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New and Revised Content in USP 34–NF 29 Revisions to General Notices New & Revised General Chapters <1> Injections <11> Reference Standards <90> Fetal Bovine Serum Quality Attributes and Functionality Tests <521> Sulfonamides <561> Articles of Botanical Origin <621> Chromatography <795> Pharmaceutical Compounding— Nonsterile Preparations <1053> Biotechnology-derived Articles— Capillary Electrophoresis <1070> Emergency Medical Services Vehicle and Ambulances—Storage of Preparations <1163> Quality Assurance in Pharmaceutical Compounding <1230> Water for Health Applications <1788> Particulate Matter Determination in Parenteral and Ophthalmic Products <2030> Supplemental Information for Articles of Botanical Origin <2040> Disintegration and Dissolution of Dietary Supplements New & Revised Monographs Drugs & Dosage Forms amifostine amifostine for injection amoxicillin ampethamine sulfate azithromycin balsalazide disodium capsules buspirone hydrochloride cabergoline capreomycin for injection capreomycin sulfate cefepime for injection cefepime hydrochloride cetirizine hydrochloride and pseudoepehedrine hydrochloride extended-release tablets chlorhexidine acetate chlorhexidine acetate topical solution chlorhexidine gluconate solution chlorhexidine gluconate topical solution chlorhexidine hydrochloride clotrimazole clotrimazole cream dactinomycin for injection deferoxamine mesylate desflurane diltiazem hydrochloride tablets diluted nitroglycerin donepezil hydrochloride ethambutol hydrochloride flavoxate hydrochloride gadodiamide injection galantamine hydrobromide glyburide and metformin hydrochloride tablets halobetasol propionate hydromorphone hydrochloride oral solution iodixanol injection iohexol injection irbesartan and hydrochlorothiazide tablets lamotrigine tablets letrozole letrozole tablets levetiracetam tablets levocabastine hydrochloride levofloxacin levonorgestrel and ethinyl estradiol tablets lithium carbonate tablets methylphenidate hydrochloride methylphenidate hydrochloride extended-release tablets mycophenolate mofetil for injection mycophenolate mofetil for oral suspension oseltamivir phosphate oxaliplatin paramethasone acetate paramethasone acetate tablets pilocarpine hydrochloride pioglitazone hydrochloride pioglitazone tablets propafenone hydrochloride quinidine sulfate oral suspension rivastigmine tartrate rivastigmine tartrate capsules ropinirole hydrochloride ropivacaine hydrochloride sertraline tablets sevoflurane simethicone emulsion sodium fluoride gel sprionolactone sulfasalazine sulfasalazine tablets terbinafine hydrochloride terbinafine tablets venlafaxine hydrochloride venlafaxine tablets water for hemodialysis water for injection – Excipients acetyltributyl citrate aluminum oxide benzalkonium chloride benzalkonium chloride solution butylated hydroxyanisole L-glutamic acid, hydrochloride partially-neutralized methacrylic acid and ethyl acrylate copolymer polyethylene oxide polyoxyl stearyl ether triethyl citrate – Dietary Supplements alpha lipoic acid capsules alpha lipoic acid tablets American ginseng capsules American ginseng tablets arginine capsules Asian ginseng tablets black cohosh tablets cat’s claw capsules cat’s claw tablets fish oil containing omega-3 acids capsules ginger capsules oil-soluble vitamins capsules oil-soluble vitamins tablets pygeum capsules saw palmetto capsules soy isoflavones capsules soy isoflavones tablets valerian tablets September 2010

revised monographs in USP34NF29

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Page 1: revised monographs in USP34NF29

New and Revised Content in USP 34–NF 29

New & Revised Monographs – Drugs & Dosage Forms

amifostine

amifostine for injection

amoxicillin

ampethamine sulfate

azithromycin

balsalazide disodium capsules

buspirone hydrochloride

cabergoline

capreomycin for injection

capreomycin sulfate

cefepime for injection

cefepime hydrochloride

cetirizine hydrochloride and pseudoepehedrine hydrochloride extended-release tablets

chlorhexidine acetate

chlorhexidine acetate topical solution

chlorhexidine gluconate solution

chlorhexidine gluconate topical solution

chlorhexidine hydrochloride

clotrimazole

clotrimazole cream

dactinomycin for injection

deferoxamine mesylate

desflurane

diltiazem hydrochloride tablets

diluted nitroglycerin

donepezil hydrochloride

ethambutol hydrochloride

flavoxate hydrochloride

gadodiamide injection

galantamine hydrobromide

glyburide and metformin

hydrochloride tablets

halobetasol propionate

hydromorphone hydrochloride oral solution

iodixanol injection

iohexol injection

irbesartan and hydrochlorothiazide tablets

lamotrigine tablets

letrozole

letrozole tablets

levetiracetam tablets

levocabastine hydrochloride

levofloxacin

levonorgestrel and ethinyl estradiol tablets

lithium carbonate tablets

methylphenidate hydrochloride

methylphenidate hydrochloride extended-release tablets

mycophenolate mofetil for injection

mycophenolate mofetil for oral suspension

oseltamivir phosphate

oxaliplatin

paramethasone acetate

paramethasone acetate tablets

pilocarpine hydrochloride

pioglitazone hydrochloride

pioglitazone tablets

propafenone hydrochloride

quinidine sulfate oral suspension

rivastigmine tartrate

rivastigmine tartrate capsules

ropinirole hydrochloride

ropivacaine hydrochloride

sertraline tablets

sevoflurane

simethicone emulsion

sodium fluoride gel

sprionolactone

sulfasalazine

sulfasalazine tablets

terbinafine hydrochloride

terbinafine tablets

venlafaxine hydrochloride

venlafaxine tablets

water for hemodialysis

water for injection

– Excipients

acetyltributyl citrate

aluminum oxide

benzalkonium chloride

benzalkonium chloride solution

butylated hydroxyanisole

L-glutamic acid, hydrochloride partially-neutralized methacrylic acid and ethyl acrylate copolymer

