枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数250
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.454747714757484767234759714756174757660.15
217.594746984744114745540.05
单位质量响应值RSD%判断
27264.5326978.620.75数据可信
供试品溶液-2024051712批-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%
5min1316061-31606159.00961.384.5759.0161.384.57
2314368-31436858.69358.69
3321753-32175360.07160.07
4341203-34120363.70363.70
5327019-32701961.05461.05
6352223-35222365.76065.76
10min1318664-31866459.49561.043.7959.5961.153.80
2318041-31804159.37859.48
3315344-31534458.87558.97
4347885-34788564.95065.06
5328261-32826161.28661.39
6333594-33359462.28262.39
15min1318377-31837759.44160.863.5259.6461.063.52
2317492-31749259.27659.47
3314604-31460458.73758.93
4344939-34493964.40064.61
5328749-32874961.37761.58
6331566-33156661.90362.12
20min1317346-31734659.24960.913.8759.5561.213.87
2316926-31692659.17059.47
3312321-31232158.31058.61
4344522-34452264.32264.64
5335198-33519862.58262.89
6331010-33101061.80062.12
30min1317582-31758259.29360.453.5759.6960.863.57
2316422-31642259.07659.47
3312244-31224458.29658.69
4344138-34413864.25164.68
5323515-32351560.40060.81
6328822-32882261.39161.81
45min1316094-31609459.01560.373.6059.5160.883.60
2314351-31435158.68959.18
3311366-31136658.13258.62
4341984-34198463.84864.38
5326782-32678261.01061.52
6329690-32969061.55362.08
极限1313890-31389058.60359.683.1059.2060.293.10
2313998-31399858.62359.21
3308802-30880257.65358.24
4336693-33669362.86163.50
5323189-32318960.33960.95
6321439-32143960.01360.64
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数250
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.454759284759834764454758844782364764950.21
217.594761474757154759310.07
单位质量响应值RSD%判断
27306.3027056.910.65数据可信
供试品溶液-2024051712批-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%
5min1310503-31050357.84357.652.5457.8457.652.54
2306254-30625457.05157.05
3315392-31539258.75358.75
4295453-29545355.03955.04
5312243-31224358.16758.17
6317046-31704659.06159.06
10min1314653-31465358.61658.052.6158.7158.142.61
2310429-31042957.82957.92
3318980-31898059.42259.52
4296094-29609455.15855.25
5316159-31615958.89658.99
6313367-31336758.37658.47
15min1314485-31448558.58458.162.9858.7858.352.97
2312013-31201358.12458.32
3318400-31840059.31459.51
4294089-29408954.78554.97
5314751-31475158.63458.83
6319444-31944459.50859.70
20min1313644-31364458.42857.972.6558.7258.262.65
2309017-30901757.56657.85
3315882-31588258.84559.14
4296001-29600155.14155.42
5312698-31269858.25158.54
6319765-31976559.56859.86
30min1313383-31338358.37957.822.9258.7758.212.92
2308859-30885957.53657.92
3314966-31496658.67459.07
4293228-29322854.62454.99
5312843-31284358.27858.67
6319092-31909259.44359.84
45min1312569-31256958.22757.692.7558.7158.172.75
2308280-30828057.42857.91
3314252-31425258.54159.03
4293600-29360054.69455.15
5311374-31137458.00558.49
6317999-31799959.23959.73
极限1304656-30465656.75357.052.5057.3457.622.50
2306659-30665957.12657.70
3310795-31079557.89758.49
4292022-29202254.40054.95
5309476-30947657.65158.23
6313763-31376358.45059.04
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数250
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.454753594758944761324756174758984757800.07
217.594750434746134748280.07
单位质量响应值RSD%判断
27265.3326994.200.71数据可信
供试品溶液-2024051713批-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%
5min1317390-31739059.23958.643.9859.2458.643.98
2312832-31283258.38858.39
3310144-31014457.88657.89
4292534-29253454.59954.60
5326427-32642760.92560.93
6325690-32569060.78860.79
10min1322069-32206960.11259.643.9860.2159.743.98
2315010-31501058.79458.89
3324806-32480660.62360.72
4296292-29629255.30155.39
5331786-33178661.92662.03
6327316-32731661.09161.19
15min1319069-31906959.55259.133.6159.7559.323.61
2315131-31513158.81759.01
3315420-31542058.87159.07
4296380-29638055.31755.50
5328646-32864661.34061.54
6326063-32606360.85761.06
20min1318972-31897259.53459.143.6559.8359.443.65
2321015-32101559.91560.21
3312586-31258658.34258.64
4296294-29629455.30155.58
5330094-33009461.61061.92
6322364-32236460.16760.47
30min1318085-31808559.36859.114.4359.7759.504.42
2313876-31387658.58358.98
3311920-31192058.21858.61
4295888-29588855.22555.59
5338846-33884663.24363.65
6321610-32161060.02660.43
45min1316186-31618659.01458.603.5959.5159.093.59
2321042-32104259.92060.41
3309541-30954157.77458.26
4293261-29326154.73555.19
5323571-32357160.39260.91
6320180-32018059.75960.26
极限1313076-31307658.43458.393.6659.0358.983.66
2309145-30914557.70058.29
3323351-32335160.35160.94
4292038-29203854.50755.06
5320636-32063659.84560.46
6318885-31888559.51860.12
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数250
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.454753714750914762964758714752424755740.11
217.594868454866874867660.03
单位质量响应值RSD%判断
27253.5227672.881.08数据可信
供试品溶液-2024051713批-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%
5min1316113-31611358.28654.577.1558.2954.587.16
2270240-27024049.82849.83
3301688-30168855.62655.63
4280698-28069851.75651.76
5283700-28370052.31052.31
6323435-32343559.63659.64
10min1318991-31899158.81756.354.9658.9156.444.96
2289864-28986453.44653.53
3308783-30878356.93457.03
4290499-29049953.56353.65
5298948-29894855.12155.21
6326473-32647360.19660.30
15min1319721-31972158.95156.165.5259.1556.355.52
2282411-28241152.07252.24
3308684-30868456.91657.10
4290540-29054053.57153.75
5300334-30033455.37755.56
6325944-32594460.09960.30
20min1319364-31936458.88556.025.0959.1856.305.09
2284068-28406852.37752.64
3307417-30741756.68356.97
4291413-29141353.73254.00
5297903-29790354.92855.20
6322771-32277159.51459.81
30min1318352-31835258.69955.665.3059.0956.045.31
2282283-28228352.04852.39
3303989-30398956.05056.43
4287793-28779353.06453.42
5297103-29710354.78155.14
6321836-32183659.34159.74
45min1313965-31396557.89055.355.1358.3855.815.14
2280718-28071851.76052.19
3303903-30390356.03556.50
4286666-28666652.85653.30
5295697-29569754.52254.98
6320143-32014359.02959.53
极限1312196-31219657.56454.865.7258.1555.425.72
2273003-27300350.33750.86
3303130-30313055.89256.46
4285535-28553552.64853.18
5293052-29305254.03454.58
6318391-31839158.70659.30
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