Type of Posting: Notice of Intent to Revise
Posting Date: 31–Oct–2014; updated 8–May–2015*
Targeted Official Date: 01–May–2016
Expert Committee: General Chapters—Chemical Analysis
*The notice was edited May 8, 2015 to indicate that the new general chapters <852>, <853>, <854>, <855>, <857> will not be applicable until May 1, 2016.
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to the omission of General Chapter <851> Spectrophotometry and Light-Scattering. General Chapter <851> is being replaced by a new series of general chapters describing the specific spectroscopic techniques that are included therein:
- Atomic Absorption Spectroscopy <852>
- Fluorescence Spectroscopy <853>
- Mid-Infrared Spectroscopy <854>
- Nephelometry, Turbidimetry, and Visual Comparison <855>
- Ultraviolet-Visible Spectroscopy <857>
The omission of General Chapter <851> and associated reference changes will appear in USP 39–NF 34, which will be released on November 1, 2015 and become official on May 1, 2016. Until the omission of USP 39–NF 34 becomes official on May 1, 2016, monographs and general chapters will continuing referencing General Chapter <851>. Likewise, although the new general chapters, <852>, <853>, <854>, <855>, <857> may already be official, they will not be applicable, until May 1, 2016 when the references in the associated monographs become official.
Should you have any questions or comments, please contact Horacio Pappa, Director, General Chapters at (301-816-8319 or hp@usp.org).
USP has identified the following monographs and general chapters that reference General Chapter <851> and thus require some degree of revision to assure the appropriate General Chapter is referenced:
- <1024> Bovine Serum
- <1057> Biotechnology-Derived Articles–Total Protein Assay
- <1059> Excipient Performance
- <1061> Color–Instrumental Measurement
- <1120> Raman Spectroscopy
- <1125> Nucleic Acid-Based Techniques–General
- <1126> Nucleic Acid-Based Techniques–Extraction, Detection, and Sequencing
- <1151> Pharmaceutical Dosage Forms
- <1231> Water for Pharmaceutical Purposes
- <130> Protein A Quality Attributes
- <181> Identification–Organic Nitrogenous Bases
- <197> Spectrophotometric Identification Tests
- <206> Aluminum
- <208> Anti-Factor Xa and Anti-Factor Iia Assays For Unfractionated and Low Molecular Weight Heparins
- <221> Chloride and Sulfate
- <231> Heavy Metals
- <381> Elastomeric Closures for Injections
- <571> Vitamin A Assay
- <661> Containers–Plastics
- <90> Fetal Bovine Serum–Quality Attributes and Functionality Tests
- <92> Growth Factors and Cytokines Used In Cell Therapy Manufacturing
- meso-Zeaxanthin
- meso-Zeaxanthin Preparation
- p-Phenylenediamine Hydrochloride
- Acetaminophen and Tramadol Hydrochloride Tablets
- Acetohydroxamic Acid
- Adenine
- Alcohol
- Alfadex
- Alfuzosin Hydrochloride Extended-Release Tablets
- Alpha-Lactalbumin
- Alprostadil
- Alteplase
- Alumina and Magnesium Carbonate Oral Suspension
- Alumina and Magnesium Carbonate Tablets
- Alumina and Magnesium Trisilicate Tablets
- Alumina, Magnesia, Calcium Carbonate, and Simethicone Chewable Tablets
- Alumina, Magnesia, and Simethicone Chewable Tablets
- Alumina, Magnesia, and Simethicone Oral Suspension
- Aluminum Oxide
- 4-Amino-6-chloro-1,3-benzenedisulfonamide
- Amino Methacrylate Copolymer
