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Revisions to USP 31–NF 26, Second Supplement

Commentary  (67KB) (published May 2008)

Published April 2008

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Monographs: A–C   D–N   O–S   T–Z


Monograph Title Section Head Scientific Liaison
DANTROLENE SODIUM CAPSULES PF 33(4) Pg. 645 Dissolution <711>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Title
DEHYDROACETIC ACID PF 33(4) Pg. 703 Chemical Info
DEHYDROACETIC ACID PF 33(4) Pg. 703 Definition
DEHYDROACETIC ACID PF 33(4) Pg. 703 Packaging and storage
DEHYDROACETIC ACID PF 33(4) Pg. 703 USP Reference standards <11>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Identification
DEHYDROACETIC ACID PF 33(4) Pg. 703 Heavy Metals, Method II <231>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Loss on drying <731>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Melting range, Class I <741>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Residue on ignition <281>
DEHYDROACETIC ACID PF 33(4) Pg. 703 Assay
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Title
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Definition
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Packaging and storage
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Labeling
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 USP Reference stadards
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Identification
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Uniformity of dosage units
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Loss on drying
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Related compounds
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 32(3) Pg. 784 Assay
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Title
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Definition
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Labeling
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Loss on drying <731>
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Acid-neutralizing capacity <301>
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Related compounds
DIDANOSINE TABLETS FOR ORAL SUSPENSION PF 33(5) Pg. 903 Assay
DILTIAZEM HYDROCHLORIDE PF 33(5) Pg. 907 Definition
DIMENHYDRINATE INJECTION PF 33(5) Pg. 907 USP Reference standards <11>
DIMENHYDRINATE INJECTION PF 33(5) Pg. 907 Identification
DIMENHYDRINATE PF 33(5) Pg. 907 Identification
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Title
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Definition
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Packaging and storage
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Labeling
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 USP Reference standards <11>
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Identification
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Bacterial endotoxins <85>
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Sterility <71>
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 pH <791>
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Other requirements
DINOPROST TROMETHAMINE INJECTION PF 33(5) Pg. 908 Assay
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Title
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Definition
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Packaging and storage
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Labeling
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 USP Reference standards
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Identification A, B, C
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Clarity
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Color
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 pH
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Benzyl alcohol content
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Free sulfate content
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Anti-factor IIa activity
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Anti-factor Xa to anti-factor IIa ratio
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Other requirements - Sterility Tests <71>
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Other requirements
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Assay (anti-factor Xa activity)
ENOXAPARIN SODIUM INJECTION PF 31(3) Pg. 761 Bacterial endotoxins
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Definition
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Appearance of solution (Clarity and degree of color of liquids)
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Benzyl alcohol content (if present)
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Bacterial endotoxins <85>
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Free sulfate content
ENOXAPARIN SODIUM INJECTION PF 33(1) Pg. 58 Assay (anti-factor Xa activity)
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Title
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Chemical structure
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 CAS number
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Definition
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Packaging and storage
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 USP Reference standards
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Identification A, B, C, D, E
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Appearance of solution
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Specific absorbance
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 pH
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Loss on drying
