Identification: The IR absorption spectrum exhibits maxima only at the same wavelengths as that of similar preparation of the cor…
Identification:
The IR absorption spectrum exhibits maxima only at
the same wavelengths as that of similar preparation of
the corresponding reference standard.
HPLC (Retention time):
The retention time of the major peak in the
chromatogram of the assay preparation corresponds
to that in th chromatogram of the standard
preparation as obtained in the assay.
PH: 4.3~5.3
Loss on drying: ≤ 0.5%
Residue on iginition :≤ 0.1%
Heavy metals :≤ 0.002%
Related compounds:
Individual largest :≤ 0.1%
Total :≤ 0.3%
Residual solvents
Chloroform :≤ 60ppm
Tetrahydrofuran :≤720ppm
Microbial limit
Total aerobic microbial count: ≤ 1000CFU/g.
Total combined yeasts and molds count :≤ 100CFU/g.
Assay(C9H8C1N5S.HCL) :≥ 98.5%( anhydrous substance)
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