590.39391.421.9290.9592.021.93
2337803-33780389.83790.44
3341883-34188390.92291.50
4356289-35628994.75395.39
5344953-34495391.73892.36
6341751-34175190.88791.50
60min1345779-34577991.95892.881.6292.6793.631.63
2343896-34389691.45792.21
3348388-34838892.65293.38
4360078-36007895.76196.56
5348995-34899592.81393.58
6348308-34830892.63193.40
极限1357970-35797095.20095.451.3096.0796.361.31
2354037-35403794.15495.06
3358318-35831895.29396.17
4367852-36785297.82898.79
5357302-35730295.02395.95
6357908-35790895.18496.11
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