Nifedipine Extended-Release Tablets
DEFINITION
Nifedipine Extended-Release Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of nifedipine (C17H18N2O6). [Note—Nifedipine, when exposed to daylight and certain wavelengths of artificial light, readily converts to a nitrosophenylpyridine derivative. Exposure to UV light leads to the formation of a nitrophenylpyridine derivative. Perform assays and tests in the dark or under golden fluorescent or other low-actinic light. Use low-actinic glassware. ]
IDENTIFICATION
• A.
The retention time of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
• B. Ultraviolet Absorption 
197U
197U
Standard stock solution and Sample stock solution:
Prepare as directed in the Assay.
Standard solution:
0.02 mg/mL in Mobile phase from the Standard stock solution
Sample solution:
0.02 mg/mL in Mobile phase from the Sample stock solution
ASSAY
• Procedure
[Note—Conduct the Assay promptly after preparation of the Standard solution and the Sample solution. ]
Mobile phase:
Acetonitrile, methanol, and water (25:25:50)
Standard stock solution:
1 mg/mL of USP Nifedipine RS in methanol
Standard solution:
0.1 mg/mL of USP Nifedipine RS from the Standard stock solution in Mobile phase
Sample stock solution:
Dissolve an amount equivalent to 420 mg of nifedipine from powdered Tablets in 130 mL of water in a 250-mL volumetric flask; or transfer the intact Tablets to a 400-mL, high-speed blender cup containing 130 mL of water. Homogenize until a uniform suspension is achieved (about 2 min), and transfer the suspension with the aid of a mixture of acetonitrile and methanol (1:1) to a 250-mL volumetric flask. Dilute with a mixture of acetonitrile and methanol (1:1) to volume, and stir for 30 min. Centrifuge the resulting suspension to obtain a clear supernatant.
Sample solution:
0.1 mg/mL of nifedipine prepared as follows. Transfer 3.0 mL of the Sample stock solution to a 50-mL volumetric flask, dilute with Mobile phase to volume, and filter. [Note—Reserve a portion of this solution for use as the Sample solution in the test for Organic Impurities. ]
Chromatographic system
Mode:
LC
Detector:
UV 265 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Guard column:
2.1-mm × 3-cm; packing L1
Flow rate:
1 mL/min
Injection size:
25 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 4000 theoretical plates
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 1.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of nifedipine (C17H18N2O6) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Nifedipine RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of nifedipine in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Test 1:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1.
Medium:
Water; 50 mL
Apparatus 7:
(See Drug Release 724.) 15–30 cycles/min. Do not use the reciprocating disk; use a 25-cm plexiglas rod, the perimeter of the Tablets being affixed to the rod with a water-insoluble glue. The solution containers are 25-mm test tubes, 150–200 mm in length, and the water bath is maintained at 37 ± 0.5
. At the end of each specified test interval, the systems are transferred to the next row of new test tubes containing 50 mL of fresh Medium.
724.) 15–30 cycles/min. Do not use the reciprocating disk; use a 25-cm plexiglas rod, the perimeter of the Tablets being affixed to the rod with a water-insoluble glue. The solution containers are 25-mm test tubes, 150–200 mm in length, and the water bath is maintained at 37 ± 0.5. At the end of each specified test interval, the systems are transferred to the next row of new test tubes containing 50 mL of fresh Medium.
Times:
4, 8, 12, 16, 20, and 24 h
Diluent:
Methanol and water (1:1)
Standard solution:
Transfer 50 mg of USP Nifedipine RS to a 100-mL volumetric flask. Dissolve in 50 mL of methanol, and dilute with water to volume. Quantitatively dilute this solution with Diluent to obtain solutions having suitable known concentrations.
Sample solution:
Use portions of the solution under test, passed through a suitable filter of 0.4-µm pore size, suitably diluted with methanol, and stepwise if necessary, with Diluent to obtain a final mixture consisting of equal parts of methanol and water.
Instrumental conditions
Mode:
UV
Analytical wavelength:
338 nm
Cell:
0.5 cm
Analysis:
Determine the amount of nifedipine (C17H18N2O6) released in the Sample solution at each 4-h interval from UV absorbances. [Note—For the 4-h time period, determine the absorbance at 456 nm, and use this determination to correct for excipient interference. ]
Tolerances:
See Table 1.