polyethylene oxide

polyoxyl stearyl ether

triethyl citrate

– Dietary Supplements

alpha lipoic acid capsules

alpha lipoic acid tablets

American ginseng capsules

American ginseng tablets

arginine capsules

Asian ginseng tablets

black cohosh tablets

cat’s claw capsules

cat’s claw tablets

fish oil containing omega-3 acids capsules

ginger capsules

oil-soluble vitamins capsules

oil-soluble vitamins tablets

pygeum capsules

saw palmetto capsules

soy isoflavones capsules

soy isoflavones tablets

valerian tablets

Revisions to General Notices

New & Revised General Chapters <1> Injections

<11> Reference Standards

<90> Fetal Bovine Serum Quality Attributes and Functionality Tests

<521> Sulfonamides

<561> Articles of Botanical Origin

<621> Chromatography

<795> Pharmaceutical Compounding— Nonsterile Preparations

<1053> Biotechnology-derived Articles— Capillary Electrophoresis

<1070> Emergency Medical Services Vehicle and Ambulances—Storage of Preparations

<1163> Quality Assurance in Pharmaceutical Compounding

<1230> Water for Health Applications

<1788> Particulate Matter Determination in Parenteral and Ophthalmic Products

<2030> Supplemental Information for Articles of Botanical Origin

<2040> Disintegration and Dissolution of Dietary Supplements

New & Revised Monographs – Drugs & Dosage Forms

amifostine

amifostine for injection

amoxicillin

ampethamine sulfate

azithromycin

balsalazide disodium capsules

buspirone hydrochloride

cabergoline

capreomycin for injection

capreomycin sulfate

cefepime for injection

cefepime hydrochloride

cetirizine hydrochloride and pseudoepehedrine hydrochloride extended-release tablets

chlorhexidine acetate

chlorhexidine acetate topical solution

chlorhexidine gluconate solution

chlorhexidine gluconate topical solution

chlorhexidine hydrochloride

clotrimazole

clotrimazole cream

dactinomycin for injection

deferoxamine mesylate

desflurane

diltiazem hydrochloride tablets

diluted nitroglycerin

donepezil hydrochloride

ethambutol hydrochloride

flavoxate hydrochloride

gadodiamide injection

galantamine hydrobromide

glyburide and metformin

hydrochloride tablets

halobetasol propionate

hydromorphone hydrochloride oral solution

iodixanol injection

iohexol injection

irbesartan and hydrochlorothiazide tablets

lamotrigine tablets

letrozole

letrozole tablets

levetiracetam tablets

levocabastine hydrochloride

levofloxacin

levonorgestrel and ethinyl estradiol tablets

lithium carbonate tablets

methylphenidate hydrochloride

methylphenidate hydrochloride extended-release tablets

mycophenolate mofetil for injection

mycophenolate mofetil for oral suspension

oseltamivir phosphate

oxaliplatin

paramethasone acetate

paramethasone acetate tablets

pilocarpine hydrochloride

pioglitazone hydrochloride

pioglitazone tablets

propafenone hydrochloride

quinidine sulfate oral suspension

rivastigmine tartrate

rivastigmine tartrate capsules

ropinirole hydrochloride

ropivacaine hydrochloride

sertraline tablets

sevoflurane

simethicone emulsion

sodium fluoride gel

sprionolactone

sulfasalazine

sulfasalazine tablets

terbinafine hydrochloride

terbinafine tablets

venlafaxine hydrochloride

venlafaxine tablets

water for hemodialysis

water for injection

– Excipients

acetyltributyl citrate

aluminum oxide

benzalkonium chloride

benzalkonium chloride solution

butylated hydroxyanisole

L-glutamic acid, hydrochloride partially-neutralized methacrylic acid and ethyl acrylate copolymer

polyethylene oxide

polyoxyl stearyl ether

triethyl citrate

– Dietary Supplements

alpha lipoic acid capsules

alpha lipoic acid tablets

American ginseng capsules

American ginseng tablets

arginine capsules

Asian ginseng tablets

black cohosh tablets

cat’s claw capsules

cat’s claw tablets

fish oil containing omega-3 acids capsules

ginger capsules

oil-soluble vitamins capsules

oil-soluble vitamins tablets

pygeum capsules

saw palmetto capsules

soy isoflavones capsules

soy isoflavones tablets

valerian tablets

Revisions to General Notices

New & Revised General Chapters <1> Injections

<11> Reference Standards

<90> Fetal Bovine Serum Quality Attributes and Functionality Tests

<521> Sulfonamides

<561> Articles of Botanical Origin

<621> Chromatography

<795> Pharmaceutical Compounding— Nonsterile Preparations

<1053> Biotechnology-derived Articles— Capillary Electrophoresis

<1070> Emergency Medical Services Vehicle and Ambulances—Storage of Preparations

<1163> Quality Assurance in Pharmaceutical Compounding

<1230> Water for Health Applications

<1788> Particulate Matter Determination in Parenteral and Ophthalmic Products

<2030> Supplemental Information for Articles of Botanical Origin

<2040> Disintegration and Dissolution of Dietary Supplements

September 2010