Famotidin USP 32
Famotidin USP 32
Factor IX Complex
132270
(Comment on this Monograph)id=m32590=Factor IX Complex=F-Monos.pdf) DEFINITION Factor IX Complex conforms to the regulations of the federal Food and Drug Administration concerning biologics (see Biologics 1041). It is a sterile, freeze-dried powder consisting of partially purified Factor IX fraction, as well as concentrated Factors II, VII, and X fractions, of venous plasma obtained from healthy human donors. It contains no preservative. It meets the requirements of the test for potency in having NLT 80% and NMT 120% of the potency stated on the label in Factor IX Units by comparison with the U.S. Factor IX Standard or with a working reference that has been calibrated with it. ADDITIONAL REQUIREMENTS PACKAGING AND STORAGE: Preserve in hermetic containers in a refrigerator. EXPIRATION DATE: The expiration date is not later than 2 years from the date of manufacture. LABELING: Label it with a warning that it is to be used within 4 h after constitution, and to state that it is for intravenous administration and that a filter is to be used in the administration equipment.
Famotidine
(Comment on this Monograph)id=m32600=Famotidine=FMonos.pdf)
337.45 C8H15N7O2S3 Propanimidamide, N-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-; [1-Amino-3-[[[2-[(diaminomethylene)amino]-4thiazolyl]methyl]thio]propylidene]sulfamide [76824-35-6]. DEFINITION Famotidine contains NLT 98.5% and NMT 101.0% of C8H15N7O2S3, calculated on the dried basis. IDENTIFICATION A. INFRARED ABSORPTION 197K B. ULTRAVIOLET ABSORPTION 197U Analytical wavelength: 265 nm Medium: Adjust 250 mL of 0.02 M phosphoric acid with a 100 mg/mL sodium hydroxide solution to a pH of 2.5, and dilute with water to 500 mL. Sample solution: 25 g/mL Acceptance criteria: The absorptivities calculated on the dried basis, do not differ by more than 3.0%. ASSAY PROCEDURE Sample solution: 3.125 mg/mL of Famotidine in glacial acetic acid Analysis: Titrate 80 mL of the Sample solution with 0.1 N perchloric acid VS (see Titrimetry 541), using a suitable anhydrous electrode system. Any aqueous electrolyte solution contained in the electrodes employed should be removed, the electrode rendered anhydrous and filled with
Famotidine Injection
(Comment on this Monograph)id=m32605=Famotidine Injection=F-Monos.pdf) DEFINITION Famotidine Injection is a sterile, concentrated solution of Famotidine. It contains NLT 90.0% and NMT 110.0% of the labeled amount of famotidine (C8H15N7O2S3). It may contain suitable preservatives. IDENTIFICATION The retention time of the famotidine peak from the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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