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Reference standards highlights



December 2012
Table of Contents
Click on sections. For all the latest information, visit
Reference Standards Highlights
Below are several Tables with the latest Reference Standard information including out-of-stock items now
available; new Reference Standards released in November 2012; backordered items with estimated
availability dates; items that have a new price and/or have a new package size; items with lots that are (or
soon will be) no longer valid; and items with new lots since the last email notice.
Please contact your USP Customer Service Representative to place an order at +1-301-881-0666 or 1-800-227-8772.
European customers can call 00-800-4875-5555. You can also order online at
USP is pleased to announce that we have posted a list ofthat we
expect to release within six months. The list is organized by calendar quarter, and can be downloaded as an MS
Excel (xls) spreadsheet. It will be updated four times a year.
The Reference Standards Release Notification Service can be used to notify you when a new never-before-
released Reference Standard becomes available. The Notification Service does not communicate the release of back-
ordered items or lot changeovers. To participate fill out the form online at



New Reference Standards Now Available
Catalog # Description
Acyclovir Related Compound G Ampicillin System Suitability Mixture Antimony Trioxide Artesunate Related Compound C Azelastine Related Compound E Flutamide Related Compound A Glycopyrrolate Related Compound L Moexipril Hydrochloride Moexipril Related Compound F Paliperidone Related Compound D Powdered Valerian Extract Previously Out-of-Stock Items Now Available
Catalog # Description
Chlorhexidine Acetate Trypsin Crystallized Backorder Availability Estimates, December 10, 2012
Catalog #
Description
Expected Availability* Atorvastatin Related Compound D (20 mg) Benztropine Mesylate (200 mg) Guanethidine Monosulfate (200 mg) Mafenide Acetate (400 mg) Menthyl Anthranilate (500 mg/ampule) (Meradimate) Orlistat Related Compound D (10 mg) Ritonavir (200 mg) Temozolomide (200 mg) *Dates are targets and may change at any time. Q4/12=October–December 2012; Q1/13 January–March 2013 Items with New Package Size or New Description
Catalog #
Description
Gabapentin Related Compound E Tubocurarine Chloride Valproic Acid Related Compound B* *This Item has changed from an Authentic Substance to a Reference Standard



RS Lots That are No Longer Valid
These Tables list previous RS lots that are (or will soon be) no longer valid for official use. If you still have any of these materials on hand, do not use them for compendial testing purposes after the last day of the month for the valid use dates listed. To test products, always be sure you use a current, valid lot of USP RS. Current lot numbers and valid use dates for previous lots are available in the USP Store onlinusing the Reference Standards: Alphabetical Listings to look up the item of interest. No Longer Valid as of November 30, 2012
Catalog Description

Previous Lot/
Current Price
Valid Use Date
Acetylcysteine (200 mg) Articaine Hydrochloride (125 mg) Ascorbic Acid (1 g) (Vitamin C) Carvedilol (200 mg) Cyclomethicone 4 (200 mg) Galantamine Hydrobromide (200 mg) Near IR System Suitability Pantoprazole Related Compound B (25 mg) Piroxicam (125 mg) Potassium Guaiacolsulfonate (500 mg) Residual Solvents Class 2 - Mixture A (1.2 mL/ampule; Sucralose (400 mg) Travoprost (3 mL) (COLD SHIPMENT REQUIRED) Valsartan (350 mg) Voriconazole Related Compound B (10 mg) Yohimbine Hydrochloride (200 mg)



