Table Of Content

USP 32 MONOGRAPH LIST / 1 Acarbose Acetaminophen and Pseudoephedrine Hydrochloride Tablets Acebutolol Hydrochloride Acetazolamide Acebutolol Hydrochloride Capsules Acetazolamide for Injection Acepromazine Maleate Acetazolamide Oral Suspension Acepromazine Maleate Injection Acetazolamide Tablets Acepromazine Maleate Tablets Glacial Acetic Acid Acetaminophen Acetic Acid Irrigation Acetaminophen Capsules Acetic Acid Otic Solution Acetaminophen Oral Solution Acetohexamide Acetaminophen for Effervescent Oral Solution Acetohexamide Tablets Acetaminophen Suppositories Acetohydroxamic Acid Acetaminophen Oral Suspension Acetohydroxamic Acid Tablets Acetaminophen Tablets Acetylcholine Chloride Acetaminophen Extended-Release Tablets Acetylcholine Chloride for Ophthalmic Solution Acetaminophen and Aspirin Tablets Acetylcysteine Acetaminophen, Aspirin, and Caffeine Tablets Acetylcysteine Solution Acetaminophen and Caffeine Tablets Acetylcysteine and Isoproterenol Hydrochloride Inhalation Solution Capsules Containing at Least Three of the Following—Acet- aminophen and Salts of Chlorpheniramine, Dex- Acitretin tromethorphan, and Phenylpropanolamine Acitretin Capsules Oral Solution Containing at Least Three of the Following— Acyclovir Acetaminophen and Salts of Chlorpheniramine, Dex- tromethorphan, and Phenylpropanolamine Acyclovir Capsules Tablets Containing at Least Three of the Following—Acet- Acyclovir for Injection aminophen and Salts of Chlorpheniramine, Dex- tromethorphan, and Phenylpropanolamine Acyclovir Ointment Capsules Containing at Least Three of the Following—Acet- Acyclovir Oral Suspension aminophen and Salts of Chlorpheniramine, Dex- Acyclovir Tablets tromethorphan, and Pseudoephedrine Adenine Oral Powder Containing at Least Three of the Following— Acetaminophen and Salts of Chlorpheniramine, Dex- Adenosine tromethorphan, and Pseudoephedrine Adenosine Injection Oral Solution Containing at Least Three of the Following— Acetaminophen and Salts of Chlorpheniramine, Dex- Medical Air tromethorphan, and Pseudoephedrine Alanine Tablets Containing at Least Three of the Following—Acet- Albendazole aminophen and Salts of Chlorpheniramine, Dex- tromethorphan, and Pseudoephedrine Albendazole Oral Suspension Acetaminophen, Chlorpheniramine Maleate, and Dex- Albendazole Tablets tromethorphan Hydrobromide Tablets Albumin Human Acetaminophen and Codeine Phosphate Capsules Albuterol Acetaminophen and Codeine Phosphate Oral Solution Albuterol Sulfate Acetaminophen and Codeine Phosphate Oral Suspension Albuterol Tablets Acetaminophen and Codeine Phosphate Tablets Alclometasone Dipropionate Acetaminophen, Dextromethorphan Hydrobromide, Doxyl- amine Succinate, and Pseudoephedrine Hydrochloride Oral Alclometasone Dipropionate Cream Solution Alclometasone Dipropionate Ointment Acetaminophen and Diphenhydramine Citrate Tablets Alcohol Acetaminophen, Diphenhydramine Hydrochloride, and Dehydrated Alcohol Pseudoephedrine Hydrochloride Tablets Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination 2 / MONOGRAPH LIST USP 32 Dehydrated Alcohol Injection Aluminum Chloride Rubbing Alcohol Aluminum Chlorohydrate Alcohol in Dextrose Injection Aluminum Chlorohydrate Solution Alendronate Sodium Aluminum Chlorohydrex Polyethylene Glycol Alendronate Sodium Tablets Aluminum Chlorohydrex Propylene Glycol Alfentanil Hydrochloride Aluminum Dichlorohydrate Alfentanil Injection Aluminum Dichlorohydrate Solution Alfuzosin Hydrochloride Aluminum Dichlorohydrex Polyethylene Glycol Allantoin Aluminum Dichlorohydrex Propylene Glycol Allopurinol Aluminum Hydroxide Gel Allopurinol Oral Suspension Dried Aluminum Hydroxide Gel Allopurinol Tablets Dried Aluminum Hydroxide Gel Capsules Allyl Isothiocyanate Dried Aluminum Hydroxide Gel Tablets Aloe Aluminum Phosphate Gel Alprazolam Aluminum Sesquichlorohydrate Alprazolam Oral Suspension Aluminum Sesquichlorohydrate Solution Alprazolam Tablets Aluminum Sesquichlorohydrex Polyethylene Glycol Alprostadil Aluminum Sesquichlorohydrex Propylene Glycol Alprostadil Injection Aluminum Subacetate Topical Solution Alteplase Aluminum Sulfate