Amorolfine Hydrochloride Impurity – B
Mixture of (2RS)-1-[N-[(2R)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate and (2RS)-1-[N-[(2S)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate
| Chemical Name | Mixture of (2RS)-1-[N-[(2R)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate and (2RS)-1-[N-[(2S)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate |
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Amorolfine Hydrochloride Impurity – B
Amorolfine Hydrochloride Impurity – B is identified as a process-related impurity of Amorolfine Hydrochloride, recognized under the EP monograph. Chemically, it is described as Mixture of (2RS)-1-[N-[(2R)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate and (2RS)-1-[N-[(2S)-2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]formamido]propan-2-yl acetate. It plays a key role in stability-indicating assay development and regulatory impurity profiling for Amorolfine Hydrochloride. Available with a Certificate of Analysis (CoA) as a high-purity reference standard suitable for HPLC and LC-MS applications.
Amorolfine Hydrochloride impurities reference standards are useful in pharmaceutical research. They are useful in product development, ANDA and DMF filing, Quality control (QC), method validation, and stability studies. It is also useful in the identification of unknown impurities and the assessment of genotoxic potential.
We are the BHAVANISH LIFE SCIENCES specializes in manufacturing and supplying of Amorolfine Hydrochloride impurities that meet specific pharmacopeial standards (USP/EP/BP/IP) as well as process-related impurities.
This related products or Impurities are thoroughly characterized. Supplied with detailed COA & analytical data Like NMR / MASS / HPLC / GC / IR / TGA / Potency / Structure elucidation data (SER Report) meeting regulatory compliance.
BHAVANISH LIFE SCIENCES provides this compound for research and development and Analytical testing use only, and is not meant for human consumption. With product information including CAS number, molecular formula, molecular weight details.
BHAVANISH LIFE SCIENCES in providing high-quality impurity standards to support pharmaceutical companies in maintaining drug safety and efficacy.
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