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Second Supplement to USP 35–NF 30 Biological Tests / 〈85〉 Bacterial Endotoxins Test 5625 General Chapters General Tests and Assays Biological Tests and REAGENTS AND TEST SOLUTIONS Assays Amoebocyte Lysate—A lyophilized product obtained …
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USP 35 General Information / 〈1227〉 Validation of Microbial Recovery 883 〈1227〉 VALIDATION OF culture preparation. The conditions of organism preparation and storage must be standardized for the neutralizer evalua-MICROBIAL RECOVERY FROM tion and should reflect the conditions of the antimicrobial
2.2.45. Supercritical fluid chromatography EUROPEAN PHARMACOPOEIA 7.0 Control solutions.In addition to the TOC water control, prepare suitable blank solutions or other solutions needed for establishing the baseline or for calibration adjustments
766 〈1151〉 Pharmaceutical Dosage Forms / General Information USP 35 Figure 1. Compendial Taxonomy for Pharmaceutical Dosage Forms. volumes recommended in the accompanying table are usu- Identification—Identification tests are discussed in the
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2.2.25. Absorption spectrophotometry, ultraviolet and visible EUROPEAN PHARMACOPOEIA 7.0 acquired using suitable purged instruments or ensuring that sample and background single beam spectra are acquired under
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Stage 6 Harmonization Official December 1, 2012 〈85〉 Bacterial Endotoxins Test1 〈85〉 BACTERIAL ENDOTOXINS Change to read: TEST PREPARATION OF SOLUTIONS Standard Endotoxin Stock Solution—A Standard Endo- toxin Stock Solution is prepared from a USP Endotoxin Refer- Change to read: ence Standard that has been calibrated to the current WHO International Standard …
Revision Bulletin 〈797〉 Pharmaceutical Compounding—Sterile Preparations1 Change to read: quality standards for CSPs of drugs and nutrients based on current scientific information and best sterile compounding practices. The use of technol-ogies, techniques, materials, and procedures other
The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia.
26 Fig. 1.01-1 1.01 Alcohol Number Determination / General Tests JP XVI When the samples contain the following substances, carry out pretreatment as follows before distillation.