Table 1
| Time (h) | Amount Dissolveda |
|---|---|
| 4 | 5%–17% |
| 8 | — |
| 12 | 43%–80% |
| 16 | — |
| 20 | — |
| 24 | NLT 80% |
|
a
The amount dissolved is expressed in terms of the labeled Tablet strength rather than in terms of the labeled total contents.
|
|
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6), released at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
Test 2:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
Solution A:
Dissolve 330.9 mg of sodium phosphate and 38 g of citric acid in water in a 1-L volumetric flask. Add 10 mL of phosphoric acid, and dilute with water to volume.
Medium:
Mix 125.0 mL of Solution A and 1 L of 10% sodium lauryl sulfate solution, and dilute to 10 L. Adjust, if necessary, to a pH of 6.8; 900 mL.
Apparatus 2:
50 rpm, with sinkers. (See Figure 2a in Dissolution 711.)
711.)
Times:
3, 6, and 12 h
Mobile phase:
Acetonitrile and water (7:3)
Standard stock solution:
1.11 mg/mL of USP Nifedipine RS in methanol
Standard solution:
0.1 mg/mL of USP Nifedipine RS from the Standard stock solution in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Chromatographic system
Mode:
LC
Detector:
UV 350 nm
Column:
4.0-mm × 125-mm; 3-µm packing L1
Temperature:
40
Flow rate:
1.5 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 2000 theoretical plates
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Determine the amount of nifedipine (C17H18N2O6) dissolved.
Tolerances:
See Table 2.
Table 2
| Time (h) | Amount Dissolved |
|---|---|
| 3 | 10%–30% |
| 6 | 40%–65% |
| 12 | NLT 80% |
The percentages of the labeled amount of nifedipine (C17H18N2O6), released in vivo and dissolved at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
Test 3:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.
For Tablets labeled to contain 30 mg of nifedipine: Phase 1
Medium:
0.05 M phosphate buffer, pH 7.5; 900 mL
Apparatus 2:
100 rpm
Time:
1 h
Standard solution:
0.034 mg/mL of USP Nifedipine RS in Medium. [Note—If necessary, a volume of methanol, not exceeding 10% of the final volume, can be used to help solubilize nifedipine. ]
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
238 nm
Cell:
0.5 cm
Analysis:
[Note—After the run, take the Tablet out of the dissolution vessel, adapt a sinker to it, and transfer the Tablet with the sinker to the dissolution vessel containing the Medium for Phase 2. ] Determine the amount of nifedipine (C17H18N2O6) released in Phase 1, using filtered portions of the Sample solution, in comparison with the Standard solution, using the Medium as the blank.
For Tablets labeled to contain 30 mg of nifedipine: Phase 2
Medium:
0.5% sodium lauryl sulfate in simulated gastric fluid without enzyme, pH 1.2; 900 mL
Apparatus 2:
100 rpm
Times:
1, 4, 8, and 12 h
Standard solution:
0.034 mg/mL of USP Nifedipine RS in Medium. [Note—If necessary, a volume of methanol, not exceeding 10% of the final volume, can be used to help solubilize nifedipine. ]
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
238 nm
Analysis:
Determine the amount of nifedipine (C17H18N2O6) released in Phase 2, using filtered portions of the Sample solution, in comparison with the Standard solution, using Medium as the blank.
Tolerances:
See Table 3.
Table 3
| Time (h) | Amount Dissolveda |
|---|---|
| 1 | NMT 30% |
| 4 | 30%–55% |
| 8 | NLT 60% |
| 12 | NLT 80% |
|
a
For each dosage unit, add the amount dissolved in phosphate buffer, pH 7.5 from Phase 1 to the amount dissolved at each time point in Phase 2.
|
|
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6), released in vivo and dissolved at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
For Tablets labeled to contain 60 mg of nifedipine: Phase 1
Medium:
0.05 M phosphate buffer, pH 7.5; 900 mL
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
238 nm
Analysis:
[Note—After the run, take the Tablet out of the dissolution vessel, adapt a sinker to it, and transfer the Tablet with the sinker to the dissolution vessel containing the Medium for Phase 2. ] Determine the amount of nifedipine (C17H18N2O6) released in Phase 1, using filtered portions of the Sample solution, in comparison with the Standard solution, using the Medium as the blank.
