Japanese Pharmacopoeial Forum
Vol. 32 No. 1March 2023

Contents

Revision Drafts
Revision Drafts for Second Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
2.46 Residual Solvents ································ 352
9.41 Reagents, Test Solutions ····················· 360
２. Official Monographs(1) Addition
Aripiprazole ············································ 360
Febuxostat ·············································· 362
Febuxostat Tablets ···································· 364
Gefitinib Tablets ········································ 366
Goserelin Acetate ······································ 367
Lornoxicam ············································· 369
Lornoxicam Tablets ···································· 372
Oxaliplatin ············································· 374
Oxaliplatin Injection ································· 377
Tolvaptan ··············································· 379
Tolvaptan Tablets ····································· 381(2) Revision
Low Substituted Hydroxypropylcellulose··········· 382
Hypromellose ··········································· 383
Methylcellulose ········································· 384
３. Official Monographs－Crude Drugs(1) Addition
Shin’iseihaito Extract ································ 384(2) Revision
Gentian ·················································· 387
Powdered Gentian ···································· 387
Ophiopogon Root ····································· 387
Uncaria Hook ·········································· 388
Yokukansankachimpihange Extract ·············· 388
４. Infrared Reference Spectra
Febuxostat ··············································· 389
Lornoxicam ············································· 390
Oxaliplatin··············································· 390
Tolvaptan ················································ 390

５. Ultraviolet-visible Reference Spectra
Febuxostat ··············································· 391
Lornoxicam ·············································· 391
Oxaliplatin ··············································· 391
Tolvaptan ················································ 392
６. General Informatoin(1) Addition
Analyses of Size and Morphology ofNanoparticles by Atomic Force Microscope <G19-182> ··················································· 392
Evaluation Method of Insoluble Particulate Matter in
Biotechnological Products (Biopharmaceuticals)Drug Substances/Drug Products by Flow Imaging
Method 〈G3-17-182〉 ······························· 395
Flow Cytometry〈G3-16-182〉 ···················· 398
Revision and new general information drafts concerningbalances
１. General Tests, Processes and Apparatus(1) Revision
9.62 Measuring Instruments, Appliances ······· 401
２. General Informatoin(1) Addition
Calibration, Inspection, and Weight of aweighing instrument (balance) <G1-7-182> ···· 402
Concept of Weighing in the JapanesePharmacopoeia <G1-6-182> ························ 403
Installation Environment, Basic Handling
Method, and Precautions for Weighing of aBalance <G1-8-182> ································· 405
Revision of the description of crude drugs (addition of
the sentence, “calculated on the basis of the content
obtained by qNMR”, to taken amount (MS) in theAssay) for listed articles (official monographs) ········· 407

Useful Information
Briefing on General Test and General Information
related to Balances ······································· 408

Pharmacopoeial Harmonization
１. Stage 2 (Official Inquiry Stage Draft)(1) Monographs
1)Revision①Corn Starch··········································· 197
２. Harmonized Document)(1) Tests
1)Revision①Bulk density of powders (Revision 4) ········· 200②Peptide Mapping(Revision 1) ··················· 207③Powder flow(Revision 1) ·························· 225(2) Monographs1)Correction① Carboxymethylcellulose Calcium (Correction1) ···························································· 233② Hydroxypropylcellulose, Low Substituted(Correction 3) ··········································· 238③Hypromellose (Correction 1) ···················· 243④Methylcellulose (Correction 1) ·················· 250⑤Lactose, Anhydrous (Correction 2) ············ 257⑥Lactose, Monohydrate (Correction 2) ········· 263
2)Correction of sign-off coversheet①Calcium Disodium Edetate ······················ 267②Dibasic Calcium Phosphate ····················· 269③Anhydrous Dibasic Calcium Phosphate ····· 271④Croscarmellose Sodium ··························· 273⑤Cellulose, Microcrystalline······················· 275⑥Cellulose, Powdered ······························· 277⑦Cellulose Acetate Phthalate ····················· 279⑧Citric Acid Anhydrous····························· 281⑨Citric Acid Monohydrate·························· 283⑩Crospovidone ········································· 285⑪Ethylcellulose ········································ 287⑫Hydroxyethylcellulose ····························· 289⑬Hydroxypropylcellulose ··························· 291⑭Hypromellose Phthalate ·························· 293⑮Magnesium Stearate ······························· 295⑯Methyl Parahydroxybenzoate ··················· 297⑰Petrolatum ············································ 299⑱White Petrolatum ··································· 301⑲Polysorbate 80 ······································· 303⑳Povidone ··············································· 305㉑Sodium Chloride ···································· 308㉒Sodium Starch Glycolate ························· 310㉓Stearic Acid ··········································· 312㉔Ethyl Parahydroxybenzoate ····················· 314㉕Propyl Parahydroxybenzoate ···················· 316㉖Butyl Parahydroxybenzoate ····················· 318㉗Carmellose ············································ 320㉘Copovidone ············································ 322㉙Gelatin ················································· 324㉚Glucose Anhydrous/Monohydrate·············· 326㉛Mannitol ··············································· 328㉜Isomalt ················································· 330

Reference Standards
PMRJ
ReferenceStandards
Ordering
Information for Foreign Users ····················· 410

Publishing Schedule (Vol.32, No.2): June 2023