Alteplase for Injection Aluminum Sulfate and Calcium Acetate for Topical Solution Altretamine Aluminum Sulfate and Calcium Acetate Tablets for Topical Solution Altretamine Capsules Aluminum Zirconium Octachlorohydrate Ammonium Alum Aluminum Zirconium Octachlorohydrate Solution Potassium Alum Aluminum Zirconium Octachlorohydrex Gly Alumina and Magnesia Oral Suspension Aluminum Zirconium Octachlorohydrex Gly Solution Alumina and Magnesia Tablets Aluminum Zirconium Pentachlorohydrate Alumina, Magnesia, and Calcium Carbonate Oral Suspension Aluminum Zirconium Pentachlorohydrate Solution Alumina, Magnesia, and Calcium Carbonate Tablets Aluminum Zirconium Pentachlorohydrex Gly Alumina, Magnesia, and Calcium Carbonate Chewable Tablets Aluminum Zirconium Pentachlorohydrex Gly Solution Alumina, Magnesia, Calcium Carbonate, and Simethicone Aluminum Zirconium Tetrachlorohydrate Tablets Aluminum Zirconium Tetrachlorohydrate Solution Alumina, Magnesia, Calcium Carbonate, and Simethicone Aluminum Zirconium Tetrachlorohydrex Gly Chewable Tablets Aluminum Zirconium Tetrachlorohydrex Gly Solution Alumina, Magnesia, and Simethicone Oral Suspension Aluminum Zirconium Trichlorohydrate Alumina, Magnesia, and Simethicone Tablets Aluminum Zirconium Trichlorohydrate Solution Alumina, Magnesia, and Simethicone Chewable Tablets Aluminum Zirconium Trichlorohydrex Gly Alumina and Magnesium Carbonate Oral Suspension Aluminum Zirconium Trichlorohydrex Gly Solution Alumina and Magnesium Carbonate Tablets Amantadine Hydrochloride Alumina, Magnesium Carbonate, and Magnesium Oxide Tablets Amantadine Hydrochloride Capsules Alumina and Magnesium Trisilicate Oral Suspension Amantadine Hydrochloride Oral Solution Alumina and Magnesium Trisilicate Tablets Amcinonide Aluminum Acetate Topical Solution Copyright 2ª 008 The United States Pharmacopeial Convention. 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For Discussion Purposes Only — Not for Dissemination USP 32 MONOGRAPH LIST / 3 Amcinonide Cream Amitriptyline Hydrochloride Amcinonide Ointment Amitriptyline Hydrochloride Injection Amifostine Amitriptyline Hydrochloride Tablets Amifostine for Injection Amlodipine Besylate Amikacin Aromatic Ammonia Spirit Amikacin Sulfate Ammonium Chloride Amikacin Sulfate Injection Ammonium Chloride Injection Amiloride Hydrochloride Ammonium Chloride Delayed-Release Tablets Amiloride Hydrochloride Tablets Ferric Ammonium Citrate Amiloride Hydrochloride and Hydrochlorothiazide Tablets Ferric Ammonium Citrate for Oral Solution Amiloxate Ammonium Molybdate Aminobenzoate Potassium Ammonium Molybdate Injection Aminobenzoate Potassium Capsules Amobarbital Sodium Aminobenzoate Potassium for Oral Solution Amobarbital Sodium for Injection Aminobenzoate Potassium Tablets Amodiaquine Aminobenzoate Sodium Amodiaquine Hydrochloride Aminobenzoic Acid Amodiaquine Hydrochloride Tablets Aminobenzoic Acid Gel Amoxapine Aminobenzoic Acid Topical Solution Amoxapine Tablets Aminocaproic Acid Amoxicillin Aminocaproic Acid Injection Amoxicillin Boluses Aminocaproic Acid Oral Solution Amoxicillin Capsules Aminocaproic Acid Tablets Amoxicillin Intramammary Infusion Aminoglutethimide Amoxicillin for Injectable Suspension Aminoglutethimide Tablets Amoxicillin Oral Suspension Aminohippurate Sodium Injection Amoxicillin for Oral Suspension Aminohippuric Acid Amoxicillin Tablets Aminopentamide Sulfate Amoxicillin Tablets for Oral Suspension Aminopentamide Sulfate Injection Amoxicillin and Clavulanate Potassium for Oral Suspension Aminopentamide Sulfate Tablets Amoxicillin and Clavulanate Potassium Tablets Aminophylline Amphetamine Sulfate Aminophylline Injection Amphetamine Sulfate Tablets Aminophylline Oral Solution Amphotericin B Aminophylline Rectal Solution Amphotericin B Cream Aminophylline Suppositories Amphotericin B for Injection Aminophylline Tablets Amphotericin B Lotion Aminophylline Delayed-Release Tablets Amphotericin B Ointment Aminosalicylate Sodium Ampicillin Aminosalicylate Sodium Tablets Ampicillin Boluses Aminosalicylic Acid Ampicillin Capsules Aminosalicylic Acid Tablets Ampicillin for Injection Amitraz Ampicillin Soluble Powder Amitraz Concentrate for Dip Ampicillin for Injectable Suspension Copyright 2ª 008 The United States Pharmacopeial Convention. 