- Aminoglutethimide Tablets
- Aminopentamide Sulfate Injection
- Aminopentamide Sulfate Tablets
- Ammonium Molybdate Injection
- Amodiaquine
- Anhydrous Citric Acid
- Anhydrous Lactose
- Anthrax Vaccine Adsorbed
- Anticoagulant Heparin Solution
- Aprotinin
- Aspartame Acesulfame
- Astaxanthin Esters
- Atorvastatin Calcium
- Aztec Marigold Zeaxanthin Extract
- Bacitracin Zinc
- Benazepril Hydrochloride
- Benzyl Alcohol
- Beta Carotene
- Beta Carotene Capsules
- Beta Carotene Preparation
- Beta Glucan
- Betadex
- Bicalutamide Tablets
- Bismuth Citrate
- Bismuth Subcarbonate
- Bismuth Subsalicylate
- Bismuth Subsalicylate Magma
- Bismuth Subsalicylate Oral Suspension
- Bismuth Subsalicylate Tablets
- Bleomycin Sulfate
- BlueTetrazolium
- Bromocriptine Mesylate Capsules
- Bromocriptine Mesylate Tablets
- Bupropion Hydrochloride Extended-Release Tablets
- Calcium Acetate
- Calcium Acetate Tablets
- Calcium Carbonate
- Calcium Carbonate Lozenges
- Calcium Carbonate Tablets
- Calcium Carbonate, Magnesia, and Simethicone Chewable Tablets
- Calcium Citrate Tablets
- Calcium Gluconate
- Calcium Gluconate Tablets
- Calcium Propionate
- Calcium Silicate
- Calcium and Vitamin D with Minerals Tablets
- Calcium with Vitamin D Tablets
- Carboxymethylcellulose Sodium 12
- Cascara Sagrada
- Cascara Sagrada Extract
- Cascara Tablets
- Ceftazidime for Injection
- Cellaburate
- Cephalexin Capsules
- Cephalexin Tablets
- Cephalexin Tablets for Oral Suspension
- Cetirizine Hydrochloride Tablets
- Cetylpyridinium Chloride Lozenges
- Chlorophyllin Copper Complex Sodium
- Chondroitin Sulfate Sodium
- Chromic Chloride Injection
- Chromium Picolinate
- Chromium Picolinate Tablets
- Ciprofloxacin Tablets
- Citalopram Tablets
- Citric Acid Monohydrate
- Clofazimine Capsules
- Clonidine
- Codeine Sulfate Tablets
- Colloidal Activated Attapulgite
- Copovidone
- Copper Gluconate
- Corn Syrup Solids
- Cupric Chloride
- Cupric Chloride Injection
- Cupric Sulfate
- Cyanocobalamin
- Cyclobenzaprine Hydrochloride Tablets
- Cycloserine
- Deferoxamine Mesylate for Injection
- Dehydrated Alcohol
- Desflurane
- Desoxycholic Acid
- Dextran 1
- Diatrizoic Acid
- Dibasic Calcium Phosphate Tablets
- Dihydroxyaluminum Sodium Carbonate
- Dimethicone
- Docusate Calcium Capsules
- Docusate Sodium Syrup
- Donepezil Hydrochloride Tablets
- Doxycycline Hyclate Tablets
- Doxycycline Tablets
- Dried Ferrous Sulfate
- Ecamsule Solution
- Efavirenz Capsules
- Efavirenz Tablets
- Enoxaparin Sodium
- Enoxaparin Sodium Injection
- Enrofloxacin
- Entacapone Tablets
- Enzymatically-Hydrolyzed Carboxymethylcellulose Sodium
- Epinephrine
- Epinephrine Bitartrate
- Erythorbic Acid
- Erythritol
- Erythromycin Ethylsuccinate Tablets
- Escitalopram Tablets
- Esomeprazole Magnesium
- Ethambutol Hydrochloride
- Ethambutol Hydrochloride Tablets
- Ethyl Maltol
- Ethynodiol Diacetate
- Famotidine Tablets
- Fenofibrate Capsules
- Fenofibrate Tablets
- Ferric Ammonium Citrate
- Ferric Oxide
- Ferrosoferric Oxide
- Ferrous Fumarate
- Ferrous Fumarate Tablets
- Ferrous Fumarate and Docusate Sodium Extended-Release Tablets
- Ferrous Gluconate
- Ferrous Gluconate Capsules
- Ferrous Gluconate Tablets
- Ferrous Sulfate
- Ferrous Sulfate Tablets
- Ferumoxides Injection
- Fludarabine Phosphate
- Fluvoxamine Maleate Tablets
- Fully Hydrogenated Rapeseed Oil