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Nitrogen content
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Heavy metals
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Sodium content
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Molar ratio of sulfate to carboxylate
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Benzyl alcohol content
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Anti-factor IIa activity
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Assay (anti-factor Xa activity)
ENOXAPARIN SODIUM PF 29(6) Pg. 1876 Bacterial endotoxins
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Definition
ENOXAPARIN SODIUM PF 33(1) Pg. 52 USP Reference standards <11>
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Identification
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Appearance of solution (Clarity and degree of color of liquids)
ENOXAPARIN SODIUM PF 33(1) Pg. 52 pH <791>
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Molar ratio of sulfate to carboxylate (see Chromatography <621>)
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Benzyl alcohol content
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Anti-factor IIa activity
ENOXAPARIN SODIUM PF 33(1) Pg. 52 Assay (anti-factor Xa activity)
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS PF 31(5) Pg. 1364 Dissolution
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS PF 33(2) Pg. 220 Dissolution
ETHINYL ESTRADIOL TABLETS PF 31(4) Pg. 1067 Disintegration
ETHIONAMIDE PF 33(4) Pg. 648 Assay
FAMOTIDINE TABLETS PF 33(4) Pg. 649 Dissolution <711>
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650 Definition
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650 Labeling
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650 Content of methanol
FORMALDEHYDE SOLUTION PF 33(4) Pg. 650 Assay
FULVESTRANT PF 33(5) Pg. 909 Title
FULVESTRANT PF 33(5) Pg. 909 Chemical Info
FULVESTRANT PF 33(5) Pg. 909 Definition
FULVESTRANT PF 33(5) Pg. 909 Packaging and storage
FULVESTRANT PF 33(5) Pg. 909 USP Reference standards <11>
FULVESTRANT PF 33(5) Pg. 909 Identification
FULVESTRANT PF 33(5) Pg. 909 Specific rotation <781S>
FULVESTRANT PF 33(5) Pg. 909 Water, Method Ic <921>
FULVESTRANT PF 33(5) Pg. 909 Residue on ignition <281>
FULVESTRANT PF 33(5) Pg. 909 Related compounds
FULVESTRANT PF 33(5) Pg. 909 Diastereoisomer ratio
FULVESTRANT PF 33(5) Pg. 909 Assay
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Microbial limits
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Title
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Molecular weight
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Packaging and storage
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Identification A, B, C
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Specific rotation
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Loss on drying
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Residue on ignition
GAMMA CYCLODEXTRIN PF 31(3) Pg. 812 Heavy metals
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Chemical Info
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Definition
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 USP Reference standards <11>
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Color and clarity of solution
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Related compounds
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Reducing substances
GAMMA CYCLODEXTRIN PF 33(4) Pg. 707 Assay
GLUCOSAMINE HYDROCHLORIDE PF 33(4) Pg. 691 Specific rotation <781S>
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Pg. 692 Identification
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Pg. 692 Specific rotation <781S>
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE PF 33(4) Pg. 692 Residue on ignition <281>
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. 692 Identification
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. 692 Specific rotation <781S>
GLUCOSAMINE SULFATE SODIUM CHLORIDE PF 33(4) Pg. 692 Residue on ignition <281>
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS PF 33(4) Pg. 654 Labeling
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS PF 33(4) Pg. 654 Dissolution <711>
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Title
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Chemical Info
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Definition
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Packaging and storage
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Identification
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Limit of chloride
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Limit of lead
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Water-dispersible substances
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Loss on ignition <733>
HYDROPHOBIC COLLOIDAL SILICA PF 33(5) Pg. 976 Assay
HYOSCYAMINE SULFATE PF 33(4) Pg. 659 Specific rotation <781S>
INOSITOL PF 33(4) Pg. 711 Title
INOSITOL PF 33(4) Pg. 711 Chemical Info
INOSITOL PF 33(4) Pg. 711 Definition
INOSITOL PF 33(4) Pg. 711 Packaging and storage
INOSITOL PF 33(4) Pg. 711 USP Reference standards <11>
INOSITOL PF 33(4) Pg. 711 Clarity of solution
INOSITOL PF 33(4) Pg. 711 Color of solution
INOSITOL PF 33(4) Pg. 711 Identification
INOSITOL PF 33(4) Pg. 711 Conductivity
INOSITOL PF 33(4) Pg. 711 Water, Method I <921>
INOSITOL PF 33(4) Pg. 711 Barium
INOSITOL PF 33(4) Pg. 711 Limit of lead
INOSITOL PF 33(4) Pg. 711 Related compounds
INOSITOL PF 33(4) Pg. 711 Assay
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS PF 33(4) Pg. 659 Dissolution <711>
ISOTRETINOIN CAPSULES PF 33(4) Pg. 666 Dissolution <711>
