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GMP Management Products

CertiPro

FUJIFILM Wako provides pharmaceutical raw materials that can be used in the manufacturing process of pharmaceutical products. CertiPro is a series of raw materials for pharmaceutical products, which is manufactured under GMP control.

Pharmaceutical Raw Materials

  • GMP Management Products

    Pharmaceutical raw materials manufactured under GMP management. The lineup includes products conforming to the Japanese Pharmacopoeia, Japanese Pharmaceutical Codex (JPC), and part of the Japanese Pharmaceutical Excipients (JPE).

    Features
    • GMP management
    • Products listed in the Japanese Pharmacopoeia and JPC, and some listed in the JPE
    • Conforming to the specifications in the USP and Ph. Eur. (different depending on the product)
  • Non-GMP Products

    The lineup includes products conforming to the Japanese Pharmacopoeia and Japanese Pharmaceutical Excipients (JPE). Non-compendial products (ingredients not listed in official compendia) are provided in accordance with our in-house specifications.

    Features
    • Lineup including products listed in the Japanese Pharmacopoeia and JPE, and non-compendial products
    • ISO 9001 management

Features

  • GMP management
  • With each product offering the document support as requested*1
  • Some products meet the USP (United States Pharmacopoeia) and Ph. Eur. (European Pharmacopoeia) in addition to the Japanese Pharmacopoeia, Japanese Pharmaceutical Codex, and Japanese Pharmaceutical Excipients*2

*1: To request information on ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities), etc., please contact individually. Information is provided partially for a fee depending on items.
*2: Products are controlled according to the latest versions.

CertiPro Product Lineup

Product Name CAS RN® Grade Conformity Endotoxin Package Size Principal Use
USP/NF Ph.Eur.
Calcium Chloride Hydrate 10035-04-8 JP - 500g Stabilizer
Calcium Gluconate Hydrate 299-28-5 JP Less than 1.5EU/g 500g Calcium strengthener
Citric Acid Hydrate 5949-29-1 JP Less than 8EU/g 500g Stabilizer・Buffer
10kg
Dibasic Potassium Phosphate 7758-11-4 JPC - 500g Buffer
20kg
Dibasic Sodium Phosphate Hydrate  10039-32-4 JP Less than 0.2EU/g 500g Buffer
10kg
Disodium Edetate Hydrate 6381-92-6 JP Less than 10EU/g 500g Stabilizer
20kg
Dried Sodium Carbonate 497-19-8 JP Less than 10EU/g 500g Buffer
10kg
Glucose 50-99-7 JP Less than 10EU/g 500g Stabilizer
10kg
Glycine 56-40-6 JP Less than 10EU/g 500g Stabilizer
Hydrochloric Acid 7647-01-0 JP Less than 10EU/mg 500mL Stabilizer・Buffer
Lactose Hydrate 64044-51-5 JP Less than 25EU/g 500g Excipients
Magnesium Sulfate Hydrate 10034-99-8 JP Less than 10EU/g 500g Stabilizer
D-Mannitol 69-65-8 JP - 500g Stabilizer
Monobasic Potassium Phosphate 7778-77-0 JPC - 500g Buffer
25kg
Potassium Chloride 7447-40-7 JP - 500g Buffer
Potassium Iodide 7681-11-0 JP - 500g Stabilizer・Soluble agent
Purified Glucose 50-99-7 JP Less than 2EU/g 500g Stabilizer
10kg
Sodium Acetate Hydrate 6131-90-4 JP - 500g Buffer
Sodium Bicarbonate 144-55-8 Less than 10EU/mg 500g Buffer
10kg
Sodium Chloride 7647-14-5 JP Less than 3.1EU/g 500g Stabilizer・Buffer
10kg
Sodium Citrate Hydrate 6132-04-3 JP Less than 5.2EU/g 500g Stabilizer・Buffer
10kg
Sodium Dihydrogen Phosphate Dihydrate 13472-35-0 JPE Less than 2EU/g 500g Buffer
10kg
Sodium L-Glutamate Hydrate 6106-04-3 JPC (NF) Less than 3.9EU/g 500g Stabilizer・Buffer
20kg
Sodium Hydroxide 1310-73-2 JP (NF) Less than 10EU/g 500g Buffer
10kg
Sucrose 57-50-1 JP (NF) Less than 2EU/g 500g Stabilizer
10kg
Trometamol 77-86-1 JPC Less than 0.03IU/g 500g Buffer
10kg
Urea 57-13-6 JP - 500g Stabilizer
10kg

Certificate of analysis

Certificate of analysis(CoA) of each product can be viewed in "Search CoAs".
Click here to see how to obtain CoAs.

Example of CoA

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Product List

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For research use or further manufacturing use only. Not for use in diagnostic procedures.

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

If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.

877-714-1920

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