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GMP compliant Products CertiPro

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

Pharmaceutical Raw Materials

GMP compliant Products CertiPro

Pharmaceutical raw materials manufactured under GMP management. The lineup includes products listed in the Japanese Pharmacopoeia (JP), Japanese Pharmaceutical Codex (JPC), and Japanese Pharmaceutical Excipients (JPE).

Features

  • ・GMP compliant.
  • ・Products listed in the JP, JPC, and JPE
  • ・Conforming to the specifications in the USP-NF and Ph. Eur. (depending on the product)

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

CertiPro-L

CertiPro

Features

  • ・GMP compliant
  • ・Products listed in the JP, JPC, and JPE＊1
  • ・Conforming to the specifications in the USP and Ph. Eur. (depending on the product)＊2

＊1 Information such as ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities) can be obtained from “Statement”. Please contact us for more details.
＊2 Specification of products reflects latest versions of pharmacopeia.

CertiPro 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.
Acetylcysteine 616-91-1 JP ✓ ✓ Less than 10EU/g 10 kg 013-28757 Culture medium additive EN
Calcium Chloride Hydrate 10035-04-8 JP Less than 2.5EU/g 500 g 030-19555 Stabilizer EN
Calcium Gluconate Hydrate 299-28-5 JP Less than 1.5EU/g 500 g 037-26035 Calcium strengthener EN
10 kg 033-26037
Citric Acid Hydrate 5949-29-1 JP ✓ ✓ Less than 8EU/g 500 g 032-25245 Stabilizer・
Buffer		 EN
Dibasic Potassium Phosphate 7758-11-4 JPC ー 500 g 047-29015 Buffer EN
20 kg 043-29017
Dibasic Sodium Phosphate Hydrate 10039-32-4 JP ✓ ✓ Less than 0.2EU/g 500 g 047-34385 Buffer EN
10 kg 043-34387
Disodium Edetate Hydrate 6381-92-6 JP Less than 10EU/g 500 g 046-34615 Stabilizer EN
20 kg 042-34617
Dried Sodium Carbonate 497-19-8 JP Less than 10EU/g 500 g 049-34345 Buffer EN
10 kg 045-34347
Glucose 50-99-7 JP ー 500 g 076-05705 Stabilizer EN
10 kg 072-05707
Glycine 56-40-6 JP ✓ ✓ Less than 1.2EU/g 500 g 075-06875 Stabilizer EN
Hydrochloric Acid 7647-01-0 JP ✓ Less than 10EU/g 500 mL 082-10475 Stabilizer・
Buffer		 EN
Lactose Hydrate 64044-51-5 JP ＊3 Less than 25EU/g 500 g 121-06685 Excipients EN
Magnesium Sulfate Hydrate 10034-99-8 JP Less than 10EU/g 500 g 130-18925 Stabilizer EN
D-Mannitol 69-65-8 JP ＊3 Less than 2.5EU/g 500 g 133-14495 Stabilizer EN
Monobasic Potassium Phosphate 7778-77-0 JPC ー 500 g 136-14485 Buffer EN
25 kg 132-14487
Sodium L-Glutamate Hydrate 6106-04-3 JPC (NF) ―＊4 Less than 3.9EU/g 500 g 135-15555 Stabilizer・
Buffer		 EN
20 kg 131-15557
Potassium Chloride 7447-40-7 JP ー 500 g 163-22105 Buffer EN
Potassium Iodide 7681-11-0 JP ー 500 g 161-21925 Stabilizer・
Soluble agent		 EN
Purified Glucose 50-99-7 JP ＊3 Less than 2EU/g 500 g 168-28515 Stabilizer EN
10 kg 164-28517
Sodium Acetate Hydrate 6131-90-4 JP Less than 2.5EU/g 500 g 197-13235 Buffer EN
Sodium Bicarbonate 144-55-8 JP ✓ Less than 10EU/g 500 g 197-18475 Buffer EN
10 kg 193-18477
Sodium Chloride 7647-14-5 JP ✓ ✓ Less than 3.1EU/g 500 g 194-18505 Stabilizer・
Buffer		 EN
10 kg 190-18507
Sodium Citrate Hydrate 6132-04-3 JP ✓ ✓ Less than 5.2EU/g 500 g 197-18855 Stabilizer・
Buffer		 EN
10 kg 193-18857
Sodium Dihydrogen Phosphate Dihydrate 13472-35-0 JPE ✓ ✓ Less than 2.0EU/g 500 g 191-18495 Buffer EN
10kg 197-18497
Sodium Hydroxide 1310-73-2 JP (NF) ✓ Less than 10EU/g 500 g 190-18465 Buffer EN
10 kg 196-18467
Sodium Thiosulfate Hydrate 10102-17-7 JP   Less than 10EU/g 500 g 196-19165 Stabilizer・
Solubilizer		 EN
20 kg 192-19167
Sucrose 57-50-1 JP (NF) ✓ Less than 2EU/g 500 g 198-18385 Stabilizer EN
10 kg 194-18387
Sucrose [Low endotoxin type (Less than 0.2EU/g)] 57-50-1 JP (NF) ✓ Less than 0.2EU/g 500 g 197-19195 Stabilizer EN
10 kg 193-19197
Trometamol 77-86-1 JPC ✓ ✓ Less than 0.03IU/g 500 g 203-21035 Buffer EN
10 kg 209-21037
Urea 57-13-6 JP Less than 2.5EU/g 500 g 213-01295 Stabilizer EN

＊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.
＊4 This product is not listed in Ph.Eur.

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