Apparatus 2:
100 rpm
Time:
25 min
Standard solution:
0.067 mg/mL of USP Nifedipine RS in Medium. [Note—If necessary, a volume of methanol, not exceeding 10% of the final volume, can be used to help solubilize nifedipine. ]
For Tablets labeled to contain 60 mg of nifedipine: Phase 2
Medium:
0.5% sodium lauryl sulfate in simulated gastric fluid without enzyme, pH 1.2; 900 mL
Apparatus 2:
100 rpm
Times:
1, 4, 8, and 12 h
Standard solution:
0.067 mg/mL of USP Nifedipine RS in Medium. [Note—If necessary, a volume of methanol, not exceeding 10% of the final volume, can be used to help solubilize nifedipine. ]
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
238 nm
Analysis:
Determine the amount of nifedipine (C17H18N2O6) released in Phase 2, using filtered portions of the Sample solution, in comparison with the Standard solution, using Medium as the blank.
Tolerances:
See Table 4.
Table 4
| Time (h) | Amount Dissolveda |
|---|---|
| 1 | NMT 30% |
| 4 | 40%–70% |
| 8 | NLT 70% |
| 12 | NLT 80% |
|
a
For each dosage unit, add the amount dissolved in phosphate buffer, pH 7.5 from Phase 1 to the amount dissolved at each time point in Phase 2.
|
|
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6), released in vivo and dissolved at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
Test 4:
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 4.
Medium:
0.5% sodium lauryl sulfate in simulated gastric fluid without enzyme, pH 1.2; 900 mL
Apparatus 2:
100 rpm
Times:
1, 4, and 12 h
Standard solution:
0.067 mg/mL of USP Nifedipine RS for Tablets labeled to contain 60 mg, and 0.034 mg/mL of USP Nifedipine RS for Tablets labeled to contain 30 mg, in Medium. [Note—If necessary, a volume of methanol, not exceeding 10% of the final volume, can be used to help solubilize nifedipine. ]
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
UV 238 nm
Cell:
0.5 cm
Analysis:
Determine the amount of nifedipine (C17H18N2O6) released, using filtered portions of the Sample solution, in comparison with the Standard solution, using the Medium as the blank.
Tolerances:
See Table 5 and Table 6.
Table 5
| For Tablets Labeled to Contain 30 mg of Nifedipine | |
|---|---|
| Time (h) | Amount Dissolved |
| 1 | 12%–35% |
| 4 | 44%–67% |
| 12 | NLT 80% |
Table 6
| For Tablets Labeled to Contain 60 mg of Nifedipine | |
|---|---|
| Time (h) | Amount Dissolved |
| 1 | 10%–30% |
| 4 | 40%–63% |
| 12 | NLT 80% |
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6), released at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
Test 5:
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 5.
Medium:
Water; 50 mL
Apparatus 7:
(See Drug Release 724.) Use a 25-cm plexiglas rod, the perimeter of the Tablets being affixed to the rod with a water-insoluble glue; 30 dips/min. The solution containers are 25-mm test tubes, 150–200 mm in length, and the water bath is maintained at 37 ± 0.5.
724.) Use a 25-cm plexiglas rod, the perimeter of the Tablets being affixed to the rod with a water-insoluble glue; 30 dips/min. The solution containers are 25-mm test tubes, 150–200 mm in length, and the water bath is maintained at 37 ± 0.5.
Times:
4, 12, and 24 h
Diluent A:
Methanol and acetonitrile (1:1)
Diluent B:
Diluent A and water (1:1)
Standard stock solution:
50 mg of USP Nifedipine RS in Diluent A and water (50:50)
Standard solutions:
0.01, 0.05, and 0.20 mg/mL solutions, from the Standard stock solution in Diluent B, that are used at 4-, 12-, and 24-h sampling
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Instrumental conditions
Mode:
UV
Analytical wavelength:
238 nm
Cell:
0.5 cm
Analysis:
[Note—For the 4-h time period, filter the solution under test, and determine the absorbance at 456 nm. Use this absorbance value to correct for excipient interference at the other time points. ] Determine the amount of nifedipine released at each interval on portions of the Sample solution passed through a suitable filter of 0.45-µm pore size, suitably diluted, if necessary, with Diluent A and water to obtain a final mixture of water, methanol, and acetonitrile (2:1:1), in comparison with the appropriate Standard solution, using Diluent B as the blank.
