Analytical Reference substance
Bendamustine USP RC A
4-[5-[Bis(2-hydroxyethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid HCl
Product Number: OLYBE0010.0RC A
CAS Number: 109882-30-6 (base)
Lot Number:
Molecular Formula: C16H23N3O4 (base) ; C16H24ClN3O4 (HCl salt)
Molecular Weight: MW: 321.37 ; MW: 357.83
Long Term Storage: 02-08 °C
Appearance:
Melting Point:
Purity By HPLC: NLT 95%
| Sr No. | Test | Results | Date ref. |
|---|---|---|---|
| 1 | 1H NMR | Confirm | Report Attached |
| 2 | Mass | Confirm | Report Attached |
| 3 | HPLC | NLT 95% | Report Attached |
This certificate is valid for two years from the date of Manufacturing Provided the substance is stored under the recommended conditions.
Document data reference:
Prepared by
Dr. Ashish Keche
Head of QA & QC
Dr. Ashish Keche
Head of QA & QC
Reviewed by
Dr. Girish Hatnapure
Head of R& D
Dr. Girish Hatnapure
Head of R& D
Approved by
Dr. Atish Rodge
Managing Director
Dr. Atish Rodge
Managing Director
Corporate Office: Unit No F/10, 1st Floor Shubha Parvti Industrial Premises, Dombivali (E) Thane-421204 www.olympusimpuritiesstandard.com, +91-7506256625, Info@olympusimpuritiesstandard.com