CONTRACTED MANUFACTUREPHARMACEUTICAL

Pharmaceutical Raw Materials

Since its establishment in 1922, we have provided a broad range of high purity laboratory chemicals and reagents. We manufacture pharmaceutical raw materials by utilizing reagent manufacturing technology, which we have acquired and improved over the last decades.

CertiPro Series Products

All CertiPro Series products are manufactured under the Good Manufacturing Practice (GMP) guidelines for Active Pharmaceutical Ingredients (API) to meet quality risk assessments and strict regulations of the industry. Furthermore, all CertiPro Series items are tested regarding bacterial endotoxins. Apart from that we provide supplementary information for residual solvents and elemental impurities (some services require additional charges).

Japanese Pharmacopoeia (JP) ・ Japanese Pharmaceutical Codex (JPC) ・ Japanese Pharmaceutical Excipients (JPE)

We carry a wide selection of pharmacopoeia-graded products. They are manufactured and packaged according to GMP guidelines.

CertiPro Series Products

  • All CertiPro Series products are endotoxin tested.
  • Additional tested for European Pharmacopoeia (Ph.Eur.) and United States Pharmacopeia (USP). The test content varies depending on the item.
  • Various reports like residual solvent or elemental impuries can be issued. (some services are chargeable)

イメージ

Product name Synonyms Molecular formula Specification Specification Bacterial endotoxins Microbial limit
[CAS RN®] USP Ph.Eur.
Citric Acid Hydrate Citric Acid Monohydrate C6H8O7・H2O Japanese Pharmacopoeia ● ● less than 8EU/g 　
[5949-29-1]
Purified Glucose 　 C6H12O6 Japanese Pharmacopoeia
(JP is harmonaized with the Ph.Eur and the USP)		 　 　 less than 2EU/g 　
[50-99-7]
Lactose Hydrate Lactose Monohydrate C12H22O11･H2O Japanese Pharmacopoeia 　 　 less than 25EU/g ●
[64044-51-5]
Magnesium Sulfate Hydrate 　 MgSO4・7H2O Japanese Pharmacopoeia 　 　 less than 10EU/g 　
[10034-99-8]
Sodium Bicarbonate 　 NaHCO3 Japanese Pharmacopoeia 　 ● less than 10EU/g 　
[144-55-8]
Dried Sodium Carbonate Sodium Carbonate Na2CO3 Japanese Pharmacopoeia 　 　 less than 10EU/g 　
[497-19-8]
Sodium Chloride 　 NaCl Japanese Pharmacopoeia ● ● less than 3.1EU/g 　
[7647-14-5]
Sodium Dihydrogen Phosphate Dihydrate Sodium Phosphate Monobasic Dihydrate NaH2PO4・2H2O Japanese Pharmaceutical Excipients ● ● less than 2.0EU/g 　
[13472-35-0]
Sodium Hydroxide 　 NaOH Japanese Pharmacopoeia ● ● less than 10EU/g 　
[1310-73-2]
Dibasic Sodium Phosphate Hydrate Sodium Phosphate 12-Water Na2HPO4・12H2O Japanese Pharmacopoeia ● ● less than 0.2EU/g 　
[10039-32-4]
Sucrose Sucrose C12H22O11 Japanese Pharmacopoeia ● ● less than 10EU/g 　
[57-50-1]

Japanese Pharmacopoeia・Japanese Pharmaceutical Codex・Japanese　Pharmaceutical Excipients Products

