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-> PRODUCTS ->
Biochemicals, Diagnostics and Buffers
-> Ampicillin
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SPECIFICATIONS
AMPICILLIN SODIUM STERILE CRYSTALLINE USP
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TEST
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SPECIFICATIONS
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Description
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White to off-white or practically odorless,
crystalline powder. Is hygroscopic.
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Solubility
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Very
soluble in water and in isotonic sodium chloride
and dextrose solution.
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Identification (IR)
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The IR absorption spectrum of the sample
concordant with the reference spectrum of
Ampicillin anhydrous WS.
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Crystallinity
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The particles should show birefringence and
exhibit extinction positions.
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pH
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8.00 to 10.00
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Water
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NMT 2.0 % w/w
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Methylene Chloride
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NMT 0.2% w/w
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Sterility Test
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To comply as per USP
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Bacterial Endotoxine
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NMT 0.15 IU mg
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Assay
(on anhydrous basis)
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845 mcg/mg to 988 mcg/mg
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Particulate Matter
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To comply as per USP
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Particulate Matter
(by LBPC)
a) ≥ 10 µ
b) ≥ 25 µ
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NMT 6,000
NMT 600
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Residual Solvents
(by GC)
Acetonitrile
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NMT 410 ppm
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*N,N-Dimethylaniline is not being used in the
manufacturing process, hence not tested.
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