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For Discussion Purposes Only — Not for Dissemination 4 / MONOGRAPH LIST USP 32 Ampicillin for Oral Suspension Arginine Hydrochloride Ampicillin Tablets Arginine Hydrochloride Injection Ampicillin and Probenecid for Oral Suspension Arsanilic Acid Ampicillin Sodium Ascorbic Acid Ampicillin and Sulbactam for Injection Ascorbic Acid Injection Amprolium Ascorbic Acid Oral Solution Amprolium Soluble Powder Ascorbic Acid Tablets Amprolium Oral Solution Aspartic Acid Amyl Nitrite Aspirin Amyl Nitrite Inhalant Aspirin Boluses Anileridine Aspirin Capsules Anileridine Injection Aspirin Delayed-Release Capsules Anileridine Hydrochloride Aspirin Suppositories Anileridine Hydrochloride Tablets Aspirin Tablets Antazoline Phosphate Buffered Aspirin Tablets Anthralin Aspirin Delayed-Release Tablets Anthralin Cream Aspirin Effervescent Tablets for Oral Solution Anthralin Ointment Aspirin Extended-Release Tablets Anthrax Vaccine Adsorbed Aspirin, Alumina, and Magnesia Tablets Anticoagulant Citrate Dextrose Solution Aspirin, Alumina, and Magnesium Oxide Tablets Anticoagulant Citrate Phosphate Dextrose Solution Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules Anticoagulant Citrate Phosphate Dextrose Adenine Solution Aspirin and Codeine Phosphate Tablets Anticoagulant Heparin Solution Aspirin, Codeine Phosphate, Alumina, and Magnesia Tablets Anticoagulant Sodium Citrate Solution Astemizole Antihemophilic Factor Astemizole Tablets Cryoprecipitated Antihemophilic Factor Atenolol Antimony Potassium Tartrate Atenolol Injection Antimony Sodium Tartrate Atenolol Oral Solution Antipyrine Atenolol Tablets Antipyrine and Benzocaine Otic Solution Atenolol and Chlorthalidone Tablets Antipyrine, Benzocaine, and Phenylephrine Hydrochloride Atovaquone Otic Solution Atovaquone Oral Suspension Antithrombin III Human Atracurium Besylate Antivenin (Crotalidae) Polyvalent Atracurium Besylate Injection Antivenin (Latrodectus mactans) Atropine Antivenin (Micrurus fulvius) Atropine Sulfate Apomorphine Hydrochloride Atropine Sulfate Injection Apomorphine Hydrochloride Tablets Atropine Sulfate Ophthalmic Ointment Apraclonidine Hydrochloride Atropine Sulfate Ophthalmic Solution Apraclonidine Ophthalmic Solution Atropine Sulfate Tablets Aprotinin Activated Attapulgite Aprotinin Injection Colloidal Activated Attapulgite Arginine Aurothioglucose Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination USP 32 MONOGRAPH LIST / 5 Aurothioglucose Injectable Suspension Azathioprine Tablets Avobenzone Azathioprine Sodium for Injection Azaperone Azithromycin Azaperone Injection Azithromycin Capsules Azatadine Maleate Azithromycin for Oral Suspension Azatadine Maleate Tablets Aztreonam Azathioprine Aztreonam Injection Azathioprine Oral Suspension Aztreonam for Injection Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination USP 32 Official Monographs / Acarbose 1 A 132270 carbose Analysis Samples: Standard solution and Sample solution (Comment on this Monograph)id=m115=Acarbose=A- Calculate the percentage of C H NO in the portion of Monos.pdf) 25 43 18 Acarbose taken: Result = (r /r) ·(C /C ) ·100 U S S U r = peak response from the Sample solution U r = peak response from the Standard solution S C = concentration of USP Acarbose RS in the S Standard solution (mg/mL) C = concentration of the Sample solution (mg/mL) C H NO 645.60 U D-2G5lu43cose1, 8O-4,6-dideoxy-4-[[[1S-(1,a4,a5 b,6)a]-4,5,6- Acceptance criteria: 95.0%–102.0% trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]--a D- IMPURITIES glucopyranosyl-(14fi )-O--a D-glucopyranosyl-(14fi )-; Inorganic Impurities O-(g4hl,u6ycd-Doropidxyeyraomnxeoyt-sh4yy-l-[l()[1-(214fi-S)c,-y4OcR-l,-ao5hSe,6xDSe-)ng--4l1u,-5cyo,l6]pa-ytmrriahinnyoods]r-yo-al-x(Dy1--4fi3)-- D- O••rRHgEEaSAInVDiYUc E M IOmENTp AIuGLrSN,iI tTMiIeOesNth 2Æo8d1 I:æI 2Æ 3 1N:æ MT N0.M2%T ,2 d0e pteprmmined on 1.0g glucose [56180-94-0]. • PROCEDURE Mobile phase, System suitability solution, and DEFINITION Chromatographic system: Proceed as directed in the Acarbose is produced by certain strains of Actinoplanes Assay. utahensis. It contains NLT 95.0% and NMT 102.0% of Sample stock solution: Use the Sample solution, as C H NO , calculated on the anhydrous basis. 