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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

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

  • Product Specifications Sheet, SDS, and Certificate of Analysis can be obtained from the links for each product name.
  • If there is a ✉ mark in the Statement column, it is currently being prepared, so please request it using the inquiry form at the link.
  • For information about our Statement for pharmaceutical raw materials, click here.
  • If you have any requests for dilution or changes in capacity, please contact us using the inquiry form.
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.10 EU/g 500 g 012-28445 Buffer EN
10 kg 018-28447
L-Ascorbic Acid Phosphate Magnesium Salt n-Hydrate 1713265-25-8 ― Less than
10 EU/g		 500 g 018-28545 Culture medium additive EN
Bis-Tris 6976-37-0 ― Less than
10 EU/g		 500 g 027-19905 Buffer
Butyl Parahydroxybenzoate(Oxyben™ B) 94-26-8 JP (NF) ✓ Less than
10 EU/g		 500 g 021-19925 Preservative EN
10 kg 027-19927
Disodium Hydrogen Phosphate Anhydrous 7558-79-4 JPE Less than
2.5 EU/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 Less than
2.0 EU/g		 500 g 075-05155 Buffer EN
HEPES 7365-45-9 ― Less than
10 EU/g		 500 g 086-10755 Buffer
Magnesium Stearate 557-04-0 JP *3 500 g 136-15105 Lubricant EN
MES 145224-94-8 ― Less than
10 EU/g		 500 g 138-19565 Buffer
Methyl Parahydroxybenzoate(Oxyben® M) 99-76-3 JP (NF) ✓ 5 kg 132-19421 Preservative EN
MOPS 1132-61-2 ― Less than
10 EU/g		 500 g 139-19615 Buffer
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(Oxyben® P) 94-13-3 JP (NF) ✓ 5 kg 169-29221 Preservative EN
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
50 EU/g		 25 g 196-19182 Culture medium additive EN
500 g 190-19185
Sodium Dihydrogen Phosphate Anhydrous 7558-80-7 JPE ―*2 Less than
2.0 EU/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 Excipient 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.

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