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ISO 9001 compliant Products

CertiPro-L

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.

Features

  • ・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).

CertiPro-L

Features

  • ・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 Conformity Endotoxin Package Size Product Code Principal Use Statement
USP-NF Ph.Eur.
2-Amino-2-hydroxymethyl-1,3-propanediol Hydrochloride 1185-53-1 Max.10EU/g 500 g 012-28445 Buffer
10 kg 018-28447
Disodium Hydrogen Phosphate Anhydrous 7558-79-4 JPE Less than 2.5EU/g 500 g 048-29665 Buffer EN
10 kg 044-29667
Fumaric Acid 110-17-8 JPE *2 500 g 068-05105 Buffer EN
20 kg 064-05107
Glucono-δ-Lactone 90-80-2 JPE *2 500 g 075-05155 Buffer EN
Magnesium Stearate 557-04-0 JP *3 500 g 136-15105 Lubricant EN
Methyl Parahydroxybenzoate 99-76-3 JP *3 5 kg 857-40412 Preservative
Polysorbate20 9005-64-5 JPE 25 g 168-22792 Stabilizer EN
Potassium Acetate 127-08-2 JPE 500 g 169-21965 Buffer EN
Propyl Parahydroxybenzoate 94-13-3 JP *3 5 kg 857-40532 Preservative
Sodium Bisulfite 7631-90-5 JP *2 500 g 198-13265 Stabilizer・Buffer EN
20 kg 194-13267
Sodium Dextran Sulfate 5000 9011-18-1 Less than 50EU/g 25 g 196-19182 special use
500 g 190-19185
Sodium Dihydrogen Phosphate Anhydrous 7558-80-7 JPE *2 Less than 2.0EU/g 500 g 194-14105 Buffer EN
10 kg 190-14107
Sodium L-Tartrate 6106-24-7 JPE *2 500 g 197-13975 Buffer EN
Sodium Pyrosulfite 7681-57-4 JP 500 g 193-14055 Preservative EN
10 kg 199-14057
Titanium Oxide 13463-67-7 JP 500 g 204-16055 Excipients EN
10 kg 903-40303 EN

*2 These products are not listed in USP-NF and Ph.Eur.
*3 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.