API reference standards and impurity standards (CRS)
19 listings from 11 suppliers · 5 Japanese makers
Japanese name: 原薬参照標準品・不純物標準（CRS）
Reference standards and impurity standards are highly characterized materials that serve as the benchmark for assay and purity tests. They cover drug substances, impurities, degradation products and residual solvents, and they calibrate test methods and support decisions on compliance with specifications. Buyers compare primary pharmacopoeial standards (USP, Ph. Eur., Japanese Pharmacopoeia) with secondary standards and certified reference materials traceable to them, certificates of analysis, and specialist sources for nitrosamines and elemental impurities. The page covers the products we track, who makes them, and who sells them in Japan.
| Product | Maker | Where to buy in Japan |
|---|---|---|
| USP Reference Standards | USP | Not yet confirmed |
| Pharmaceutical Analytical Impurities (PAI) | USP | Not yet confirmed |
| Residual Solvents Mixture (Class 1 / Class 2) | USP | Not yet confirmed |
| Ph. Eur. Chemical Reference Substances (CRS) | EDQM | Not yet confirmed |
| Elemental Impurity CRS (elemental impurity standards) | EDQM | Not yet confirmed |
| Japanese Pharmacopoeia reference standards and others | PMRJJP maker | From the maker |
| Product | Maker | Where to buy in Japan |
|---|---|---|
| Pharmaceutical Secondary Standards (CRM) | Merck | Merck Ltd., Japan (Japanese subsidiary, Life Science) |
| EP Impurity / Related Compound CRM (e.g. Metoprolol EP Impurity E) | Merck | Merck Ltd., Japan (Japanese subsidiary, Life Science) |
| Mikromol Impurity Reference Standards | LGC | Not yet confirmed |
| TRC Impurities & Metabolites Standards | LGC | Not yet confirmed |
| Cerilliant Certified Reference Materials (solution CRM) | Merck | Merck Ltd., Japan (Japanese subsidiary, Life Science) |
| Product | Maker | Where to buy in Japan |
|---|---|---|
| Nitrosamine Reference Materials | LGC Standards | Not yet confirmed |
| Daicel impurity reference standards (DCTI) | DaicelJP maker | From the maker |
| Reference standards for impurity analysis | FUJIFILM WakoJP maker | From the maker |
| Product | Maker | Where to buy in Japan |
|---|---|---|
| TraceCERT ICP/AAS Single-Element Standards | Merck | Merck Ltd., Japan (Japanese subsidiary, Life Science) |
| Elemental Impurities ICH Q3D Standard (mixed CRM) | Merck | Merck Ltd., Japan (Japanese subsidiary, Life Science) |
| Standard solutions for ICP and mixed metal standard solutions (Cica) | Kanto ChemicalJP maker | From the maker |
| HYDRANAL CRM Water Standard (1.0 / 10.0) | Honeywell | Not yet confirmed |
| NMIJ CRM (organic reference materials, for quantitative NMR and others) | NMIJ, AISTJP maker | From the maker |
“Where to buy in Japan” shows only sales relationships we have confirmed on the company’s or the distributor’s own website. “Not yet confirmed” means we have not checked yet, not that the product is unavailable in Japan. Product names link to the maker’s own page.