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(EST)
Printed by: Nguyen Nhan Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
1

Add the following: CU = nominal concentration of acarbose in the Sample

solution (mg/mL)
▲
Acarbose Tablets Acceptance criteria: 90.0%–110.0%
DEFINITION PERFORMANCE TESTS
Acarbose Tablets contain NLT 90.0% and NMT 110.0% of the • DISSOLUTION á711ñ
labeled amount of acarbose (C25H43NO18). Medium: Water, 900 mL, deaerated
Apparatus 2: 75 rpm
IDENTIFICATION Time: 30 min
• A. The retention time of the major peak of the Sample Determine the percentage of the labeled amount of acarbose
solution corresponds to that of the Standard solution, as (C25H43NO18) dissolved by using the following procedure.
obtained in the Assay.
Buffer: 0.6 mg/mL of monobasic potassium phosphate and
0.35 mg/mL of dibasic sodium phosphate in water,
Change to read: adjusted to a pH of 6.8. Filter and degas.
• B. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Mobile phase: Acetonitrile and Buffer (5:95)
Spectroscopy: 197K▲ (CN 1-May-2020): The spectrum obtained Standard stock solution: 10 mg/mL of USP Acarbose RS in
from the Sample solution shows IR maxima in the regions of Medium
3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm– Standard solution A (for Tablets labeled to contain 100 mg
1
. of acarbose): 0.1 mg/mL of USP Acarbose RS from the
Standard stock solution in Medium
ASSAY Standard solution B (for Tablets labeled to contain 50 mg
• PROCEDURE of acarbose): 0.05 mg/mL of USP Acarbose RS from

al
Buffer: 0.6 mg/mL of monobasic potassium phosphate and Standard solution A in Medium
0.35 mg/mL of dibasic sodium phosphate in water. Filter Standard solution C (for Tablets labeled to contain 25 mg
and degas. of acarbose): 0.025 mg/mL of USP Acarbose RS from
Mobile phase: Acetonitrile and Buffer (75:25) Standard solution A in Medium
System suitability solution: 20 mg/mL of USP Acarbose ci Sample solution: Pass a portion of the solution under test
System Suitability Mixture RS in water through a suitable filter.
Standard solution: 10 mg/mL of USP Acarbose RS Chromatographic system
Sample solution: Nominally 10 mg/mL of acarbose in (See Chromatography á621ñ, System Suitability)
water, prepared as follows. Transfer a portion of the Mode: LC
powder, from NLT 20 Tablets, equivalent to 100 mg of Detector: UV 210 nm
ffi
acarbose to a suitable volumetric flask and add water to Column: 4.0-mm × 12.5-cm; 5-µm packing L1
50%–70% of the flask volume. Sonicate to dissolve and Column temperature: 40°
dilute with water to volume. Pass through a suitable filter Flow rate: 1.8 mL/min
of 0.45-µm pore size. Injection volume: 100 µL
Chromatographic system System suitability
(See Chromatography á621ñ, System Suitability.) Samples: Standard solution A, Standard solution B, or
O

Mode: LC Standard solution C

Detector: UV 210 nm Suitability requirements
Column: 4.0-mm × 25-cm; 5-µm packing L8 Relative standard deviation: NMT 2.0% for the
Column temperature: 35° acarbose peak of Standard solution A, Standard solution
Flow rate: 2 mL/min B, or Standard solution C
Injection volume: 10 µL Analysis
Run time: NLT 2.5 times the retention time of acarbose Samples: Standard solution A, Standard solution B, or
System suitability Standard solution C; and Sample solution
Samples: System suitability solution and Standard solution Calculate the percentage of the labeled amount of acarbose
Suitability requirements (C25H43NO18) dissolved:
Peak-to-valley ratio: The ratio of the height of the
impurity A peak to the height of the valley between the Result = (rU/rS) × CS × (1/L) × V × 100
impurity A peak and the acarbose peak is NLT 1.2,
System suitability solution rU = peak response from the Sample solution
Tailing factor: NMT 2.0, Standard solution rS = peak response from Standard solution A, Standard
Relative standard deviation: NMT 2.0%, Standard solution B, or Standard solution C
solution CS = concentration of USP Acarbose RS in Standard
Analysis solution A, Standard solution B, or Standard
Samples: Standard solution and Sample solution solution C (mg/mL)
Calculate the percentage of the labeled amount of acarbose L = label claim (mg/Tablet)
(C25H43NO18) in the portion of Tablets taken: V = volume of Medium, 900 mL

