1 Front Matter: USP 29: 2 Front Matter: NF 24: 3 Reference Tables: Description and Solubility - A: 4 Reference Tables: Description and Solubility - B: 5 Reference Tables: Description and Solubility - C: 6 Reference Tables: Description and Solubility - D: 7 Reference Tables: Description and Solubility - E: 8 Reference Tables: Description and ...

Guidelines for Packaging and Storage Statements in USP–NF Monographs— In order to provide users of the USP–NF with proper guidance on how to package and store compendial articles, every monograph in the USP–NF is required to have a packaging and storage specification.

As a consequence, therefore, it is necessary to consult only USP 29–NF 24 and the latest Supplement for the complete list of USP Reference Standards currently specified in USP–NF monographs and general chapters. The list provides up-to-date and complete names, applicable chemical information, and handling instructions for the USP Reference ...

In the absence of a bacterial endotoxins limit in the official monograph or other CSP formula source, the CSP must not exceed the amount of USP Endotoxin Units (EU per hour per kg of body weight or m 2 of body surface area) specified in the above chapter for the appropriate route of administration.

Revisions Appearing in USP 29 That Were Not Included in USP 28 Including Supplements

In the case of compendial methods, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical method; or the use of an established general method with a new product or raw material (see below under …

29 General Chapters: USP Reference Standards - A: 30 General Chapters: USP Reference Standards - B: 31 General Chapters: USP Reference Standards - C: 32 General Chapters: USP Reference Standards - D: 33 General Chapters: USP Reference Standards - E: 34 General Chapters: USP Reference Standards - F: 35 General Chapters: USP Reference Standards - G

Mix the L-cystine, sodium chloride, dextrose, yeast extract, and pancreatic digest of casein with the purified water, and heat until solution is effected.Dissolve the sodium thioglycollate or thioglycolic acid in the solution and, if necessary, add 1 N sodium hydroxide so that, after sterilization, the solution will have a pH of 7.1 ± 0.2.

This chapter includes discussions on (1) the classification of a clean room based on particulate count limits; (2) microbiological evaluation programs for controlled environments; (3) training of personnel; (4) critical factors in design and implementation of a microbiological evaluation program; (5) development of a sampling plan; (6) establishment of microbiological Alert and …

Heat with frequent agitation, and boil for 1 minute. Sterilize, cool to between 45 and 50, and add 10 mL of sterile potassium tellurite solution (1 in 100) and 50 mL of egg-yolk emulsion.Mix intimately but gently, and pour into plates. (Prepare the egg-yolk emulsion by disinfecting the surface of whole shell eggs, aseptically cracking the eggs, and separating out intact yolks into …