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[求助]
头孢拉定质量标准
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xiaoqihu
铁杆木虫 (著名写手)
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真强必胜: ? 2014-09-22 18:26:55
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DEFINITION Cefadroxil has a potency equivalent to NLT 950 µg/mg and NMT 1050 µg/mg of cefadroxil (C16H17N3O5S), calculated on the anhydrous basis. IDENTIFICATION • A. Infrared Absorption 197K Change to read: • B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution , as obtained in the Assay SPECIFIC TESTS • Optical Rotation, Specific Rotation781S Sample solution: 10 mg/mL in water Acceptance criteria: +165.0 to +178.0 • Crystallinity 695: Meets the requirements • pH 791 Sample solution: 50 mg/mL suspension in water Acceptance criteria: 4.0–6.0 • Water Determination, Method I 921: 4.2%–6.0%, except where it is labeled as being in the hemihydrate form it is between 2.4% and 4.5% ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. • Labeling: The hemihydrate form is so labeled. Table 2 Name Relative Retention Time Acceptance Criteria, NMT (%) Amoxicillin related compound Ia 0.16 0.5 Cefadroxil R -sulfoxideb 0.22 0.15 Cefadroxil S -sulfoxidec 0.41 0.15 Cefadroxil related compound Bd 0.49 0.5 Dimethylformamidee 0.55 — Cefadroxil related compound Df 0.71 0.5 Cefadroxil related compound Ig 0.80 0.15 Diketopiperazine derivativeh 0.87 0.5 Cefadroxil 1.0 — N -Phenylglycyl delta-3 cefadroxili 1.4 0.15 Cefadroxil ethyl homologj 1.5 0.15 N -Phenylglycyl cefadroxilk 1.8 0.5 3-Hydroxy-4-methylthiophenonel 2.0 0.5 N -Ethoxycarbonyl 7-aminodesacetoxycephalosporanic acidm 2.1 0.15 O -Ethoxycarbonyl cefadroxiln 2.3 0.3 Cefadroxil dimero 2.4 0.15 Any individual unspecified impurity — 0.10 Total impurities — 2.0 |
2楼2014-09-22 16:41:26
3楼2014-10-11 23:18:12