Result = (rU/rS) × (CS/CU) × 100 Tolerances: NLT 80% (Q) of the labeled amount of
acarbose (C25H43NO18) is dissolved.
rU = peak response of acarbose from the Sample • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
solution requirements
rS = peak response of acarbose from the Standard
solution IMPURITIES
CS = concentration of USP Acarbose RS in the Standard • ORGANIC IMPURITIES
solution (mg/mL) Buffer, Mobile phase, System suitability solution,
Standard solution, Sample solution, and

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2

Chromatographic system: Proceed as directed in the Table 1

Assay. Relative Relative Acceptance
Standard solution 1: Prepare a 0.2-mg/mL solution of USP Retention Response Criteria,
Acarbose RS in water by pipetting 1.0 mL of the Standard Name Time Factor NMT (%)
solution from the Assay into a 50-mL volumetric flask. Dilute Impurity Da 0.5 1.3 1.2
with water to volume.
Sensitivity solution: Prepare a 0.02-mg/mL solution of USP Impurity Bb 0.8 1.6 0.5
Acarbose RS in water by pipetting 10.0 mL of Standard Impurity Ac 0.9 1.0 1.6
solution 1 into a 100-mL volumetric flask. Dilute with water
to volume. Impurity Cd 1.2 1.0 1.0
System suitability Any unspecified
Samples: System suitability solution, Standard solution 1, —
impurity 1.0 0.2
and Sensitivity solution
Total impurities — — 3.0
Suitability requirements
Peak-to-valley ratio: The ratio of the height of the a 4-O-(4,6-Dideoxy-4-{[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)
impurity A peak to the height of the valley between the cyclohex-2-en-1-yl]amino}-α-D-glucopyranosyl)-D-glucose.
impurity A peak and the acarbose peak is NLT 1.2, b (1R,4R,5S,6R)-4,5,6-Trihydroxy-2-(hydroxymethyl)cyclohex-2-en-1-yl 4-O-
System suitability solution (4,6-dideoxy-4-{[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-
2-en-1-yl]amino}-α-D-glucopyranosyl)-α-D-glucopyranoside.
Tailing factor: NMT 2.0, Standard solution 1 c O-4,6-Dideoxy-4-{[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)
Relative standard deviation: NMT 2.0%, Standard cyclohex-2-en-1-yl]amino}-α-D-glucopyranosyl-(1→4)-O-α-D-glucopyranosyl-
solution 1 (1→4)-D-arabino-2-hexulopyranose.
Signal-to-noise ratio: NLT 10, Sensitivity solution d α-D-Glucopyranosyl 4-O-(4,6-dideoxy-4-{[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-

Analysis
Samples: Sample solution and Standard solution 1
Calculate the percentage of each impurity in the portion of
Tablets taken:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
al
(hydroxymethyl)cyclohex-2-en-1-yl]amino}-α-D-glucopyranosyl)-α-D-
glucopyranoside.
• MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
SPECIFIED MICROORGANISMS á62ñ: The total aerobic
microbial count is NMT 103 cfu/g, and the total combined

rU = peak response of any individual impurity from the

Sample solution
ci yeasts and molds count is NMT 102 cfu/g. It meets the
requirements of the testing of products for the absence of
Escherichia coli (per gram).
rS = peak response of acarbose from Standard solution ADDITIONAL REQUIREMENTS
1 • PACKAGING AND STORAGE: Preserve in tight, light-resistant
ffi
CS = concentration of USP Acarbose RS in Standard containers at controlled room temperature.
solution 1 (mg/mL) • USP REFERENCE STANDARDS á11ñ
CU = nominal concentration of acarbose in the Sample USP Acarbose RS
solution (mg/mL) USP Acarbose System Suitability Mixture RS▲ (USP 1-May-2019)
F = relative response factor (see Table 1)
O

Acceptance criteria: See Table 1.

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