25 43 18 directed in the Assay. IDENTIFICATION Sample solution: Sample stock solution and water (1:99) • A. INFRARED ABSORPTION 1Æ 97Kæ Analysis • B. The retention time of the Sample solution corresponds to Samples: Sample stock solution and Sample solution that of the Standard solution, as obtained in the Assay. Calculate the percentage of each impurity in the portion of Acarbose taken: ASSAY • PROCEDURE Result = (ri/ra) ·RRF ·100 Solution A: 0.6 mg/mL of monobasic potassium phosphate and 0.35 mg/mL of dibasic sodium phosphate ri = peak response for each impurity Mobile phase: Acetonitrile and Solution A (3:1) ra = response of the main acarbose peak in the System suitability solution: Reconstitute a vial of USP chromatogram of the Sample solution Acarbose System Suitability Mixture RS in 1 mL of water. RRF = relative response factor for each impurity, as Standard solution: Reconstitute a vial of USP Acarbose RS listed in the Impurity Table in 5.0 mL of water. Acceptance criteria Sample solution: 20 mg/mL of Acarbose in water Individual impurities: See Impurity Table. Chromatographic system Total impurities: NMT 3.0% (See Chromatography 6Æ 21,æ System Suitability.) Mode: LC Impurity Table Detector: UV 210 nm Column: 4-mm ·25-cm; packing L8 Relative Relative Acceptance Temperature: 35(cid:176) Retention Response Criteria, Flow rate: 2 mL/min Name Time Factor NMT (%) Injection size: 10 Lm Impurity Aa 0.9 1 0.6 System suitability Impurity Bb 0.8 1.6 0.5 Sample: System suitability solution [NOTE—Identify the acarbose peak and the peaks due to Impurity Cc 1.2 1 1.5 the impurities listed in the Impurity Table.] Impurity Dd 0.5 1.33 1.0 Suitability requirements Impurity Ee 1.7 0.8 0.2 Height to valley ratio: NLT 1.2 for the impurity A peak, and the valley between the impurity A peak and the Impurity Ff 1.9 0.8 0.3 acarbose peak Impurity Gg 2.2 0.8 0.3 [NOTE—The chromatogram obtained is similar to the Impurity Hh 0.6 1 0.2 chromatogram supplied with USP Acarbose System Suitability Mixture RS.] Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination 2 Acarbose / Official Monographs USP 32 Impurity Table (continued) USP Acarbose System Suitability Mixture RS Relative Relative Acceptance Retention Response Criteria, Name Time Factor NMT (%) Acebutolol Hydrochloride Any individual — — 0.2 (Comment on this Monograph)id=m125=Acebutolol unknown impurity Hydrochloride=A-Monos.pdf) aO-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl-(14fi )-O--a D- glucopyranosyl-(14fi )- D-arabino-hex-2-ulopyranose. b(1R,4R,5S,6R)-4,5,6-Trihydroxy-2-(hydroxymethyl)cyclohex-2-enyl 4-O- [4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl]--a D- glucopyranoside. c-a D-Glucopyranosyl 4-O-[4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl]- C18H28N2O4 · HCl 372.89 -a D-glucopyranoside. Butanamide, N-[3-acetyl-4-[2-hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl]-, monohydrochloride, (hd4y-dOro-[x4y,6m-Detihdyelo)cxyyc-l4o-h[[e(x1-S2,4-eRn,5ylS],a6mS)in-4o,]5-,-a6-Dtr-ighlyudcoropxyyr-a3n-osyl]-D- ()–-(3)–-¢-A;cetyl-4-¢[2-hydroxy-3-(isopropylamino)propoxy]- glucopyranose. butyranilide monohydrochloride [34381-68-5]. eO-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl-(14fi )-O--a D- DEFINITION glucopyranosyl-(14fi )-O--a D-glucopyranosyl-(14fi )- D-arabino-hex-2- Acebutolol Hydrochloride contains NLT 98.0% and NMT ulopyranose (4-O--aacarbosyl- D-fructopyranose). 