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Title
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Definition
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Packaging and storage
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Labeling
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 USP Reference standards <11>
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Identification
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Bacterial endotoxins <85>
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Sterility <71>
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Other requirements
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Assay for ivermectin
IVERMECTIN AND CLORSULON INJECTION PF 33(5) Pg. 921 Assay for clorsulon
IVERMECTIN INJECTION PF 33(5) Pg. 913 Title
IVERMECTIN INJECTION PF 33(5) Pg. 913 Definition
IVERMECTIN INJECTION PF 33(5) Pg. 913 Packaging and storage
IVERMECTIN INJECTION PF 33(5) Pg. 913 Labeling
IVERMECTIN INJECTION PF 33(5) Pg. 913 USP Reference standards <11>
IVERMECTIN INJECTION PF 33(5) Pg. 913 Identification
IVERMECTIN INJECTION PF 33(5) Pg. 913 Bacterial endotoxins <85>
IVERMECTIN INJECTION PF 33(5) Pg. 913 Sterility <71>
IVERMECTIN INJECTION PF 33(5) Pg. 913 Chromatographic purity
IVERMECTIN INJECTION PF 33(5) Pg. 913 Other requirements
IVERMECTIN INJECTION PF 33(5) Pg. 913 Assay
IVERMECTIN PASTE PF 33(5) Pg. 914 Title
IVERMECTIN PASTE PF 33(5) Pg. 914 Definition
IVERMECTIN PASTE PF 33(5) Pg. 914 Packaging and storage
IVERMECTIN PASTE PF 33(5) Pg. 914 Labeling
IVERMECTIN PASTE PF 33(5) Pg. 914 USP Reference standards <11>
IVERMECTIN PASTE PF 33(5) Pg. 914 Identification
IVERMECTIN PASTE PF 33(5) Pg. 914 Chromatographic purity
IVERMECTIN PASTE PF 33(5) Pg. 914 Assay
IVERMECTIN PF 33(5) Pg. 912 Definition
IVERMECTIN TABLETS PF 33(5) Pg. 918 Title
IVERMECTIN TABLETS PF 33(5) Pg. 918 Definition
IVERMECTIN TABLETS PF 33(5) Pg. 918 Packaging and storage
IVERMECTIN TABLETS PF 33(5) Pg. 918 USP Reference standards <11>
IVERMECTIN TABLETS PF 33(5) Pg. 918 Identification
IVERMECTIN TABLETS PF 33(5) Pg. 918 Uniformity of dosage units <905>
IVERMECTIN TABLETS PF 33(5) Pg. 918 Limit of 8a-oxo-H2B1a
IVERMECTIN TABLETS PF 33(5) Pg. 918 Assay
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Title
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Definition
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Packaging and storage
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Labeling
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 USP Reference standards <11>
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Identification
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Chromatographic purity
IVERMECTIN TOPICAL SOLUTION PF 33(5) Pg. 916 Assay
LIGHT MINERAL OIL PF 33(5) Pg. 972 Definition
LIGHT MINERAL OIL PF 33(5) Pg. 972 Packaging and storage
LIGHT MINERAL OIL PF 33(5) Pg. 972 Labeling
LIGHT MINERAL OIL PF 33(5) Pg. 972 USP Reference standards <11>
LIGHT MINERAL OIL PF 33(5) Pg. 972 Identification
LIGHT MINERAL OIL PF 33(5) Pg. 972 Viscosity <911>
LIGHT MINERAL OIL PF 33(5) Pg. 972 Acidity,Readily carbonizable substances, Limit of polycyclic aromatic hydrocarbons, Limit of sulfur compounds, and Solid paraffin
MAGALDRATE AND SIMETHICONE ORAL SUSPENSION PF 33(5) Pg. 923 Defoaming activity
MAGALDRATE AND SIMETHICONE TABLETS PF 33(5) Pg. 923 Defoaming activity
MAGALDRATE AND SIMETHICONE TABLETS PF 33(5) Pg. 923 Defoaming activity
MEFLOQUINE HYDROCHLORIDE PF 33(4) Pg. 667 Assay
MINERAL OIL PF 33(5) Pg. 962 Chemical Info
MINERAL OIL PF 33(5) Pg. 962 Definition
MINERAL OIL PF 33(5) Pg. 962 Packaging and storage
MINERAL OIL PF 33(5) Pg. 962 Labeling
MINERAL OIL PF 33(5) Pg. 962 USP Reference standards <11>
MINERAL OIL PF 33(5) Pg. 962 Identification
MINERAL OIL PF 33(5) Pg. 962 Neutrality
MINERAL OIL PF 33(5) Pg. 962 Acidity
MINERAL OIL PF 33(5) Pg. 962 Readily carbonizable substances
MINERAL OIL PF 33(5) Pg. 962 Limit of polycyclic aromatic hydrocarbons
MINERAL OIL PF 33(5) Pg. 962 Limit of sulfur compounds
MINERAL OIL PF 33(5) Pg. 962 Viscosity
MINERAL OIL, RECTAL PF 33(5) Pg. 964 Packaging and storage
MINERAL OIL, RECTAL PF 33(5) Pg. 964 USP Reference standards <11>
MINERAL OIL, RECTAL PF 33(5) Pg. 964 Identification
MINERAL OIL, RECTAL PF 33(5) Pg. 964 Viscosity
MINERAL OIL, RECTAL PF 33(5) Pg. 964 Neutrality
MINERAL OIL, RECTAL PF 33(5) Pg. 964 Acidity
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Title
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Chemical Info
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Definition
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Packaging and storage
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 USP Reference standards <11>
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Identification
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Melting range, Class Ia <741>
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Loss on drying <731>
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Residue on ignition <281>
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Heavy metals, Method II <231>
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Related compounds
MYCOPHENOLATE MOFETIL PF 33(5) Pg. 924 Assay
NAPHAZOLINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 33(5) Pg. 926 Assay
NICOTINE TRANSDERMAL SYSTEM PF 33(5) Pg. 927 Drug release <724>
NICOTINE TRANSDERMAL SYSTEM PF 33(5) Pg. 927 Assay
NORETHINDRONE TABLETS PF 32(6) Pg. 1736 Labeling
NORETHINDRONE TABLETS PF 32(6) Pg. 1736 Disintegration <701>
NORETHINDRONE TABLETS PF 33(3) Pg. 432 Dissolution <711>

General Chapters  
Monographs: A–C   D–N   O–S   T–Z