supplement ii to the japanese pharmacopoeia fifteenth edition - NIHS

GENERAL TESTS, PROCESSAND APPARATUSChange the introduction to read:General Tests, Processes and Apparatus includes commonmethods for tests, useful test methods for quality recognition ofdrugs and other articles related to them. Unless otherwise specified,acid-neutralizing capacity determination of gastrointestinalmedicines, alcohol number determination, amino acid analysisof proteins, ammonium determination, arsenic determination,atomic absorption spectrophotometry, boiling point determination,chloride determination, conductivity measurement, congealingpoint determination, determination of bulk and tappeddensities, digestion test, disintegration test, dissolution test, distillingrange determination, endpoint determination in titrimetry,flame coloration, fluorometry, foreign insoluble matter test forinjetcions, foreign insoluble matter test for ophthalmic solutions,gas chromatography, heavy metal determination, infrared spectrophotometry,insoluble particulate matter test for injections,insoluble particulate matter test for ophthalmic solutions, irondetermination, liquid chromatography, loss on drying determination,loss on ignition determination, microbial assay for antibiotics,melting point determination, methanol determination,mineral oil determination, nitrogen determination, nuclearmagnetic resonance spectroscopy, optical rotation determination,osmolarity determination, oxygen flask combustion method,particle size determination, particle size distribution test forpreparations, pH determination, powder particle density determination,qualitative test, refractive index determination, residualsolvents test, residue on ignition determination, specificgravity and density determination, specific surface area determination,sulfate determination, test for bacterial endotoxins,test for glass containers for injections, test for metal particles inophthalmic ointments, test for microbial limit, test for microbiallimit for crude drugs, test for plastic containers, test for pyrogen,test for readily carbonizable substances, test for rubber closurefor aqueous infusions, test for sterility, test for total organiccarbon, test of extractable volume for injection , thermal analysis,thin-layer chromatography, ultraviolet-visible spectrophotometry,uniformity of dosage units (test for content uniformity,mass variation test), viscosity determination, vitamin A assay,water determination, and X-ray powder diffraction are performedas directed in the corresponding articles under the GeneralTests, Processes and Apparatus. The tests for melting pointof fats, congealing point of fatty acids, specific gravity, acidvalue, saponification value, ester value, hydroxyl value,unsaponifiable matter and iodine value of fats and fatty oils areperformed as directed in the corresponding items under Fats andFatty Oils Test, and sampling, preparation of sample for analysis,microscopic examination, purity test, loss on drying, total ash,acid-insoluble ash, extract content, and essential oil content ofcrude drugs are performed as directed in the correspondingitems under Crude Drugs Test.The number of each test method is a category number givenindividually. The number in blackets (< >) appeared inmonograph indicates the number corresponding to the generaltest method.1.07 Heavy Metals Limit TestChange (3) Method 3 under the Preparation oftest solutions and control solutions to read:(3) Method 3Place an amount of the sample, directed in the monograph, ina quartz or porcelain crucible, heat cautiously, gently at first,and then incinerate by ignition between 500ºC and 600ºC. Aftercooling, add 1 mL of aqua regia, evaporate to dryness on a waterbath, moisten the residue with 3 drops of hydrochloric acid, add10 mL of hot water, and warm for 2 minutes. Add 1 drop ofphenolphthalein TS, add ammonia TS dropwise until thesolution develops a pale red color, add 2 mL of dilute acetic acid,filter if necessary, wash with 10 mL of water, transfer the filtrateand washings to a Nessler tube, and add water to make 50 mL.Designate it as the test solution.The control solution is prepared as follows: Evaporate 1 mLof aqua regia to dryness on a water bath. Hereinafter, proceed asdirected for the test solution, and add the volume of StandardLead Solution directed in the monograph and water to make 50mL.1.08 Nitrogen Determination(Semimicro-Kjeldahl Method)Change the following to read:Nitrogen Determination is a method to determine nitrogen inan organic substance in which the nitrogen is converted intoammonia nitrogen by thermal decomposition of the organicsubstance with sulfuric acid, and the ammonia liberated byalkali and trapped by distillation with steam is determined bytitration.1. ApparatusUse the apparatus illustrated in Fig. 1.08-1. It is thoroughlyconstructed of hard glass, and ground glass surfaces may beused for joints. All rubber parts used in the apparatus should beboiled for 10 to 30 minutes in sodium hydroxide TS and for 30to 60 minutes in water, and finally washed thoroughly withwater before use.2043