102.0% of C H NO ·HCl, calculated on the dried basis. fO-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- 18 28 2 4 (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl-(14fi )-O--a D- IDENTIFICATION glucopyranosyl-(14fi )-O--a D-glucopyranosyl-(14fi )- D-glucopyranose (4-O- • A. INFRARED ABSORPTION 1Æ 97Kæ -aacarbosyl- D-glucopyranose)O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- • B. PROCEDURE trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl- Sample solution: Prepare a mixture of the Standard solution (14fi )-O--a D-glucopyranosyl-(14fi )-O--a D-glucopyranosyl-(14fi )- D- and the Sample solution (1:1) from the Assay. glucopyranose (4-O--aacarbosyl- D-glucopyranose). Analysis: Chromatograph the Sample solution as directed in g-a D-Glucopyranosyl O-4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- the Assay. (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl-(14fi )-O--a D- Acceptance criteria: The chromatogram thus obtained glucopyranosyl-(14fi )-O--a D-glucopyranoside (-a D-glucopyranosyl -a exhibits a single major peak due to acebutolol. acarboside)-a D-Glucopyranosyl O-4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6- • C. IDENTIFICATION TESTS—GENERAL, Chloride 1Æ 91:æ Meets the trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl- requirements, when tested as directed for alkaloidal (14fi )-O--a D-glucopyranosyl-(14fi )-O--a D-glucopyranoside (-a D- hydrochlorides glucopyranosyl -aacarboside). hO-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3- ASSAY (hydroxymethyl)cyclohex-2-enyl]amino]--a D-glucopyranosyl-(14fi )-O-6- • PROCEDURE deoxy--a D-glucopyranosyl-(14fi )- D-glucopyranoseO-4,6-Dideoxy-4-[ Mobile phase: Methanol, glacial acetic acid, and 0.3% [(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino]- aqueous solution of sodium dodecyl sulfate (675:20:325) -a D-glucopyranosyl-(14fi )-O-6-deoxy--a D-glucopyranosyl-(14fi )- D- [NOTE—Make adjustments if necessary to achieve a glucopyranose. retention time for acebutolol of between 4 and 7 min.] Standard solution: 0.14 mg/mL of USP Acebutolol Hydrochloride RS SPECIFIC TESTS Sample solution: 0.14 mg/mL of Acebutolol Hydrochloride • OPTICAL ROTATION, Specific Rotation 7Æ 81S:æ +168 (cid:176)to +183(cid:176) Chromatographic system Sample solution: 10 mg/mL (See Chromatography 6Æ 21,æ System Suitability.) • PH 7Æ 91:æ 5.5–7.5, in a solution containing 50 mg/mL • WATER DETERMINATION, Method Ic 9Æ 21:æ NMT 4.0% ADDITIONAL REQUIREMENTS • PACKAGING AND STORAGE: Preserve in tight containers. • USP REFERENCE STANDARDS 1Æ 1æ USP Acarbose RS Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination USP 32 Official Monographs / Acebutolol 3 Mode: LC ADDITIONAL REQUIREMENTS Detector: UV 254 nm • PACKAGING AND STORAGE: Preserve in tight containers, and Column: 3.9-mm ·30-cm; packing L1 store at controlled room temperature. Flow rate: 2 mL/min • USP REFERENCE STANDARDS 1Æ 1æ Injection size: 10 Lm USP Acebutolol Hydrochloride RS System suitability Sample: Standard solution Suitability requirements Acebutolol Hydrochloride Capsules Column efficiency: NLT 1500 theoretical plates Tailing factor: NMT 2.5 (Comment on this Monograph)id=m127=Acebutolol Relative standard deviation: NMT 2.0% Hydrochloride Capsules=A-Monos.pdf) Analysis Samples: Standard solution and Sample solution DEFINITION Calculate the percentage of C H NO · HCl in the Acebutolol Hydrochloride Capsules contain the equivalent of 18 28 2 4 Acebutolol Hydrochloride taken: NLT 90.0% and NMT 110.0% of the labeled amount of acebutolol (C H NO). 18 28 2 4 Result = (r /r) ·(C /C ) ·100 U S S U IDENTIFICATION r = peak response from the Sample solution • The retention time of the Sample solution corresponds to that U r = peak response from the Standard solution of the Standard solution, as obtained in the Assay. S C = concentration of USP Acebutolol Hydrochloride S ASSAY RS in the Standard solution (mg/mL) C = concentration of the Sample solution (mg/mL) • PROCEDURE U Solution A: Dissolve 2.4g of sodium 1-decanesulfonate in Acceptance criteria: 98.0%–102.0% 1000 mL of water. Adjust with glacial acetic acid to a pH of IMPURITIES 3.5. Inorganic Impurities Mobile phase: Methanol and Solution A (3:2) • RESIDUE ON IGNITION 2Æ 81:æ NMT 0.1% Standard solution: 0.22 mg/mL of USP Acebutolol • HEAVY METALS, Method II 2Æ 31:æ NMT 20 ppm Hydrochloride RS in methanol Organic Impurities [NOTE—This is equivalent to 0.2 mg/mL of acebutolol.] • PROCEDURE Sample stock solution: Weigh and mix, as