Tolerances:
See Table 7.
Table 7
| Time (h) | Amount Dissolved |
|---|---|
| 4 | NMT 14% |
| 12 | 39%–75% |
| 24 | NLT 75% |
The cumulative percentages of the labeled amount of nifedipine, released in vivo and dissolved at the times specified, conform to Acceptance Table 2 in Dissolution 711.
711.
Test 6:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 6.
Medium:
Simulated gastric fluid without enzyme containing 0.5% of sodium lauryl sulfate, pH 1.2; 900 mL, deaerated
Apparatus 1:
100 rpm
Times:
1, 4, and 12 h
Standard stock solution:
0.33 mg/mL of USP Nifedipine RS in methanol
Standard solution:
Quantitatively dilute the Standard stock solution with Medium to obtain a solution having a concentration of about 0.033 mg/mL.
Sample solution:
Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.
Detector:
UV 329 nm
Path length:
0.5 cm
Blank:
Medium
Tolerances:
See Table 8.
Table 8
| Time (h) | Amount Dissolved |
|---|---|
| 1 | NMT 15% |
| 4 | 20%–40% |
| 12 | NLT 80% |
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6) dissolved at the times specified conform to Acceptance Table 2 in Dissolution 711.
711.
Test 7:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 7.
Medium:
Simulated gastric fluid without enzyme containing 0.5% sodium lauryl sulfate, pH 1.2; 900 mL
Apparatus 2:
100 rpm, with three-prong sinker
Times:
1, 4, and 12 h
Standard solution:
(L/900) mg/mL of USP Nifedipine RS in Medium, where L is the label claim, in mg/Tablet, of nifedipine. A small amount of methanol, not exceeding 6–7% of the final volume of the first dilution, can be used to solubilize nifedipine.
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Detector:
UV 238 nm
Path length:
1 mm, flow cell
Blank:
Medium
Tolerances:
See Table 9.
Table 9
| Time (h) | Amount Dissolved |
|---|---|
| 1 | NMT 15% |
| 4 | 25%–50% |
| 12 | NLT 80% |
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6) dissolved at the times specified conform to Acceptance Table 2 in Dissolution 711.
711.
Test 8:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 8.
Acid stage medium:
Simulated gastric fluid without enzyme containing 3% polysorbate 80, pH 1.2; 250 mL
Apparatus 3:
20 dpm, 20-mesh polypropylene screen on the bottom; 1 min drip time. The Tablet is automatically transferred by the apparatus to the next set of vessels for each time point.
Time:
1 h
Buffer stage medium:
0.01 M sodium phosphate buffer, pH 6.8, containing 3% polysorbate 80 (dissolve 8.3 g of monobasic sodium phosphate and 1 g of sodium hydroxide in 6 L of water, adjust with either diluted sodium hydroxide or phosphoric acid to a pH of 6.8 ± 0.05, and add 180 g of polysorbate 80); 250 mL
Times:
2, 8, 12, and 24 h
Mobile phase:
Acetonitrile, methanol, and water (35:35:30)
Standard stock solution:
1 mg/mL of USP Nifedine RS in Buffer stage medium. An amount of methanol, about 40% of the final volume, can be used to dissolve nifedipine.
Standard solution:
(L/1000) mg/mL in Buffer stage medium, from the Standard stock solution, where L is the label claim in mg/Tablet
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Chromatographic system
Mode:
LC
Detector:
UV 338 nm
Column:
4.6-mm × 25-cm; packing L1
Temperature:
30
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 4000 theoretical plates
Tailing factor:
NMT 1.7
Relative standard deviation:
NMT 2.0%
Analysis:
Calculate the percentage of the labeled amount of nifedipine dissolved at each time point.
