{"id":19331,"date":"2025-10-24T17:11:13","date_gmt":"2025-10-24T10:11:13","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=19331"},"modified":"2025-10-24T17:11:33","modified_gmt":"2025-10-24T10:11:33","slug":"nevirapine-oral-suspension","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nevirapine-oral-suspension\/","title":{"rendered":"Nevirapine Oral Suspension"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

Action and use<\/strong><\/p>\n

Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV).<\/p>\n

DEFINITION<\/h2>\n
Nevirapine Oral Suspension is a suspension of Nevirapine Hemihydrate in a suitable vehicle.<\/p>\n
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.<\/em><\/p>\n
Content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O<\/strong><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 190 to 400 nm.<\/p>\n
The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);
\nthe retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 25 revolutions per minute.<\/p>\n
(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n
PROCEDURE<\/h4>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solution A:\u00a0 equal volumes of ethanol and water.<\/p>\n
(1) Shake the oral suspension for 30 seconds and place a volume equivalent to one dose into each dissolution vessel. After 45 minutes withdraw a sample of the medium and filter (a 0.45-\u03bcm Nylon filter is suitable). Use the filtered medium, diluted with the dissolution medium, if necessary, to produce a solution expected to contain the equivalent of 0.0056% w\/v of nevirapine.<\/p>\n
(2) 1.4% w\/v of nevirapine BPCRS in solution A. Dilute with the dissolution medium to produce a solution containing 0.0056% w\/v of nevirapine BPCRS.<\/p>\n
(3) 0.5% w\/v of nevirapine BPCRS and 0.75% w\/v of methyl parahydroxybenzoate in solution A. Dilute with the dissolution medium to produce a solution containing 0.004% w\/v of nevirapine BPCRS and 0.006% w\/v of methyl parahydroxybenzoate.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 3.9 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u00b5m) (Symmetry C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.0 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 214 nm.<\/p>\n
(f) Inject 10 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
23 volumes of acetonitrile R1 and 77 volumes of water R1.<\/p>\n
When the chromatograms are recorded under the prescribed conditions the retention time of nevirapine is about 5 minutes.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to nevirapine and methyl parahydroxybenzoate is at least 5.0.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O, in the medium from the chromatograms obtained and using the declared content of C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O in nevirapine BPCRS.<\/p>\n}}}}}}
LIMITS<\/h4>\n
The amount of nevirapine released is not less than 80% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Mix with the aid of ultrasound a quantity of the oral suspension containing the equivalent of 60 mg of nevirapine in 40 mL of methanol, and dilute to 200 mL with water.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes with water. Dilute 1 volume of this solution to 5 volumes with water.<\/p>\n
(3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL of methanol (80%).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with cyanosilyl silica gel for chromatography (3.5 \u00b5m) (Zorbax SB-CN is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/p>\n
(d) Use a column temperature of 35\u00b0.<\/p>\n
(e) Use a detection wavelength of 254 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Solution B:\u00a0 Dissolve 6.8 g of potassium dihydrogen orthophosphate in 950 mL of water, and adjust to pH 3.0 with orthophosphoric acid. Dilute to 1000 mL with water and filter through a 0.45-\u00b5m membrane filter.<\/p>\n
Mobile phase A<\/em>: 3 volumes of acetonitrile and 97 volumes of solution B.<\/p>\n
Mobile phase B<\/em>: 24 volumes of acetonitrile and 76 volumes of solution B.<\/p>\n\n\n\n\n\n\n\n
Time (Minutes)<\/strong><\/td>\n Mobile phase A (% v\/v)<\/strong><\/td>\n Mobile phase B (% v\/v)<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-3<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
3-33<\/td>\n 100\u21920<\/td>\n 0\u2192100<\/td>\n linear gradient<\/td>\n<\/tr>\n
33-34<\/td>\n 0\u2192100<\/td>\n 100\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
34-42<\/td>\n 100<\/td>\n 0<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to nevirapine (retention time about 23 minutes) are: impurity B, about 0.9; impurity A, about 1.1; impurity C, about 1.2<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and nevirapine is at least 1.7. the resolution between the peaks due to nevirapine and impurity A is at least 3.0.<\/p>\n
LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n
the sum of the areas of all secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%).<\/p>\n
Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Mix with the aid of ultrasound a weighed quantity of the oral suspension containing the equivalent of 60 mg of nevirapine in 40 mL of methanol, and dilute to 200 mL with water.<\/p>\n
(2) 0.25% w\/v of nevirapine BPCRS in methanol. Dilute 3 volumes to 25 volumes with water.<\/p>\n
(3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL of methanol (80%).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 1.7.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O, weight in volume, using the declared content of C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O in nevirapine BPCRS.<\/p>\n}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Nevirapine Hemihydrate.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV). DEFINITION Nevirapine Oral Suspension is a suspension of Nevirapine Hemihydrate in a suitable vehicle. The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Content of nevirapine, C15H14N4O 95.0 to 105.0% of the…<\/p>\n","protected":false},"author":5,"featured_media":19332,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19331","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19331"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331\/revisions"}],"predecessor-version":[{"id":19347,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331\/revisions\/19347"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19332"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19331"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19331"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/strong><\/td>\n	Mobile phase A (% v\/v)<\/strong><\/td>\n	Mobile phase B (% v\/v)<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-3<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
3-33<\/td>\n	100\u21920<\/td>\n	0\u2192100<\/td>\n	linear gradient<\/td>\n<\/tr>\n
33-34<\/td>\n	0\u2192100<\/td>\n	100\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
34-42<\/td>\n	100<\/td>\n	0<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to nevirapine (retention time about 23 minutes) are: impurity B, about 0.9; impurity A, about 1.1; impurity C, about 1.2<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n the resolution between the peaks due to impurity B and nevirapine is at least 1.7. the resolution between the peaks due to nevirapine and impurity A is at least 3.0.<\/p>\n LIMITS<\/h4>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%).<\/p>\n Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Mix with the aid of ultrasound a weighed quantity of the oral suspension containing the equivalent of 60 mg of nevirapine in 40 mL of methanol, and dilute to 200 mL with water.<\/p>\n (2) 0.25% w\/v of nevirapine BPCRS in methanol. Dilute 3 volumes to 25 volumes with water.<\/p>\n (3) Dissolve the contents of a vial of nevirapine for peak identification EPCRS in 2 mL of methanol (80%).<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n The chromatographic conditions described under Related substances may be used.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 1.7.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O, weight in volume, using the declared content of C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O in nevirapine BPCRS.<\/p>\n}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Nevirapine Hemihydrate.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV). DEFINITION Nevirapine Oral Suspension is a suspension of Nevirapine Hemihydrate in a suitable vehicle. The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Content of nevirapine, C15H14N4O 95.0 to 105.0% of the…<\/p>\n","protected":false},"author":5,"featured_media":19332,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-19331","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=19331"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331\/revisions"}],"predecessor-version":[{"id":19347,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/19331\/revisions\/19347"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/19332"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=19331"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=19331"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=19331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nComply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 2, rotating the paddle at 25 revolutions per minute.<\/p>\n(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