completely as Standard solution: 1.0 mg/mL of USP Acebutolol possible, the contents of NLT 20 Capsules. Transfer a portion Hydrochloride RS in methanol of the powder, equivalent to 200 mg of acebutolol, to a Reference solution A: Dilute 3.0 mL of the Standard 200-mL volumetric flask. Add 180 mL of methanol, and stir solution with methanol to 100 mL. by mechanical means for 30 min. Dilute with methanol to Reference solution B: Dilute 5.0 mL of the Standard volume. solution with methanol to 100 mL. Sample solution: Dilute 5.0 mL of the Sample stock solution Sample solution A: 10 mg/mL of Acebutolol with methanol to 25 mL. Hydrochloride in methanol Chromatographic system Sample solution B: Sample solution A and methanol (1:9) (See Chromatography 6Æ 21,æ System Suitability.) Developing solvent system: Butyl alcohol, glacial acetic Mode: LC acid, and water (4:1:5) Detector: UV 254 nm Chromatographic system Column: 3.9-mm ·15-cm; 5-mm packing L1 (See Chromatography 6Æ 21,æ Thin-Layer Chromatography.) Flow rate: 1 mL/min Mode: TLC Injection size: 20 Lm Adsorbent: 0.25-mm layer of chromatographic silica gel System suitability mixture Sample: Standard solution Application volume: 20 Lm Suitability requirements Analysis Tailing factor: NMT 1.5 Samples: Standard solution, Reference solution A, Reference Relative standard deviation: NMT 2.0% solution B, Sample solution A, and Sample solution B Analysis Proceed as directed in the chapter. Develop the Samples: Standard solution and Sample solution chromatogram in the Developing solvent system until the Calculate the percentage of C18H28N2O4 in the Capsules solvent front has moved three-fourths the length of the taken: plate. Examine the plate under short-wavelength UV light. Result = (rU/rS) ·(C S/CU) ·(M r1/Mr2) ·100 Acceptance criteria: The chromatograms from Sample r = peak response from the Sample solution solution B and the Standard solution show principal spots at U r = peak response from the Standard solution the same R value. No secondary spot from Sample solution S F C = concentration of USP Acebutolol Hydrochloride A, excluding the area at the point of application, is more S RS in the Standard solution (mg/mL) intense than the principal spot of Reference solution A C = nominal concentration of the Sample solution (0.3%); NMT two secondary spots from Sample solution A U (mg/mL) are more intense than the principal spot of Reference M = molecular weight of acebutolol, 336.44 solution B (0.1%); and the total of all impurities detected in r1 M = molecular weight of acebutolol hydrochloride, the chromatogram of Sample solution A is NMT 0.5%. r2 372.89 SPECIFIC TESTS • MELTING RANGE OR TEMPERATURE 7Æ 41:æ 140–(cid:176) 144(cid:176) • PH 7Æ 91:æ 4.5–7.0, in a solution (1 in 100) • LOSS ON DRYING 7Æ 31:æ Dry it at 105 (cid:176)for 3 h: it loses NMT 1.0% of its weight Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination 4 Acebutolol / Official Monographs USP 32 Acceptance criteria: 90.0%–110.0% r = peak response from the Standard solution S C = concentration of USP Acebutolol Hydrochloride S PERFORMANCE TESTS RS in the Standard solution (gm /mL) • DISSOLUTION 7Æ 11æ C = nominal concentration of the Sample solution U Medium: Water; 900 mL (gm /mL) Apparatus 2: 50 rpm M = molecular weight of acebutolol, 336.44 r1 Time: 30 min M = molecular weight of acebutolol hydrochloride, Sample solution: Sample per Dissolution 7Æ 11.æ r2 372.89 Standard solution: USP Acebutolol Hydrochloride RS in Test 2 Medium Solution A: Prepare as directed in the Assay. Spectrometric conditions Mobile phase: Methanol and Solution A (1:1) Mode: UV Standard solution: Transfer 30 mg of USP Acebutolol Analytical wavelength: 232 nm Hydrochloride RS to a 50-mL volumetric flask. Add 12 mL Analysis: Determine the amount of C18H28N2O4 dissolved of methanol, swirl to dissolve, and dilute with Mobile by employing the UV absorption on filtered portions of the phase to volume. Dilute a volume of this stock solution Sample solution in comparison with a Standard solution in with Mobile phase to obtain a concentration of 1.4 gm /mL the same