- Gadodiamide
- Gadopentetate Dimeglumine Injection
- Galactose
- Galantamine Hydrobromide
- Galantamine Tablets
- Gelatin
- Gemcitabine for Injection
- Gentian Violet
- Glyburide and Metformin Hydrochloride Tablets
- Glyceryl Distearate
- Glyceryl Tristearate
- Haloperidol Tablets
- Halothane
- Horse Chestnut
- Hydrochlorothiazide Tablets
- Hydrocortisone Tablets
- Hydrogenated Coconut Oil
- Hydrogenated Cottonseed Oil
- Hydrogenated Palm Oil
- Hydrogenated Polydecene
- Hydrogenated Polydextrose
- Hydrogenated Soybean Oil
- Hydroxocobalamin
- Hydroxypropyl Cellulose Ocular System
- Hymetellose
- Hypromellose Acetate Succinate
- Indium In 111 Chloride Solution
- Indomethacin Extended-Release Capsules
- Inositol
- Iron Dextran Injection
- Iron Sucrose Injection
- Isoetharine Hydrochloride
- Isoetharine Mesylate
- Isoflupredone Acetate
- Isomalt
- Isoproterenol Hydrochloride
- Ketoprofen Capsules
- Krill Oil
- Krill Oil Capsules
- Krill Oil Delayed-Release Capsules
- Lactase
- Lactose Monohydrate
- Lamivudine
- Lamotrigine Tablets
- Leflunomide Tablets
- Lemon Oil
- Leucovorin Calcium Tablets
- Levamisole Hydrochloride
- Levocarnitine
- Levofloxacin Tablets
- Light Mineral Oil
- Lincomycin Hydrochloride Capsules
- Lomustine Capsules
- Lutein
- Lutein Capsules
- Lutein Preparation
- Lycopene
- Lycopene Preparation
- Magnesium Aluminum Silicate
- Magnesium Carbonate
- Magnesium Carbonate and Sodium Bicarbonate for Oral Suspension
- Magnesium Chloride
- Magnesium Citrate
- Magnesium Gluconate Tablets
- Magnesium Oxide
- Magnesium Stearate
- Magnesium Sulfate
- Maltitol
- Maltitol Solution
- Mandelic Acid
- Manganese Chloride Injection
- Manganese Gluconate
- Mannitol
- Maritime Pine
- Maritime Pine Extract
- Mebendazole Tablets
- Meclofenamate Sodium
- Medium-Chain Triglycerides
- Mefloquine Hydrochloride Tablets
- Meglumine
- Mercaptopurine
- Meropenem for Injection
- Mesoridazine Besylate Injection
- Metaproterenol Sulfate
- Metformin Hydrochloride Tablets
- Methocarbamol Injection
- Methylene Blue Injection, Veterinary
- Methylpyrrolidone
- Minerals Capsules
- Minerals Tablets
- Mirtazapine Orally Disintegrating Tablets
- Mirtazapine Tablets
- Modafinil Tablets
- Monosodium Glutamate
- Multiple Electrolytes Injection Type 1
- Multiple Electrolytes Injection Type 2
- Mycophenolate Mofetil Capsules
- Mycophenolate Mofetil for Oral Suspension
- Myristic Acid
- Neotame
- Niacin
- Niacin Tablets
- Nifedipine Extended-Release Tablets
- Nitric Acid,Lead-Free–
- Noncrystallizing Sorbitol Solution
- Norepinephrine Bitartrate
- Ofloxacin Tablets
- Oil- and Water-Soluble Vitamins Capsules
- Oil- and Water-Soluble Vitamins Oral Solution
- Oil- and Water-Soluble Vitamins Tablets
- Oil- and Water-Soluble Vitamins with Minerals Capsules
- Oil- and Water-Soluble Vitamins with Minerals Oral Solution
- Oil- and Water-Soluble Vitamins with Minerals Tablets
- Oil-Soluble Vitamins Capsules
- Oil-Soluble Vitamins Oral Solution
- Oil-Soluble Vitamins Tablets
- Oil-Soluble Vitamins with Minerals Capsules
- Oil-Soluble Vitamins with Minerals Oral Solution
- Oil-Soluble Vitamins with Minerals Tablets
- Olanzapine Orally Disintegrating Tablets
- Olive Oil
- Omeprazole Magnesium
- Ondansetron Tablets
- Orange Oil
- Orcinol
- Oxaliplatin
- Oxazepam Tablets
- Oxidized Cellulose