MOBILE PHASE<\/h4>\n23 volumes of acetonitrile R1 and 77 volumes of water R1.<\/p>\nWhen the chromatograms are recorded under the prescribed conditions the retention time of nevirapine is about 5 minutes.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to nevirapine and methyl parahydroxybenzoate is at least 5.0.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of nevirapine, C15<\/sub>H14<\/sub>N4<\/sub>O, in the medium from the chromatograms obtained and using the declared content of C15<\/sub>H14<\/sub>N4<\/sub>O in nevirapine BPCRS.<\/p>\n

LIMITS<\/h4>\nThe amount of nevirapine released is not less than 80% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\nthe resolution between the peaks due to impurity B and nevirapine is at least 1.7. the resolution between the peaks due to nevirapine and impurity A is at least 3.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Related substances may be used.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 1.7.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nDetermine the weight per mL of the oral suspension, Appendix V G, and calculate the content of nevirapine, C15<\/sub>H14<\/sub>N4<\/sub>O, weight in volume, using the declared content of C15<\/sub>H14<\/sub>N4<\/sub>O in nevirapine BPCRS.<\/p>\n

Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 25 revolutions per minute.<\/p>\n
(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

MOBILE PHASE<\/h4>\n
23 volumes of acetonitrile R1 and 77 volumes of water R1.<\/p>\n
When the chromatograms are recorded under the prescribed conditions the retention time of nevirapine is about 5 minutes.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to nevirapine and methyl parahydroxybenzoate is at least 5.0.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O, in the medium from the chromatograms obtained and using the declared content of C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O in nevirapine BPCRS.<\/p>\n}}}}}}

LIMITS<\/h4>\n
The amount of nevirapine released is not less than 80% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and nevirapine is at least 1.7. the resolution between the peaks due to nevirapine and impurity A is at least 3.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related substances may be used.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and nevirapine is at least 1.7.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of nevirapine, C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O, weight in volume, using the declared content of C_{15<\/sub>H_{14<\/sub>N_{4<\/sub>O in nevirapine BPCRS.<\/p>\n}}}}}}