Medium. of USP Acebutolol Hydrochloride RS. Tolerances: NLT 80% (Q) of the labeled amount of Sample solution: Transfer a portion of the contents of 20 C18H28N2O4 is dissolved. opened Capsules, equivalent to 250 mg of acebutolol, to • UNIFORMITY OF DOSAGE UNITS 9Æ 05:æ Meet the requirements a 100-mL volumetric flask, add 25 mL of methanol, and shake by mechanical means for 15 min. Dilute with Mobile IMPURITIES phase to volume. Centrifuge a portion of this solution, Organic Impurities • PROCEDURE vaonldu mtraentrsifce rfl a1s0k..0 D miluLt eo fw tihthe cMleoabri lseu pphearnsea ttaon tv otolu ma e1.00-mL Test 1 Chromatographic system Solution A: Prepare as directed in the Assay. (See Chromatography 6Æ 21,æ System Suitability.) Mobile phase: Methanol and Solution A (44:56) Mode: LC Diluent: Methanol and Solution A (1:1) Detector: UV 240 nm Standard solution: Transfer 30 mg of USP Acebutolol Column: 3.9 mm ·15 cm; 4-mm packing L1 Hydrochloride RS to a 50-mL volumetric flask. Add 12 mL Flow rate: 1 mL/min of methanol, swirl to dissolve, and dilute with Diluent to Injection size: 70 Lm volume. Dilute a volume of this solution with Diluent to obtain a concentration of 1.4 gm /mL of USP Acebutolol System suitability Sample: Standard solution Hydrochloride RS. Suitability requirements Sample solution: Transfer a portion of the contents of 20 Relative standard deviation: NMT 6.0% opened Capsules, equivalent to 250 mg of acebutolol, to Analysis a 100-mL volumetric flask, add 25 mL of methanol, and Samples: Mobile phase, Standard solution, and Sample shake by mechanical means for 15 min. Dilute with solution Diluent to volume. Centrifuge a portion of this solution, Calculate the percentage of each impurity eluting after and transfer 10.0 mL of the clear supernatant to a 100-mL the acebutolol peak in the portion of Capsules taken: volumetric flask. Dilute with Diluent to volume. Chromatographic system Result = (r /r) ·(C /C ) ·(M /M ) ·100 (See Chromatography 6Æ 21,æ System Suitability.) U S S U r1 r2 Mode: LC r = peak response for any individual impurity from U Detector: UV 240 nm the Sample solution Column: 3.9-mm 1· 5-cm; 4-mm packing L1 r = peak response from the Standard solution S Flow rate: 1 mL/min C = concentration of USP Acebutolol Hydrochloride Injection size: 35 Lm S RS in the Standard solution (gm /mL) System suitability C = nominal concentration of the Sample solution U Sample: Standard solution (gm /mL) Suitability requirements M = molecular weight of acebutolol, 336.44 r1 Relative standard deviation: NMT 6.0% M = molecular weight of acebutolol hydrochloride, r2 Analysis 372.89 Samples: Diluent, Standard solution, and Sample solution Acceptance criteria [NOTE—Record the chromatograms for two times the Test 1: NMT 0.5% of any individual impurity retention time of acebutolol, and measure the Test 2: NMT 0.5% of any individual impurity responses for all the peaks, disregarding any peaks Sum of impurities found in Test 1 and Test 2: NMT corresponding to those obtained from the Diluent.] 1.0% Calculate the percentage of each impurity eluting prior to the acebutolol peak in the portion of Capsules taken: ADDITIONAL REQUIREMENTS • PACKAGING AND STORAGE: Preserve in tight containers, and Result = (rU/rS) ·(C S/CU) ·(M r1/Mr2) ·100 store at controlled room temperature. • USP REFERENCE STANDARDS 1Æ 1æ rU = peak response for any individual impurity from USP Acebutolol Hydrochloride RS the Sample solution Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination USP 32 Official Monographs / Acepromazine 5 Acepromazine Maleate Acceptance criteria: 98.0%–101.0% (Comment on this Monograph)id=m134=Acepromazine IMPURITIES Maleate=A-Monos.pdf) Inorganic Impurities • RESIDUE ON IGNITION 2Æ 81:æ NMT 0.2% Organic Impurities • PROCEDURE [NOTE—Conduct this test without exposure to daylight, and with the minimum necessary exposure to artificial light.] Diluent: Methanol and diethylamine (19:1) Standard solution: Dilute 1 volume of the Sample solution with 200 volumes of Diluent (0.1 mg/mL). C H NOS·CHO 442.53 19 22 2 4 4 4 Sample solution: 20.0 mg/mL in Diluent Ethanone, 