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Bendamustine Hydrochloride Hcl

Bendamustine Hydrochloride Hcl

Product Details

SPECIFICATION

Product nameBendamustine Hydrochloride Hcl
FormulaC16H21Cl2N3O2.
CAS
3543-75-7

Appearance

White or off-white crystalline powder

Content of Active ingredient

99% by HPLC

Melting point

152.0-156.0°C

Chloride identification (CI)

Active

Relative impurity
HP1
BMDCE
Others
Total impurity


NMT0.3%
NMT0.2%
NMT0.1%
NMT2.0%
TasteCharacteristic

Loss on drying

NMT2.0%

Residue on ignition

NMT0.5%

Heavy Metals

NMT 10ppm

Residual Solvents

Eur.Pharm.
Total Plate CountNMT 1000cfu/g
Yeast & MouldsNMT 100cfu/g

E.Coli.

Negative

Salmonella

Negative

Enterobacteria

Negative

Staphylococcus aureus

Negative

Conclusion  

Conform with specification

Packing

25 kg/paper drum
Storage

Store in sealed containers at cool & dry place.

Protect from light, moisture and pest infestation.

Shelf life          

2 years when properly stored


USAGE

Product nameBendamustine Hydrochloride Hcl
ProductDescription:
Chemical Name: 4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid CAS No.: 3543-75-7
Molecular formula: C16H22Cl3N3O2             
Melting Point:152.0-156.0°C
Appearance: White or off-white crystalline powder
Assay: 99%min
Usage

Main Functions

Bendamustine Hydrochloride Hcl is used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), multiple myeloma. The drug is a nitrogen mustard derivative carrying a quinoid-like benzimidazole ring, which has a dual action mechanism of an alkylating agent and a guanidine analog (antimetabolite).

Common adverse reactions are typical for the class of nitrogen mustards, and include nausea, fatigue, vomiting, diarrhea, fever, constipation, loss of appetite, cough, headache, unintentional weight loss, difficulty breathing, rashes, and stomatitis, as well as immunosuppression, anemia, and low platelet counts. Notably, this drug has a low incidence of hair loss (alopecia) unlike most other chemotherapy drugs.


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