• ISO 9001 compliant Products CertiPro-L

ISO 9001 compliant Products


FUJIFILM Wako Pure Chemical provides pharmaceutical raw materials that can be used in the manufacturing process of pharmaceutical products. CertiPro-L is a series of pharmaceutical raw materials which is manufactured under ISO9001.

Pharmaceutical Raw Materials

ISO 9001 compliant Products CertiPro-L

Pharmaceutical raw materials manufactured under ISO 9001.
The lineup includes products conforming to the Japanese Pharmacopoeia (JP) and Japanese Pharmaceutical Excipients (JPE). Non-compendial products not listed in official compendia are provided in accordance with our own specifications.


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

These products are classified into two categories depending on management standards: CertiPro (GMP management products) and CertiPro-L (ISO9001 management products).



  • ・Lineup including products listed in the JP and JPE
  • ・Non-compendial products not listed in official compendia) are provided in accordance with our own specifications.
  • ・ISO 9001 compliant
  • ・With each product offering the document support as requested※1

※1 Please contact us for information such as ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities).

CertiPro-L Product Lineup

Please contact us for individual requests regarding capacity.

Product Name CAS RN® Grade Package Size Product Code Principal Use
2-Amino-2-hydroxymethyl-1,3-propanediol Hydrochloride 1185-53-1 500 g 012-28445 Buffer
10 kg 018-28447
Sodium Bisulfite 7631-90-5 JP 500 g 198-13265 Stabilizer・
20 kg 194-13267
Glucono-δ-Lactone 90-80-2 JPE 500 g 075-05155 Buffer
Potassium Acetate 127-08-2 JPE 500 g 169-21965 Buffer
Titanium Oxide 13463-67-7 JP 500 g 204-16055 Excipients
10 kg 903-40303
Sodium L-Tartrate 6106-24-7 JPE 500 g 197-13975 Buffer
Magnesium Stearate 557-04-0 JP 500 g 136-15105 Lubricant
Propyl Parahydroxybenzoate 94-13-3 JP 5 kg 857-40532 Preservative
Methyl Parahydroxybenzoate 99-76-3 JP 5 kg 857-40412 Preservative
Sodium Pyrosulfite 7681-57-4 JP 500 g 193-14055 Preservative
10 kg 199-14057
Fumaric Acid 110-17-8 JPE 500 g 068-05105 Buffer
20 kg 064-05107
Polysorbate20 9005-64-5 JPE 25 g 168-22792 Stabilizer
Disodium Hydrogen Phosphate Anhydrous 7558-79-4 JPE 500 g 048-29665 Buffer
10 kg 044-29667
Sodium Dihydrogen Phosphate Anhydrous 7558-80-7 JPE 500 g 194-14105 Buffer
10 kg 190-14107

These products are tested according to JP method. Some of the test items are harmonized to USP-NF, Ph. Eur.. For details, please check the product specifications.