1-[10-[3-(dimethylamino)propyl]-10H-phenothiazin-2- Developing solvent system: n-Heptane, isobutyl alcohol, yl]-, (Z)-2-butenedioate (1:1); and diethylamine (75:17:8) 10-[3-(Dimethylamino)propyl]phenothiazin-2-yl methyl ketone Chromatographic system maleate (1:1) [3598-37-6]. (See Chromatography 6Æ 21,æ Thin-Layer Chromatography.) DEFINITION Mode: TLC Acepromazine Maleate contains NLT 98.0% and NMT 101.0% Adsorbent: 0.25-mm layer of chromatographic silica gel of C H NOS·CHO, calculated on the anhydrous basis. mixture [NOTE1—9 T2h2ro2ughou4t t4he4 following procedures, protect samples, Application volume: 10 Lm the USP Reference Standard, and solutions containing them, Analysis by conducting the procedures without delay, under subdued Samples: Standard solution and Sample solution light, or using low-actinic glassware.] Develop the chromatogram in the Developing solvent system until the solvent front has moved three-fourths IDENTIFICATION the length of the plate. Examine the plate under short- • A. INFRARED ABSORPTION 1Æ 97Kæ wavelength UV light. • B. The retention time of the peak from the Sample solution Acceptance criteria: No spot, other than the principal corresponds to that of the Standard solution, as obtained in acepromazine spot and any at the origin, observed in the the Assay. chromatogram of the Sample solution is more intense than the principal spot observed in the chromatogram of the ASSAY Standard solution (0.5%). • PROCEDURE Solution A: Add 6 mL of triethylamine to 700 mL of water, SPECIFIC TESTS and adjust with phosphoric acid to a pH of 2.5. • MELTING RANGE OR TEMPERATURE 7Æ 41:æ 136–(cid:176) 139(cid:176) Mobile phase: Acetonitrile and Solution A (300:700) • PH 7Æ 91:æ 4.0–5.5 in a solution (1 in 100) Standard stock solution: 1 mg/mL of USP Acepromazine • WATER DETERMINATION, Method I 9Æ 21:æ NMT 1.0% Maleate RS in 0.05N hydrochloric acid Standard solution: 0.1 mg/mL of USP Acepromazine ADDITIONAL REQUIREMENTS Maleate RS in water, from Standard stock solution • PACKAGING AND STORAGE: Preserve in well-closed containers, Sample stock solution: 1 mg/mL of Acepromazine Maleate protected from light. Store at room temperature. in 0.05N hydrochloric acid • LABELING: Label it to indicate that it is for veterinary use Sample solution: 0.1 mg/mL of Acepromazine Maleate in only. water, from Sample stock solution • USP REFERENCE STANDARDS 1Æ 1æ Chromatographic system USP Acepromazine Maleate RS (See Chromatography 6Æ 21,æ System Suitability.) Mode: LC Detector: UV 280 nm Acepromazine Maleate Injection Column: 4 mm ·15 cm; 5-mm packing L7 Flow rate: 1 mL/min (Comment on this Monograph)id=m137=Acepromazine Injection size: 10 Lm Maleate Injection=A-Monos.pdf) System suitability DEFINITION Sample: Standard solution Acepromazine Maleate Injection is a sterile solution of Suitability requirements Acepromazine Maleate in Water for Injection. It contains NLT Column efficiency: NLT 1500 theoretical plates 90.0% and NMT 110.0% of the labeled amount of Tailing factor: NMT 2.5 Relative standard deviation: NMT 2.0% acepromazine maleate (C19H22N2OS·C4H4O4). Analysis [NOTE—Throughout the following procedures, protect samples, the Reference Standard, and solutions containing them, by Samples: Standard solution and Sample solution Calculate the percentage of C H NOS·CHO in the conducting the procedures without delay, under subdued 19 22 2 4 4 4 light, or using low-actinic glassware.] Acepromazine Maleate taken: Result = (rU/rS) ·(C S/CU) ·100 I•DAEN. ITNIFFRIACRAETD IOABNSORPTION 1Æ 97Kæ r = peak response from the Sample solution Sample: To a volume of Injection equivalent to 20 mg of rU = peak response from the Standard solution acepromazine maleate, add 2 mL of water and 3 mL of 2N CS = concentration of USP Acepromazine Maleate RS sodium hydroxide, and extract with two 5-mL portions of S cyclohexane. Combine the cyclohexane extracts, and in the Standard solution (mg/mL) C = concentration of the Sample solution (mg/mL) U Copyright 2ª 008 The United States Pharmacopeial Convention. All Rights Reserved. For Discussion Purposes Only — Not for Dissemination