Product name Synonyms Molecular formula Specification Specification Bacterial endotoxins Microbial limit
[CAS RN®] USP Ph.Eur.
Calcium Chloride Hydrate 　 CaCl2・2H2O
[10035-04-8]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Calcium Gluconate Hydrate 　 C12H22CaO14・H2O
[299-28-5]		 Japanese Pharmacopoeia 　 　 　 　
Dibasic Calcium Phosphate Hydrate 　 CaHPO4・2H2O
[7789-77-7]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Disodium Hydrogen Phosphate Anhydrous Disodium Hydrogen Phosphate Na2HPO4
[7558-79-4]		 Japanese Pharmaceutical Excipients 　 　 　 　
　 　 　 　
Fumaric Acid 　 C4H4O4
[110-17-8]		 Japanese Pharmaceutical Excipients 　 　 　 　
　 　 　 　
Glucono-δ-Lactone D-(+)-Glucono-1,5-lactone C6H10O6
[90-80-2]		 Japanese Pharmaceutical Excipients 　 　 　 　
Glucose D(+)-Glucose C6H12O6
[50-99-7]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Glycine 　 C2H5NO2
[56-40-6]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Hydrochloric Acid 　 HCl
[7647-01-0]		 Japanese Pharmacopoeia 　 ● less than 10EU/g 　
Magnesium Stearate 　 ―
[557-04-0]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
D-Mannitol D-Mannite C6H14O6
[69-65-8]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Methyl Parahydroxybenzoate
Oxyben® M		 Methyl p-hydroxybenzoate C8H8O3
[99-76-3]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Monobasic Potassium Phosphate Potassium Dihydrogen phosphate KH2PO4
[7778-77-0]		 Japanese Pharmaceutical Codex 　 　 　 　
　 　 　 　
Monosodium L-Glutamate Monohydrate 　 C5H8NNaO4・H2O
[6106-04-3]		 Japanese Pharmaceutical Codex 　 　 　 　
Polysorbate 20 Tween 20 ―
[9005-64-5]		 Japanese Pharmaceutical Excipients 　 　 　 　
　 　 　 　
Potassium Acetate 　 CH3COOK
[127-08-2]		 Japanese Pharmaceutical Excipients 　 　 　 　
Potassium Chloride 　 KCl
[7447-40-7]		 Japanese Pharmacopoeia 　 　 　 　
Potassium Iodide 　 KI
[7681-11-0]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Dibasic Potassium Phosphate Dipotassium hydrogen phosphate K2HPO4
[7758-11-4]		 Japanese Pharmaceutical Codex 　 　 　 　
　 　 　 　
Propyl Parahydroxybenzoate
Oxyben®P		 Propyl p-hydroxybenzoate C10H12O3
[94-13-3]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Sodium Acetate Hydrate Sodium Acetate Trihydrate C2H3NaO2・3H2O
[6131-90-4]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Sodium Bisulfite 　 NaHSO3
[7631-90-5]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Sodium Citrate Hydrate Trisodium citrate dihydrate C6H5Na3O7･2H2O
[6132-04-3]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Sodium Dihydrogen Phosphate Anhydrous Sodium Dihydrogen Phosphate NaH2PO4
[7558-80-7]		 Japanese Pharmaceutical Excipients 　 　 　 　
　 　 　 　
Sodium Pyrosulfite Sodium Disulfite Na2S2O5
[7681-57-4]		 Japanese Pharmacopoeia 　 　 　 　
Sodium L-Tartrate Sodium (+)-tartrate dihydrate C4H4Na2O6・2H2O
[6106-24-7]		 Japanese Pharmaceutical Excipients 　 　 　 　
　 　 　 　
Sodium Thiosulfate Hydrate Sodium thiosulfate pentahydrate Na2S2O3・5H2O
[10102-17-7]		 Japanese Pharmacopoeia 　 　 　 　
Titanium Oxide 　 TiO2
[1317-70-0]		 Japanese Pharmacopoeia 　 　 　 　
　 　 　 　
Trometamol 2-Amino-2-hydroxymethyl-1,3-propanediol
Trizma™ Base		 C4H11NO3
[77-86-1]		 Japanese Pharmaceutical Codex 　 　 　 　
　 　 　 　
Urea 　 CH4N2O
[57-13-6]		 Japanese Pharmacopoeia 　 　 　 　

Japanese Pharmacopoeia (JP)

JP was established and published to regulate the properties and quality of drugs by the Minister of Health, Labour and Welfare after hearing the opinion of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC).
The JP consists of general notices, rules for crude drugs, preparations, tests as well as processes, apparatus and official monographs. Selected entries in the JP are highly important to health care regarding the necessity of the drug in medical practice, wide application and experience of use.

Japanese Pharmaceutical Codex (JPC)

JPC is a standard created for important ingredients which are not listed in the JP. It is determined by notifications from the Pharmaceutical Safety Bureau of the Ministry of Health, Labor and Welfare.
In 1982, the “Japanese standards of pharmaceutical ingredients,1982” was published and whose name was changed to “Japanese Pharmaceutical Codex” in 1993.

Japanese Pharmaceutical Excipients (JPE)

JPE is a standard for pharmaceutical additives not listed in the JP. The latest version was published in 2018.