Pharmaceutical Raw Materials

Since its establishment in 1922, the FUJIFILM Wako group has provided a broad range of high purity laboratory chemicals and reagents. We manufacture pharmaceutical raw materials by utilizing the 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 the quality risk assessments and strict regulations. 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 are chargeable).

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

The FUJIFILM Wako group carries a wide selection of pharmacopoeia-graded products. They are manufactured and packaged according to GMP guidelines.

CertiPro Series Products

Features

  • 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)

CoA (Sample)

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CertiPro Series Products

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]
  • USP and Ph. Eur. specifications for injection, dialysis, and transportation are optional services. Optional testing is available upon request (paid service).

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.

Product List

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CertiPro Series Products

JP / JPC / JPE

Product content may differ from the actual image due to minor specification changes etc.

877-714-1920

Hours of Operation: 8:00 - 17:00 (EST)For other hours than the above, please contact us via the inquiry form.