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Rabeprazole Impurities

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1H-benzo[d]imidazole-2-thiol.

1H-benzo[d]imidazole-2-thiol.

  • CAT Number DCTI-C-001805
  • CAS Number  583-39-1
  • Molecular Formula C7H6N2S
  • Molecular Weight 150.2

2-Hydroxybenzimidazole

  • CAT Number DCTI-C-001420
  • CAS Number 615-16-7
  • Molecular Formula C7H6N2O
  • Molecular Weight 134.14
4-(1H-Benzimidazol-2-yloxy)-3-methylpicolinic acid

4-(1H-Benzimidazol-2-yloxy)-3-methylpicolinic acid

  • CAT Number DCTI-C-001872
  • CAS Number 1286104-27-5
  • Molecular Formula C14H11N3O3
  • Molecular Weight 269.26

Rabeprazole Des-Methyl-Thio ether (M4)

  • CAT Number DCTI-C-004719
  • CAS Number 117976-91-7
  • Molecular Formula C17H19N3O2S
  • Molecular Weight 329.42
Rabeprazole Impurity-2

Rabeprazole Impurity-2

  • CAT Number DCTI-C-001867
  • CAS Number NA
  • Molecular Formula C11H15NO4 (Free base) C11H16ClNO4 (HCl Salt)
  • Molecular Weight 225.24 (Free base) 261.70 (HCl Salt)

Rabeprazole Impurity-5

  • CAT Number DCTI-C-000247
  • CAS Number 1807988-36-8
  • Molecular Formula C18H19N3O4
  • Molecular Weight 341.37

Rabeprazole Methoxy Analog

  • CAT Number DCTI-C-003558
  • CAS NUMBER 102804-77-3
  • MOLECULAR FORMULA C15H15N3O2S
  • MOLECULAR WEIGHT 301.36

Rabeprazole methoxy sulfide analog Impurity

  • CAT Number DCTI-C-001185
  • CAS Number 102804-82-0
  • Molecular Formula C15H15N3OS
  • Molecular Weight 285.37

Rabeprazole N-Oxide (Rabeprazole Related Compound B)

  • CAT Number DCTI-C-001249
  • CAS Number 924663-38-7
  • Molecular Formula C18H21N3O4S
  • Molecular Weight 375.44
Rabeprazole Related Compound A

Rabeprazole Related Compound A

  • CAT Number DCTI-C-001626
  • CAS Number 1163685-30-0
  • Molecular Formula C14H11N3O3
  • Molecular Weight 269.26

Rabeprazole Related compound-F

  • CAT Number DCTI-C-001186
  • CAS Number 168167-42-8
  • Molecular Formula C14H12ClN3OS
  • Molecular Weight 305.78

Rabeprazole sulfide (Rabeprazole Related Compound E)

  • CAT Number DCTI-C-001419
  • CAS Number 117977-21-6
  • Molecular Formula C18H21N3O2S
  • Molecular Weight 343.45

Rabeprazole Sulfone

  • CAT Number DCTI-C-001250
  • CAS Number 117976-47-3
  • Molecular Formula C18H21N3O4S
  • Molecular Weight 375.44

Rabeprazole Sulfone N-Oxide

  • CAT Number DCTI-C-001251
  • CAS Number 924663-37-6
  • Molecular Formula C18H21N3O5S
  • Molecular Weight 391.44

General Information

Rabeprazole Impurities and Rabeprazole

Daicel Pharma offers Rabeprazole impurity standards which include Rabeprazole Sulfone, Rabeprazole Impurity-5, Rabeprazole Impurity-2, Rabeprazole Sulfone N-Oxide, Rabeprazole Related compound-F, Rabeprazole Related Compound A and more. Their presence can influence the effectiveness, stability, and safety of Rabeprazole. Daicel Pharma offers Rabeprazole impurities with international delivery convenience to meet our client’s needs.

Rabeprazole [CAS: 117976-89-3] belongs to the benzimidazole, sulfoxide, and pyridine groups. It is an anti-ulcer drug and treats stomach acid production. It is a proton pump inhibitor.

Rabeprazole: Use and Commercial Availability 

Rabeprazole is used to treat acid reflux disease (GERD), peptic ulcer disease, H. pylori eradication, and prevent gastrointestinal bleeding when combined with NSAIDs. This drug is marketed under the tradenames of Aciphex and Aciphex Sprinkle.

Rabeprazole Structure and Mechanism of ActionRabeprazole Structure and Mechanism of Action

The chemical name of Rabeprazole is 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole. Its chemical formula is C18H21N3O3S, and its molecular weight is approximately 359.4 g/mol.

Rabeprazole blocks gastric H+, K+ ATPase at the secretory surface of gastric cells.

Rabeprazole Impurities and Synthesis 

Rabeprazole manufacture and storage can result in the formation of impurities, which can affect its purity and efficacy. It is critical to verify the purity of the starting components and precisely manage the reaction conditions during the synthetic process1 to reduce impurity formation.

Daicel Pharma provides a Certificate of Analysis (CoA) for Rabeprazole impurity standards such as Rabeprazole Sulfone, Rabeprazole Impurity-5, Rabeprazole Impurity-2, Rabeprazole Sulfone N-Oxide, Rabeprazole Related compound-F, Rabeprazole Related Compound A, and more. The Certificate of Analysis (CoA) contains a detailed characterization report with information from techniques, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additionally, upon request, we can supply supplementary data such as 13C-DEPT. Further, upon request, Daicel Pharma can offer unknown Rabeprazole impurities.

References
FAQ's

References

  1. Souda, Shigeru; Ueda, Norihiro; Miyazawa, Shuhei; Tagami, Katsuya; Nomoto, Seiichiro; Okita, Makoto; Shimomura, Naoyuki; Kaneko, Toshihiko; Fujimoto, Masatoshi, Pyridine derivatives, pharmaceutical compositions comprising the same, the use of the same for the manufacture of medicaments having therapeutic or preventative value, and a process for preparing the same, Eisai Co., Ltd., Japan, EP0268956A2, June 1, 1988
  2. El-Gindy, Alaa; El-Yazby, Fawzy; Maher, Moustafa M., Spectrophotometric and chromatographic determination of rabeprazole in presence of its degradation products, Journal of Pharmaceutical and Biomedical Analysis, Volume: 31, Issue: 2, Pages: 229-242, 2003

Frequently Asked Questions

Regulatory authorities play a crucial role in monitoring and setting standards for Rabeprazole impurities to ensure the safety and efficacy of the drug.

Yes, Rabeprazole impurities are evaluated during clinical trials to assess their safety and ensure compliance with regulatory standards.

Yes, impurities in Rabeprazole can impact the drug's stability.

Rabeprazole impurities are stored at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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