- Oxidized Regenerated Cellulose
- Oxycodone Hydrochloride Extended-Release Tablets
- Oxycodone Hydrochloride Tablets
- Palm Kernel Oil
- Paraffin
- Paricalcitol Injection
- Pectate Lyase
- Pectin
- Pioglitazone Tablets
- Polacrilin Potassium
- Polydextrose
- Polyethylene Glycol
- Polyoxyl 15 Hydroxystearate
- Polysorbate 20
- Potassium Acetate
- Potassium Acetate Injection
- Potassium Bromide Oral Solution, Veterinary
- Potassium Chloride Oral Solution
- Potassium Citrate Tablets
- Potassium Gluconate
- Potassium Gluconate Tablets
- Potassium Gluconate and Potassium Chloride Oral Solution
- Potassium Gluconate and Potassium Chloride for Oral Solution
- Potassium Gluconate and Potassium Citrate Oral Solution
- Potassium Gluconate, Potassium Citrate, and Ammonium Chloride Oral Solution
- Potassium Nitrate
- Povidone
- Powdered Horse Chestnut Extract
- Powdered Stinging Nettle
- Powdered Stinging Nettle Extract
- Pramipexole Dihydrochloride
- Prazosin Hydrochloride
- Prochlorperazine Suppositories
- Promethazine Hydrochloride Tablets
- Propanediol
- Propranolol Hydrochloride Extended-Release Capsules
- Propyl Gallate
- Protamine Sulfate
- Pullulan
- Purified Bentonite
- Pyrene,
- Pyridoxine Hydrochloride Tablets
- Quinidine Sulfate Extended-Release Tablets
- Quinine Sulfate Capsules
- Quinine Sulfate Tablets
- Racemethionine
- Racepinephrine
- Ramipril
- Riboflavin
- Riboflavin 5' -Phosphate Sodium
- Ringer's Injection
- Ropivacaine Hydrochloride
- Saccharin
- Saccharin Calcium
- Saccharin Sodium
- Sargramostim
- Selenious Acid Injection
- Selenomethionine
- Senna Leaf
- Senna Pods
- Sennosides
- Sennosides Tablets
- Simethicone Emulsion
- Small Intestinal Submucosa Wound Matrix
- Sodium Bicarbonate
- Sodium Bromide Injection, Veterinary
- Sodium Bromide Oral Solution, Veterinary
- Sodium Chloride
- Sodium Chromate Cr 51 Injection
- Sodium Metabisulfite
- Sodium Sulfite
- Somatropin
- Sorbitol
- Sorbitol Solution
- Sorbitol Sorbitan Solution
- Stannous Fluoride Gel
- Stinging Nettle
- Strontium Chloride Sr 89 Injection
- Sulfamethizole Tablets
- Sulfasalazine
- Sulfasalazine Delayed-Release Tablets
- Sulfasalazine Tablets
- Sulfinpyrazone Capsules
- Sulfinpyrazone Tablets
- Sumatriptan Tablets
- Superglycerinated Fully Hydrogenated Rapeseed Oil
- Synthetic Paraffin
- Tadalafil Tablets
- Tagatose
- Talc
- Terazosin Capsules
- Terazosin Tablets
- Terbinafine Tablets
- Thiamine Hydrochloride
- Thimerosal
- Thioguanine Tablets
- Thioridazine Hydrochloride Tablets
- Tiamulin
- Tizanidine Tablets
- Tolcapone
- Tolcapone Tablets
- Tolmetin Sodium Capsules
- Tolmetin Sodium Tablets
- Torsemide Tablets
- Tramadol Hydrochloride and Acetaminophen Tablets
- Trehalose
- Trenbolone Acetate
- Tricitrates Oral Solution
- Trikates Oral Solution
- Tylosin Tartrate
- Tyloxapol
- Valacyclovir Tablets
- Valganciclovir Tablets
- Valsartan and Hydrochlorothiazide Tablets
- Vanillin
- Vinblastine Sulfate for Injection
- Vincristine Sulfate for Injection
- Vinpocetine Tablets
- Water-Soluble Vitamins with Minerals Capsules
- Water-Soluble Vitamins with Minerals Oral Solution
- Water-Soluble Vitamins with Minerals Tablets
- Xanthan Gum
- XyleneCyanole FF
- Zaleplon Capsules
- Zinc Carbonate
- Zinc Chloride Injection
- Zinc Citrate Tablets
- Zinc Gluconate
- Zinc Sulfate Injection
- Zinc and Vitamin C Lozenges