At 1 h:
D1 = (rU/rS) × (CS/L) × V × 100
At 2 h:
D = (rU/rS) × (CS/L) × V × 100
D2 = D1 + D
At 8 h:
D = (rU/rS) × (CS/L) × V × 100
D8 = D2 + D
At 12 h:
D = (rU/rS) × (CS/L) × V × 100
D12 = D8 + D
At 24 h:
D = (rU/rS) × (CS/L) × V × 100
D24 = D12 + D
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| L | = | = label claim (mg/Tablet) |
| V | = | = volume of Medium, 250 mL |
Tolerances
Acid stage:
NMT 5% of the labeled amount of nifedipine is dissolved in 1 h.
Buffer stage:
See Table 10.
Table 10
| Time (h) | Amount Dissolved |
|---|---|
| 1 | NMT 5% |
| 2 | 0%–10% |
| 8 | 25%–60% |
| 12 | 45%–85% |
| 24 | NLT 80% |
The cumulative percentages of the labeled amount of nifedipine (C17H18N2O6) dissolved at the times specified conform to Acceptance Table 2 in Dissolution 711.
711.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
IMPURITIES
• Organic Impurities
[Note—Conduct this test promptly after preparation of the Standard nifedipine solution and the Sample solution. ]
Mobile phase:
Acetonitrile, methanol, and water (25:25:50)
Quantitative limit stock solution A:
1 mg/mL of USP Nifedipine Nitrophenylpyridine Analog RS in methanol
Quantitative limit solution A:
6 µg/mL of USP Nifedipine Nitrophenylpyridine Analog RS from Quantitative limit stock solution A in Mobile phase
Quantitative limit stock solution B:
1 mg/mL of USP Nifedipine Nitrosophenylpyridine Analog RS in methanol
Quantitative limit solution B:
1.5 µg/mL of USP Nifedipine Nitrosophenylpyridine Analog RS from Quantitative limit stock solution B in Mobile phase
Standard nifedipine stock solution:
1 mg/mL of USP Nifedipine RS in methanol
Standard nifedipine solution:
0.3 mg/mL of USP Nifedipine RS from Standard nifedipine stock solution in Mobile phase
System suitability solution:
Quantitative limit solution A, Quantitative limit solution B, and Standard nifedipine solution (1:1:1)
Standard solution:
Mobile phase, Quantitative limit solution A, and Quantitative limit solution B (1:1:1). [Note—Each mL of this solution contains about 2 µg of USP Nifedipine Nitrophenylpyridine Analog RS and 0.5 µg of USP Nifedipine Nitrosophenylpyridine Analog RS. ]
Sample solution:
Use a portion of the Sample solution prepared as directed in the Assay.
Chromatographic system
Mode:
LC
Detector:
UV 265 nm
Column:
4.6-mm × 25-cm; packing L1
Guard column:
2.1-mm × 3-cm; packing L1
Flow rate:
1 mL/min
Injection size:
25 µL
System suitability
Sample:
System suitability solution
Suitability requirements
Resolution:
NLT 1.5 between the nitrophenylpyridine analog and nitrosophenylpyridine analog peaks; NLT 1.0 between the nitrosophenylpyridine analog and nifedipine peaks
Relative standard deviation:
NMT 10% for each analog
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each analog in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of each analog from the Sample solution |
| rS | = | = peak response of each analog from the Standard solution |
| CS | = | = concentration of the appropriate analog USP Reference Standard in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of nifedipine in the Sample solution (µg/mL) |
Acceptance criteria:
NMT 2.0% of nifedipine nitrophenylpyridine analog and NMT 0.5% of nifedipine nitrosophenylpyridine analog, both relative to the nifedipine content
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers, and store at controlled room temperature.
• Labeling:
The labeling indicates the Dissolution Test with which the product complies.
• USP Reference Standards 11
11
USP Nifedipine RS 
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USP Nifedipine Nitrophenylpyridine Analog RS
Dimethyl 4-(2-nitrophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate.
C17H16N2O6 344.33
Dimethyl 4-(2-nitrophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate.
C17H16N2O6 344.33
USP Nifedipine Nitrosophenylpyridine Analog RS
Dimethyl 4-(2-nitrosophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate.
C17H16N2O5 328.33
Dimethyl 4-(2-nitrosophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate.
C17H16N2O5 328.33
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4052
Pharmacopeial Forum: Volume No. 34(3) Page 638