No Longer Valid as of December 31, 2012
Catalog Description

Previous Lot/
Current Price
Valid Use Date
Amitriptyline Related Compound B (25 mg) Benzaldehyde (2 x 1 mL) (List Chemical)
Benzyl Alcohol (500 mg/ampule) Bupropion Hydrochloride Related Compound C (COLD SHIPMENT REQUIRED) Chlorobutanol (200 mg) Chondroitin Sulfate Sodium (300 mg) Clocortolone Pivalate (200 mg) Clopidogrel Bisulfate (125 mg) Desmopressin Acetate (1.93 mg) (COLD SHIPMENT Diethylene Glycol (0.5 mL) Donepezil Hydrochloride (200 mg) Drospirenone (200 mg) Gabapentin Related Compound B (30 mg) Iopamidol Related Compound B (50 mg) Leflunomide Related Compound A (100 mg) Lorazepam Related Compound E (25 mg) L-Lysine Acetate (200 mg) Mebendazole (200 mg) L-Methionine (200 mg) Norepinephrine Bitartrate (125 mg) Olanzapine Related Compound A (20 mg) Oleic Acid (1 g) Oxacillin Sodium (200 mg) Phosphated Riboflavin (100 mg) Polysorbate 60 (2 g) Procarbazine Hydrochloride (200 mg) Propofol (200 mg) Ranitidine Resolution Mixture (20 mg) Sevoflurane Related Compound B (0.2 mL) L-Valine (200 mg) No Longer Valid as of January 31, 2013
Catalog Description

Previous Lot/
Current Price
Valid Use Date
Albendazole (200 mg) Amantadine Hydrochloride (200 mg) Amprolium (200 mg) Azithromycin N-Oxide (15 mg) Bacitracin (1 g) (Susceptibility disk standard) Benazepril Related Compound B (15 mg) Cefmetazole (200 mg) Citalopram Related Compound F (200 mg) Dextrose (500 mg) Docosahexaenoic Acid Ethyl Ester (500 mg) Fluvastatin Sodium (350 mg) Guanfacine Hydrochloride (125 mg) Halcinonide (200 mg) Hydrocortisone Butyrate (200 mg) Irinotecan Related Compound C (10 mg) Lorazepam Related Compound B (25 mg) 3-Mercapto-2-methylpropanoic Acid 1,2- Diphenylethylamine Salt (75 mg) High Density Polyethylene (3 strips) Potassium Benzoate (1 g) Quinine Sulfate (500 mg) Rivastigmine Tartrate (200 mg) Sorbic Acid (1 g) Thiamine Hydrochloride (500 mg) (Vitamin B1 Triprolidine Hydrochloride (300 mg) Uracil Arabinoside (50 mg) Vancomycin B with Monodechlorovancomycin (300 mg) Vinorelbine Tartrate (200 mg)
Items with New Lots

Catalog Description
Previous Lot/
Current Price
Valid Use Date
1031503 Amoxicillin (200 mg) K0H332 (11/13) L0K359 1097104 Cefadroxil (200 mg) 1097614 Cefdinir (300 mg) F0G231 (11/13) G0K367 1098195 Ceftriaxone Sodium E-Isomer (25 mg) I1I212 (11/13) I2K393 1111103 Chlorhexidine Acetate (200 mg) 1134244 Citalopram Related Compound A (25 mg) F0G046 (10/13) G0L327 1287369 Gabapentin Related Compound E (25 mg) F1J405 (11/13) G0K277 1304038 Heparin Sodium Identification (50 mg) (COLD SHIPMENT 1344804 Iopromide (400 mg) 1354900 Kaempferol (15 mg) 1367005 Lincomycin Hydrochloride (200 mg) 1398009 Methadone Hydrochloride CII (200 mg)
1477900 Octinoxate (500 mg) (Octyl Methoxycinnamate) 1643361 Taurine (100 mg) 1677002 Triamcinolone Acetonide (500 mg) 1680506 Triazolam CIV (200 mg)
1683606 Triethyl Citrate (500 mg) 1702008 Tubocurarine Chloride (175 mg) 1708718 Valproic Acid Related Compound B (25 mg) USP Publication Highlights

