Beruflich Dokumente
Kultur Dokumente
the ratios of the response of the methyl ethyl ketone to the pH 〈791〉: between 3.2 and 3.8.
response of the internal standard obtained from the Test Assay—
preparation and the Standard preparation, respectively. The Internal standard solution, Standard solution, Standard
limit is 0.05 mg per mL. preparations, Chromatographic system, and System suitability
Assay— and standard curve—Proceed as directed in the Assay under
Internal standard solution—Dissolve a suitable quantity of Isosorbide Concentrate.
triethylene glycol in water to obtain a solution containing Assay preparation—Transfer an accurately measured vol-
about 15 mg per mL. ume of Oral Solution, equivalent to about 450 mg of
Standard solution—Prepare a solution of USP Isosorbide isosorbide, to a 250-mL volumetric flask, add 25.0 mL of
RS in water containing an accurately known concentration Internal standard solution, then add water to volume, and
equivalent to about 25 mg of C6H10O4 per mL. mix.
Standard preparations—Pipet 2-, 3-, 4-, and 5-mL quanti- Procedure—Proceed as directed for Procedure in the Assay
ties of Standard solution into separate 50-mL volumetric under Isosorbide Concentrate. Calculate the quantity, in mg,
flasks, add 5.0 mL of Internal standard solution to each, add of isosorbide (C6H10O4) in each mL of the Oral Solution
water to volume, and mix. taken by the formula:
Assay preparation—Transfer about 200 mg of Concen-
trate, accurately weighed, to a 100-mL volumetric flask, add 250(C/V)
10.0 mL of Internal standard solution, add water to volume,
and mix. in which C is the concentration, in mg per mL, of isosorbide
in the Assay preparation found by reference to the Standard
Chromatographic system—The gas chromatograph is curve; and V is the volume, in mL, of Oral Solution taken.
equipped with a flame-ionization detector and a 3-mm ×
0.6-m glass column packed with support S9. The column is
maintained at 230°, and nitrogen is used as the carrier gas.
The retention time of the isosorbide peak is about 1.5, rela-
tive to that of triethylene glycol.
.
USP Monographs
the ratio of the peak responses, and determine the concen- DEFINITION
tration, C, in mg per mL, of isosorbide in the Assay prepara- Diluted Isosorbide Dinitrate is a dry mixture of isosorbide
tion by reference to the Standard curve. Calculate the quan- dinitrate (C6H8N2O8) with Lactose, Mannitol, or suitable
tity, in mg, of C6H10O4 in the Concentrate taken by the inert excipients to permit safe handling. It may contain up
formula: to 1.0% of a suitable stabilizer, such as Ammonium Phos-
phate. It contains NLT 95.0% and NMT 105.0% of the
100C. labeled amount of isosorbide dinitrate (C6H8N2O8). It usu-
ally contains approximately 25% of isosorbide dinitrate.
[CAUTION—Exercise proper precautions in handling undiluted
isosorbide dinitrate, which is a powerful explosive and can
be exploded by percussion or excessive heat. Only ex-
ceedingly small amounts should be isolated.]
Isosorbide Oral Solution
.
IDENTIFICATION
» Isosorbide Oral Solution contains not less than Change to read:
90.0 percent and not more than 110.0 percent of
the labeled amount of isosorbide (C6H10O4). • ▲
. A.▲USP41
Sample solution: Transfer to a medium-porosity,
Packaging and storage—Preserve in tight containers. sintered-glass filtering crucible a quantity of Diluted
USP Reference standards 〈11〉— Isosorbide Dinitrate, equivalent to about 50 mg of
USP Isosorbide RS isosorbide dinitrate, and pass three 5-mL portions of ac-
Identification—The retention time of the major peak in etone through it. Evaporate the combined extracts at a
the chromatogram of the Assay preparation corresponds to temperature not exceeding 35°, with the aid of a gen-
that in the chromatograms of the Standard preparations, as tle current of air, and dry the residue under vacuum
obtained in the Assay. over calcium chloride at room temperature for 16 h.
Uniformity of dosage units 〈905〉— Prepare a solution (1 in 40) of the residue so obtained,
in chloroform.
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS:
Standard solution: A similar preparation from the resi-
meets the requirements. due obtained from USP Diluted Isosorbide Dinitrate RS
Deliverable volume 〈698〉— Acceptance criteria: The IR absorption spectrum of the
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: Sample solution, determined in a 0.1-mm cell, exhibits
meets the requirements. maxima only at the same wavelengths as that of the
Standard solution.