Be Prepared for Compliance in 2013—Order USP 36–NF 31 Today!
The 2013 edition of USP–NF published on November 1. Order today for access
to important updates, including:
 New General Chapters: <17> Prescription Container Labeling, <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients, and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy  Revised General Chapters: <788> Particulate Matter in Injections, <921> Water Determination, and <1136> Packaging—Unit of Use  89 new and revised monographs Available in print, online, and USB flash drive formats. Subscribe today at or call USP Customer Service at 1-800-227-8772 (U.S. and Canada), +1-301-881-0666, or 00-800-4875-5555 (Select Europe).
New Food Chemicals Codex (FCC), Eighth Edition.
The FCC, Eighth Edition, features more than 1,100 monographs, appendices
with step-by-step methods, and helpful information for manufacturers, suppliers,
and users of food ingredients—including data from the new USP Food Fraud
Database. Subscription includes the main edition plus three supplements (the
first supplement published on Sept. 1, 2012 and became effective Dec. 1,
2012), which publish at six-month intervals during the subscription period.
Print and online formats. Order ator call
USP Customer Service at 1-800-227-8772 (U.S. and Canada), +1-301-881- 0666, or 00-800-4875-5555 (Select Europe).
New 2012 Dietary Supplements Compendium (DSC)—Two-Volume Set
Available Now!
The recently updated DSC has 64 new dietary supplement monographs, 23
Admission Criteria Safety Reviews, Guidance Documents, 330 pages of full-
color illustrations/images, and more. Order ator call USP Customer Service at 1-
800-227-8772 (U.S. and Canada), +1-301-881-0666, or 00-800-4875-5555
(Select Europe).
Event Highlights

USP User Forums Coming to a City Near You!
The USP Account Management Team will be traveling around the world holding free seminars to
discuss timely USP initiatives and how to use available USP resources to your advantage.

More information including locations and dates is available or contact

USP web forums and workshops encourage discussion of a wide range of current scientific findings and regulatory trends. Participants discuss hot topics that concern the public and exchange practical advice. Information on workshops is available Pharmacopeial Education
USP's Pharmacopeial Education division is dedicated to providing quality education for chemists, scientists, and healthcare practitioners in the United States and around the world. We seek to improve the effective implementation of standards that affect best practices for the development, manufacture, regulation, compounding, storage, and dispensing of pharmaceuticals, dietary supplements, food additives, and other therapeutics. To find a course, please visit Sign upto receive Pharmacopeial Education information.

Compendial Highlights

Revision Bulletins:
(posted 30–Nov–2012)
(posted 30–Nov–2012)
(posted 30–Nov–2012)
(posted
30–Nov–2012; official 01–Dec–2012)
(posted 30–Nov–2012; official 01–Dec–2012)
(posted 30–Nov–2012; official 01–Dec–2012)
(posted 30–Nov–2012; official 01–Dec–2012)
(posted 15–Nov–2012; updated 21–Nov–2012)
(posted 30–Nov–2012; official 01–Jan–2013)
(posted 30–Nov–2012; official 01–Jan–2013)

New
(posted 30–Nov–2012; official 01–Dec–2012)
(posted 30–Nov–2012)
(posted 30–Nov–2012)
(posted 30–Nov–2012)
(posted 15–Nov–2012; updated 21–Nov–2012)

Sign up to receive updates electronically

Featured in PF 38(6), November–December 2012  An Assessment of the Impact on Pharmaceutical Product Quality Resulting from Humidity Exposure during Distribution by Modeling Moisture Ingress  Methods for Measuring Uniformity in USP Tip of the Month

Beginning January 1, 2013, we will use a new lot numbering format for USP Reference Standards.
Each lot number assigned after January 1 will be a 6-character alphanumeric string which allows for
many more unique lot numbers for a given USP Reference Standard item. This will resolve some
logistical issues with the previous lot numbering format.
The new format will not be applied to existing USP Reference Standard lot numbers, only to newly
assigned lot numbers.

Question of the Month
I have a question about the monograph redesign process. Who do I contact? Please send any question or comments about redesign to

Source: http://www.meryer.com/uploads/UploadFile/20130308105227.pdf

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